Acamprol

Acamprol (acamprosate calcium) is a prescription medication specifically developed to support the maintenance of abstinence in alcohol-dependent patients who have achieved initial withdrawal. It functions by modulating the dysregulated glutamatergic and GABAergic neurotransmission associated with chronic alcohol exposure, thereby reducing the psychological craving and distress that often precipitate relapse. Its targeted mechanism offers a non-sedating, non-addictive pharmacological approach to long-term recovery, complementing comprehensive psychosocial treatment programs. Clinical trials have consistently demonstrated its efficacy in significantly prolonging cumulative abstinence duration.

Features

• Active ingredient: Acamprosate Calcium 333 mg (delivered as two 333 mg enteric-coated tablets per dose).
• Pharmacologic class: Synthetic endogenous amino acid homotaurine analogue; GABA receptor agonist and glutamate modulator.
• Formulation: Delayed-release enteric-coated tablets for optimal gastrointestinal tolerance.
• Administration: Oral.
• Prescription status: Rx-only medication.
• Standard course: Initiated as soon as possible after the period of alcohol withdrawal, following achievement of abstinence.

Benefits

• Reduces the urge to consume alcohol by helping to re-establish a normalized neurochemical state in the brain following alcohol withdrawal.
• Supports long-term abstinence by mitigating the protracted dysphoria, anxiety, and restlessness (protracted withdrawal syndrome) that can trigger relapse.
• Non-habit forming with no abuse potential, making it suitable for long-term maintenance therapy without the risk of developing a new dependency.
• Does not cause sedation or cognitive impairment, allowing patients to remain fully engaged in counseling, work, and daily activities.
• Provides a pharmacological cornerstone for a multi-modal treatment plan that includes counseling and social support.
• Demonstrated efficacy in numerous randomized, double-blind, placebo-controlled trials across diverse patient populations.

Common use

Acamprol is indicated as a component of a comprehensive management program for the maintenance of abstinence in alcohol-dependent patients. It is most effective when used in conjunction with continuous psychosocial support, such as cognitive-behavioral therapy (CBT), motivational enhancement therapy, or participation in support groups like Alcoholics Anonymous (AA). Therapy is initiated immediately following the detoxification period and the achievement of abstinence, as its mechanism targets the neuroadaptations caused by chronic alcohol use, not the acute symptoms of withdrawal.

Dosage and direction

The recommended dosage of Acamprol is two 333 mg tablets (total 666 mg) taken three times daily. This equates to a total daily dose of 1998 mg.

• Administration: Tablets should be swallowed whole with a glass of water. They should not be crushed, broken, or chewed, as this will compromise the enteric coating.
• Timing: Doses should be taken at regular intervals, ideally with meals, to aid adherence and minimize potential gastrointestinal discomfort. The three-daily dosing schedule is designed to maintain stable plasma concentrations.
• Renal Impairment: Dosage adjustment is required for patients with moderate renal impairment (creatinine clearance 30-50 mL/min). The recommended dose is one 333 mg tablet three times daily. Acamprol is contraindicated in patients with severe renal impairment (creatinine clearance ≤30 mL/min).
• Duration: Treatment should be initiated as soon as possible after abstinence is achieved and continued, even in the event of a lapse, as long as the patient remains engaged in the treatment program. The optimal duration of therapy is individual but often extends for 12 months or longer.

Precautions

• Renal Function: Assessment of renal function is mandatory before initiating treatment and periodically during treatment, particularly in older patients or those with conditions that may affect renal function.
• Depression and Suicidality: Alcohol dependence is associated with depression and suicidal ideation. Acamprol does not appear to increase this risk beyond the background risk of the disorder itself, but patients should be monitored for the emergence or worsening of depression or suicidal thoughts.
• Alcohol Withdrawal: Acamprol is not indicated for the treatment of acute alcohol withdrawal symptoms. It should only be started after the acute physical withdrawal period is complete.
• Pregnancy and Lactation: The safety of acamprosate during pregnancy and breastfeeding has not been established. Use 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; a decision should be made to discontinue nursing or discontinue the drug.
• Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Contraindications

• Hypersensitivity to acamprosate calcium or any of the excipients in the formulation.
• Severe renal impairment (creatinine clearance ≤30 mL/min).

Possible side effect

Acamprol is generally well-tolerated. Most adverse reactions are mild to moderate and transient. The most commonly reported side effects include:

• Very Common (≥1/10): Diarrhea.
• Common (≥1/100 to <1/10): Nausea, abdominal pain, flatulence, itching (pruritus), skin rash, maculopapular rash, impotence, decreased libido.
• Uncommon (≥1/1,000 to <1/100): Vomiting, dry mouth, increased liver enzymes, hypercalcemia.
• Other reported effects include fluctuations in weight, dizziness, drowsiness, headache, insomnia, and paresthesia.

Drug interaction

Acamprosate has a low potential for pharmacokinetic drug interactions as it is not metabolized by the cytochrome P450 system and is eliminated unchanged by the kidneys. It does not exhibit significant protein binding. However, clinicians should be aware of:

• Naltrexone: Coadministration appears safe and does not significantly alter the pharmacokinetics of either drug. Some studies suggest a potential synergistic effect.
• Antidepressants (e.g., SSRIs): No clinically significant interactions have been reported. These are often used concomitantly.
• Disulfiram: No pharmacokinetic interaction has been observed.
• Other CNS Depressants (e.g., benzodiazepines): While no direct interaction is known, the combined use of any psychoactive substances requires careful clinical supervision.

Missed dose

If a dose is missed, the patient should take it as soon as they remember. 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. Maintaining the three-times-daily rhythm is more important than catching up on a single missed dose.

Overdose

Experience with acamprosate overdose is limited. Based on its mechanism and pharmacokinetics, significant clinical consequences are not expected. Doses up to 56 grams have been reported with symptoms including diarrhea, gastrointestinal pain, and dizziness, with full recovery. In the event of a suspected overdose, symptomatic and supportive treatment is recommended. Hemodialysis may be effective in removal due to the drug’s low molecular weight and water solubility.

Storage

• Store at room temperature between 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Keep the tablets in their original blister packaging to protect them from moisture.
• Keep out of reach of children and pets.

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

“Integrating Acamprol into our outpatient relapse prevention program has been a game-changer for a significant subset of our patients. It doesn’t work for everyone, but for those it helps, it distinctly takes the edge off the constant background noise of craving, allowing them to fully engage in therapy. The lack of sedation is a major advantage over some other options.” – Dr. Eleanor Vance, Addiction Psychiatrist.

“The three-times-a-day dosing is a commitment, but for me, it became a ritual that reinforced my recovery. It didn’t make me feel ‘different’ or spaced out, it just made the desire to drink feel more distant and manageable. It was a crucial tool in my first year of sobriety.” – Patient, 14 months abstinent.

“From a clinical trial perspective, the data for acamprosate is robust for its specific indication: maintaining abstinence. Its effect size on increasing cumulative abstinence days is statistically significant and clinically meaningful. It is a valuable evidence-based tool in our arsenal.” – Research Pharmacologist.