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Reglan (Metoclopramide Hydrochloride)
Metoclopramide stimulates upper GI tract motility by sensitizing tissues to acetylcholine action.
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.
At a glance
| Generic name | Metoclopramide Hydrochloride |
|---|---|
| Sponsor | Hikma |
| Drug class | Prokinetic agent |
| Target | Acetylcholine receptor sensitization; dopamine antagonism (implied) |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1979 |
Mechanism of action
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. Metoclopramide 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.
Approved indications
- Chemotherapy-induced nausea and vomiting
- Diabetic gastroparesis
- Gastroesophageal reflux disease
- Gastrointestinal Radiography Adjunct
- Intubation of gastrointestinal tract
- Prevention of Post-Operative Nausea and Vomiting
Boxed warnings
- 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 )
Common side effects
- Diarrhoea
- Fatigue
- Constipation
- Decreased appetite
- Neutropenia
- Headache
- Neutrophil count decreased
- Alopecia
- Nausea
- Hiccups
- Myalgia
Drug interactions
- Antipsychotics
- Strong CYP2D6 inhibitors (quinidine, bupropion, fluoxetine, paroxetine)
- Monoamine Oxidase Inhibitors (MAOIs)
- CNS depressants (alcohol, sedatives, hypnotics, opiates, anxiolytics)
- Drugs that impair gastrointestinal motility
Key clinical trials
- Restoration of Hypoglycemia Awareness With Metoclopramide (PHASE2)
- A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults (PHASE1)
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (PHASE1)
- Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting (PHASE3)
- Granisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After Laparoscopic Cholecystectomy (PHASE4)
- IV Injection of Metoclopramide With or Without Dexamethasone (EARLY_PHASE1)
- Antibiotics and Vaccine Immune Responses Study (PHASE4)
- Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 11020361 | 2029-12-22 | Method of Use |
| 12194009 | 2029-12-22 | Method of Use |
| 12194008 | 2029-12-22 | Method of Use |
| 8334281 | 2030-05-16 | Formulation |
| 11628150 | 2029-12-22 | Formulation |
| 12377064 | 2038-11-17 | Method of Use |
| 11813231 | 2029-12-22 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Reglan CI brief — competitive landscape report
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- Hikma portfolio CI