Vicodin label

Vicodin

Vicodin Recall

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Questions & Answers

Question

Blair Pearl

Vicodin makes my stomach hurt if I take it for more than two, continual does.

posted on October 26, 2015

Side Effects & Adverse Reactions

Respiratory Depression

At high doses or in sensitive patients, hydrocodone may produce doserelated respiratory depression by acting directly on the brain stem respiratory center. Hydro codone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Misuse, Abuse, and Diversion of Opioids

VICODIN tablets contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.

VICODIN tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing VICODIN tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

VICODIN tablets are indicated for the relief of moderate to moderately severe pain.

History

There is currently no drug history available for this drug.

Other Information

Hydrocodone bitartrate and acet aminophen is supplied in tablet form for oral administration.

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5⟨-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

Chemical structure for Hydrocodone bitartrate.

C18H21NO3•C4H6O6•2½H2O   M.W. 494.50

Acetaminophen, 4’-hydroxyacetani lide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and anti pyretic. It has the following structural formula:

Chemical structure for acetaminophen.

C8H9NO2    M.W. 151.16

Each VICODIN tablet contains:

Hydrocodone Bitartrate 5 mg

Acetaminophen 500 mg

In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, starch, cros carmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, povidone, and stearic acid.

Meets USP Dissolution Test 2.

Vicodin Manufacturers

  • Vicodin | Cardinal Health
    No Recall

    Vicodin | Cardinal Health

    Vicodin | Cardinal Health

    Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

    The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.

  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Vicodin | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    No Recall

    Vicodin | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

    Vicodin | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

    Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

    The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.