Acamprol: Clinically Proven Relief for Alcohol Dependence
| Product dosage: 333 mg | |||
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Synonyms | |||
Acamprol (acamprosate calcium) is a prescription medication specifically developed to support maintenance of abstinence in alcohol-dependent patients. It functions by modulating neurotransmitter systems disrupted by chronic alcohol consumption, particularly glutamatergic hyperactivity, thereby reducing the psychological distress associated with alcohol withdrawal and craving. This pharmacological agent is indicated as part of a comprehensive management program that includes psychosocial support. Its delayed-release tablet formulation ensures consistent plasma concentrations, supporting long-term therapy adherence. Clinical trials and post-marketing surveillance have established its efficacy and safety profile in diverse patient populations.
Features
- Active ingredient: Acamprosate calcium 333 mg enteric-coated tablets
- Mechanism: Modulates glutamate and GABA neurotransmission to rebalance neuronal excitability
- Formulation: Delayed-release to ensure optimal bioavailability and reduce gastrointestinal irritation
- Packaging: Blister packs of 180 tablets (month supply based on standard dosing)
- Prescription status: Schedule IV controlled substance in some jurisdictions
- Manufacturer compliance: Produced under cGMP standards with batch traceability
Benefits
- Reduces the frequency of relapse episodes in abstinent alcohol-dependent patients
- Decreases the intensity of alcohol craving by normalizing neuroadaptive imbalances
- Supports long-term abstinence when combined with psychosocial interventions
- Exhibits a favorable safety profile with no abuse potential or hepatotoxicity concerns
- Does not require dosage adjustment in patients with renal impairment (with monitoring)
- Minimal drug-drug interactions, facilitating use in comorbid conditions
Common use
Acamprol is primarily prescribed for the maintenance of abstinence in alcohol-dependent patients who have achieved initial detoxification. It is most effective when initiated as soon as possible after the acute withdrawal period, typically within one week of abstinence. The medication is used as adjunctive therapy within a comprehensive treatment program that includes counseling, behavioral therapy, and support group participation. It is particularly beneficial for patients who experience persistent craving despite other interventions. Treatment duration is generally recommended for one year, though continuation may be warranted based on individual patient response and risk assessment.
Dosage and direction
The recommended dosage of Acamprol is two 333 mg tablets taken three times daily (total 1998 mg/day). Tablets should be swallowed whole with water and not crushed or chewed. Administration with food may improve gastrointestinal tolerance but is not required for absorption. For patients with moderate renal impairment (creatinine clearance 30-50 mL/min), the dosage should be reduced to one tablet three times daily. Not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min). Treatment should be initiated as soon as possible after abstinence is achieved and maintained throughout the risk period for relapse.
Precautions
Patients should be monitored for emergence of depression or suicidal ideation, particularly during early treatment. Renal function should be assessed before initiation and periodically during treatment. Use with caution in patients with history of seizure disorders, as alcohol withdrawal may lower seizure threshold. Contains calcium content (approximately 0.15 mEq calcium per tablet) – consider in patients with conditions affected by calcium balance. Pregnancy Category C: use only if potential benefit justifies potential risk to fetus. Not studied in pediatric populations. Elderly patients may require renal function assessment before dosing.
Contraindications
Hypersensitivity to acamprosate calcium or any component of the formulation. Severe renal impairment (creatinine clearance <30 mL/min). Concurrent use with naltrexone may require careful monitoring due to theoretical neuroexcitatory effects, though clinical significance remains uncertain. Not indicated for patients who have not achieved abstinence prior to initiation. Should not be used as monotherapy without accompanying psychosocial support.
Possible side effects
Most common adverse reactions (≥5% and twice placebo): diarrhea (10-17%), nausea (4-8%), abdominal pain (5-7%), flatulence (3-5%), and pruritus (2-4%). Less frequent reactions include headache, insomnia, anxiety, and dizziness. Rare cases of suicidal ideation, maculopapular rash, and weight changes have been reported. Generally well-tolerated with most side effects being mild to moderate and transient. No documented withdrawal syndrome upon discontinuation.
Drug interaction
Minimal cytochrome P450 interactions. Does not affect metabolism of diazepam, imipramine, or warfarin. Theoretical potential for interaction with other NMDA antagonists (e.g., amantadine, memantine) though clinical evidence lacking. Calcium content may interfere with absorption of tetracycline antibiotics and fluoroquinolones – separate administration by at least 2 hours. No clinically significant interactions with disulfiram or antidepressants.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. Do not double the dose to make up for a missed administration. Maintaining consistent three-times-daily dosing is important for sustained therapeutic effect. Patients should be advised to establish routine administration times (e.g., with meals) to improve adherence.
Overdose
Experience with acute overdose is limited. Maximum reported ingestion was 28 tablets (9.3 g) with no serious consequences. Symptoms may include gastrointestinal distress (diarrhea, nausea) and possible electrolyte imbalance due to calcium content. Management should be supportive with monitoring of renal function and electrolyte status. Hemodialysis removes approximately 30-40% of circulating acamprosate but is not routinely recommended. Contact poison control center for latest management guidelines.
Storage
Store at controlled room temperature (20-25°C or 68-77°F). Keep in original blister packaging to protect from moisture. Dispense in tight, light-resistant container. Keep out of reach of children and pets. Do not use beyond expiration date printed on packaging.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Acamprol is available by prescription only and should be used under appropriate medical supervision. Healthcare professionals should reference full prescribing information before initiation. Patients should disclose complete medical history and current medications to their prescribing physician. Individual results may vary based on patient-specific factors and adherence to comprehensive treatment program.
Reviews
Clinical studies demonstrate consistent efficacy across multiple trials. A meta-analysis of 17 randomized controlled trials (n=4,987) showed significant improvement in continuous abstinence rates (RR 1.88, 95% CI 1.57-2.25) compared to placebo. Real-world evidence supports maintained effectiveness in diverse clinical settings, with particular benefit noted in patients with high baseline craving intensity. Patient-reported outcomes indicate improved quality of life measures and treatment satisfaction scores. Long-term follow-up studies suggest sustained benefits post-discontinuation in patients who achieve stable remission.