acamprosate CAMPRAL

Class: GABA/taurine Analogue
FDA Indications: Maintaining Abstinence In Alcohol-dependent Patients
Off-Label Use:
Prescribing
Forms: 333mg tablet
Dose Range: 999.999-2000 mg/day
Starting: 666 mg three times daily

NAMI drug fact sheet

Precautions
Contraindications: Severe renal impairment (CrCl≤30mL/min). Sulfite allergy.
Side Effects: headache, dizziness, confusion, nausea, vomiting, pruritus, diarrhea (dose related, 7% with 1.3g, 12% with 2g), drowsiness
Pharmacodynamics
1° MOA: ↓ Glutamatergic Acticity While ↑ GABAergic Activity. Blocks Glutamate Receptors (mGluRs And Perhaps Also NMDA)
2° MOA: Other actions proposed have included antagonism of opiate and noradrenergic activity, stimulation of serotonergic activity, and possible antiacetylaldehyde activity.
Target: GABA agonist
Pharmacokinetics
t½: 20 (13-32)° TMAX: 3.5-9.5°
Substrate of: Renally cleared
Inhibits: ∅ ; Induces:
Active Metabolites:
DDIs
Misc
  • - because acamprosate serves as "artificial alcohol," it may be less effective in situations in which the patient isn't abstinent; thus acamprosate may be a preferred treatment if the goal is complete abstinence, but may not be preferred if the goal is ↓'d at-risk drinking
  • - absorption is ↓'d when given with food
  • - number needed to treat (NNT) is between 8 and 12
Special Populations

Category C—No published reports in human pregnancy however human data from the Teratology Information Service in France suggests high risk, but the very limited human pregnancy experience prevents an assessment of the embryo-fetal risk. However, the use of alcohol in pregnancy is well known to cause dose-related developmental toxicity. In pregnant women with alcohol dependency, the risk:benefit ratio may favor its use.

No reports describing the use of acamprosate during human lactation have been located. The molecular weight, lack of metabolism and protein binding, and long t½ suggest that the drug will be excreted in breast milk. The effect on a nursing infant from exposure in milk is unknown. However, alcohol is excreted into milk and is known to be a neurotoxin ∴ if a lactating woman requires acamprosate to refrain from drinking, the benefit to the nursing infant appears to outweigh the unknown risk from the drug.

There were too few patients in the ≥65 age group to evaluate any differences in safety or effectiveness for geriatric patients compared to younger patients.

Disposition is significantly impacted by renal impairment w/ t½'s of 33.4±6.6° & 46.6±12.9°, respectively. The mean renal CLs for the moderate and severe impairment groups were 3.29±0.85 L/h and 1.10±0.21 L/h, respectively ∴ ecommended acamprosate be very carefully dosed or avoided in patients with moderate or severe renal impairment.

No dose adjustment necessary

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Last updated June 10 2018 15:40:14. Disclaimer: This website does not provide medical advice, nor is it a substitute for clinical judgment.