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Acamprosate

	Pronunciation
	U.S. Brand Names
	Synonyms
	Generic Available
	Use
	Pregnancy Risk Factor
	Pregnancy Implications
	Lactation
	Contraindications
	Warnings/Precautions
	Adverse Reactions
	Overdosage/Toxicology
	Drug Interactions

	Ethanol/Nutrition/Herb Interactions
	Stability
	Mechanism of Action
	Pharmacodynamics/Kinetics
	Dosage
	Administration
	Dietary Considerations
	Patient Education
	Dental Health: Effects on Dental Treatment
	Dental Health: Vasoconstrictor/Local Anesthetic Precautions
	Dosage Forms
	References
	International Brand Names

Pronunciation

(a kam PROE sate)

U.S. Brand Names

Campral®

Synonyms

Acamprosate Calcium; Calcium Acetylhomotaurinate

Generic Available

No

Use

Maintenance of alcohol abstinence

Pregnancy Risk Factor

C

Pregnancy Implications

Teratogenic in animal studies. No adequate or well controlled studies in pregnant women, use only if potential benefit outweighs possible risk to the fetus.

Lactation

Excretion in breast milk unknown/use caution

Contraindications

Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (Clcr<30 mL/minute)

Warnings/Precautions

Should be used as part of a comprehensive program to treat alcohol dependence. Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence. Acamprosate does not eliminate or diminish the symptoms of alcohol withdrawal. Use caution in moderate renal impairment (Clcr 30-50 mL/minute). Suicidal ideation, attempts and completed suicides have occurred in acamprosate-treated patients; monitor for depression and/or suicidal thinking. Traces of sulfites may be present in the formulation. Safety and efficacy have not been established in pediatric patients.

Adverse Reactions

Note: Many adverse effects associated with treatment may be related to alcohol abstinence; reported frequency range may overlap with placebo.

>10%: Gastrointestinal: Diarrhea (10% to 17%)

1% to 10%:

Cardiovascular: Syncope, palpitation, edema (peripheral)

Central nervous system: Insomnia (6% to 9%), anxiety (5% to 8%), depression (4% to 8%), dizziness (3% to 4%), pain (2% to 4%), paresthesia (2% to 3%), headache, somnolence, amnesia, tremor, chills

Dermatologic: Pruritus (3% to 4%), rash

Endocrine and metabolic: Weight gain, libido decreased

Gastrointestinal: Anorexia (2% to 5%), flatulence (1% to 3%), nausea (3% to 4%), abdominal pain, dry mouth (1% to 3%), vomiting, dyspepsia, constipation, appetite increased, taste perversion

Genitourinary: Impotence

Neuromuscular & skeletal: Weakness (5% to 7%), back pain, myalgia, arthralgia

Ocular: Abnormal vision

Respiratory: Rhinitis, dyspnea, pharyngitis, bronchitis

Miscellaneous: Diaphoresis (2% to 3%), suicide attempt

<1%, postmarketing, and/or case reports (limited to important or life-threatening): Angina, asthma, exfoliative dermatitis, gastrointestinal hemorrhage, hallucinations, hypothyroidism, MI, ophthalmitis, pancreatitis, photosensitivity, psychosis, pulmonary embolus, renal calculus, renal failure, seizure, suicidal ideation, suicide attempts, suicide completion

Overdosage/Toxicology

Symptoms may include diarrhea and (in chronic overdose) hypocalcemia. Treatment is symptom-directed and supportive.

Drug Interactions

No clinically-significant drug-to-drug interactions have been identified.

Ethanol/Nutrition/Herb Interactions

Ethanol: Abstinence is required during treatment. Ethanol does not affect the pharmacokinetics of acamprosate; however, the continued use of ethanol will decrease desired efficacy of acamprosate.

Food: Food decreases absorption of acamprosate (not clinically significant).

Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Mechanism of Action

Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol dependence. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion.

Pharmacodynamics/Kinetics

Distribution: Vd: 1 L/kg

Protein binding: Negligible

Metabolism: Not metabolized

Bioavailability: 11%

Half-life elimination: 20-33 hours

Excretion: Urine (as unchanged drug)

Dosage

Oral: Adults: Alcohol abstinence: 666 mg 3 times/day (a lower dose may be effective in some patients)

Adjustment in patients with low body weight (unlabeled): A lower dose (4 tablets/day) may be considered in patients with low body weight (eg, <60 kg).

Note: Treatment should be initiated as soon as possible (following the period of alcohol withdrawal) when the patient has achieved abstinence.

Dosage adjustment in renal impairment:

Clcr 30-50 mL/minute: Initial dose should be reduced to 333 mg 3 times/day.

Clcr<30 mL/minute: Contraindicated in severe renal impairment.

Administration

May be administered without regard to meals. Tablet should be swallowed whole; do not crush or chew.

Dietary Considerations

May be taken without regard to meals. Each 333 mg tablet contains 33 mg of elemental calcium.

Patient Education

Taking this medication helps maintain abstinence only when used as part of a treatment program that includes counseling and support. Swallow tablet whole. Do not chew or crush. Maintain adequate hydration (2-3 L/day unless instructed to restrict intake by prescriber). Can cause drowsiness (use caution when driving or engaging in activities requiring alertness until response to drug is known). You may experience diarrhea (buttermilk, boiled milk, or yogurt may help), peripheral edema, insomnia, anxiety, depression, and generalized weakness. Report persistent diarrhea, excessive or sudden weight gain, swelling of extremities, respiratory difficulties, fainting, or thoughts of suicide. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber before breast-feeding.

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Dosage Forms

Tablet, enteric coated, delayed release, as calcium: 333 mg [contains calcium 33 mg and sulfites]

References

Brasser SM, McCaul ME, and Houtsmuller EJ, "Alcohol Effects During Acamprosate Treatment: A Dose-Response Study in Humans,"Alcohol Clin Exp Res, 2004, 28(7):1074-83.

Graham R, Wodak AD, and Whelan G, "New Pharmacotherapies for Alcohol Dependence,"Med J Aust, 2002, 177(2):103-7.

Overman GP, Teter CJ, and Guthrie SK, "Acamprosate For the Adjunctive Treatment of Alcohol Dependence,"Ann Pharmacother, 2003, 37(7-8):1090-9.