Benzhydrocodone and acetaminophen (Oral)
Medically reviewed by Drugs.com. Last updated on Dec 10, 2021.
Benzhydrocodone/acetaminophen exposes 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 benzhydrocodone/acetaminophen, and monitor all patients regularly for the development of these behaviors and conditions.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 Risk Evaluation and Mitigation Strategy (REMS) for these products.Serious, life-threatening, or fatal respiratory depression may occur with use of benzhydrocodone/acetaminophen. Monitor for respiratory depression, especially during initiation of benzhydrocodone/acetaminophen or following a dose increase.Accidental ingestion of even one dose of benzhydrocodone/acetaminophen, especially by children can result in a fatal overdose of hydrocodone.Prolonged use of benzhydrocodone/acetaminophen 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 prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.The concomitant use of benzhydrocodone/acetaminophen 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 concentration. Monitor patients receiving benzhydrocodone/acetaminophen and any CYP3A4 inhibitor or inducer.This product contains acetaminophen. 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 4000 mg/day, and often involve more than one acetaminophen-containing product.Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of benzhydrocodone/acetaminophen and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation .
Commonly used brand name(s)
In the U.S.
- Apadaz
Available Dosage Forms:
- Tablet
Therapeutic Class: Analgesic Combination, Opioid
Chemical Class: Opioid
Uses for benzhydrocodone and acetaminophen
Benzhydrocodone and acetaminophen combination is used to relieve short-term pain (no more than 14 days) in patients who have taken other pain treatments (eg, non-opioid pain medicines) that did not work well.
Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when tak..