NORCO- hydrocodone bitartrate and acetaminophen tablet
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
Addiction, Abuse, and Misuse
NORCO ® 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 NORCO , 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 NORCO . Monitor for respiratory depression, especially during initiation of NORCO or following a dose increase [see WARNINGS ].
Accidental ingestion of NORCO , especially by children, can result in a fatal overdose of NORCO [see WARNINGS ].
Neonatal Opioid Withdrawal Syndrome
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. 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 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. In addition, discontinuation of a concomitantly used C ytochrome P450 3A4 inducer may result in an increase in NORCO plasma concentration s . Monitor patients receiving NORCO and any Cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation [see CLINICAL PHARMACOLOGY , WARNINGS , and PRECAUTIONS; Drug Interactions ].
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 sedation, respiratory depression, coma, and death [see WARNINGS and PRECAUTIONS; Drug Interactions ] .
- Reserve concomitant prescribing of NORCO 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.
NORCO® (hydrocodone bitartrate and acetaminophen) is available in tablet form for oral administration.
Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:
C18 H21 NO3 •C4 H6 O6 •2½H2 O M.W. = 494.49
Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
C8 H9 NO2 M.W. = 151.16
Each NORCO Tablet, 5 mg/325 mg contains:
Hydrocodone Bitartrate ……..5 mg
Acetaminophen ………………..325 mg
Each NORCO Tablet, 7.5 mg/325 mg contains:
Hydrocodone Bitartrate ……..7.5 mg
Acetaminophen ………………..325 mg
Each NORCO Tablet, 10 mg/325 mg contains:
Hydrocodone Bitartrate ……..10 mg
Acetaminophen ………………..325 mg
In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
Meets USP Dissolution Test 1.
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.
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