Acamprol: A Clinically Validated Treatment for Alcohol Dependence
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Synonyms | |||
Acamprol (acamprosate calcium) is a prescription medication specifically developed to support the maintenance of abstinence in patients with alcohol dependence who have achieved initial withdrawal and are committed to a comprehensive treatment program. It is one of the few pharmacotherapies with a robust evidence base, offering a non-addictive, well-tolerated option for long-term management. By helping to stabilize the chemical imbalances in the brain caused by chronic alcohol use, Acamprol reduces the psychological distress and craving that often lead to relapse, thereby supporting sustained recovery.
Features
- Active Ingredient: Acamprosate calcium 333 mg (delivered as two 333 mg enteric-coated tablets per dose).
- Mechanism of Action: Modulates the glutamatergic system, specifically acting as a functional antagonist at NMDA receptors and a positive modulator of GABA-A receptors.
- Formulation: Delayed-release enteric-coated tablets for optimal gastrointestinal tolerance.
- Prescription Status: Schedule IV controlled substance, requiring a prescription from a licensed healthcare provider.
- Treatment Duration: Designed for long-term use as part of a sustained management plan.
- Non-Habit Forming: Does not exhibit abuse potential or produce euphoric effects.
Benefits
- Reduces Craving: Significantly diminishes the urge to consume alcohol by normalizing brain neurochemistry altered by chronic alcohol use.
- Supports Sustained Abstinence: Clinically proven to increase the cumulative number of days of continuous abstinence compared to placebo.
- Non-Abusive Profile: As a non-opioid and non-benzodiazepine agent, it carries no risk of misuse or dependence, making it suitable for long-term therapy.
- Integrates with Therapy: Works synergistically with psychosocial interventions like cognitive behavioral therapy (CBT) and counseling to reinforce behavioral changes.
- Well-Tolerated: Generally exhibits a favorable side effect profile, with most adverse reactions being mild and transient.
- Improves Quality of Life: By supporting sobriety, it contributes to the restoration of physical health, mental well-being, and social functioning.
Common use
Acamprol is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. It is most effective when incorporated into a comprehensive management program that includes psychosocial support, such as counseling, behavioral therapy, and participation in support groups like Alcoholics Anonymous (AA). Treatment should be initiated as soon as possible after the acute alcohol withdrawal period is complete and the patient has achieved abstinence. It is not intended for use in the management of acute withdrawal symptoms.
Dosage and direction
The recommended dosage of Acamprol for most patients is two 333 mg enteric-coated tablets taken three times daily (total daily dose 1998 mg). For patients with moderate renal impairment (creatinine clearance of 30-50 mL/min), a reduced dosage of one 333 mg tablet three times daily is recommended. It is contraindicated in patients with severe renal impairment (creatinine clearance ≤30 mL/min). Tablets should be swallowed whole with a glass of water; they must not be crushed or chewed as this will damage the enteric coating. Acamprol can be taken with or without food, although taking it with meals may help some patients remember their doses. Consistency in dosing timing is important for maintaining stable plasma concentrations.
Precautions
- Renal Impairment: Acamprol is contraindicated in patients with severe renal impairment. Dosage must be adjusted in patients with moderate renal impairment. Renal function should be assessed before initiating treatment.
- Depression and Suicidality: Alcohol-dependent patients, including those taking Acamprol, should be monitored for the development of symptoms of depression or suicidal ideation. Pre-existing depression may be unmasked during abstinence.
- Continued Alcohol Use: Acamprol does not eliminate or diminish the intoxicating effects of alcohol. Patients should be advised that consumption of alcohol while on Acamprol will undermine the therapeutic goal of treatment.
- Pregnancy and Lactation: The safety of Acamprol in pregnancy has not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether acamprosate is excreted in human milk; caution is advised if administered to a nursing woman.
- Pediatric Use: Safety and effectiveness in patients below the age of 18 have not been established.
Contraindications
Acamprol is contraindicated in the following patient populations:
- Patients with known hypersensitivity to acamprosate calcium or any of the excipients in the formulation.
- Patients with severe renal impairment (creatinine clearance of 30 mL/min or less).
Possible side effect
The most common adverse reactions are gastrointestinal in nature and are often dose-related and transient. The following is not an exhaustive list:
- Very Common (≥1/10): Diarrhea.
- Common (≥1/100 to <1/10): Nausea, abdominal pain, flatulence, itching (pruritus), rash, impotence, decreased libido.
- Uncommon (≥1/1,000 to <1/100): Vomiting, dry mouth, increased liver enzymes, hypercalcemia, fluctuations in weight, increased or decreased appetite, insomnia, drowsiness, dizziness, paresthesia (tingling sensation), sweating.
- Rare (<1/1,000): Suicidal ideation and attempts, hallucinations, confusion, angioedema, urticaria, visual disturbances, tinnitus, palpitations, syncope.
Drug interaction
Formal drug interaction studies have shown no clinically significant interactions with medications commonly used in this patient population. However, considerations include:
- Antidepressants (e.g., SSRIs, TCAs): No known pharmacokinetic interactions, though pharmacodynamic interactions regarding mood should be monitored.
- Disulfiram or Naltrexone: No clinically significant pharmacokinetic interactions have been observed; these medications can be used concomitantly as part of a comprehensive treatment plan.
- Other CNS Depressants (e.g., benzodiazepines): While no direct interaction is known, additive sedative effects are possible.
- Medications Affecting Renal Function: Since Acamprol is eliminated renally, co-administration with drugs that impair renal function could increase acamprosate levels.
Missed dose
If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed one.
Overdose
Experience with Acamprol overdose is limited. In reported cases, symptoms have included gastrointestinal complaints (diagrrhoea), dizziness, and headache. All cases recovered without sequelae. Given its pharmacological profile, no specific antidote exists. In the event of a suspected overdose, general supportive measures should be instituted, gastric lavage may be considered, and the patient’s vital signs should be monitored. Treatment should be symptomatic and supportive. Due to the drug’s water solubility and low molecular weight, Acamprol is dialyzable.
Storage
Store Acamprol tablets at room temperature, between 15°C and 30°C (59°F and 86°F). Keep the medication in its original blister packaging to protect it from moisture. Keep all medications out of the reach of children and pets. Do not use beyond the expiration date printed on the packaging.
Disclaimer
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.
Reviews
Clinical trials and post-marketing surveillance form the basis of Acamprol reviews from a medical perspective. Meta-analyses of randomized controlled trials consistently demonstrate its efficacy in promoting abstinence, with a number needed to treat (NNT) that is favorable compared to other interventions. Expert consensus guidelines, such as those from the American Psychiatric Association, recognize Acamprol as a first-line pharmacotherapy for alcohol use disorder. Reviews often highlight its specific utility in reducing craving rather than causing alcohol aversion. Its favorable safety and tolerability profile, particularly the lack of hepatotoxicity and abuse potential, are frequently cited strengths in comparative reviews with other pharmacotherapies. Patient-reported outcomes in studies often note an improved ability to resist urges and a greater sense of control, which are critical for long-term recovery success.