Acamprosate calcium

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Acamprosate calcium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Overview

Acamprosate calcium is an ethanol dependency that is FDA approved for the {{{indicationType}}} of maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Common adverse reactions include accidental injury, asthenia, pain, anorexia, diarrhea, flatulence, nausea, anxiety, depression, dizziness, dry mouth, insomnia, paresthesia, pruritus and sweating..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acamprosate Calcium is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.

  • Treatment with Acamprosate Calcium should be part of a comprehensive management program that includes psychosocial support.
  • Dosage: Two 333 mg tablets (each dose should total 666 mg) taken three times daily.
  • 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Acamprosate calcium in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Acamprosate calcium in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Acamprosate calcium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Acamprosate calcium in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Acamprosate calcium in pediatric patients.

Contraindications

Hypersensitivity to Acamprosate Calcium

  • Acamprosate Calcium is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components.

Severe Renal Impairment

  • Acamprosate Calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min).

Warnings

Renal Impairment

  • Treatment with Acamprosate Calcium in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) requires a dose reduction.
  • Acamprosate Calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min).

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 2272 (0.13%) patients in the pooled acamprosate group from all controlled studies and 2 of 1962 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 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.

Alcohol Withdrawal

  • Use of Acamprosate Calcium does not eliminate or diminish withdrawal symptoms.

Adverse Reactions

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.

The adverse event data described below reflect the safety experience in over 7000 patients exposed to Acamprosate Calcium for up to one year, including over 2000 Acamprosate Calcium-exposed patients who participated in placebo-controlled trials.

Adverse Events Leading to Discontinuation

In placebo-controlled trials of 6 months or less, 8% of Acamprosate Calcium-treated patients discontinued treatment due to an adverse event, as compared to 6% of patients treated with placebo. In studies longer than 6 months, the discontinuation rate due to adverse events was 7% in both the placebo-treated and the Acamprosate Calcium-treated patients. Only diarrhea was associated with the discontinuation of more than 1% of patients (2% of Acamprosate Calcium-treated vs. 0.7% of placebo-treated patients). Other events, including nausea, depression, and anxiety, while accounting for discontinuation in less than 1% of patients, were nevertheless more commonly cited in association with discontinuation in Acamprosate Calcium-treated patients than in placebo-treated patients.

Common Adverse Events Reported in Controlled Trials

Common adverse events were collected spontaneously in some controlled studies and using a checklist in other studies. The overall profile of adverse events was similar using either method. TABLE 1 shows those 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. The reported frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed, without regard to the causal relationship of the events to the drug.

Postmarketing Experience

There is limited information regarding Acamprosate calcium Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Acamprosate calcium Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Acamprosate calcium in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Acamprosate calcium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Acamprosate calcium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Acamprosate calcium in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Acamprosate calcium in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Acamprosate calcium in geriatric settings.

Gender

There is no FDA guidance on the use of Acamprosate calcium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Acamprosate calcium with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Acamprosate calcium in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Acamprosate calcium in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Acamprosate calcium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Acamprosate calcium in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Acamprosate calcium Administration in the drug label.

Monitoring

There is limited information regarding Acamprosate calcium Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Acamprosate calcium and IV administrations.

Overdosage

There is limited information regarding Acamprosate calcium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Acamprosate calcium Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Acamprosate calcium Mechanism of Action in the drug label.

Structure

There is limited information regarding Acamprosate calcium Structure in the drug label.

Pharmacodynamics

There is limited information regarding Acamprosate calcium Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Acamprosate calcium Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Acamprosate calcium Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Acamprosate calcium Clinical Studies in the drug label.

How Supplied

There is limited information regarding Acamprosate calcium How Supplied in the drug label.

Storage

There is limited information regarding Acamprosate calcium Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Acamprosate calcium Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Acamprosate calcium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Acamprosate calcium Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Acamprosate calcium Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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