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Cheap qualitative Hydrocodone Bitartrate with Acetaminophen 10/325 mg tablets



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VICODIN, VICODIN ES, VICODIN HP (HYDROCODONE/ACETAMINOPHEN) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Hydrocodone Bitartrate and Acetaminophen are 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).

Acetaminophen (Paracetamol), 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic.

Each Vicodin (Hydrocodone Bitartate and Acetaminophen Tablets, USP 5 mg / 300 mg) contains:

Hydrocodone Bitartrate 5 mg
Acetaminophen 300 mg

Each Vicodin ES (Hydrocodone Bitartate and Acetaminophen Tablets, USP 7.5 mg / 300 mg) contains:

Hydrocodone Bitartrate 7.5 mg
Acetaminophen 300 mg

Each Vicodin HP (Hydrocodone Bitartate and Acetaminophen Tablets, USP 10 mg / 300 mg) contains:

Hydrocodone Bitartrate 10 mg
Acetaminophen 300 mg

In addition, each tablet contains the following inactive ingredients: crospovidone, colloidal silicon dioxide, magnesium stearate, povidone, microcrystalline cellulose, pregelatinized starch, stearic acid.

This product complies with USP dissolution test 2.


CLINICAL PHARMACOLOGY

Mechanism of Action

Hydrocodone is a full opioid agonist with relative selectivity for the mu-opioid () receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone in Vicodin, Vicodin ES, Vicodin HP tablets 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

Vicodin, Vicodin ES, Vicodin HP pharmacodynamics


PHARMACOKINETICS

Vicodin, Vicodin ES, Vicodin HP pharmacokinetics


INDICATIONS AND USAGE

Vicodin (Hydrocodone Bitartrate, 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 hydrocodone bitartrate and acetaminophen tablets 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

    Vicodin, Vicodin ES, Vicodin HP tablets are 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

    Vicodin, Vicodin ES, Vicodin HP warnings


    SPECIAL WARNINGS

    Vicodin, Vicodin ES, Vicodin HP special warnings


    RISKS

    Vicodin, Vicodin ES, Vicodin HP risks


    WITHDRAWAL

    Vicodin, Vicodin ES, Vicodin HP withdrawal


    PRECAUTIONS

    Vicodin, Vicodin ES, Vicodin HP precautions


    DRUG INTERACTIONS

    Vicodin, Vicodin ES, Vicodin HP drug interactions


    NONCLINICAL TOXICOLOGY

    Vicodin, Vicodin ES, Vicodin HP nonclinical toxicology


    USE IN SPECIAL POPULATIONS

    Vicodin, Vicodin ES, Vicodin HP use in special populations


    ADVERSE REACTIONS

    Vicodin, Vicodin ES, Vicodin HP adverse reactions


    DRUG ABUSE AND DEPENDENCE

    Vicodin, Vicodin ES, Vicodin HP drug abuse and dependence


    OVERDOSAGE

    Vicodin, Vicodin ES, Vicodin HP overdosage


    DOSAGE AND ADMINISTRATION

    Vicodin, Vicodin ES, Vicodin HP dosage and administration


    HOW SUPPLIED

    Vicodin, Vicodin ES, Vicodin HP (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP are supplied as:

    Vicodin 5 mg / 300 mg: white, capsule-shaped, bisected tablets debossed "5" score "300" on one side and "VICODIN" on the other side in bottles of 100 and 500 tablets.

    Vicodin ES 7.5 mg / 300 mg: white, capsule-shaped, bisected tablets debossed "7.5" score "300" on one side and "VICODIN ES" on the other side in bottles of 100 and 500 tablets.

    Vicodin HP 10 mg / 300 mg: white, capsule-shaped, bisected tablets debossed "10" score "300" on one side and "VICODIN HP" on the other side in bottles of 100 and 500 tablets.

    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 AbbVie, Mikart pharmaceutical companies and theit divisions.

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