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NORCO (HYDROCODONE/ACETAMINOPHEN) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

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 4,5-alpha-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following formula: C18H21NO3xC4H6O6x21/2H2O; M. W. = 494.49

Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, nonsalicylate analgesic and antipyretic. It has the following formula: C8H9NO2; 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: crospovidone, croscarmellose sodium, magnesium stearate, povidone, microcrystalline cellulose, pregelatinized starch, and stearic acid.


CLINICAL PHARMACOLOGY

Mechanism of Action

Hydrocodone in Norco tablets is full opioid agonist with relative selectivity for the mu-opioid (Łg) 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.


PHARMACODYNAMICS

Norco pharmacodynamics


PHARMACOKINETICS

Norco pharmacokinetics


INDICATIONS AND USAGE

Norco (Hydrocodone Bitartrate and Acetaminophen) tablets are indicated for the management of 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, reserve Norco 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


    CONTRAINDICATIONS

    Norco (Hydrocodone Bitartrate and Acetaminophen) is contraindicated in patients with:

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis)


    WARNINGS

    Norco warnings


    SPECIAL WARNINGS

    Norco special warnings


    RISKS

    Norco risks


    WITHDRAWAL

    Norco withdrawal


    PRECAUTIONS

    Norco precautions


    DRUG INTERACTIONS

    Norco drug interactions


    NONCLINICAL TOXICOLOGY

    Norco nonclinical toxicology


    USE IN SPECIAL POPULATIONS

    Norco use in special populations


    ADVERSE REACTIONS

    Norco adverse reactions


    DRUG ABUSE AND DEPENDENCE

    Norco drug abuse and dependence


    OVERDOSAGE

    Norco overdosage


    DOSAGE AND ADMINISTRATION

    Norco dosage and administration


    HOW SUPPLIED

    Norco (Hydrocodone, Acetaminophen) is supplied as:

    Norco 5/325 capsule-shaped, white tablets bisected on one side and debossed with "NORCO 071" on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100.

    Norco 7.5/325 capsule-shaped, white tablets bisected on one side and debossed with "NORCO 729" on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.

    Norco 10/325 capsule-shaped, white tablets bisected on one side and debossed with "NORCO 539" on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.

    Storage

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

    Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.

    Manufactured and distributed by Allergan, Warner Chilcott pharmaceutical companies and their divisions.

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