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Acamprosate Calcium DR 333 Mg Tablets 180 By Glenmark

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Acamprosate Calcium DR 333 Mg Tablets 180 By Glenmark

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Acamprosate Calcium DR 333 Mg Tablets 180 By Glenmark Item Number.:RXD3634276/RXB10125225/RXA323340
Size : 180
Selling UoM : EA
NDC: 68462-0435-18
UPC Barcode : 304563330018
Supplier: 0050001394 GLENMARK GENERICS INC.
Supplier Material : 043518
Generic Code : 025600 ACAMPROSATE CALCIUM ORAL TABLET DR 333 M
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

Tablet , enteric-coated , white , round round
White to off-whiteBiconvexDebossed

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.

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.

INDICATIONS

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.
DOSAGE AND ADMINISTRATION

The recommended dose of CAMPRAL is two 333 mg tablets (each dose should total 666 mg) taken three times daily. Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested as an aid to compliance in those patients who regularly eat three meals daily. A lower dose may be effective in some patients.

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.

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. Patients with severe renal impairment (creatinine clearance of ≤ 30 mL/min) should not be given CAMPRAL.

SIDE EFFECTS

The adverse event data described below reflect the safety experience in over 7000 patients exposed to CAMPRAL for up to one year, including over 2000 CAMPRAL-exposed patients who participated in placebo-controlled trials.

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