Acamprosate Calcium

ACAMPROSATE CALCIUM- acamprosate calcium tablet, delayed release
Mylan Institutional Inc.

1 INDICATIONS AND USAGE

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 tablet treatment. The efficacy of acamprosate calcium in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.

2 DOSAGE AND ADMINISTRATION

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.

2.1 Dosage in Renal Impairment

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 ≤ 30 mL/min) [see Contraindications (4.2), Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Acamprosate calcium delayed-release 333 mg tablets are white enteric-coated, round, unscored tablets imprinted with M over AC in black ink on one side of the tablet and blank on the other side.

4 CONTRAINDICATIONS

4.1 Hypersensitivity to Acamprosate Calcium

Acamprosate calcium delayed-release tablets are contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components.

4.2 Severe Renal Impairment

Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine clearance of ≤ 30 mL/min) [see Dosage and Administration (2.1), Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] .

5 WARNINGS AND PRECAUTIONS

May contain sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

5.1 Renal Impairment

Treatment with acamprosate calcium in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min) requires a dose reduction [see Dosage and Administration (2.1)]. Acamprosate is contraindicated in patients with severe renal impairment (creatinine clearance of ≤ 30 mL/min) [see Dosage and Administration (2.1), Contraindications (4.2), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

5.2 Suicidality and Depression

In controlled clinical trials of acamprosate calcium, adverse events of a suicidal nature (suicidal ideation, suicide attempts, completed suicides) were infrequent overall, but were more common in acamprosate calcium-treated patients than in patients treated with placebo (1.4% vs. 0.5% in studies of 6 months or less; 2.4% vs. 0.8% in year-long studies). Completed suicides occurred in 3 of 2,272 (0.13%) patients in the pooled acamprosate group from all controlled studies and 2 of 1,962 patients (0.10%) in the placebo group. Adverse events coded as “depression” were reported at similar rates in acamprosate calcium-treated and placebo-treated patients. Although many of these events occurred in the context of alcohol relapse, and the interrelationship between alcohol dependence, depression and suicidality is well-recognized and complex, no consistent pattern of relationship between the clinical course of recovery from alcoholism and the emergence of suicidality was identified. Alcohol-dependent patients, including those patients being treated with acamprosate calcium, should be monitored for the development of symptoms of depression or suicidal thinking. Families and caregivers of patients being treated with acamprosate 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.

5.3 Alcohol Withdrawal

Use of acamprosate calcium does not eliminate or diminish withdrawal symptoms.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinically significant serious adverse reactions associated with acamprosate calcium described elsewhere in labeling include suicidality and depression and acute kidney failure [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].

The adverse event data described below reflect the safety experience in over 7,000 patients exposed to acamprosate calcium for up to one year, including over 2,000 acamprosate calcium -exposed patients who participated in placebo-controlled trials.

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