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Acamprosate

Pronunciation

(a kam PROE sate)

Index Terms

  • Acamprosate Calcium
  • Calcium Acetylhomotaurinate
  • Campral

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet Delayed Release, Oral, as calcium:

Campral: 333 mg [DSC]

Generic: 333 mg

Brand Names: U.S.

  • Campral [DSC]

Pharmacologic Category

  • GABA Agonist/Glutamate Antagonist

Pharmacology

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. Insignificant CNS activity, outside its effect on alcohol dependence, was observed including no anxiolytic, anticonvulsant, or antidepressant activity.

Distribution

Vd: ~1 L/kg

Metabolism

Not metabolized

Excretion

Urine (as unchanged drug)

Time to Peak

Plasma: 3 to 8 hours

Half-Life Elimination

20 to 33 hours

Protein Binding

Negligible

Special Populations: Renal Function Impairment

Cmax in patients with moderate or severe renal impairment were 2- and 4-fold higher, respectively.

Use: Labeled Indications

Alcohol abstinence: Maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation, as part of a comprehensive management program

Limitations of use: Efficacy has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning treatment. Efficacy in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.

Contraindications

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

Dosing: Adult

Alcohol abstinence: Oral: 666 mg 3 times daily (a lower dose may be effective in some patients). Note: Treatment should be initiated as soon as possible following the period of alcohol withdrawal when the patient has achieved abstinence and should be maintained if patient relapses.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

CrCl 30 to 50 mL/minute: Initial dose: 333 mg 3 times daily

CrCl ≤30 mL/minute: Use is contraindicated.

Dosing: Hepatic Impairment

Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in manufacturer's labeling.

Administration

Oral: May be administered without regard to meals (administered with meals during clinical trials to possibly increase compliance). Tablet should be swallowed whole; do not crush or chew.

Dietary Considerations

Abstinence is required for initiation of treatment; however, treatment should be continued in the event of a relapse.

Storage

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

Drug Interactions

There are no known significant interactions.

Adverse Reactions

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: Chest pain, hypertension, palpitations, peripheral edema, syncope, vasodilatation

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%), abnormality in thinking, amnesia, attempted suicide, chills, drowsiness, headache

Dermatologic: Pruritus (3% to 4%), diaphoresis (2% to 3%), skin rash

Endocrine & metabolic: Decreased libido, weight gain

Gastrointestinal: Anorexia (2% to 5%), nausea (3% to 4%), flatulence (1% to 4%), xerostomia (1% to 3%), abdominal pain, constipation, dysgeusia, dyspepsia, increased appetite, vomiting

Genitourinary: Impotence

Infection: Infection

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

Ophthalmic: Visual disturbance

Respiratory: Bronchitis, dyspnea, flu-like symptoms, increased cough, pharyngitis, rhinitis

<1% (Limited to important or life-threatening): Abnormal hepatic function tests, agitation, alopecia, anemia, angina pectoris, asthma, brain disease, colitis, confusion, deafness, diabetes mellitus, duodenal ulcer, eosinophilia, epistaxis, exfoliative dermatitis, fever, gastrointestinal hemorrhage, gout, hallucination, hemorrhage, hepatic cirrhosis, hepatitis, hostility, hyperbilirubinemia, hyperesthesia, hyperglycemia, hypersensitivity reaction, hyperuricemia, hyponatremia, hypotension, hypothyroidism, increased serum creatinine, increased serum transaminases, leukopenia, lymphadenopathy, lymphocytosis, myocardial infarction, nephrolithiasis, neuralgia, ophthalmic inflammation, orthostatic hypotension, pancreatitis, pneumonia, psychoneurosis, psychosis, pulmonary embolism, rectal hemorrhage, renal failure, seizure, skin photosensitivity, suicidal ideation, tachycardia, thrombocytopenia, urticaria, withdrawal syndrome

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

• Suicidal thinking/behavior: Attempted and completed suicides have occurred in acamprosate-treated patients; use with caution in suicidal ideation. Monitor for depression and/or suicidal thinking.

Disease-related concerns:

• Alcohol dependence: Appropriate use: 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.

• Renal impairment: Use with caution and reduce dose in patients with moderate renal impairment (CrCl 30 to 50 mL/minute). Contraindicated in patients with severe renal impairment (CrCl ≤30 mL/minute).

Dosage form specific issues:

• Sulfites: Traces of sulfites may be present in the formulation.

Monitoring Parameters

Alcohol abstinence; symptoms of depression or suicidal thinking; renal function.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, loss of strength or energy, lack of appetite, or insomnia. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), behavioral changes, agitation, irritability, panic attacks, or mood changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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