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Acamprosate Calcium (Acamprosate Calcium)

Trade Name : Acamprosate Calcium

Marlex Pharmaceuticals Inc

TABLET, DELAYED RELEASE

Strength 333 mg/1

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 Marlex Pharmaceuticals 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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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.

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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.

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.

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  • 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 psychosocialu00a0support.
  • 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 alcoholu00a0abstinenceu00a0prior 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 adequatelyu00a0assessed.
  • Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients withu00a0alcoholu00a0dependence who areu00a0abstinentu00a0atu00a0treatmentu00a0initiation (,u00a0).n
  • Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial supportu00a0().
  • The recommended dose of acamprosate calcium delayed-release tablets is two 333 mg tablets (each doseu00a0shouldu00a0totalu00a0666u00a0mg)u00a0takenu00a0threeu00a0timesu00a0daily.u00a0Au00a0loweru00a0doseu00a0mayu00a0beu00a0effectiveu00a0inu00a0someu00a0patients.
  • 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 treatmentu00a0program.
  • 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 u226430 mL/min) n n n n n n n n n n n n n .
  • Recommendedu00a0dose:u00a0666u00a0mgu00a0(twou00a0333u00a0mgu00a0tablets)u00a0takenu00a0threeu00a0timesu00a0dailyu00a0().n
  • Dose reduction to one 333 mg tablet taken three times daily for patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min)u00a0().n
  • Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine clearanceu00a0ofu00a0u226430 mL/min)u00a0(,u00a0,u00a0,u00a0,u00a0).
  • Acamprosate calcium delayed-release tablets, 333 mg are white to off white, round, biconvex, enteric coated tablets, with u2018435u2019 debossed on one side and plain on other u00a0side.
  • Enteric-coated tablets, 333 mgu00a0().
  • No data
  • Acamprosate calcium is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its componentsu00a0().n
  • Acamprosate calcium is contraindicated in patients with severe renal impairmentu00a0().
  • No data
  • Dose reduction is required for patients with moderate renal impairmentu00a0().n
  • Monitoru00a0patientsu00a0foru00a0depressionu00a0or suicidalu00a0ideation andu00a0promptu00a0patients,u00a0families,u00a0andu00a0caregiversu00a0tou00a0reportu00a0such symptoms to the health care provideru00a0().
  • 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 sweatingu00a0().
  • 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 n n n n .
  • No data
  • Pregnancy: Acamprosate calcium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetusu00a0().n
  • Nursing Mothers: Caution should be exercised when acamprosate calcium is administered to a nursing womanu00a0().n
  • Renal Impairment: Dose reduction required for moderate renal impairment; contraindicated in severe renal impairmentu00a0(,u00a0,u00a0,u00a0,u00a0)
  • 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 andu00a0supportive.
  • 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 u03b3-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name is calcium bis [3-(acetylamino) propane-1-sulfonate]. Its chemical formula is CHCaNOSand 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.
  • 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 AUCu00a0basis) showed no evidence of increased tumoru00a0incidence.
  • 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 usingu00a0Chinese Hamster Lung V79 cells. No clastogenicity was observed in an chromosomal aberration assay in human lymphocytes and no chromosomal damage detected in an n mouse micronucleusu00a0assay.
  • 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/mbasis). 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/mbasis) 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 u00a0treatment.
  • 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 overu00a0placebo.
  • Acamprosate calcium delayed-release tablets, 333 mg are white to off white, round, biconvex, enteric coated tablets, with u2018435u2019 debossed on one side and plain on otheru00a0side.
  • Opaque HDPE bottles of 180- NDCu00a010135-0636-32
  • Storage and Handling
  • Store at 25u00baC (77u00baF); excursions permitted to 15u00ba to 30u00baC (59u00ba to 86u00baF) [see USP Controlled Room Temperature].
  • Physicians are advised to discuss the following issues with patients for whom they prescribe acamprosate calcium.
  • Renalu00a0Impairment
  • A lower dose is recommended for patients with moderate renal impairment. Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of u226430 mL/min) n n n n n n n n u00a0n n n n n .
  • 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 health care provider n n n n .
  • Alcoholu00a0Withdrawal
  • Use of acamprosate calcium does not eliminate or diminish withdrawal symptoms n n n n .
  • Pregnancy and Breastu00a0Feeding
  • Relapse tou00a0Drinking
  • Manufacturedu00a0for:n n New Castle, DEu00a019720
  • Distributedu00a0by:n n New Castle, DEu00a019720
  • Rev.07/16GM
  • NDC 10135-0636-32Acamprosate CalciumDelayed-ReleaseTablets333 mgRx Only180 TABLETS

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