(a kam PROE sate)
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.
Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (CrCl ≤30 mL/minute)
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.
Refer to adult dosing.
CrCl 30 to 50 mL/minute: Initial dose: 333 mg 3 times daily
CrCl ≤30 mL/minute: Use is contraindicated.
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 manufacturers labeling.
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.
Abstinence is required for initiation of treatment; however, treatment should be continued in the event of a relapse.
Store at 25 ‚ °C (77 ‚ °F); excursions permitted to 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F).
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
There are no known significant interactions.
Alcohol abstinence; symptoms of depression or suicidal thinking; renal function.
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
Cmax in patients with moderate or severe renal impairment were 2- and 4-fold higher, respectively.
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.
C
Adverse events were observed in animal reproduction studies.
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.
Vd: ~1 L/kg
Not metabolized
Urine (as unchanged drug)
Plasma: 3 to 8 hours
20 to 33 hours
Negligible
- 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.