{"id":"hydrocodone-bitartrate-and-acetaminophen","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":["WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Acetaminophen Tablets, USP, expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Hydrocodone Bitartrate and Acetaminophen Tablets, USP, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings] . Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to • complete a REMS-compliant education program, • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and • consider other tools to improve patient, household, and community safety. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Acetaminophen Tablets, USP. Monitor for respiratory depression, especially during initiation of Hydrocodone Bitartrate and Acetaminophen Tablets, USP or following a dose increase [see WARNINGS]. Accidental Ingestion Accidental ingestion of Hydrocodone Bitartrate and Acetaminophen Tablets, USP, especially by children, can result in a fatal overdose of Hydrocodone Bitartrate and Acetaminophen Tablets, USP [see WARNINGS]. Neonatal Opioid Withdrawal Syndrome Prolonged use of Hydrocodone Bitartrate and Acetaminophen Tablets, USP during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS]. Cytochrome P450 3A4 Interaction The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets, USP with all Cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used Cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentrations. Monitor patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets, USP and any Cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation [see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; Drug Interactions]. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see WARNINGS, OVERDOSAGE]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedat"],"drugInteractions":["Drug Interactions Inhibitors of CYP3A4 and CYP2D6 The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone from Hydrocodone Bitartrate and Acetaminophen Tablets, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets and both CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Acetaminophen Tablets is achieved [see WARNINGS ] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease [see CLINICAL PHARMACOLOGY ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Hydrocodone Bitartrate and Acetaminophen Tablets. If concomitant use is necessary, consider dosage reduction of Hydrocodone Bitartrate and Acetaminophen Tablets until stable drug effects are achieved. Follow patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Hydrocodone Bitartrate and Acetaminophen Tablets dosage until stable drug effects are achieved . Follow for signs or symptoms of opioid withdrawal. Inducers of CYP3A4 The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of hydrocodone [see CLINICAL PHARMACOLOGY ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone [see WARNINGS ] . After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [see CLINICAL PHARMACOLOGY ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. If concomitant use is necessary, consider increasing the Hydrocodone Bitartrate and Acetaminophen Tablets dosage until stable drug effects are achieved [see DOSAGE AND ADMINISTRATION ] . Follow the patient for signs and symptoms of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Hydrocodone Bitartrate and Acetaminophen Tablets dosage reduction and follow for signs of respiratory depression. Benzodiazepines and Other CNS Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants, such as benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see WARNINGS ]. Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see PRECAUTIONS; Information for Patients ]. If concomitant use is warranted, carefully follow the patient, particularly during t"],"commonSideEffects":["ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets and Tablets. 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 frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. Other adverse reactions include: Central Nervous System - Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes. Gastrointestinal System- Constipation. Genitourinary System- Ureteral spasm, spasm of vesical sphincters, and urinary retention. Special Senses- Cases of Hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Dermatological- Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions Hematological - Thrombocytopenia, agranulocytosis. Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. • Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. • Anaphylaxis : Anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Acetaminophen Tablets. • Androgen deficiency : Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY ]. DRUG ABUSE AND DEPENDENCE Controlled Substance Hydrocodone Bitartrate and Acetaminophen Tablets, USP contains hydrocodone, a Schedule II controlled substance. Abuse Hydrocodone Bitartrate and Acetaminophen Tablets, USP contains hydrocodone, a substance with a high potential for abuse similar to other opioids including. Hydrocodone Bitartrate and Acetaminophen Tablets, USP can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “Drug seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. Hydrocodone Bitartrate and Acetaminophen Tablets, USP, like other opioids, can be diverted for non-medical use into illicit c"],"contraindications":["CONTRAINDICATIONS Hydrocodone Bitartrate and Acetaminophen Tablets, USP are contraindicated in patients with: • Significant respiratory depression [see WARNINGS ] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] • Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see WARNINGS, ADVERSE REACTIONS]"]},"status":"discontinued","trials":["NCT01011634","NCT03121963","NCT00935311","NCT02991261","NCT03137017","NCT02312739","NCT03988075","NCT01780428","NCT01974609","NCT01053637","NCT02029235","NCT04558840","NCT06712290","NCT00195728","NCT02110719","NCT03372382","NCT04976387","NCT00236535","NCT07195669","NCT01982799","NCT00315887","NCT04990804","NCT02381132","NCT03529331","NCT03879408","NCT02487108","NCT03619785","NCT04240626","NCT04939987","NCT02465866","NCT03447353","NCT00404222","NCT02991222","NCT01592708","NCT05024825","NCT02358850","NCT03657810","NCT00325949","NCT04622839","NCT04307940","NCT03457116","NCT05240755","NCT04452344","NCT03137030","NCT03820193","NCT03570320","NCT05800847","NCT01517295","NCT07296770","NCT01530191"],"aliases":["Norco"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"aiSummary":"","brandName":"hydrocodone bitartrate and acetaminophen","companyId":"rush-university-medical-center","ecosystem":[],"mechanism":{"drugClass":"","explanation":"INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of moderate to moderately severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Hydrocodone Bitartrate and Acetaminophen Tablets, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): • have not been tolerated, or are not expected to be tolerated, • have not provided adequate analgesia, or are not expected to provide adequate analgesia","oneSentence":"Mechanism of Action Hydrocodone is full opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions."},"commercial":null,"references":[],"biosimilars":[],"companyName":"Rush University Medical Center","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"hydrocodone bitartrate and acetaminophen","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT01011634","phase":"Phase 4","title":"A Double Blinded, Placebo-controlled Randomized Control Trial Comparing Intravenous Moderate Sedation and Oral/Sublingual Analgesia/Anxiolysis for First Trimester Surgical Abortions","status":"TERMINATED","sponsor":"University of California, San Francisco","isPivotal":false,"enrollment":18,"indication":"Undesired Intrauterine Pregnancy, First Trimester 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Brown","isPivotal":false,"enrollment":18,"indication":"Driving Behavior","completionDate":"2016-10-25"},{"nctId":"NCT00404222","phase":"Phase 2","title":"A Randomized, Multicenter, Single-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (N","status":"COMPLETED","sponsor":"Abbott","isPivotal":false,"enrollment":90,"indication":"Pain","completionDate":"2006-02"},{"nctId":"NCT02991222","phase":"Phase 1","title":"A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001 in Healthy, Adult Volunteers Under Fed and Fasted Conditions\"","status":"COMPLETED","sponsor":"Sun Pharma Advanced Research Company Limited","isPivotal":false,"enrollment":24,"indication":"Healthy","completionDate":"2017-04"},{"nctId":"NCT01592708","phase":"NA","title":"A Prospective Evaluation of an Anesthesia Protocol to Reduce Post-operative and Post-discharge Nausea and Vomiting in a High Risk Orthognathic Surgery Population","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","isPivotal":false,"enrollment":233,"indication":"Post-operative Nausea, Post-operative Vomiting","completionDate":"2014-04"},{"nctId":"NCT05024825","phase":"Phase 4","title":"Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy","status":"TERMINATED","sponsor":"Albany Medical College","isPivotal":false,"enrollment":17,"indication":"Pain, Postoperative","completionDate":"2021-05-19"},{"nctId":"NCT02358850","phase":"Phase 4","title":"Post-tonsillectomy Pain Control in Adults: a Randomized Prospective Study","status":"TERMINATED","sponsor":"University of Nebraska","isPivotal":false,"enrollment":27,"indication":"Pain, Postoperative, Postoperative Nausea and Vomiting","completionDate":"2019-01-24"},{"nctId":"NCT03657810","phase":"Phase 3","title":"A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg (Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg) as a Treatment for Mod","status":"COMPLETED","sponsor":"Charleston Laboratories, Inc","isPivotal":true,"enrollment":349,"indication":"Pain, Nausea","completionDate":"2018-11-30"},{"nctId":"NCT00325949","phase":"Phase 3","title":"A Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) Compared ","status":"COMPLETED","sponsor":"Abbott","isPivotal":true,"enrollment":770,"indication":"Chronic Low Back Pain","completionDate":"2007-06"},{"nctId":"NCT04622839","phase":"NA","title":"Post-Operative Pain Control Following Shoulder Surgery","status":"COMPLETED","sponsor":"Johns Hopkins University","isPivotal":false,"enrollment":74,"indication":"Shoulder Pain","completionDate":"2022-07-31"},{"nctId":"NCT04307940","phase":"Phase 4","title":"A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain","status":"COMPLETED","sponsor":"Bayer","isPivotal":false,"enrollment":221,"indication":"Pain","completionDate":"2020-10-05"},{"nctId":"NCT03457116","phase":"Phase 4","title":"Narcotics vs Non-steroidal Ant Inflammatory Drugs Post-operative Analgesia in Outpatient Rhinoplasty","status":"COMPLETED","sponsor":"NYU Langone Health","isPivotal":false,"enrollment":70,"indication":"Rhinoplasty, Non-steroidal Ant Inflammatory Drugs","completionDate":"2020-11-02"},{"nctId":"NCT05240755","phase":"EARLY/Phase 1","title":"Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery","status":"COMPLETED","sponsor":"Foundation for Orthopaedic Research and Education","isPivotal":false,"enrollment":40,"indication":"Post-operative Pain","completionDate":"2024-08-20"},{"nctId":"NCT04452344","phase":"Phase 3","title":"Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain","status":"ACTIVE_NOT_RECRUITING","sponsor":"Rutgers, The State University of New Jersey","isPivotal":true,"enrollment":1815,"indication":"Opioid Use","completionDate":"2026-07-31"},{"nctId":"NCT03137030","phase":"Phase 1","title":"A Relative Bioavailability Trial to Investigate the Pharmacokinetics of Different Amounts of Tablets of Two Immediate Release Fixed Dose Combinations of Hydrocodone Bitartrate 5 mg/Acetaminophen 325 m","status":"WITHDRAWN","sponsor":"Grünenthal GmbH","isPivotal":false,"enrollment":0,"indication":"Opioid-Related Disorders, Pain, Acute","completionDate":"2018-01"},{"nctId":"NCT03820193","phase":"EARLY/Phase 1","title":"Traditional vs. Nonopioid Analgesia After Arthroscopic Meniscus Surgery","status":"COMPLETED","sponsor":"Henry Ford Health System","isPivotal":false,"enrollment":61,"indication":"Meniscus Disorder, Narcotic Use","completionDate":"2021-01-20"},{"nctId":"NCT03570320","phase":"NA","title":"Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries?","status":"COMPLETED","sponsor":"John Yanik","isPivotal":false,"enrollment":48,"indication":"Opioid Use","completionDate":"2020-02-29"},{"nctId":"NCT05800847","phase":"Phase 4","title":"Gabapentin Following Arthroscopic Rotator Cuff Repair: Evaluation of Postoperative Opioid Use and Sleep Quality","status":"UNKNOWN","sponsor":"Hughston Clinic","isPivotal":false,"enrollment":130,"indication":"Rotator Cuff Tears","completionDate":"2024-07"},{"nctId":"NCT01517295","phase":"Phase 4","title":"Evaluating the Pharmacokinetic Profile of Hydromorphone in Chronic Pain Patients Taking Hydrocodone/APAP","status":"COMPLETED","sponsor":"NEMA Research, Inc.","isPivotal":false,"enrollment":30,"indication":"Chronic Pain","completionDate":"2012-09"},{"nctId":"NCT07296770","phase":"Phase 3","title":"An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service","status":"NOT_YET_RECRUITING","sponsor":"University of California, San Francisco","isPivotal":true,"enrollment":126,"indication":"Postsurgical Pain Management, Postsurgical Pain, Chronic","completionDate":"2028-07-01"},{"nctId":"NCT01530191","phase":"N/A","title":"Factors Affectign Perioperative Outcomes After Surgery for Pelvic Organ Prolapse","status":"WITHDRAWN","sponsor":"University of Oklahoma","isPivotal":false,"enrollment":0,"indication":"Pelvic Organ Prolapse","completionDate":"2013-06"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"ORAL","dosage_text":"DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS ]. Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with Hydrocodone Bitartrate and Acetaminophen Tablets, USP and adjust the dosage accordingly [see WARNINGS ]. Initial Dosage Initiating Treatment with Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets . Conversion from Other Opioids to Hydrocodone Bitartrate and Acetaminophen Tablets There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of Hydrocodone Bitartrate and Acetaminophen Tablets. It is safer to underestimate a patient’s 24-hour Hydrocodone Bitartrate and Acetaminophen Tablets dosage than to overestimate the 24-hour Hydrocodone Bitartrate and Acetaminophen Tablets dosage and manage an adverse reaction due to overdose. Conversion from Hydrocodone Bitartrate and Acetaminophen Tablets to Extended-Release Hydrocodone The relative bioavailability of hydrocodone from Hydrocodone Bitartrate and Acetaminophen Tablets compared to extended-release hydrocodone products is unknown, so conversion to extended-release products must be accompanied by close observation for signs of excessive sedation and respiratory depression. Titration and Maintenance of Therapy Individually titrate Hydrocodone Bitartrate and Acetaminophen Tablets, USP to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets, USP to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS ]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Hydrocodone Bitartrate and Acetaminophen Tablets, USP dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. Discontinuation of Hydrocodone Bitartrate and Acetaminophen Tablets, USP When a patient who has been taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP regularly and may be physically dependent no longer requires therapy with Hydrocodone Bitartrate and Acetaminophen Tablets, USP, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Hydrocodone Bitartrate and Acetaminophen Tablets, USP in a physically-dependent patient [see WARNINGS, DRUG ABUSE AND DEPENDENCE ]."},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}