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acamprosate calc dr 333 mg tab

Out of Stock Manufacturer GLENMARK PHARMA 68462043518
Out of Stock

Uses

Alcohol Dependence

Acamprosate calcium is used in the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at the time acamprosate therapy is initiated. Acamprosate should be used in conjunction with a comprehensive management program that includes psychosocial support. Acamprosate has not been shown to provide therapeutic benefit in individuals who have not undergone detoxification and have not achieved abstinence from alcohol ingestion prior to initiation of the drug. Whether acamprosate is effective in promoting abstinence from alcohol ingestion in individuals who abuse multiple substances has not been established to date.

When used in conjunction with psychosocial support, acamprosate reportedly helps maintain abstinence from alcohol ingestion. In several randomized, placebo-controlled clinical studies evaluating acamprosate as an adjunct to psychosocial therapy in alcohol-dependent patients who had undergone inpatient detoxification and were abstinent on the day of randomization, reported rates of abstinence throughout the duration of the studies (90-360 days) were higher in patients receiving acamprosate (18-45%) than in those receiving placebo (11-25%). However, in some randomized, placebo-controlled studies in alcohol-dependent patients who received little psychosocial support and who underwent detoxification but were not required to be abstinent at or near the time of study-drug initiation, rates of abstinence in patients receiving acamprosate were similar to rates in patients receiving placebo. Acamprosate was no more effective than placebo in a study in alcohol-dependent patients that included individuals who had a history of multiple-substance abuse and/or had not undergone detoxification; in addition, patients enrolled in this study were not required to be abstinent at study entry.

Although comparative studies are limited, efficacy of acamprosate appears to be comparable to that of naltrexone. Acamprosate can be used in conjunction with naltrexone or disulfiram.

Dosage and Administration

Administration

Acamprosate calcium can be administered orally without regard to meals. However, for patients who regularly eat 3 meals a day, administration of the drug with meals may improve compliance.

Dosage

The recommended dosage of acamprosate calcium for maintenance of abstinence from alcohol ingestion in adults with normal renal function (creatinine clearance exceeding 50 mL/minute) is 666 mg 3 times daily. A lower dosage (1.3 g daily given in 3 unequally divided doses of 666, 333, and 333 mg each) also was evaluated in clinical studies and may be effective in some patients.

Therapy with acamprosate should be initiated as soon as possible after alcohol withdrawal, when the patient has achieved abstinence from alcohol ingestion. Therapy with acamprosate can be continued even if the patient relapses.

Special Populations

The recommended initial dosage of acamprosate calcium for maintenance of abstinence from alcohol ingestion in adults with moderate renal impairment (creatinine clearance of 30-50 mL/minute) is 333 mg 3 times daily.(See Cautions: Renal Impairment.) The drug is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/minute).

No dosage adjustment is necessary in patients with mild to moderate hepatic impairment.(See Cautions: Hepatic Impairment.)

Dosage should be selected carefully in geriatric patients.(See Cautions: Geriatric Patients.)

Cautions

Contraindications

Known hypersensitivity to acamprosate or any ingredient in the formulation.

Severe renal impairment (creatinine clearance less than 30 mL/minute).

Warnings/Precautions

General Precautions

Withdrawal Symptoms

Acamprosate does not eliminate or diminish withdrawal symptoms.

Suicide Risk

In clinical studies of 1 year's duration, suicidality (i.e., suicidal ideation, suicide attempt, completed suicide) was reported more frequently in patients receiving acamprosate than in those receiving placebo (2.4 versus 0.8%). Completed suicide occurred in 0.13% of patients receiving acamprosate in clinical studies and in 0.1% of those receiving placebo. While many of these events occurred in the context of alcohol relapse, a consistent pattern between recovery from alcoholism and the emergence of suicidality was not identified. These studies excluded patients with severe psychiatric impairment, and review of safety data did not show a difference in the incidence of adverse events designated as depression between those receiving acamprosate and those receiving placebo. The existence of a relationship between alcohol dependence, depression, and suicidality is well known.

Closely monitor patients for symptoms of depression and suicidal thinking.

Specific Populations

Pregnancy

Category C.

Lactation

Acamprosate is distributed into milk in rats; caution if used in nursing women.

Pediatric Use

Safety and efficacy not established in children younger than 18 years of age. Acamprosate has been evaluated in a limited number of adolescents 16-19 years of age.

Geriatric Use

Experience in those 65 years of age or older insufficient to determine whether they respond differently than younger adults.

Pharmacokinetics not evaluated in geriatric individuals. Because geriatric patients frequently have decreased renal function, plasma concentrations of acamprosate are expected to be higher in geriatric individuals than in younger adults. Select drug dosage carefully. Consider monitoring renal function.

Hepatic Impairment

Pharmacokinetics not altered in patients with mild or moderate hepatic impairment (Child-Pugh class A or B). Safety and pharmacokinetics not evaluated in patients with severe hepatic impairment.

Renal Impairment

Acamprosate is eliminated in urine as unchanged drug; clearance depends on renal function. Dosage adjustment recommended in patients with creatinine clearance of 30-50 mL/minute.(See Dosage and Administration: Special Populations.) Contraindicated in patients with creatinine clearance less than 30 mL/minute.

Common Adverse Effects

Adverse effects reported in 5% or more of patients receiving acamprosate and more frequently than placebo include diarrhea and asthenia.

Drug Interactions

Safety profile in patients receiving acamprosate in conjunction with anxiolytics, hypnotics and sedatives (including benzodiazepines), or nonopiate analgesics in clinical studies was similar to that in patients receiving these drugs with placebo.

Alcohol

Pharmacokinetic interaction unlikely.

Antidepressants

Changes in weight (i.e., loss or gain) reported more frequently in patients receiving acamprosate concomitantly with an antidepressant than in patients receiving either agent alone.

No change in the pharmacokinetics of desipramine or imipramine.

Diazepam

Pharmacokinetic interaction unlikely.

Disulfiram

Pharmacokinetic interaction unlikely.

Naltrexone

Pharmacokinetic interaction (increased plasma concentrations of acamprosate; no change in plasma concentrations of naltrexone or its major metabolite, 6-β-naltrexol). No dosage adjustment recommended.

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