Acamprosate
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.
International Brand Names
Aotal® (FR); Besobrial® (ZA); Campral® (AU, BE, BR, CH, CL, CZ, DE, DK, ES, GB, HU, IE, LU, NL, NO, PL, PT, SE); Zulex® (ES)
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