Campral label

Campral

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Manufacturer Warnings

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Uses

Campral® is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with Campral should be part of a comprehensive management program that includes psychosocial support.

The efficacy of Campral in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning Campral treatment. The efficacy of Campral in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.

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History

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Other Information

Campral (acamprosate calcium) is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analogue of the amino acid neurotransmitter γ-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name is calcium acetylaminopropane sulfonate. Its chemical formula is C10H20N2O8S2Ca and molecular weight is 400.48. Its structural formula is:

Structural Formula

Acamprosate calcium is a white, odorless or nearly odorless powder. It is freely soluble in water, and practically insoluble in absolute ethanol and dichloromethane.

Each Campral tablet contains acamprosate calcium 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in Campral tablets include: crospovidone, microcrystalline cellulose, magnesium silicate, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, talc, propylene glycol and Eudragit® L 30 D or equivalent. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product.

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Campral Manufacturers

  • Forest Laboratories, Inc.
    Campral |
    No Recall

    Campral |

    Campral |

    The recommended dose of Campral is two 333 mg tablets (each dose should total 666 mg) taken three times daily. A lower dose may be effective in some patients.

    Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested in those patients who regularly eat three meals daily.

    Treatment with Campral should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses. Campral should be used as part of a comprehensive psychosocial treatment program.

    2.1 Dosage in Renal Impairment

    For patients with moderate renal impairment (creatinine clearance of 30-50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended. Campral is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [see Contraindications (4.2), Warnings and Precautions (5.1), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

  • Carilion Materials Management
    Campral | Carilion Materials Management
    No Recall

    Campral | Carilion Materials Management

    Campral | Carilion Materials Management

    The recommended dose of Campral is two 333 mg tablets (each dose should total 666 mg) taken three times daily. A lower dose may be effective in some patients.

    Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested in those patients who regularly eat three meals daily.

    Treatment with Campral should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses. Campral should be used as part of a comprehensive psychosocial treatment program.

    2.1 Dosage in Renal Impairment

    For patients with moderate renal impairment (creatinine clearance of 30-50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended. Campral is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [ and ]. see Contraindications ( ), Warnings and Precautions ( ), Use in Specific Populations ( ), 4.25.18.6Clinical Pharmacology ( ) 12.3

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