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Acamprosate Calcium
Overview
What is Acamprosate Calcium?
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 C
H
CaN
O
S
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.
What does Acamprosate Calcium look like?
What are the available doses of Acamprosate Calcium?
Enteric-coated tablets, 333 mg (
).
What should I talk to my health care provider before I take Acamprosate Calcium?
How should I use Acamprosate Calcium?
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.
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.
What interacts with Acamprosate Calcium?
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What are the warnings of Acamprosate Calcium?
Sorry No Records found
What are the precautions of Acamprosate Calcium?
Sorry No Records found
What are the side effects of Acamprosate Calcium?
Sorry No records found
What should I look out for while using Acamprosate Calcium?
Acamprosate calcium is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components (
).
Acamprosate calcium is contraindicated in patients with severe renal impairment (
).
What might happen if I take too much Acamprosate Calcium?
In all reported cases of acute overdosage with acamprosate calcium (total reported doses of up to 56 grams of acamprosate calcium), the only symptom that could be reasonably associated with acamprosate calcium was diarrhea. Hypercalcemia has not been reported in cases of acute overdose. A risk of hypercalcemia should be considered in chronic overdosage only. Treatment of overdose should be symptomatic and supportive.
How should I store and handle Acamprosate Calcium?
Store at 25°C (77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Acamprosate calcium delayed-release tablets, 333 mg are white to off white, round, biconvex, enteric coated tablets, with ‘435’ debossed on one side and plain on other side.Unit dose packages of 30 (5 x 6) NDC 60687-121-25 Storage and Handling Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Acamprosate calcium delayed-release tablets, 333 mg are white to off white, round, biconvex, enteric coated tablets, with ‘435’ debossed on one side and plain on other side.Unit dose packages of 30 (5 x 6) NDC 60687-121-25 Storage and Handling Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Acamprosate calcium delayed-release tablets, 333 mg are white to off white, round, biconvex, enteric coated tablets, with ‘435’ debossed on one side and plain on other side.Unit dose packages of 30 (5 x 6) NDC 60687-121-25 Storage and Handling Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Acamprosate calcium delayed-release tablets, 333 mg are white to off white, round, biconvex, enteric coated tablets, with ‘435’ debossed on one side and plain on other side.Unit dose packages of 30 (5 x 6) NDC 60687-121-25 Storage and Handling Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Acamprosate calcium delayed-release tablets, 333 mg are white to off white, round, biconvex, enteric coated tablets, with ‘435’ debossed on one side and plain on other side.Unit dose packages of 30 (5 x 6) NDC 60687-121-25 Storage and Handling Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of acamprosate in maintenance of alcohol abstinence is not completely understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition.
and
studies in animals have provided evidence to suggest acamprosate may interact with glutamate and GABA neurotransmitter systems centrally, and has led to the hypothesis that acamprosate restores this balance.
Non-Clinical Toxicology
Acamprosate calcium is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components ( ).Acamprosate calcium is contraindicated in patients with severe renal impairment ( ).
Other sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol.
Albuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of albuterol on the vascular system may be potentiated.
Beta-receptor blocking agents and albuterol inhibit the effect of each other.
Treatment with acamprosate calcium in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min) requires a dose reduction [ ]. Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [ and ].
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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