In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. It has the following structural formula:Įach NORCO Tablet, 7.5 mg/325 mg contains:Įach NORCO Tablet, 10 mg/325 mg contains: It has the following structural formula:Īcetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. NORCO ® (hydrocodone bitartrate and acetaminophen) is available in tablet form for oral administration.

Follow patients for signs and symptoms of respiratory depression and sedation.

Limit dosages and durations to the minimum required.

Reserve concomitant prescribing of NORCO and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

Risks From Concomitant Use With Benzodiazepines Or Other CNS DepressantsĬoncomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, 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. Īcetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Monitor patients receiving NORCO and any Cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation. In addition, discontinuation of a concomitantly used C ytochrome P450 3A4 inducer may result in an increase in NORCO plasma concentration s. The concomitant use of NORCO with all C ytochrome P450 3A4 inhibitors may result in an increase in NORCO plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. 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. Prolonged use of NORCO 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. Īccidental ingestion of NORCO, especially by children, can result in a fatal overdose of NORCO. Monitor for respiratory depression, especially during initiation of NORCO or following a dose increase. Serious, life-threatening, or fatal respiratory depression may occur with use of NORCO.

consider other tools to improve patient, household, and community safety.

emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and.

counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,.

complete a REMS-compliant education program,.

Healthcare providers are strongly encouraged to Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. 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. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Assess each patient’s risk prior to prescribing NORCO, and monitor all patients regularly for the development of these behaviors and conditions. NORCO ® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

WARNING: ADDICTION, ABUSE, AND MISUSE RISK EVALUATION AND MITIGATION ST R ATEGY (REMS) LIFE-THREATENING RESPIRATORY DEPRESSION ACCIDENTAL INGESTION NEONATAL OPIOID WITHDRAWAL SYNDROME CYTOCHROME P450 3A4 INTERACTION HEPATOTOXICITY and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Norco pain medication