Acamprosatedrug info
acamprosate calcium 333 MG Delayed Release Oral Tablet
What it is used for
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. 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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 6, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Acamprosate calcium, USP is supplied in 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 acetylaminopropane sulfonate. Its chemical formula is C 10 H 20 N 2 O 8 S 2 Ca and molecular weight is 400.5.
Its structural formula is: Acamprosate calcium, USP is a white or almost white powder. It is freely soluble in water, practically insoluble in alcohol and in methylene chloride. Each acamprosate calcium delayed-release tablet intended for oral administration contains 333 mg of acamprosate calcium, USP equivalent to 300 mg of acamprosate. In addition, each tablet contains the following inactive ingredients: colloidal anhydrous silica, methacrylic acid copolymer type c, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium bicarbonate, sodium lauryl sulfate, 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. figure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 6, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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