Acamprosate Calcium
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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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
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.
History
There is currently no drug history available for this drug.
Other Information
Acamprosate calcium delayed-release tablets are supplied as 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 bis [3-(acetylamino) propane-1-sulfonate]. Its chemical formula is C10H20CaN2O8S2 and molecular weight is 400.5. Its structural formula is:
Acamprosate calcium 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 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.
Sources
Acamprosate Calcium Manufacturers
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American Health Packaging
![Acamprosate Calcium Tablet, Delayed Release [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Acamprosate Calcium | Unifirst First Aid Corporation
remove tamper evident seal and cap flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle. -
Glenmark Generics Inc.,usa
Acamprosate Calcium | Glenmark Pharmaceuticals Inc., Usa
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.
2.1 Dosage in Renal ImpairmentFor 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)].
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Forest Laboratories, Inc.
Acamprosate Calcium | Forest Laboratories, Inc.
The recommended dose of Acamprosate Calcium 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 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 should be used as part of a comprehensive psychosocial treatment program.
2.1 Dosage in Renal ImpairmentFor 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. Acamprosate Calcium 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)].
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Mylan Pharmaceuticals Inc.
Acamprosate Calcium | Mylan Pharmaceuticals Inc.
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.
2.1 Dosage in Renal ImpairmentFor 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)].
![Acamprosate Calcium Tablet, Delayed Release [Glenmark Generics Inc.,usa]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
![Acamprosate Calcium Tablet, Coated [Forest Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dbcce015-13fb-4a9e-a9a8-553e2aef4242&name=aca00-0000-02.jpg)
![Acamprosate Calcium (Acamprosate Calcium Enteric-coated) Tablet, Delayed Release [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=75ddfd10-55b2-426e-bc74-3413cd0d7c94&name=5bf6f9a0-c65b-4301-b599-653fac1b60c2-02.jpg)
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