Drug Catalog - Product Detail
ACAMPROSATE CALCIUM TB 333MG 180
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0435-18 | GLENMARK PHARMACEUTICALS | 180 | 333MG | TABLET |
PACKAGE FILES
Generic Name
ACAMPROSATE CALCIUM
Substance Name
ACAMPROSATE CALCIUM
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202229
Description
11 DESCRIPTION Acamprosate calcium delayed-release tablets are supplied as an enteric-coated tablet for oral administration. Acamprosate calcium, USP 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 bis [3-(acetylamino) propane-1-sulfonate]. Its chemical formula is C 10 H 20 CaN 2 O 8 S 2 and molecular weight is 400.5 g/mol. Its structural formula is: Acamprosate calcium, USP is a white to almost white powder, odorless or nearly odorless powder. It is freely soluble in water and practically insoluble in alcohol and methylene chloride. Each acamprosate calcium delayed-release tablet contains acamprosate calcium, USP 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in acamprosate calcium delayed-release tablets include: colloidal silicon dioxide, crospovidone, methacrylic acid copolymer dispersion, magnesium silicate, magnesium stearate, microcrystalline cellulose, polyvinyl pyrollidone, propylene glycol, sodium starch glycolate, and talc. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product. Structure.jpg
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Acamprosate calcium delayed-release tablets, 333 mg are white to off-white, round, biconvex, enteric-coated tablets debossed with ‘435’ on one side and plain on the other side. Bottle of 180, NDC 68462-435-18 Carton of 100 (10 x 10 Unit-Dose Blisters), NDC 68462-435-11 Storage and Handling Store at 20ºC to 25°C(68° F to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed. • Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation ( 1 , 14 ). • Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support ( 1 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dose of acamprosate calcium delayed-release tablets 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 acamprosate calcium delayed-release tablets 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. Acamprosate calcium delayed-release tablets should be used as part of a comprehensive psychosocial treatment program. • Recommended dose: 666 mg (two 333 mg tablets) taken three times daily ( 2 ). • Dose reduction to one 333 mg tablet taken three times daily for patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min) ( 2.1 ). • Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) ( 2.1 , 4.2 , 5.1 , 8.6 , 12.3 ). 2.1 Dosage in Renal Impairment For patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended. Acamprosate calcium delayed-release tablets are 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 )] .