{"id":"metoclopramide-hydrochloride","rwe":[],"_fda":{"id":"9e77216c-c14e-4318-8569-288652321db9","set_id":"3cc8ca5b-8b71-4c77-a181-9ce154597b9a","openfda":{"unii":["W1792A2RVD"],"route":["ORAL"],"rxcui":["104884"],"spl_id":["9e77216c-c14e-4318-8569-288652321db9"],"brand_name":["Metoclopramide"],"spl_set_id":["3cc8ca5b-8b71-4c77-a181-9ce154597b9a"],"package_ndc":["0121-0576-16","0121-1576-10"],"product_ndc":["0121-0576","0121-1576"],"generic_name":["METOCLOPRAMIDE HYDROCHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["METOCLOPRAMIDE HYDROCHLORIDE"],"manufacturer_name":["PAI Holdings, LLC dba PAI Pharma"],"application_number":["ANDA072744"],"is_original_packager":[true]},"version":"15","pregnancy":["8.1 Pregnancy Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta- analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery [see Clinical Considerations ]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [see Warnings and Precautions (5.1 , 5.2) , Use in Specific Populations (8.4) ] . Data Animal Data Reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area. No evidence of adverse developmental effects due to metoclopramide were observed."],"overdosage":["10 OVERDOSAGE Manifestations of metoclopramide overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with metoclopramide use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with metoclopramide overdose and concomitant treatment with another drug associated with NMS [see Warnings and Precautions (5.1 , 5.2 , 5.3) ]. There are no specific antidotes for metoclopramide overdosage. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage . Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may be fatal. Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amounts of metoclopramide."],"description":["11 DESCRIPTION Metoclopramide, is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white crystalline, odorless substance, freely soluble in water. Its chemical name is 4-amino­5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. The molecular formula is C 14 H 22 ClN 3 O 2 ∙HCl∙H 2 O. Its molecular weight is 354.3. The structural formula is: Metoclopramide Oral Solution USP is an orange-colored, berry-citrus flavored liquid for oral administration and is available in 10 mg/10 mL oral solution. Each 5 mL (teaspoonful) for oral administration contains: Metoclopramide base (as the monohydrochloride monohydrate) 5 mg. Inactive ingredients: Citric acid, FD&C Yellow No. 6 (Sunset Yellow), flavoring, glycerin, methylparaben, propylparaben, purified water, and sorbitol solution. Chemical Structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Metoclopramide Oral Solution USP, 5 mg metoclopramide base (as the monohydrochloride monohydrate) per 5 mL (teaspoonful) is available as an orange-colored, berry-citrus flavored, sugar-free solution and is supplied in the following oral dosage forms: NDC 0121-0576-16: 16 fl oz (473 mL) bottle NDC 0121-1576-10: 10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each. STORAGE Dispense in a tight, light-resistant container. Store at controlled room temperature between 20°C to 25°C (68°F to 77°F)."],"spl_medguide":["This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: September 2017 MEDICATION GUIDE Metoclopramide (met-o-KLO-pra-mide) Oral Solution USP Read this Medication Guide before you start taking Metoclopramide and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as REGLAN injection, REGLAN orally disintegrating tablets, or metoclopramide oral solution), you should read the Medication Guide that comes with that product. Some of the information may be different. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about Metoclopramide? Metoclopramide can cause serious side effects, including: Tardive dyskinesia (abnormal muscle movements). These movements happen mostly in the face muscles. You cannot control these movements. They may not go away even after stopping Metoclopramide. There is no treatment for tardive dyskinesia, but symptoms may decrease or go away over time after you stop taking Metoclopramide. Your chances for getting tardive dyskinesia increase: the longer you take Metoclopramide and the more Metoclopramide you take. You should not take Metoclopramide for more than 12 weeks. if you are older, especially if you are an older woman. if you have diabetes. It is not possible for your healthcare provider to know if you will get tardive dyskinesia if you take Metoclopramide. Call your healthcare provider right away if you get movements you cannot stop or control, such as: lip smacking, chewing, or puckering up your mouth frowning or scowling sticking out your tongue blinking and moving your eyes shaking of your arms and legs See the section \" What are the possible side effects of Metoclopramide?\" for more information about side effects. What is Metoclopramide? Metoclopramide is a prescription medicine used in adults: for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux when certain other treatments do not work. to relieve the symptoms of slow stomach emptying in people with diabetes. Metoclopramide is not recommended for use in children. Do not take Metoclopramide if you: have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking Metoclopramide or a medicine that works like Metoclopramide. have stomach or intestine problems that could get worse with Metoclopramide, such as bleeding, blockage or a tear in the stomach or bowel wall. have a type of tumor that can cause high blood pressure such as pheochromocytoma. have epilepsy (seizures). Metoclopramide can increase your chance for seizures and make them worse. are allergic to metoclopramide. Metoclopramide can cause serious allergic reactions. Stop taking Metoclopramide right away and get emergency help if you have any of these symptoms: swelling of your tongue, throat, lips, eyes or face. trouble swallowing or breathing. skin rash, hives, sores in your mouth, or skin blisters. Before taking Metoclopramide, tell your healthcare provider about all of your medical conditions, including if you: have diabetes. Your dose of insulin may need to be changed. had problems controlling your muscle movements after taking any medicine. have Parkinson's disease. have a type of tumor that can cause high blood pressure (pheochromocytoma). have kidney or liver disease. have or had depression or mental illness. have high blood pressure. have heart failure or heart rhythm problems. have breast cancer. drink alcohol. have seizures are pregnant or plan to become pregnant. Metoclopramide may harm your unborn baby if taken during the end of pregnancy. Talk to your healthcare provider if you become pregnant while taking Metoclopramide. are breastfeeding or plan to breastfeed. Metoclopramide can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take Metoclopramide or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Metoclopramide may affect the way other medicines work, and other medicines may affect how Metoclopramide works. Tell your healthcare provider before you start or stop other medicines. Especially tell your healthcare provider if you take: another medicine that contains metoclopramide, such as REGLAN injection or metoclopramide oral solution a medicine for Parkinson's disease a blood pressure medicine a medicine for depression, especially a Monoamine Oxidase Inhibitor (MAOI) an anti-psychotic medicine, used to treat mental illness such as schizophrenia insulin medicines that can make you sleepy, such as anti-anxiety medicines, sleep medicines, and narcotics If you are not sure if your medicine is one listed above, ask your healthcare provider or pharmacist. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take Metoclopramide? Take Metoclopramide exactly as your healthcare provider tells you. Do not change your dose unless your healthcare provider tells you to. You should not take Metoclopramide for more than 12 weeks. Take Metoclopramide at least 30 minutes before each meal and at bedtime. If you take too much Metoclopramide, call your poison control center at 1-800-222-1222 or go to the nearest emergency room right away. What should I avoid while taking Metoclopramide? Do not drink alcohol while taking Metoclopramide. Alcohol may make some side effects of Metoclopramide worse, such as feeling sleepy. Do not drive, operate machinery, or do other dangerous activities until you know how Metoclopramide affects you. Metoclopramide may cause sleepiness or dizziness. What are the possible side effects of Metoclopramide? Tardive dyskinesia (abnormal muscle movements). See \" What is the most important information I need to know about Metoclopramide?\" Other changes in muscle control and movement, such as: Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia). These muscle spasms can cause abnormal movements and body positions, and speech problems. These spasms usually start within the first 2 days of treatment. Rarely, these muscle spasms may cause trouble breathing. These spasms happen more often in adults less than 30 years of age. Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you already have Parkinson's Disease, your symptoms may become worse while you are taking Metoclopramide. Being unable to sit still or feeling you need to move your hands, feet, or body (akathisia). Symptoms can include feeling jittery, anxious, irritated or unable to sleep (insomnia), feeling the need to walk around (pacing) and tapping your feet. Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with Metoclopramide. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating. Depression, thoughts about suicide, and suicide. Some people who take Metoclopramide become depressed, even if they have no history of depression. You may have thoughts about hurting or killing yourself. Some people who have taken Metoclopramide have ended their own lives (suicide). High blood pressure. Metoclopramide can cause your blood pressure to increase. Too much body water. People who have certain liver problems or heart failure and take Metoclopramide may hold too much water in their body (fluid retention). Tell your doctor right away if you have sudden weight gain, or swelling of your hands, legs, or feet. Increased prolactin. Tell your doctor if your menstrual periods stop, your breasts get larger and make milk, or you cannot have sex (impotence). These symptoms go away when you stop taking Metoclopramide. Call your healthcare provider and get medical help right away if you: feel depressed or have thoughts about hurting or killing yourself have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating have muscle movements you cannot stop or control have muscle movements that are new or unusual The most common side effects of Metoclopramide include: restlessness drowsiness tiredness lack of energy You may have more side effects the longer you take Metoclopramide and the more Metoclopramide you take. You may still have side effects after stopping Metoclopramide. You may have symptoms from stopping Metoclopramide such as headaches, and feeling dizzy or nervous. Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of Metoclopramide. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Metoclopramide? Store Metoclopramide at room temperature between 68°F to 77°F (20°C to 25°C). Keep Metoclopramide in the bottle it comes in and away from light. Keep the bottle closed tightly. Keep Metoclopramide and all medicines out of the reach of children. General information about the safe and effective use of Metoclopramide. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Metoclopramide for a condition for which it was not prescribed. Do not give Metoclopramide to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Metoclopramide that is written for health professionals. What are the ingredients in Metoclopramide? Active ingredient: metoclopramide Inactive ingredients: Citric acid, FD&C Yellow No. 6 (Sunset Yellow), flavoring, glycerin, methylparaben, propylparaben, purified water and sorbitol solution. MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R09/17"],"boxed_warning":["WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Discontinue metoclopramide in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped [see Warnings and Precautions (5.1) ] . Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Warnings and Precautions (5.1) and Dosage and Administration (2.2 , 2.3) ]. WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage ( 5.1 ) Discontinue metoclopramide in patients who develop signs or symptoms of TD ( 5.1 ) Avoid treatment with metoclopramide for longer than 12 weeks because of the risk of developing TD with longer-term use ( 5.1 , 2.1 , 2.2 , 2.3 )"],"geriatric_use":["8.5 Geriatric Use Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal function [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] . Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a reduced dosage of metoclopramide in elderly patients [see Boxed Warning , Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ]."],"pediatric_use":["8.4 Pediatric Use Metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. The safety and effectiveness of metoclopramide in pediatric patients have not been established. Dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults [see Warnings and Precautions (5.1 , 5.2) ] . In addition, neonates have reduced levels of NADH-cytochrome b5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use in neonates [see Use in Specific Populations (8.8) ] ."],"effective_time":"20241113","pharmacodynamics":["12.2 Pharmacodynamics Gastroesophageal Reflux In patients with gastroesophageal reflux and low lower esophageal sphincter pressure (LESP), single oral doses of metoclopramide produced dose-related increases in LESP. Effects began at about 5 mg and increased through 20 mg. The increase in LESP from a 5 mg dose lasted about 45 minutes and that of 20 mg lasted between 2 and 3 hours. Increased rate of stomach emptying was observed with single oral doses of 10 mg."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption Relative to an intravenous dose of 20 mg, the absolute bioavailability of oral metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occurred at about 1 to 2 hours after a single oral dose. Similar time to peak was observed after individual doses at steady state. In a single dose study of 12 subjects, the area under the drug concentration-time curve increased linearly with doses from 20 to 100 mg (5 times the maximum recommended single dose). Peak concentrations increased linearly with dose; time to peak concentrations remained the same; whole body clearance was unchanged; and the elimination rate remained the same. The mean elimination half-life in subjects with normal renal function was 5 to 6 hours. Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. Distribution Metoclopramide is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about 3.5 L/kg), which suggests extensive distribution of drug to the tissues. Elimination Metabolism: Metoclopramide undergoes enzymatic metabolism via oxidation as well as glucuronide and sulfate conjugation reactions in the liver. Monodeethylmetoclopramide, a major oxidative metabolite, is formed primarily by CYP2D6, an enzyme subject to genetic variability [see Dosage and Administration (2.2 , 2.3) , Use in Specific Populations (8.9) ] . Excretion: Approximately 85% of the radioactivity of an orally administered dose appeared in the urine within 72 hours. After oral administration of 10 or 20 mg, a mean of 18% and 22% of the dose, respectively, was recovered as free metoclopramide in urine within 36 hours. Specific Populations Patients with Renal Impairment: In a study of 24 patients with varying degrees of renal impairment (moderate, severe, and end-stage renal disease (ESRD) requiring dialysis), the systemic exposure (AUC) of metoclopramide in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function. The AUC of metoclopramide in patients with ESRD on dialysis was about 3.5-fold the AUC in subjects with normal renal function [see Dosage and Administration (2.2 , 2.3) and Use in Specific Populations (8.6) ]. Patients with Hepatic Impairment: In a group of 8 patients with severe hepatic impairment (Child-Pugh C), the average metoclopramide clearance was reduced by approximately 50% compared to patients with normal hepatic function [see Dosage and Administration (2.2 , 2.3) and Use in Specific Populations (8.7) ]. Drug Interaction Studies Effect of Metoclopramide on CYP2D6 Substrates Although in vitro studies suggest that metoclopramide can inhibit CYP2D6, metoclopramide is unlikely to interact with CYP2D6 substrates in vivo at therapeutically relevant concentrations. Effect of CYP2D6 Inhibitors on Metoclopramide In healthy subjects, 20 mg of metoclopramide and 60 mg of fluoxetine (a strong CYP2D6 inhibitor) were administered, following prior exposure to 60 mg fluoxetine orally for 8 days. The patients who received concomitant metoclopramide and fluoxetine had a 40% and 90% increase in metoclopramide C max and AUC 0-∞ , respectively, compared to patients who received metoclopramide alone (see Table 5) [see Drug Interactions (7.1) ] . Table 5. Metoclopramide Pharmacokinetic Parameters in Healthy Subjects with and without Fluoxetine Parameter Metoclopramide alone (mean ± SD) Metoclopramide with fluoxetine (mean ± SD) C max (ng/mL) 44 ±15 62.7 ± 9.2 AUC 0-∞ (ngˑh/mL) 313 ± 113 591 ± 140 t 1/2 (h) 5.5 ± 1.1 8.5 ± 2.2"],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections of the labeling: Tardive dyskinesia [see Boxed Warning and Warnings and Precautions (5.1) ] Other extrapyramidal effects [see Warnings and Precautions (5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] Depression [see Warnings and Precautions (5.4) ] Hypertension [see Warnings and Precautions (5.5) ] Fluid retention [see Warnings and Precautions (5.6) ] Hyperprolactinemia [see Warnings and Precautions (5.7) ] Effects on the ability to drive and operate machinery [see Warnings and Precautions (5.8) ] The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of metoclopramide administration. Adverse reactions, especially those involving the nervous system, occurred after stopping metoclopramide including dizziness, nervousness, and headaches. Central Nervous System Disorders Tardive dyskinesia, acute dystonic reactions, drug-induced parkinsonism, akathisia, and other extrapyramidal symptoms Convulsive seizures Hallucinations Restlessness, drowsiness, fatigue, and lassitude occurred in approximately 10% of patients who received 10 mg four times daily. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurred less frequently. Neuroleptic malignant syndrome, serotonin syndrome (in combination with serotonergic agents). Endocrine Disorders : Fluid retention secondary to transient elevation of aldosterone. Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia Cardiovascular Disorders : Acute congestive heart failure, possible atrioventricular block, hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention Gastrointestinal Disorders : Nausea, bowel disturbances (primarily diarrhea) Hepatic Disorders : Hepatotoxicity, characterized by, e.g., jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential Renal and Urinary Disorders : Urinary frequency, urinary incontinence Hematologic Disorders : Agranulocytosis, neutropenia, leukopenia, methemoglobinemia, sulfhemoglobinemia Hypersensitivity Reactions : Bronchospasm (especially in patients with a history of asthma), urticaria; rash; angioedema, including glossal or laryngeal edema Eye Disorders : Visual disturbances Metabolism Disorders : Porphyria Most common adverse reactions (> 10%) are restlessness, drowsiness, fatigue, and lassitude. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["4 CONTRAINDICATIONS Metoclopramide is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [see Warnings and Precautions (5.1 , 5.2) ] . When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation). In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor . Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor [see Warnings and Precautions (5.5) ] . In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures [see Adverse Reactions (6) ] . In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm [see Adverse Reactions (6) ] . History of TD or dystonic reaction to metoclopramide ( 4 ) When stimulation of gastrointestinal motility might be dangerous ( 4 ) Pheochromocytoma, catecholamine-releasing paragangliomas ( 4 ) Epilepsy ( 4 ) Hypersensitivity to metoclopramide ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS Antipsychotics : Potential for additive effects, including TD, EPS, and NMS; avoid concomitant use. ( 7.1 ) CNS depressants : Increased risk of CNS depression. Avoid concomitant use and monitor for adverse reactions. ( 7.1 ) Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) : See Full Prescribing Information for recommended dosage reductions. ( 2.2 , 2.3 , 7.1 ) MAO inhibitors : Increased risk of hypertension; avoid concomitant use. ( 5.5 , 7.1 ) Additional drug interactions : See Full Prescribing Information. ( 7.1 , 7.2 ) 7.1 Effects of Other Drugs on Metoclopramide Table 3 displays the effects of other drugs on metoclopramide. Table 3. Effects of Other Drugs on Metoclopramide Antipsychotics Clinical Impact Potential for additive effects, including increased frequency and severity of tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS). Intervention Avoid concomitant use [see Warnings and Precautions (5.1 , 5.2 , 5.3) ]. Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above Clinical Impact Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms [see Clinical Pharmacology (12.3) ]. Intervention Reduce the metoclopramide dosage [see Dosage and Administration (2.2 , 2.3) ]. Examples quinidine, bupropion, fluoxetine, and paroxetine Monoamine Oxidase Inhibitors Clinical Impact Increased risk of hypertension [see Warnings and Precautions (5.5) ]. Intervention Avoid concomitant use. Central Nervous System (CNS) Depressants Clinical Impact Increased risk of CNS depression [see Warnings and Precautions (5.8) ]. Intervention Avoid metoclopramide or the interacting drug, depending on the importance of the drug to the patient. Examples alcohol, sedatives, hypnotics, opiates and anxiolytics Drugs that Impair Gastrointestinal Motility Clinical Impact Decreased systemic absorption of metoclopramide. Intervention Monitor for reduced therapeutic effect. Examples antiperistaltic antidiarrheal drugs, anticholinergic drugs, and opiates Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations Clinical Impact Decreased therapeutic effect of metoclopramide due to opposing effects on dopamine. Intervention Monitor for reduced therapeutic effect. Examples apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine 7.2 Effects of Metoclopramide on Other Drugs Table 4 displays the effects of metoclopramide on other drugs. Table 4. Effects of Metoclopramide on Other Drugs Dopaminergic Agonists and Drugs Increasing Dopamine Concentrations Clinical Impact Opposing effects of metoclopramide and the interacting drug on dopamine. Potential exacerbation of symptoms (e.g., parkinsonian symptoms). Intervention Avoid concomitant use [see Warnings and Precautions (5.2) ] . Examples Apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine Succinylcholine, Mivacurium Clinical Impact Metoclopramide inhibits plasma cholinesterase leading to enhanced neuromuscular blockade. Intervention Monitor for signs and symptoms of prolonged neuromuscular blockade Drugs with Absorption Altered due to Increased Gastrointestinal Motility Clinical Impact The effect of metoclopramide on other drugs is variable. Increased gastrointestinal (GI) motility by metoclopramide may impact absorption of other drugs leading to decreased or increased drug exposure. Intervention Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension Interaction does not apply to posaconazole delayed-release tablets , fosfomycin) : Monitor for reduced therapeutic effect of the interacting drug. For digoxin monitor therapeutic drug concentrations and increase the digoxin dose as needed (see prescribing information for digoxin). Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine) : Monitor therapeutic drug concentrations and adjust the dose as needed. See prescribing information for the interacting drug. Insulin Clinical Impact Increased GI motility by metoclopramide may increase delivery of food to the intestines and increase blood glucose. Intervention Monitor blood glucose and adjust insulin dosage regimen as needed."],"how_supplied_table":["<table><col width=\"20%\"/><col width=\"80%\"/><tbody><tr><td valign=\"top\">NDC 0121-0576-16:</td><td valign=\"top\">16 fl oz (473 mL) bottle</td></tr><tr><td valign=\"top\">NDC 0121-1576-10:</td><td valign=\"top\">10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each.</td></tr></tbody></table>"],"spl_medguide_table":["<table><col/><col/><tfoot><tr><td valign=\"top\">This Medication Guide has been approved by the U.S. Food and Drug Administration</td><td align=\"right\" valign=\"top\">Revised: September 2017</td></tr></tfoot><tbody><tr><td align=\"center\" valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">MEDICATION GUIDE</content> Metoclopramide (met-o-KLO-pra-mide) Oral Solution USP </td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\">Read this Medication Guide before you start taking Metoclopramide and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as REGLAN injection, REGLAN orally disintegrating tablets, or metoclopramide oral solution), you should read the Medication Guide that comes with that product. Some of the information may be different. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.</td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><paragraph><content styleCode=\"bold\">What is the most important information I should know about Metoclopramide?</content></paragraph><content styleCode=\"bold\">Metoclopramide can cause serious side effects, including:   Tardive dyskinesia (abnormal muscle movements). </content>These movements happen mostly in the face muscles. You cannot control these movements. They may not go away even after stopping Metoclopramide. There is no treatment for tardive dyskinesia, but symptoms may decrease or go away over time after you stop taking Metoclopramide.  Your chances for getting tardive dyskinesia increase: <list listType=\"unordered\" styleCode=\"Disk\"><item>the longer you take Metoclopramide and the more Metoclopramide you take. You should not take Metoclopramide for more than 12 weeks.</item><item>if you are older, especially if you are an older woman.</item><item>if you have diabetes.</item></list>It is not possible for your healthcare provider to know if <content styleCode=\"bold\">you </content>will get tardive dyskinesia if you take Metoclopramide. Call your healthcare provider right away if you get movements you cannot stop or control, such as: <list listType=\"unordered\" styleCode=\"Disk\"><item>lip smacking, chewing, or puckering up your mouth</item><item>frowning or scowling</item><item>sticking out your tongue</item><item>blinking and moving your eyes</item><item>shaking of your arms and legs</item></list> See the section <content styleCode=\"bold\">&quot; What are the possible side effects of Metoclopramide?&quot; </content>for more information about side effects. </td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">What is Metoclopramide?</content>  Metoclopramide is a prescription medicine used in adults: <list listType=\"unordered\" styleCode=\"Disk\"><item>for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux when certain other treatments do not work.</item><item>to relieve the symptoms of slow stomach emptying in people with diabetes.</item></list> Metoclopramide is not recommended for use in children. </td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">Do not take Metoclopramide if you:</content><list listType=\"unordered\" styleCode=\"Disk\"><item>have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking Metoclopramide or a medicine that works like Metoclopramide.</item><item>have stomach or intestine problems that could get worse with Metoclopramide, such as bleeding, blockage or a tear in the stomach or bowel wall.</item><item>have a type of tumor that can cause high blood pressure such as pheochromocytoma.</item><item>have epilepsy (seizures). Metoclopramide can increase your chance for seizures and make them worse.</item><item>are allergic to metoclopramide. Metoclopramide can cause serious allergic reactions. Stop taking Metoclopramide right away and get emergency help if you have any of these symptoms: <list listType=\"unordered\" styleCode=\"Circle\"><item> swelling of your tongue, throat, lips, eyes or face.</item><item> trouble swallowing or breathing.</item><item> skin rash, hives, sores in your mouth, or skin blisters.</item></list></item></list></td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">Before taking Metoclopramide, tell your healthcare provider about all of your medical conditions, including if you:</content><list listType=\"unordered\" styleCode=\"Disk\"><item>have diabetes. Your dose of insulin may need to be changed.</item><item>had problems controlling your muscle movements after taking any medicine.</item><item>have Parkinson&apos;s disease.</item><item>have a type of tumor that can cause high blood pressure (pheochromocytoma).</item><item>have kidney or liver disease.</item><item>have or had depression or mental illness.</item><item>have high blood pressure.</item><item>have heart failure or heart rhythm problems.</item><item>have breast cancer.</item><item>drink alcohol.</item><item>have seizures</item><item>are pregnant or plan to become pregnant. Metoclopramide may harm your unborn baby if taken during the end of pregnancy. Talk to your healthcare provider if you become pregnant while taking Metoclopramide.</item><item>are breastfeeding or plan to breastfeed. Metoclopramide can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take Metoclopramide or breastfeed.</item></list> Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.  Metoclopramide may affect the way other medicines work, and other medicines may affect how Metoclopramide works. Tell your healthcare provider before you start or stop other medicines.  <content styleCode=\"bold\">Especially tell your healthcare provider if you take:</content><list listType=\"unordered\" styleCode=\"Disk\"><item>another medicine that contains metoclopramide, such as REGLAN injection or metoclopramide oral solution</item><item>a medicine for Parkinson&apos;s disease</item><item>a blood pressure medicine</item><item>a medicine for depression, especially a Monoamine Oxidase Inhibitor (MAOI)</item><item>an anti-psychotic medicine, used to treat mental illness such as schizophrenia</item><item>insulin</item><item>medicines that can make you sleepy, such as anti-anxiety medicines, sleep medicines, and narcotics If you are not sure if your medicine is one listed above, ask your healthcare provider or pharmacist.</item></list><content styleCode=\"bold\">Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.</content></td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">How should I take Metoclopramide?</content><list listType=\"unordered\" styleCode=\"Disk\"><item>Take Metoclopramide exactly as your healthcare provider tells you. Do not change your dose unless your healthcare provider tells you to.</item><item>You should not take Metoclopramide for more than 12 weeks.</item><item>Take Metoclopramide at least 30 minutes before each meal and at bedtime.</item><item>If you take too much Metoclopramide, call your poison control center at 1-800-222-1222 or go to the nearest emergency room right away.</item></list></td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">What should I avoid while taking Metoclopramide?</content><list listType=\"unordered\" styleCode=\"Disk\"><item>Do not drink alcohol while taking Metoclopramide. Alcohol may make some side effects of Metoclopramide worse, such as feeling sleepy.</item><item>Do not drive, operate machinery, or do other dangerous activities until you know how Metoclopramide affects you.  Metoclopramide may cause sleepiness or dizziness. </item></list></td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><paragraph><content styleCode=\"bold\">What are the possible side effects of Metoclopramide?</content></paragraph><list listType=\"unordered\" styleCode=\"Disk\"><item><content styleCode=\"bold\">Tardive dyskinesia (abnormal muscle movements). </content>See <content styleCode=\"bold\">&quot; What is the most important information I need to know about Metoclopramide?&quot; </content></item><item><content styleCode=\"bold\">Other changes in muscle control and movement, such as:</content><list listType=\"unordered\" styleCode=\"Circle\"><item><content styleCode=\"bold\">Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia). </content>These muscle spasms can cause abnormal movements and body positions, and speech problems. These spasms usually start within the first 2 days of treatment. Rarely, these muscle spasms may cause trouble breathing. These spasms happen more often in adults less than 30 years of age. </item><item><content styleCode=\"bold\">Parkinsonism. </content>Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you already have Parkinson&apos;s Disease, your symptoms may become worse while you are taking Metoclopramide. </item><item><content styleCode=\"bold\">Being unable to sit still or feeling you need to move your hands, feet, or body (akathisia). </content>Symptoms can include feeling jittery, anxious, irritated or unable to sleep (insomnia), feeling the need to walk around (pacing) and tapping your feet. </item></list></item></list><list listType=\"unordered\" styleCode=\"Disk\"><item><content styleCode=\"bold\">Neuroleptic Malignant Syndrome (NMS). </content>NMS is a very rare but very serious condition that can happen with Metoclopramide. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating. </item><item><content styleCode=\"bold\">Depression, thoughts about suicide, and suicide. </content>Some people who take Metoclopramide become depressed, even if they have no history of depression. You may have thoughts about hurting or killing yourself. Some people who have taken Metoclopramide have ended their own lives (suicide). </item><item><content styleCode=\"bold\">High blood pressure. </content>Metoclopramide can cause your blood pressure to increase. </item><item><content styleCode=\"bold\">Too much body water. </content>People who have certain liver problems or heart failure and take Metoclopramide may hold too much water in their body (fluid retention). Tell your doctor right away if you have sudden weight gain, or swelling of your hands, legs, or feet. </item><item><content styleCode=\"bold\">Increased prolactin. </content>Tell your doctor if your menstrual periods stop, your breasts get larger and make milk, or you cannot have sex (impotence). These symptoms go away when you stop taking Metoclopramide. </item></list><content styleCode=\"bold\">Call your healthcare provider and get medical help right away if you:</content><list listType=\"unordered\" styleCode=\"Disk\"><item>feel depressed or have thoughts about hurting or killing yourself</item><item>have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating</item><item>have muscle movements you cannot stop or control</item><item>have muscle movements that are new or unusual </item></list>The most common side effects of Metoclopramide include: <list listType=\"unordered\" styleCode=\"Disk\"><item>restlessness</item><item>drowsiness</item><item>tiredness</item><item>lack of energy</item></list> You may have more side effects the longer you take Metoclopramide and the more Metoclopramide you take.  You may still have side effects after stopping Metoclopramide. You may have symptoms from stopping Metoclopramide such as headaches, and feeling dizzy or nervous.  Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of Metoclopramide. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">How should I store Metoclopramide?</content><list listType=\"unordered\" styleCode=\"Disk\"><item>Store Metoclopramide at room temperature between 68&#xB0;F to 77&#xB0;F (20&#xB0;C to 25&#xB0;C).</item><item>Keep Metoclopramide in the bottle it comes in and away from light. Keep the bottle closed tightly.</item></list><content styleCode=\"bold\">Keep Metoclopramide and all medicines out of the reach of children.</content></td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">General information about the safe and effective use of Metoclopramide.</content> Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Metoclopramide for a condition for which it was not prescribed. Do not give Metoclopramide to other people, even if they have the same symptoms that you have. It may harm them.  You can ask your pharmacist or healthcare provider for information about Metoclopramide that is written for health professionals. </td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">What are the ingredients in Metoclopramide?  Active ingredient: </content> metoclopramide  <content styleCode=\"bold\">Inactive ingredients: </content>Citric acid, FD&amp;C Yellow No. 6 (Sunset Yellow), flavoring, glycerin, methylparaben, propylparaben, purified water and sorbitol solution.  <content styleCode=\"bold\">MANUFACTURED BY  <content styleCode=\"italics\">Pharmaceutical  Associates, Inc. </content></content> Greenville, SC 29605  www.paipharma.com  <content styleCode=\"bold\">R09/17</content></td></tr></tbody></table>"],"mechanism_of_action":["12.1 Mechanism of Action Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine. The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter. It has little, if any, effect on the motility of the colon or gallbladder."],"recent_major_changes":["Boxed Warning 8/2017 Indications and Usage ( 1 ) 8/2017 Dosage and Administration, Dosage for Gastroesophageal Reflux ( 2.2 ) 8/2017 Dosage and Administration, Dosage for Acute and Recurrent Diabetic Gastroparesis ( 2.3 ) 8/2017 Contraindications ( 4 ) 8/2017 Warnings and Precautions, Tardive Dyskinesia ( 5.1 ) 8/2017 Warnings and Precautions, Other Extrapyramidal Symptoms ( 5.2 ) 8/2017 Warnings and Precautions, Neuroleptic Malignant Syndrome ( 5.3 ) 8/2017 Warnings and Precautions, Hyperprolactinemia ( 5.7 ) 8/2017"],"storage_and_handling":["STORAGE Dispense in a tight, light-resistant container. Store at controlled room temperature between 20°C to 25°C (68°F to 77°F)."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine. The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter. It has little, if any, effect on the motility of the colon or gallbladder. 12.2 Pharmacodynamics Gastroesophageal Reflux In patients with gastroesophageal reflux and low lower esophageal sphincter pressure (LESP), single oral doses of metoclopramide produced dose-related increases in LESP. Effects began at about 5 mg and increased through 20 mg. The increase in LESP from a 5 mg dose lasted about 45 minutes and that of 20 mg lasted between 2 and 3 hours. Increased rate of stomach emptying was observed with single oral doses of 10 mg. 12.3 Pharmacokinetics Absorption Relative to an intravenous dose of 20 mg, the absolute bioavailability of oral metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occurred at about 1 to 2 hours after a single oral dose. Similar time to peak was observed after individual doses at steady state. In a single dose study of 12 subjects, the area under the drug concentration-time curve increased linearly with doses from 20 to 100 mg (5 times the maximum recommended single dose). Peak concentrations increased linearly with dose; time to peak concentrations remained the same; whole body clearance was unchanged; and the elimination rate remained the same. The mean elimination half-life in subjects with normal renal function was 5 to 6 hours. Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. Distribution Metoclopramide is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about 3.5 L/kg), which suggests extensive distribution of drug to the tissues. Elimination Metabolism: Metoclopramide undergoes enzymatic metabolism via oxidation as well as glucuronide and sulfate conjugation reactions in the liver. Monodeethylmetoclopramide, a major oxidative metabolite, is formed primarily by CYP2D6, an enzyme subject to genetic variability [see Dosage and Administration (2.2 , 2.3) , Use in Specific Populations (8.9) ] . Excretion: Approximately 85% of the radioactivity of an orally administered dose appeared in the urine within 72 hours. After oral administration of 10 or 20 mg, a mean of 18% and 22% of the dose, respectively, was recovered as free metoclopramide in urine within 36 hours. Specific Populations Patients with Renal Impairment: In a study of 24 patients with varying degrees of renal impairment (moderate, severe, and end-stage renal disease (ESRD) requiring dialysis), the systemic exposure (AUC) of metoclopramide in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function. The AUC of metoclopramide in patients with ESRD on dialysis was about 3.5-fold the AUC in subjects with normal renal function [see Dosage and Administration (2.2 , 2.3) and Use in Specific Populations (8.6) ]. Patients with Hepatic Impairment: In a group of 8 patients with severe hepatic impairment (Child-Pugh C), the average metoclopramide clearance was reduced by approximately 50% compared to patients with normal hepatic function [see Dosage and Administration (2.2 , 2.3) and Use in Specific Populations (8.7) ]. Drug Interaction Studies Effect of Metoclopramide on CYP2D6 Substrates Although in vitro studies suggest that metoclopramide can inhibit CYP2D6, metoclopramide is unlikely to interact with CYP2D6 substrates in vivo at therapeutically relevant concentrations. Effect of CYP2D6 Inhibitors on Metoclopramide In healthy subjects, 20 mg of metoclopramide and 60 mg of fluoxetine (a strong CYP2D6 inhibitor) were administered, following prior exposure to 60 mg fluoxetine orally for 8 days. The patients who received concomitant metoclopramide and fluoxetine had a 40% and 90% increase in metoclopramide C max and AUC 0-∞ , respectively, compared to patients who received metoclopramide alone (see Table 5) [see Drug Interactions (7.1) ] . Table 5. Metoclopramide Pharmacokinetic Parameters in Healthy Subjects with and without Fluoxetine Parameter Metoclopramide alone (mean ± SD) Metoclopramide with fluoxetine (mean ± SD) C max (ng/mL) 44 ±15 62.7 ± 9.2 AUC 0-∞ (ngˑh/mL) 313 ± 113 591 ± 140 t 1/2 (h) 5.5 ± 1.1 8.5 ± 2.2"],"indications_and_usage":["1 INDICATIONS AND USAGE Metoclopramide is indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide is indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. ( 1 ) Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : Metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. ( 1 , 8.4 ) Limitations of Use : Metoclopramide is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations (8.4) ]."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS) : Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson's Disease. If symptoms occur, discontinue metoclopramide and seek immediate medical attention. ( 5.1 , 5.2 , 5.3 , 7.1 , 7.2 ) Depression and suicidal ideation/suicide : Avoid use. ( 5.4 ) 5.1 Tardive Dyskinesia Metoclopramide can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Movements may be choreoathetotic in appearance. The risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage. Additionally, the risk of developing TD is increased among the elderly, especially elderly women [see Use in Specific Populations (8.5) ] , and in patients with diabetes mellitus. Due to the risk of developing TD, avoid treatment with metoclopramide for longer than 12 weeks and reduce the dosage in elderly patients [see Dosage and Administration (2.2 , 2.3) ]. Discontinue metoclopramide immediately in patients who develop signs and symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients TD may remit, partially or completely, within several weeks to months after metoclopramide is withdrawn. .Discontinue metoclopramide immediately in patients who develop signs and symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients TD may remit, partially or completely, within several weeks to months after metoclopramide is withdrawn. Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Metoclopramide is contraindicated in patients with a history of TD Avoid metoclopramide in patients receiving other drugs that are likely to cause TD (e.g., antipsychotics). Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Metoclopramide is contraindicated in patients with a history of TD [see Contraindications (4) ]. Avoid metoclopramide in patients receiving other drugs that are likely to cause TD (e.g., antipsychotics). 5.2 Other Extrapyramidal Symptoms In addition to TD, metoclopramide may cause other extrapyramidal symptoms (EPS), parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue metoclopramide. Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with metoclopramide dosages of 30 mg to 40 mg daily. Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages. EPS occurred more frequently in pediatric patients compared to adults (metoclopramide is not approved for use in pediatric patients) . Symptoms can occur in the first 24 to 48 hours after starting metoclopramide. Symptoms included involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions were present as stridor and dyspnea, possibly due to laryngospasm. Diphenhydramine hydrochloride or benztropine mesylate may be used to treat these adverse reactions. Avoid metoclopramide in patients receiving other drugs that can cause EPS (e.g., antipsychotics). Parkinsonian symptoms (bradykinesia, tremor, cogwheel rigidity, mask-like facies) have occurred after starting metoclopramide, more commonly within the first 6 months, but also after longer periods. Symptoms generally have subsided within 2 to 3 months after discontinuation of metoclopramide. Avoid metoclopramide in patients with Parkinson's disease and other patients being treated with antiparkinsonian drugs due to potential exacerbation of symptoms. Avoid treatment with metoclopramide for more than 12 weeks [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ] . Motor restlessness (akathisia) has developed and consisted of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, and foot tapping. If symptoms resolve, consider restarting at a lower dosage. 5.3 Neuroleptic Malignant Syndrome Metoclopramide may cause a potentially fatal symptom complex called neuroleptic malignant syndrome (NMS). NMS has been reported in association with metoclopramide overdosage and concomitant treatment with another drug associated with NMS. Avoid metoclopramide in patients receiving other drugs associated with NMS, including typical and atypical antipsychotics. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and manifestations of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such symptoms should be evaluated immediately.Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and manifestations of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such symptoms should be evaluated immediately. In the diagnostic evaluation, consider the presence of other serious medical conditions (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever, serotonin syndrome, and primary central nervous system pathology.In the diagnostic evaluation, consider the presence of other serious medical conditions (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever, serotonin syndrome, and primary central nervous system pathology. Management of NMS includes:Management of NMS includes: Immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy [see Drug Interactions (7.1) ] . Intensive symptomatic treatment and medical monitoring. Treatment of any concomitant serious medical problems for which specific treatments are available. 5.4 Depression Depression has occurred in metoclopramide-treated patients with and without a history of depression. Symptoms have included suicidal ideation and suicide. Avoid metoclopramide use in patients with a history of depression. 5.5 Hypertension Metoclopramide may elevate blood pressure. In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, avoid use in patients with hypertension or in patients taking monoamine oxidase inhibitors [see Drug Interactions (7.1) ] . There are also clinical reports of hypertensive crises in patients with undiagnosed pheochromocytoma. Metoclopramide is contraindicated in patients with pheochromocytoma or other catecholamine-releasing paragangliomas [see Contraindications (4) ]. Discontinue metoclopramide in any patient with a rapid rise in blood pressure. 5.6 Fluid Retention Because metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. Discontinue metoclopramide if any of these adverse reactions occur. 5.7 Hyperprolactinemia As with other dopamine D 2 receptor antagonists, metoclopramide elevates prolactin levels. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, including metoclopramide.Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, including metoclopramide. Hyperprolactinemia may potentially stimulate prolactin-dependent breast cancer. However, some clinical studies and epidemiology studies have not shown an association between administration of dopamine D2 receptor antagonists and tumorigenesis in humans Hyperprolactinemia may potentially stimulate prolactin-dependent breast cancer. However, some clinical studies and epidemiology studies have not shown an association between administration of dopamine D2 receptor antagonists and tumorigenesis in humans [see Nonclinical Toxicology (13.1) ]. 5.8 Effects on the Ability to Drive and Operate Machinery Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of central nervous system (CNS) depressants or drugs associated with EPS may increase this effect (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics). Avoid metoclopramide or the interacting drug, depending on the importance of the drug to the patient [see Drug Interactions (7.1) ]."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A 77-week study was conducted in rats with oral metoclopramide doses up to 40 mg/kg/day (about six times the maximum recommended human dose on body surface area basis). Metoclopramide elevated prolactin levels and the elevation persisted during chronic administration. An increase in mammary neoplasms was found in rodents after chronic administration of metoclopramide [see Warnings and Precautions (5.7) ]. In a rat model for assessing the tumor promotion potential, a 2-week oral treatment with metoclopramide at a dose of 260 mg/kg/day (about 35 times the maximum recommended human dose based on body surface area) enhanced the tumorigenic effect of N-nitrosodiethylamine. Mutagenesis Metoclopramide was positive in the in vitro Chinese hamster lung cell/HGPRT forward mutation assay for mutagenic effects and in the in vitro human lymphocyte chromosome aberration assay for clastogenic effects. It was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis assay with rat and human hepatocytes, and the in vivo rat micronucleus assay. Impairment of Fertility Metoclopramide at intramuscular doses up to 20 mg/kg/day (about three times the maximum recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats."],"pharmacokinetics_table":["<table><caption>Table 5. Metoclopramide Pharmacokinetic Parameters in Healthy Subjects with and without Fluoxetine</caption><col/><col/><col/><thead><tr><th styleCode=\" Lrule Rrule\"> Parameter</th><th align=\"center\" valign=\"top\" styleCode=\" Rrule\"> Metoclopramide alone  (mean &#xB1; SD) </th><th align=\"center\" valign=\"top\" styleCode=\" Rrule\"> Metoclopramide with fluoxetine  (mean &#xB1; SD) </th></tr></thead><tbody><tr><td valign=\"top\" styleCode=\" Lrule Rrule\">C <sub>max</sub> (ng/mL) </td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">44 &#xB1;15</td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">62.7 &#xB1; 9.2</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\">AUC <sub>0-&#x221E;</sub> (ng&#x2D1;h/mL) </td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">313 &#xB1; 113</td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">591 &#xB1; 140</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\">t <sub>1/2</sub> (h) </td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">5.5 &#xB1; 1.1</td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">8.5 &#xB1; 2.2</td></tr></tbody></table>"],"drug_interactions_table":["<table><caption>Table 3. Effects of Other Drugs on Metoclopramide</caption><col/><col/><thead><tr><th valign=\"top\" styleCode=\" Lrule Rrule\" colspan=\"2\"> Antipsychotics</th></tr></thead><tbody><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Clinical Impact</content></td><td valign=\"top\" styleCode=\" Rrule\">Potential for additive effects, including increased frequency and severity of tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS).</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Intervention</content></td><td valign=\"top\" styleCode=\" Rrule\">Avoid concomitant use <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_ec9be2ce-6e06-47fb-b251-4fadc3414afe\">Warnings and Precautions (5.1</linkHtml>, <linkHtml href=\"#LINK_f30cdf4e-0bde-4a1d-99cb-998e48c45da0\">5.2</linkHtml>, <linkHtml href=\"#LINK_8e878b54-db5f-40c5-aa96-569ab322bb4d\">5.3)</linkHtml>]. </content></td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above</content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Clinical Impact</content></td><td valign=\"top\" styleCode=\" Rrule\">Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_5d5901bf-30d3-4542-921d-1cbfd0bb4be3\">Clinical Pharmacology (12.3)</linkHtml>]. </content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Intervention</content></td><td valign=\"top\" styleCode=\" Rrule\">Reduce the metoclopramide dosage <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_605fd192-a4c6-452e-a7d3-8166a20520bd\">Dosage and Administration (2.2</linkHtml>, <linkHtml href=\"#LINK_4eaebdb2-17a9-4850-8176-566842069393\">2.3)</linkHtml>]. </content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Examples</content></td><td valign=\"top\" styleCode=\" Rrule\">quinidine, bupropion, fluoxetine, and paroxetine</td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">Monoamine Oxidase Inhibitors</content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Clinical Impact</content></td><td valign=\"top\" styleCode=\" Rrule\">Increased risk of hypertension <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_20c428f2-4997-4473-8920-4057c1102d13\">Warnings and Precautions (5.5)</linkHtml>]. </content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Intervention</content></td><td valign=\"top\" styleCode=\" Rrule\">Avoid concomitant use.</td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">Central Nervous System (CNS) Depressants</content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Clinical Impact</content></td><td valign=\"top\" styleCode=\" Rrule\">Increased risk of CNS depression <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_f04c754c-0774-4fb1-a8ef-9f56e1f3c3e3\">Warnings and Precautions (5.8)</linkHtml>]. </content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Intervention</content></td><td valign=\"top\" styleCode=\" Rrule\">Avoid metoclopramide or the interacting drug, depending on the importance of the drug to the patient.</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Examples</content></td><td valign=\"top\" styleCode=\" Rrule\">alcohol, sedatives, hypnotics, opiates and anxiolytics</td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">Drugs that Impair Gastrointestinal Motility</content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Clinical Impact</content></td><td valign=\"top\" styleCode=\" Rrule\">Decreased systemic absorption of metoclopramide.</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Intervention</content></td><td valign=\"top\" styleCode=\" Rrule\">Monitor for reduced therapeutic effect.</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Examples</content></td><td valign=\"top\" styleCode=\" Rrule\">antiperistaltic antidiarrheal drugs, anticholinergic drugs, and opiates</td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations</content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Clinical Impact</content></td><td valign=\"top\" styleCode=\" Rrule\">Decreased therapeutic effect of metoclopramide due to opposing effects on dopamine.</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Intervention</content></td><td valign=\"top\" styleCode=\" Rrule\">Monitor for reduced therapeutic effect.</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Examples</content></td><td valign=\"top\" styleCode=\" Rrule\">apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine</td></tr></tbody></table>","<table><caption>Table 4. Effects of Metoclopramide on Other Drugs</caption><col/><col/><thead><tr><th valign=\"top\" styleCode=\" Lrule Rrule\" colspan=\"2\"> Dopaminergic Agonists and Drugs Increasing Dopamine Concentrations</th></tr></thead><tbody><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Clinical Impact</content></td><td valign=\"top\" styleCode=\" Rrule\">Opposing effects of metoclopramide and the interacting drug on dopamine. Potential exacerbation of symptoms (e.g., parkinsonian symptoms).</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Intervention</content></td><td valign=\"top\" styleCode=\" Rrule\">Avoid concomitant use <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_f30cdf4e-0bde-4a1d-99cb-998e48c45da0\">Warnings and Precautions (5.2)</linkHtml>] </content>. </td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Examples</content></td><td valign=\"top\" styleCode=\" Rrule\">Apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine</td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">Succinylcholine, Mivacurium</content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Clinical Impact</content></td><td valign=\"top\" styleCode=\" Rrule\">Metoclopramide inhibits plasma cholinesterase leading to enhanced neuromuscular blockade.</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Intervention</content></td><td valign=\"top\" styleCode=\" Rrule\">Monitor for signs and symptoms of prolonged neuromuscular blockade</td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">Drugs with Absorption Altered due to Increased Gastrointestinal Motility</content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Clinical Impact</content></td><td valign=\"top\" styleCode=\" Rrule\">The effect of metoclopramide on other drugs is variable. Increased gastrointestinal (GI) motility by metoclopramide may impact absorption of other drugs leading to decreased or increased drug exposure.</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Intervention</content></td><td valign=\"top\" styleCode=\" Rrule\"><content styleCode=\"underline\">Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension <footnote ID=\"FOOT_23802\">Interaction does not apply to posaconazole delayed-release tablets</footnote>, fosfomycin) </content>: Monitor for reduced therapeutic effect of the interacting drug. For digoxin monitor therapeutic drug concentrations and increase the digoxin dose as needed (see prescribing information for digoxin).  <content styleCode=\"underline\">Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine)</content>: Monitor therapeutic drug concentrations and adjust the dose as needed. See prescribing information for the interacting drug. </td></tr><tr><td valign=\"top\" colspan=\"2\" styleCode=\" Lrule Rrule\"><content styleCode=\"bold\">Insulin</content></td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Clinical Impact</content></td><td valign=\"top\" styleCode=\" Rrule\">Increased GI motility by metoclopramide may increase delivery of food to the intestines and increase blood glucose.</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\"><content styleCode=\"italics\">Intervention</content></td><td valign=\"top\" styleCode=\" Rrule\">Monitor blood glucose and adjust insulin dosage regimen as needed.</td></tr></tbody></table>"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients or their caregivers that metoclopramide can cause serious adverse reactions. Instruct patients to discontinue metoclopramide and contact a healthcare provider immediately if the following serious reactions occur: Tardive dyskinesia and other extrapyramidal reactions [see Warnings and Precautions (5.1 , 5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] Depression and/or possible suicidal ideation [see Warnings and Precautions (5.4) ] Inform patients or their caregivers that concomitant treatment with numerous other medications can precipitate or worsen serious adverse reactions such as tardive dyskinesia or other extrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression [see Drug Interactions (7.1 , 7.2) ] . Explain that the prescriber of any other medication must be made aware that the patient is taking metoclopramide. Inform patients or their caregivers that metoclopramide can cause drowsiness or dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle [see Warnings and Precautions (5.8) ] ."],"spl_unclassified_section":["MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R02/22"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Gastroesophageal Reflux ( 2.2 ) Administer metoclopramide continuously or intermittently: Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks. Intermittent: Single doses up to 20 mg prior to provoking situation. Acute and Recurrent Diabetic Gastroparesis ( 2.3 ) Administer 10 mg, 30 minutes before each meal and at bedtime (maximum of 40 mg per day) for 2 to 8 weeks Dosage Adjustment in Specific Populations ( 2.2 , 2.3 ) For gastroesophageal reflux and acute and recurrent diabetic gastroparesis, see Full Prescribing Information for recommended dosage reductions for elderly patients, in patients with moderate or severe hepatic or renal impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers. 2.1 Important Administration Instructions Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ]. 2.2 Dosage for Gastroesophageal Reflux Metoclopramide may be administered continuously or intermittently in patients with symptomatic gastroesophageal reflux who fail to respond to conventional therapy: Continuous Dosing The recommended adult dosage of metoclopramide is 10 to 15 mg four times daily for 4 to 12 weeks. The treatment duration is determined by endoscopic response. Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 60 mg. Table 1 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors. Intermittent Dosing If symptoms only occur intermittently or at specific times of the day, administer metoclopramide in single dose up to 20 mg prior to the provoking situation. Consider dosage reductions for the populations and situations in Table 1. Table 1. Recommended Metoclopramide Dosage in Patients with Gastroesophageal Reflux Recommended Dosage Maximum Recommended Daily Dosage Adult patients 10 to 15 mg four times daily (thirty minutes before each meal and at bedtime) 60 mg Mild hepatic impairment (Child-Pugh A) Elderly patients [see Use in Specific Populations (8.5) ] 5 mg Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a lower starting dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 to 15 mg four times daily based upon response and tolerability. four times daily (thirty minutes before each meal and at bedtime) Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.7) ] 5 mg four times daily (thirty minutes before each meal and at bedtime), or 10 mg taken three times daily 30 mg CYP2D6 poor metabolizers [see Use in Specific Populations (8.9) ] Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions (7.1) ] Moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute) [see Use in Specific Populations (8.6) ] Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations (8.6) ] 5 mg four times daily (thirty minutes before each meal and at bedtime) or 10 mg twice daily 20 mg 2.3 Dosage for Acute and Recurrent Diabetic Gastroparesis The recommended adult dosage for the treatment of acute and recurrent diabetic gastroparesis is 10 mg four times daily for 2 to 8 weeks, depending on symptomatic response. Avoid metoclopramide treatment for greater than 12 weeks [see Warnings and Precautions (5.1) ]. Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 40 mg. Table 2 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors.Table 2 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors. If patients with diabetic gastroparesis have severe nausea or vomiting and are unable to take metoclopramide, consider starting therapy with metoclopramide injection given intramuscularly or intravenously for up to 10 days (see the prescribing information for metoclopramide injection).If patients with diabetic gastroparesis have severe nausea or vomiting and are unable to take metoclopramide, consider starting therapy with metoclopramide injection given intramuscularly or intravenously for up to 10 days (see the prescribing information for metoclopramide injection). Table 2. Recommended Metoclopramide Dosage in Patients with Acute and Recurrent Diabetic Gastroparesis Recommended Dosage Maximum Recommended Daily Dosage Adult Patients 10 mg four times daily (30 minutes before each meal and at bedtime) 40 mg Mild hepatic impairment (Child-Pugh A) Elderly patients [see Use in Specific Populations (8.5) ] 5 mg Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a lower dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 mg four times daily based upon response and tolerability. four times daily (30 minutes before each meal and at bedtime) Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.7) ] 5 mg four times daily (30 minutes before each meal and at bedtime) 20 mg CYP2D6 poor metabolizers [see Use in Specific Populations (8.9) ] Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions (7.1) ] Moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [see Use in Specific Populations (8.6) ] Patients with End-Stage Renal Disease (ESRD ) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations (8.6) ] 5 mg twice daily 10 mg"],"spl_product_data_elements":["Metoclopramide metoclopramide hydrochloride METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 GLYCERIN METHYLPARABEN PROPYLPARABEN WATER SORBITOL BERRY CITRIS Metoclopramide metoclopramide hydrochloride METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 GLYCERIN METHYLPARABEN PROPYLPARABEN WATER SORBITOL BERRY CITRUS"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Oral Solution: 10 mg/10 mL metoclopramide Oral Solution: 10 mg/10 mL metoclopramide ( 3 )"],"recent_major_changes_table":["<table><col width=\"80%\"/><col width=\"20%\"/><tbody><tr><td valign=\"bottom\"><linkHtml href=\"#LINK_af251ec9-df5a-4ea9-aee1-85c591aa4697\">Boxed Warning</linkHtml></td><td align=\"right\" valign=\"bottom\">8/2017</td></tr><tr><td valign=\"bottom\">Indications and Usage ( <linkHtml href=\"#LINK_973162a0-f865-47c9-8d75-df778ce1501d\">1</linkHtml>) </td><td align=\"right\" valign=\"bottom\">8/2017</td></tr><tr><td valign=\"bottom\">Dosage and Administration, Dosage for Gastroesophageal Reflux ( <linkHtml href=\"#LINK_605fd192-a4c6-452e-a7d3-8166a20520bd\">2.2</linkHtml>) </td><td align=\"right\" valign=\"bottom\">8/2017</td></tr><tr><td valign=\"bottom\">Dosage and Administration, Dosage for Acute and Recurrent Diabetic Gastroparesis ( <linkHtml href=\"#LINK_4eaebdb2-17a9-4850-8176-566842069393\">2.3</linkHtml>) </td><td align=\"right\" valign=\"bottom\">8/2017</td></tr><tr><td valign=\"bottom\">Contraindications ( <linkHtml href=\"#LINK_7e086dbd-33e4-49b0-9bcb-e2d37e28afd5\">4</linkHtml>) </td><td align=\"right\" valign=\"bottom\">8/2017</td></tr><tr><td valign=\"bottom\">Warnings and Precautions, Tardive Dyskinesia ( <linkHtml href=\"#LINK_ec9be2ce-6e06-47fb-b251-4fadc3414afe\">5.1</linkHtml>) </td><td align=\"right\" valign=\"bottom\">8/2017</td></tr><tr><td valign=\"bottom\">Warnings and Precautions, Other Extrapyramidal Symptoms ( <linkHtml href=\"#LINK_f30cdf4e-0bde-4a1d-99cb-998e48c45da0\">5.2</linkHtml>) </td><td align=\"right\" valign=\"bottom\">8/2017</td></tr><tr><td valign=\"bottom\">Warnings and Precautions, Neuroleptic Malignant Syndrome ( <linkHtml href=\"#LINK_8e878b54-db5f-40c5-aa96-569ab322bb4d\">5.3</linkHtml>) </td><td align=\"right\" valign=\"bottom\">8/2017</td></tr><tr><td valign=\"bottom\">Warnings and Precautions, Hyperprolactinemia ( <linkHtml href=\"#LINK_721387b4-d9b0-4e25-bc6e-8d70409350d3\">5.7</linkHtml>) </td><td align=\"right\" valign=\"bottom\">8/2017</td></tr></tbody></table>"],"clinical_pharmacology_table":["<table><caption>Table 5. Metoclopramide Pharmacokinetic Parameters in Healthy Subjects with and without Fluoxetine</caption><col/><col/><col/><thead><tr><th styleCode=\" Lrule Rrule\"> Parameter</th><th align=\"center\" valign=\"top\" styleCode=\" Rrule\"> Metoclopramide alone  (mean &#xB1; SD) </th><th align=\"center\" valign=\"top\" styleCode=\" Rrule\"> Metoclopramide with fluoxetine  (mean &#xB1; SD) </th></tr></thead><tbody><tr><td valign=\"top\" styleCode=\" Lrule Rrule\">C <sub>max</sub> (ng/mL) </td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">44 &#xB1;15</td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">62.7 &#xB1; 9.2</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\">AUC <sub>0-&#x221E;</sub> (ng&#x2D1;h/mL) </td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">313 &#xB1; 113</td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">591 &#xB1; 140</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\">t <sub>1/2</sub> (h) </td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">5.5 &#xB1; 1.1</td><td align=\"center\" valign=\"top\" styleCode=\" Rrule\">8.5 &#xB1; 2.2</td></tr></tbody></table>"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta- analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery [see Clinical Considerations ]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [see Warnings and Precautions (5.1 , 5.2) , Use in Specific Populations (8.4) ] . Data Animal Data Reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area. No evidence of adverse developmental effects due to metoclopramide were observed. 8.2 Lactation Risk Summary Limited published data report the presence of metoclopramide in human milk in variable amounts. Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation [see Data ] . Metoclopramide elevates prolactin levels [see Warnings and Precautions (5.7) ] ; however, the published data are not adequate to support drug effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for metoclopramide and any potential adverse effects on the breastfed child from metoclopramide or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs (dystonias) and methemoglobinemia [see Warnings and Precautions (5.1 , 5.2) , Use in Specific Populations (8.4) ] . Data In published clinical studies, the estimated amount of metoclopramide received by the breastfed infant was less than 10% of the maternal weight-adjusted dose. In one study, the estimated daily amount of metoclopramide received by infants from breast milk ranged from 6 to 24 mcg/kg/day in early puerperium (3 to 9 days postpartum) and from 1 to 13 mcg/kg/day at 8 to 12 weeks postpartum. 8.4 Pediatric Use Metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. The safety and effectiveness of metoclopramide in pediatric patients have not been established. Dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults [see Warnings and Precautions (5.1 , 5.2) ] . In addition, neonates have reduced levels of NADH-cytochrome b5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use in neonates [see Use in Specific Populations (8.8) ] . 8.5 Geriatric Use Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal function [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] . Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a reduced dosage of metoclopramide in elderly patients [see Boxed Warning , Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ]. 8.6 Renal Impairment The clearance of metoclopramide is decreased and the systemic exposure is increased in patients with moderate to severe renal impairment compared to patients with normal renal function, which may increase the risk of adverse reactions. Reduce the metoclopramide dosage in patients with moderate and severe renal impairment (creatinine clearance less than or equal to 60 mL/minute), including those receiving hemodialysis and continuous ambulatory peritoneal dialysis [see Dosage and Administration (2.2 , 2.3) , Clinical Pharmacology (12.3) ]. 8.7 Hepatic Impairment Patients with severe hepatic impairment (Child-Pugh C) have reduced systemic metoclopramide clearance (by approximately 50%) compared to patients with normal hepatic function. The resulting increase in metoclopramide blood concentrations increases the risk of adverse reactions. There is no pharmacokinetic data in patients with moderate hepatic impairment (Child-Pugh B). Reduce metoclopramide dosage in patients with moderate or severe (Child-Pugh B or C) hepatic impairment [see Dosage and Administration (2.2 , 2.3) ] . There is no dosage adjustment required for patients with mild hepatic impairment (Child-Pugh A). In addition, metoclopramide, by producing a transient increase in plasma aldosterone, may increase the risk of fluid retention in patients with hepatic impairment [see Warnings and Precautions (5.6) ] . Monitor patients with hepatic impairment for the occurrence of fluid retention and volume overload. 8.8 NADH-Cytochrome b5 Reductase Deficiency Metoclopramide-treated patients with NADH-cytochrome b5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia. For patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with metoclopramide-induced methemoglobinemia, methylene blue treatment is not recommended. Methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal [see Overdosage (10) ]. 8.9 CYP2D6 Poor Metabolizers Metoclopramide is a substrate of CYP2D6. The elimination of metoclopramide may be slowed in patients who are CYP2D6 poor metabolizers (compared to patients who are CYP2D6 intermediate, extensive, or ultra-rapid metabolizers); possibly increasing the risk of dystonic and other adverse reactions to metoclopramide [see Clinical Pharmacology (12.3) ]. Reduce the metoclopramide dosage in patients who are poor CYP2D6 metabolizers [see Dosage and Administration (2.2 , 2.3) ]."],"dosage_and_administration_table":["<table><caption>Table 1. Recommended Metoclopramide Dosage in Patients with Gastroesophageal Reflux</caption><col/><col/><col/><thead><tr><th styleCode=\" Lrule Rrule\"/><th align=\"center\" styleCode=\" Rrule\"> Recommended Dosage</th><th align=\"center\" styleCode=\" Rrule\"> Maximum Recommended Daily Dosage</th></tr></thead><tbody><tr><td styleCode=\" Lrule Rrule\">Adult patients</td><td rowspan=\"2\" styleCode=\" Rrule\">10 to 15 mg four times daily (thirty minutes before each meal and at bedtime)</td><td align=\"center\" rowspan=\"3\" styleCode=\" Rrule\">60 mg</td></tr><tr><td styleCode=\" Lrule Rrule\">Mild hepatic impairment (Child-Pugh A)</td></tr><tr><td styleCode=\" Lrule Rrule\">Elderly patients <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_e0253b1c-1443-4e0b-93ce-b65b57950648\">Use in Specific Populations (8.5)</linkHtml>] </content></td><td styleCode=\" Rrule\">5 mg <footnote ID=\"FOOT_23800\">Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a lower starting dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 to 15 mg four times daily based upon response and tolerability.</footnote> four times daily (thirty minutes before each meal and at bedtime) </td></tr><tr><td styleCode=\" Lrule Rrule\">Moderate or severe hepatic impairment (Child-Pugh B or C) <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_45f3365d-8301-4623-9dad-456f5b35e945\">Use in Specific Populations (8.7)</linkHtml>] </content></td><td rowspan=\"4\" styleCode=\" Rrule\">5 mg four times daily (thirty minutes before each meal and at bedtime), or 10 mg taken three times daily</td><td align=\"center\" rowspan=\"4\" styleCode=\" Rrule\">30 mg</td></tr><tr><td styleCode=\" Lrule Rrule\">CYP2D6 poor metabolizers <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_ae77abd8-f24e-433a-acd8-4e1b7a7a51fe\">Use in Specific Populations (8.9)</linkHtml>] </content></td></tr><tr><td styleCode=\" Lrule Rrule\">Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_7aa57b27-c393-4626-8be0-90d90166bc16\">Drug Interactions (7.1)</linkHtml>] </content></td></tr><tr><td styleCode=\" Lrule Rrule\">Moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute) <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_187febd7-0621-4747-ad18-ac564f14d966\">Use in Specific Populations (8.6)</linkHtml>] </content></td></tr><tr><td styleCode=\" Lrule Rrule\">Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_187febd7-0621-4747-ad18-ac564f14d966\">Use in Specific Populations (8.6)</linkHtml>] </content></td><td styleCode=\" Rrule\">5 mg four times daily (thirty minutes before each meal and at bedtime) or 10 mg twice daily</td><td align=\"center\" styleCode=\" Rrule\">20 mg</td></tr></tbody></table>","<table><caption>Table 2. Recommended Metoclopramide Dosage in Patients with Acute and Recurrent Diabetic Gastroparesis</caption><col/><col/><col/><thead><tr><th styleCode=\" Lrule Rrule\"/><th align=\"center\" styleCode=\" Rrule\"> Recommended Dosage</th><th align=\"center\" styleCode=\" Rrule\"> Maximum Recommended Daily Dosage</th></tr></thead><tbody><tr><td styleCode=\" Lrule Rrule\">Adult Patients</td><td rowspan=\"2\" styleCode=\" Rrule\">10 mg four times daily (30 minutes before each meal and at bedtime)</td><td align=\"center\" rowspan=\"3\" styleCode=\" Rrule\">40 mg</td></tr><tr><td styleCode=\" Lrule Rrule\">Mild hepatic impairment (Child-Pugh A)</td></tr><tr><td styleCode=\" Lrule Rrule\">Elderly patients <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_e0253b1c-1443-4e0b-93ce-b65b57950648\">Use in Specific Populations (8.5)</linkHtml>] </content></td><td styleCode=\" Rrule\">5 mg <footnote ID=\"FOOT_23801\">Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a lower dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 mg four times daily based upon response and tolerability.</footnote> four times daily (30 minutes before each meal and at bedtime) </td></tr><tr><td styleCode=\" Lrule Rrule\">Moderate or severe hepatic impairment (Child-Pugh B or C) <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_45f3365d-8301-4623-9dad-456f5b35e945\">Use in Specific Populations (8.7)</linkHtml>] </content></td><td rowspan=\"4\" styleCode=\" Rrule\">5 mg four times daily (30 minutes before each meal and at bedtime)</td><td align=\"center\" rowspan=\"4\" styleCode=\" Rrule\">20 mg</td></tr><tr><td styleCode=\" Lrule Rrule\">CYP2D6 poor metabolizers <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_ae77abd8-f24e-433a-acd8-4e1b7a7a51fe\">Use in Specific Populations (8.9)</linkHtml>] </content></td></tr><tr><td styleCode=\" Lrule Rrule\">Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_7aa57b27-c393-4626-8be0-90d90166bc16\">Drug Interactions (7.1)</linkHtml>] </content></td></tr><tr><td styleCode=\" Lrule Rrule\">Moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_187febd7-0621-4747-ad18-ac564f14d966\">Use in Specific Populations (8.6)</linkHtml>] </content></td></tr><tr><td styleCode=\" Lrule Rrule\">Patients with End-Stage Renal Disease (ESRD <content styleCode=\"italics\">)</content> including those treated with hemodialysis and continuous ambulatory peritoneal dialysis <content styleCode=\"italics\">[see <linkHtml href=\"#LINK_187febd7-0621-4747-ad18-ac564f14d966\">Use in Specific Populations (8.6)</linkHtml>] </content></td><td styleCode=\" Rrule\">5 mg twice daily</td><td align=\"center\" styleCode=\" Rrule\">10 mg</td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0576-16 Metoclopramide Oral Solution USP 5 mg/5 mL* *Each 5 mL (1 teaspoonful) contains: Metoclopramide 5 mg (present as the hydrochloride) PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx ONLY 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label","PRINCIPAL DISPLAY PANEL - 10 mL Cup Label D elivers 10 mL NDC 0121-1576-10 Delivers 10 mL NDC 0121-1576-10 Metoclopramide Oral Solution USP 10 mg/10 mL (present as the hydrochloride) Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 Rx ONLY F1576101021 PRINCIPAL DISPLAY PANEL - 10 mL Cup Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A 77-week study was conducted in rats with oral metoclopramide doses up to 40 mg/kg/day (about six times the maximum recommended human dose on body surface area basis). Metoclopramide elevated prolactin levels and the elevation persisted during chronic administration. An increase in mammary neoplasms was found in rodents after chronic administration of metoclopramide [see Warnings and Precautions (5.7) ]. In a rat model for assessing the tumor promotion potential, a 2-week oral treatment with metoclopramide at a dose of 260 mg/kg/day (about 35 times the maximum recommended human dose based on body surface area) enhanced the tumorigenic effect of N-nitrosodiethylamine. Mutagenesis Metoclopramide was positive in the in vitro Chinese hamster lung cell/HGPRT forward mutation assay for mutagenic effects and in the in vitro human lymphocyte chromosome aberration assay for clastogenic effects. It was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis assay with rat and human hepatocytes, and the in vivo rat micronucleus assay. Impairment of Fertility Metoclopramide at intramuscular doses up to 20 mg/kg/day (about three times the maximum recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats."]},"tags":[{"label":"Dopamine-2 Receptor Antagonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"D(3) dopamine receptor","category":"target"},{"label":"DRD3","category":"gene"},{"label":"HTR3A","category":"gene"},{"label":"HTR3B","category":"gene"},{"label":"A03FA01","category":"atc"},{"label":"Intramuscular","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Oral","category":"route"},{"label":"Injection","category":"form"},{"label":"Solution","category":"form"},{"label":"Spray","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Chemotherapy-induced nausea and vomiting","category":"indication"},{"label":"Diabetic gastroparesis","category":"indication"},{"label":"Gastroesophageal reflux disease","category":"indication"},{"label":"Gastrointestinal Radiography Adjunct","category":"indication"},{"label":"Intubation of gastrointestinal tract","category":"indication"},{"label":"Prevention of Post-Operative Nausea and Vomiting","category":"indication"},{"label":"Hikma","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Antiemetics","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Dopamine Agents","category":"pharmacology"},{"label":"Dopamine Antagonists","category":"pharmacology"},{"label":"Dopamine D2 Receptor Antagonists","category":"pharmacology"},{"label":"Gastrointestinal Agents","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Discontinue metoclopramide in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped [see Warnings and Precautions (5.1) ] . Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Warnings and Precautions (5.1) and Dosage and Administration (2.2 , 2.3) ]. WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage ( 5.1 ) Discontinue metoclopramide in patients who develop signs or symptoms of TD ( 5.1 ) Avoid treatment with metoclopramide for longer than 12 weeks because of the risk of developing TD with longer-term use ( 5.1 , 2.1 , 2.2 , 2.3 )"],"safetySignals":[{"date":"","signal":"TARDIVE DYSKINESIA","source":"FDA FAERS","actionTaken":"16216 reports"},{"date":"","signal":"EXTRAPYRAMIDAL DISORDER","source":"FDA FAERS","actionTaken":"12907 reports"},{"date":"","signal":"NERVOUS SYSTEM DISORDER","source":"FDA FAERS","actionTaken":"7523 reports"},{"date":"","signal":"DYSTONIA","source":"FDA FAERS","actionTaken":"7093 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"6272 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"5902 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"4775 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"4054 reports"},{"date":"","signal":"ECONOMIC PROBLEM","source":"FDA FAERS","actionTaken":"3962 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"3925 reports"}],"drugInteractions":[{"drug":"Antipsychotics","severity":"High","mechanism":"Additive dopamine antagonism and neurological effects","management":"Avoid concomitant use","clinicalEffect":"Increased frequency and severity of tardive dyskinesia (TD), extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS)"},{"drug":"Strong CYP2D6 inhibitors (quinidine, bupropion, fluoxetine, paroxetine)","severity":"Moderate","mechanism":"Inhibition of metoclopramide metabolism via CYP2D6","management":"Reduce metoclopramide dosage","clinicalEffect":"Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms"},{"drug":"Monoamine Oxidase Inhibitors (MAOIs)","severity":"High","mechanism":"Increased catecholamine effects","management":"Avoid concomitant use","clinicalEffect":"Increased risk of hypertension"},{"drug":"CNS depressants (alcohol, sedatives, hypnotics, opiates, anxiolytics)","severity":"Moderate","mechanism":"Additive CNS depression","management":"Avoid concomitant use or monitor for adverse reactions","clinicalEffect":"Increased risk of CNS depression"},{"drug":"Drugs that impair gastrointestinal motility","severity":"Moderate","mechanism":"Decreased GI absorption","management":"Monitor","clinicalEffect":"Decreased systemic absorption of metoclopramide"}],"commonSideEffects":[{"effect":"Diarrhoea","drugRate":"10.3%","placeboRate":"","totalAtRisk":746,"totalAffected":77,"trialsReporting":2},{"effect":"Fatigue","drugRate":"14.9%","placeboRate":"","totalAtRisk":504,"totalAffected":75,"trialsReporting":1},{"effect":"Constipation","drugRate":"7.6%","placeboRate":"","totalAtRisk":746,"totalAffected":57,"trialsReporting":2},{"effect":"Decreased appetite","drugRate":"5.4%","placeboRate":"","totalAtRisk":746,"totalAffected":40,"trialsReporting":2},{"effect":"Neutropenia","drugRate":"7.5%","placeboRate":"","totalAtRisk":504,"totalAffected":38,"trialsReporting":1},{"effect":"Headache","drugRate":"6.0%","placeboRate":"","totalAtRisk":504,"totalAffected":30,"trialsReporting":1},{"effect":"Neutrophil count decreased","drugRate":"9.1%","placeboRate":"","totalAtRisk":242,"totalAffected":22,"trialsReporting":1},{"effect":"Alopecia","drugRate":"2.7%","placeboRate":"","totalAtRisk":746,"totalAffected":20,"trialsReporting":2},{"effect":"Nausea","drugRate":"8.3%","placeboRate":"","totalAtRisk":242,"totalAffected":20,"trialsReporting":1},{"effect":"Hiccups","drugRate":"6.2%","placeboRate":"","totalAtRisk":242,"totalAffected":15,"trialsReporting":1},{"effect":"Myalgia","drugRate":"4.5%","placeboRate":"","totalAtRisk":242,"totalAffected":11,"trialsReporting":1}],"contraindications":["History of tardive dyskinesia (TD) or dystonic reaction to metoclopramide","When stimulation of gastrointestinal motility might be dangerous (gastrointestinal hemorrhage, mechanical obstruction, or perforation)","Pheochromocytoma or other catecholamine-releasing paragangliomas","Epilepsy","Hypersensitivity to metoclopramide (including laryngeal and glossal angioedema and bronchospasm)"],"specialPopulations":{"Pregnancy":"Teratogenic Effects: Pregnancy Category B. Reproduction studies performed in rats, mice and rabbits by the intramuscular, intravenous, subcutaneous (SC), and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response.","Geriatric use":"Clinical studies of reglan(R) did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects.The risk of developing parkinsonian-like side effects increases with ascending dose. Geriatric patients should receive the lowest dose of reglan(R) that is effective. If parkinsonian-like symptoms develop in geriatric patient receiving reglan(R), reglan(R) should generally be discontinued before initiating any","Paediatric use":"Safety and effectiveness in pediatric patients have not been established except as stated to facilitate small bowel intubation (see OVERDOSAGE and DOSAGE AND ADMINISTRATION).Care should be exercised in administering metoclopramide to neonates since prolonged clearance may produce excessive serum concentrations (see CLINICAL PHARMACOLOGY--Pharmacokinetics). In addition, neonates have reduced levels of nicotinamide adenine dinucleotide-methemoglobin reductase which, in combination "}},"trials":[],"aliases":[],"company":"Hikma","patents":[{"type":"Method of Use","number":"11020361","applicant":"QOL MEDICAL LLC","territory":"US","tradeName":"GIMOTI","expiryDate":"2029-12-22"},{"type":"Method of Use","number":"12194009","applicant":"QOL MEDICAL LLC","territory":"US","tradeName":"GIMOTI","expiryDate":"2029-12-22"},{"type":"Method of Use","number":"12194008","applicant":"QOL MEDICAL LLC","territory":"US","tradeName":"GIMOTI","expiryDate":"2029-12-22"},{"type":"Formulation","number":"8334281","applicant":"QOL MEDICAL LLC","territory":"US","tradeName":"GIMOTI","expiryDate":"2030-05-16"},{"type":"Formulation","number":"11628150","applicant":"QOL MEDICAL LLC","territory":"US","tradeName":"GIMOTI","expiryDate":"2029-12-22"},{"type":"Method of Use","number":"12377064","applicant":"QOL MEDICAL LLC","territory":"US","tradeName":"GIMOTI","expiryDate":"2038-11-17"},{"type":"Formulation","number":"11813231","applicant":"QOL MEDICAL LLC","territory":"US","tradeName":"GIMOTI","expiryDate":"2029-12-22"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.0502/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$18","description":"METOCLOPRAMIDE 10 MG TABLET","retrievedDate":"2026-04-07"}],"_fixedAt":"2026-03-30T11:29:00.331622","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Metoclopramide Hydrochloride","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:33:16.980384+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T23:33:16.980313+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Metoclopramide Hydrochloride","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:33:26.527086+00:00"},"mechanism":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:36:38.598239+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:33:24.087008+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:33:16.086180+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:36:38.598264+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Metoclopramide Hydrochloride","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:33:24.852217+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:33:10.545245+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of trea","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:33:10.545272+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:33:27.041898+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Serotonin 4 (5-HT4) receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:33:26.527000+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200940/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:33:26.186308+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA072744","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:33:10.545276+00:00"}},"allNames":"reglan","offLabel":[],"synonyms":["metoclopramide","metoclopramide hydrochloride","metochlopramide","methochlopramide","metoclopramide hydrochloride hydrate","metoclopramide monohydrochloride","metoclopramide HCl","AHR-3070-C","metaclopramide"],"timeline":[{"date":"1979-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BAXTER HLTHCARE CORP to Hikma"},{"date":"1979-02-07","type":"positive","source":"DrugCentral","milestone":"FDA approval (Baxter Hlthcare Corp)"},{"date":"1983-03-25","type":"positive","source":"FDA Orange Book","milestone":"Reglan approved — EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2005-06-10","type":"positive","source":"FDA Orange Book","milestone":"Reglan Odt approved — EQ 5MG BASE"},{"date":"2009-09-04","type":"positive","source":"FDA Orange Book","milestone":"Metozolv Odt approved — EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2013-04-19","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 36 manufacturers approved"},{"date":"2020-06-19","type":"positive","source":"FDA Orange Book","milestone":"Gimoti approved — EQ 15MG BASE/SPRAY"}],"aiSummary":"Metoclopramide is a prokinetic agent indicated for short-term treatment of gastroesophageal reflux and diabetic gastroparesis in adults who fail conventional therapy. The drug carries significant black box risks including tardive dyskinesia, extrapyramidal symptoms, and neuroleptic malignant syndrome, particularly with prolonged use and in combination with antipsychotics. It is contraindicated in patients with prior TD, dystonic reactions, pheochromocytoma, epilepsy, and conditions where GI stimulation is dangerous. Use requires careful patient selection, dose adjustment in renal/hepatic impairment, and avoidance of interacting medications, particularly CYP2D6 inhibitors and MAOIs.","brandName":"Reglan","ecosystem":[{"indication":"Chemotherapy-induced nausea and vomiting","otherDrugs":[{"name":"aprepitant","slug":"aprepitant","company":"Merck"},{"name":"dronabinol","slug":"dronabinol","company":"Abbvie"},{"name":"estrone","slug":"estrone","company":"Watson Labs"},{"name":"fosaprepitant","slug":"fosaprepitant","company":""}],"globalPrevalence":null},{"indication":"Diabetic gastroparesis","otherDrugs":[],"globalPrevalence":null},{"indication":"Gastroesophageal reflux disease","otherDrugs":[{"name":"algeldrate","slug":"algeldrate","company":"Sanofi Aventis Us"},{"name":"almasilate","slug":"almasilate","company":""},{"name":"cimetidine","slug":"cimetidine","company":""},{"name":"cisapride","slug":"cisapride","company":""}],"globalPrevalence":null},{"indication":"Gastrointestinal Radiography Adjunct","otherDrugs":[{"name":"glucagon","slug":"glucagon","company":""},{"name":"silicon dioxide","slug":"silicon-dioxide","company":""}],"globalPrevalence":null},{"indication":"Intubation of gastrointestinal tract","otherDrugs":[],"globalPrevalence":null},{"indication":"Prevention of Post-Operative Nausea and Vomiting","otherDrugs":[{"name":"aprepitant","slug":"aprepitant","company":"Merck"},{"name":"dolasetron","slug":"dolasetron","company":"Sanofi Aventis Us"},{"name":"estrone","slug":"estrone","company":"Watson Labs"},{"name":"granisetron","slug":"granisetron","company":"Roche"}],"globalPrevalence":null}],"mechanism":{"target":"Acetylcholine receptor sensitization; dopamine antagonism (implied)","novelty":"Follow-on","targets":[{"gene":"DRD3","source":"DrugCentral","target":"D(3) dopamine receptor","protein":"D(3) dopamine receptor","isPrimary":true,"activityType":"Ki","activityValue":7.66},{"gene":"HTR3A","source":"DrugCentral","target":"Serotonin 3 (5-HT3) receptor","protein":"5-hydroxytryptamine receptor 3A"},{"gene":"HTR3B","source":"DrugCentral","target":"Serotonin 3 (5-HT3) receptor","protein":"5-hydroxytryptamine receptor 3B"},{"gene":"HTR3C","source":"DrugCentral","target":"Serotonin 3 (5-HT3) receptor","protein":"5-hydroxytryptamine receptor 3C"},{"gene":"HTR3D","source":"DrugCentral","target":"Serotonin 3 (5-HT3) receptor","protein":"5-hydroxytryptamine receptor 3D"},{"gene":"HTR3E","source":"DrugCentral","target":"Serotonin 3 (5-HT3) receptor","protein":"5-hydroxytryptamine receptor 3E"},{"gene":"DRD2","source":"DrugCentral","target":"D(2) dopamine receptor","protein":"D(2) dopamine receptor"},{"gene":"MPO","source":"DrugCentral","target":"Myeloperoxidase","protein":"Myeloperoxidase"},{"gene":"HTR2B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2B","protein":"5-hydroxytryptamine receptor 2B"},{"gene":"CYP2D6","source":"DrugCentral","target":"Cytochrome P450 2D6","protein":"Cytochrome P450 2D6"}],"moaClass":"Dopamine D2 Antagonists","modality":"Small molecule","drugClass":"Prokinetic agent","explanation":"Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism in treating gastroesophageal reflux and diabetic gastroparesis has not been fully established, but it appears to sensitize tissues to acetylcholine action. The effect on motility is independent of intact vagal innervation but can be abolished by anticholinergic drugs.\n\nMetoclopramide increases the tone and amplitude of gastric contractions (especially antral), relaxes the pyloric sphincter and duodenal bulb, and increases peristalsis of the duodenum and jejunum, resulting in accelerated gastric emptying and intestinal transit. It also increases the resting tone of the lower esophageal sphincter. The drug has little to no effect on colon or gallbladder motility.","oneSentence":"Metoclopramide stimulates upper GI tract motility by sensitizing tissues to acetylcholine action.","technicalDetail":"Reglan (Metoclopramide) acts as a selective dopamine D2 receptor antagonist, which increases the release of acetylcholine and blocks the inhibitory effects of dopamine on the gastrointestinal tract, resulting in enhanced gastric motility and reduced nausea.","_target_confidence":0.5},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Metoclopramide","title":"Metoclopramide","extract":"Metoclopramide is a medication used to treat nausea, vomiting, gastroparesis, and gastroesophageal reflux disease. It is also used to treat migraine headaches.","wiki_history":"==History==\nMetoclopramide was first described by Louis Justin-Besançon and Charles Laville in 1964, while working to improve the anti-dysrhythmic properties of procainamide. That research project also produced the product sulpiride. Laboratoires Delagrange was acquired by Synthelabo in 1991 which eventually became part of Sanofi.\n\nA.H. Robins introduced the drug in the US under the brand name Reglan in 1979 as an injectable and an oral form was approved in 1980. in 1989 A.H. Robins was acquired by American Home Products, which changed its name to Wyeth in 2002.\n\nThe drugs were initially used to control nausea for people with severe headaches or migraines, and later used for nausea caused by radiation therapy and chemotherapy, and later yet for treating nausea caused by anesthesia.\n\nThe first generics were introduced in 1985.\n\nIn the early 1980s signs began to emerge in pharmacovigilance studies from Sweden that the drug was causing tardive dyskinesia in some patients. The FDA required a warning about tardive dyskinesia to be added to the drug label in 1985 stating that: \"tardive dyskinesia . . . may develop in patients treated with metoclopramide,\" and warned against use longer than 12 weeks, as that was how long the drug has been tested. In 2009 the FDA required that a black box warning be added to the label. The litigation was complicated since there was a lack of clarity in jurisdiction between state laws, where product liability is determined, and federal law, which determines how drugs are labelled, as well as between generics companies, which had no control over labelling, and the originator company, which did. The litigation yielded at least two important cases. In Conte v. Wyeth in the California state courts, the claims of the plaintiff against the generic companies Pliva, Teva, and Purepac that had sold the drugs that the plaintiff actually took, and the claims against Wyeth, whose product the plaintiff never took, were all dismissed by the trial court, b","wiki_society_and_culture":"==Society and culture==\n===Brand names===\n{| class=\"wikitable mw-collapsible mw-collapsed\" style=\"width:100%\"\n|+ List of brand names for metoclopramide\n|-\n|A||Adco-Contromet, Aeroflat (metoclopramide and dimeticone), Afipran, Anaflat Compuesto (metoclopramide and simeticone; pancreatin), Anagraine (metoclopramide and paracetamol), Anausin Métoclopramide, Anolexinon, Antiementin, Antigram (Metoclopramide and Acetylsalicylic Acid), Aswell\n|-\n|B||Balon, Betaclopramide, Bio-Metaclopramide, Bitecain AA\n|-\n|C||Carnotprim, Carnotprim, Cephalgan (metoclopramide and carbasalate calcium), Cerucal, Chiaowelgen, Chitou, Clifar (Metoclopramide and Simeticone), Clodaset (metoclopramide and ondansetron), Clodoxin (metoclopramide and pyridoxine), Clomitene, Clopamon, Clopan, Cloperan, Cloprame, Clopramel, Clozil\n|-\n|D||Damaben, Degan, Delipramil, Di-Aero OM (metoclopramide and simeticone), Dibertil, Digenor (Metoclopramide and Dimeticone), Digespar (Metoclopramide and Simeticone), Digestivo S. Pellegrino, Dikinex Repe (Metoclopramide and Pancreatin), Dirpasid, Doperan, Dringen\n|-\n|E||Egityl (metoclopramide and acetylsalicylic Acid), Elieten, Eline, Elitan, Emenil, Emeprid (veterinary use), Emeran, Emetal, Emoject, Emperal, Enakur, Enteran, Enzimar, Espaven M.D. (Metoclopramide and Dimethicone), Ethiferan, Eucil\n|-\n|F||Factorine (Metoclopramide and Simeticone)\n|-\n|G||Gastro-Timelets, Gastrocalm, Gastronerton, Gastrosil, Geneprami\n|-\n|H||H-Peran, Hawkperan, Hemibe, Horompelin\n|-\n|I||Imperan, Isaprandil, Itan\n|-\n|J||\n|-\n|K||K.B. Meta, Klometol, Klopra\n|-\n|L||Lexapram, Linperan, Linwels\n|-\n|M||Malon, Manosil, Maril, Matolon, Maxeran, Maxolon, Maxolone, Meclam, Meclid, Meclizine, Meclomid, Meclopstad, Meniperan, Mepram, Met-Sil, Metajex, Metalon, Metamide, Metilprednisolona Richet, Metoceolat, Metoclor, Metoco, Metocol, Metocontin, Metomide (veterinary use), Metonia, Metopar (Metoclopramide and Paracetamol), Metopar (Metoclopramide and Paracetamol), Metopelan, Metoperan, Metoperon, Meto"},"commercial":{"launchDate":"1979","_launchSource":"DrugCentral (FDA 1979-02-07, BAXTER HLTHCARE CORP)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1782","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Metoclopramide%20Hydrochloride","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Metoclopramide Hydrochloride","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Metoclopramide","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T07:05:00.381241","_validation":{"fieldsValidated":6,"lastValidatedAt":"2026-04-20T08:36:42.096812+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"cisapride","drugSlug":"cisapride","fdaApproval":"1993-07-29","patentStatus":"Unknown","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"},{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"genericName":"metoclopramide hydrochloride","indications":{"approved":[{"name":"Chemotherapy-induced nausea and vomiting","source":"DrugCentral","snomedId":236084000,"regulator":"FDA"},{"name":"Diabetic gastroparesis","source":"DrugCentral","snomedId":34140002,"regulator":"FDA"},{"name":"Gastroesophageal reflux disease","source":"DrugCentral","snomedId":235595009,"regulator":"FDA"},{"name":"Gastrointestinal Radiography Adjunct","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Intubation of gastrointestinal tract","source":"DrugCentral","snomedId":235419001,"regulator":"FDA"},{"name":"Prevention of Post-Operative Nausea and Vomiting","source":"DrugCentral","snomedId":"","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_fixedFields":["primaryTarget"],"currentOwner":"Hikma","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"cisapride","brandName":"cisapride","genericName":"cisapride","approvalYear":"1993","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT03970720","phase":"PHASE2","title":"Restoration of Hypoglycemia Awareness With Metoclopramide","status":"RECRUITING","sponsor":"Simon Fisher","startDate":"2019-05-28","conditions":["Hypoglycemia Unawareness"],"enrollment":36,"completionDate":"2027-12-31"},{"nctId":"NCT07226362","phase":"PHASE1","title":"A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults","status":"COMPLETED","sponsor":"Aspeya Switzerland SA","startDate":"2025-06-09","conditions":["Safety, and Tolerability"],"enrollment":44,"completionDate":"2025-10-02"},{"nctId":"NCT06379217","phase":"PHASE1","title":"NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2024-07-29","conditions":["Metastatic Neuroendocrine Prostate Cancer"],"enrollment":31,"completionDate":"2026-08-27"},{"nctId":"NCT07208305","phase":"PHASE3","title":"Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting","status":"RECRUITING","sponsor":"Affiliated Hospital of Qinghai University","startDate":"2026-02-03","conditions":["Nausea","Vomiting"],"enrollment":222,"completionDate":"2027-12-30"},{"nctId":"NCT07360431","phase":"PHASE4","title":"Granisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After Laparoscopic Cholecystectomy","status":"NOT_YET_RECRUITING","sponsor":"Assiut 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(ObsQOR-11)"],"enrollment":141,"completionDate":"2022-12-31"},{"nctId":"NCT06343753","phase":"NA","title":"Quality of Recovery After Laparoscopic Cholecystectomy Comparing Opioid Free Analgesia Versus Opioid Free Anesthesia","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2024-05-01","conditions":["Quality of Recovery","Pain, Postoperative","Elective Laparoscopic Cholecystectomy"],"enrollment":50,"completionDate":"2025-09-20"},{"nctId":"NCT05033041","phase":"PHASE4","title":"Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2021-10-20","conditions":["Pregnancy","Cesarean Section","Aspiration"],"enrollment":72,"completionDate":"2024-02-08"},{"nctId":"NCT04726592","phase":"PHASE3","title":"Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room","status":"TERMINATED","sponsor":"Assistance Publique - Hôpitaux de 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Undergoing Elective Surgery","status":"NOT_YET_RECRUITING","sponsor":"Mater Misericordiae University Hospital","startDate":"2025-08","conditions":["Pulmonary Aspiration During Anaesthetic Induction","Gastric Emptying Time","Preoperative Risk Assessment","Obesity (Disorder)"],"enrollment":80,"completionDate":"2026-06"},{"nctId":"NCT02098499","phase":"PHASE4","title":"Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT","status":"WITHDRAWN","sponsor":"United States Naval Medical Center, Portsmouth","startDate":"2013-06-12","conditions":["Migraine Headaches","Nausea","Restlessness"],"enrollment":0,"completionDate":"2015-02-11"},{"nctId":"NCT07086118","phase":"NA","title":"Dexamethasone Versus Metoclopramide for Prophylaxis of Nausea and Vomiting After Cataract Surgery","status":"RECRUITING","sponsor":"Alexandria 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The key indications for Reglan include chemotherapy-induced nausea and vomiting, diabetic gastroparesis, gastroesophageal reflux disease, gastrointestinal radiography adjunct, and intubation of the gastrointestinal tract. However, the revenue data for Reglan is not provided in the given sources.\n\nThe competitive landscape for Reglan is dominated by other antiemetic and prokinetic agents. According to the provided sources, Rigel Pharmaceuticals, a commercial-stage biotechnology company, anticipates full-year total revenue of approximately $275 to $290 million in 2026, including net product sales of $255 to $265 million [Rigel Provides Business Update and 2026 Outlook, PR Newswire, Jan 12, 2026]. This suggests that Reglan's revenue trajectory may be impacted by the company's financial performance.\n\nKey upcoming catalysts for Reglan include patent cliffs and potential label expansions. However, the provided sources do not provide specific information on patent expiration dates or potential label expansions. Additionally, Rigel's pipeline competitors, such as R289, may pose a threat to Reglan's market share [Rigel Provides Business Update and 2026 Outlook, PR Newswire, Jan 12, 2026]. The market outlook for Reglan is uncertain, and further research is needed to determine its potential impact on the company's revenue and market share.\n\nIn conclusion, Reglan's current market position and revenue trajectory are uncertain due to the lack of specific revenue data. The competitive landscape is dominated by other antiemetic and prokinetic agents, and potential threats from Rigel's pipeline competitors may impact Reglan's market share.","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.stocktitan.net/news/REGN/regeneron-reports-fourth-quarter-and-full-year-2025-financial-and-4uo083e9cnk0.html","date":"","title":"Regeneron Q4 2025 results: EPS $7.86, revenue $3.9B | REGN Stock News","source":"www.stocktitan.net"},{"url":"https://www.rigel.com/news-media/press-releases/detail/430/rigel-provides-business-update-and-2026-outlook","date":"","title":"Rigel Provides Business Update and 2026 Outlook","source":"www.rigel.com"},{"url":"https://www.prnewswire.com/news-releases/rigel-provides-business-update-and-2026-outlook-302658090.html","date":"","title":"Rigel Provides Business Update and 2026 Outlook - PR Newswire","source":"www.prnewswire.com"}],"disclaimer":"AI-generated analysis based on public sources. 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