Acamprosate Calcium (Acamprosate Calcium)

Trade Name : Acamprosate Calcium

Teva Pharmaceuticals USA, Inc.

TABLET, DELAYED RELEASE

Strength 333 mg/1

Storage and handling for Acamprosate Calcium

ACAMPROSATE CALCIUM

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Acamprosate Calcium (Acamprosate Calcium) which is also known as Acamprosate Calcium and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 333 mg/1 per ml. Read more

Acamprosate Calcium (Acamprosate Calcium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

No data

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 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 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 (, ).
Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support ().

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.
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 is contraindicated in patients with severe renal impairment (creatinine clearance of u2264 30 mL/min) [].

Recommended dose: 666 mg (two 333 mg tablets) taken three times daily ().
Dose reduction to one 333 mg tablet taken three times daily for patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min) ().
Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of u2264 30 mL/min) (, , , , ).

Acamprosate Calcium Delayed-release Tablets are supplied as follows:
333 mg: White to off-white, round, enteric-coated, biconvex, unscored tablet debossed with 77 on one side and 1140 on the other side.
Enteric-coated tablets, 333 mg ().

No data

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 ().

No data

Dose reduction is required for patients with moderate renal impairment ().
Monitor patients for depression or suicidal ideation and prompt patients, families, and caregivers to report such symptoms to the healthcare provider ().

Common adverse events that occurred in any acamprosate calcium treatment group at a rate of 3% or greater and greater than the placebo group in controlled clinical trials with spontaneously reported adverse events are: accidental injury, asthenia, pain, anorexia, diarrhea, flatulence, nausea, anxiety, depression, dizziness, dry mouth, insomnia, paresthesia, pruritus and sweating ().
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Acamprosate does not affect the pharmacokinetics of alcohol. The pharmacokinetics of acamprosate are not affected by alcohol, diazepam, or disulfiram, and clinically important interactions between naltrexone and acamprosate were not observed [].

No data

Pregnancy: Acamprosate calcium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus ().
Nursing Mothers: Caution should be exercised when acamprosate calcium is administered to a nursing woman ().
Renal Impairment: Dose reduction required for moderate renal impairment; contraindicated in severe renal impairment (, , , , ).

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.

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 u03b3-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name is calcium acetylaminopropane sulfonate. Its structural formula is:
CHNOSCa M.W. 400.48
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 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, hypromellose, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, 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.

No data

Dietary administration of acamprosate calcium for 2 years to Sprague-Dawley rats at doses of 25, 100 and 400 mg/kg/day (up to 3 times the maximum recommended human daily (MRHD) oral dose on an AUC basis) and CD-1 mice at doses of 400, 1200 and 3600 mg/kg/day (up to 25 times the MRHD on an AUC basis) showed no evidence of increased tumor incidence.
Acamprosate calcium was negative in all genetic toxicology studies conducted. Acamprosate calcium demonstrated no evidence of genotoxicity in an bacterial reverse point mutation assay (Ames assay) or an mammalian cell gene mutation test using Chinese Hamster Lung V79 cells. No clastogenicity was observed in an chromosomal aberration assay in human lymphocytes and no chromosomal damage detected in an mouse micronucleus assay.
Acamprosate calcium had no effect on fertility after treatment for 70 days prior to mating in male rats and for 14 days prior to mating, throughout mating, gestation and lactation in female rats at doses up to 1000 mg/kg/day (approximately 4 times the MRHD oral dose on a mg/m basis). In mice, acamprosate calcium administered orally for 60 days prior to mating and throughout gestation in females at doses up to 2400 mg/kg/day (approximately 5 times the MRHD oral dose on a mg/m basis) had no effect on fertility.

The efficacy of acamprosate calcium in the maintenance of abstinence was supported by three clinical studies involving a total of 998 patients who were administered at least one dose of acamprosate calcium or placebo as an adjunct to psychosocial therapy. Each study was a double-blind, placebo-controlled trial in alcohol-dependent patients who had undergone inpatient detoxification and were abstinent from alcohol on the day of randomization. Study durations ranged from 90 days to 360 days. Acamprosate calcium proved superior to placebo in maintaining abstinence, as indicated by a greater percentage of subjects being assessed as continuously abstinent throughout treatment.
In a fourth study, the efficacy of acamprosate calcium was evaluated in alcoholics, including patients with a history of polysubstance abuse and patients who had not undergone detoxification and were not required to be abstinent at baseline. This study failed to demonstrate superiority of acamprosate calcium over placebo.

Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Physicians are advised to discuss the following issues with patients for whom they prescribe acamprosate calcium.
Renal Impairment
A lower dose is recommended for patients with moderate renal impairment. Acamprosate calcium is contraindicated in patients with severe renal impairment (creatine clearance of u2264 30 mL/min) [].
Suicidality and Depression
Families and caregivers of patients being treated with acamprosate calcium should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient's healthcare provider [].
Alcohol Withdrawal
Use of acamprosate calcium does not eliminate or diminish withdrawal symptoms [].
Pregnancy and Breastfeeding
Relapse to Drinking
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. B 8/2016

No data

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