Dosing and uses of Campral (acamprosate)
Adult dosage forms and strengths
tablet
- 333mg
Alcholism
Indicated for maintenance of alcohol abstinence in patients who are abstinent at treatment initiation
666 mg PO TId
Renal Impairment
CrCl 30-50 mL/min: 333 mg PO TId
CrCl <30 mL/min: Do not administer
Fragile X Syndrome (Orphan)
Orphan designation for treatment of fragile X syndrome
Orphan sponsor
- Confluence Pharmaceuticals, LLC; Box 528, 351 West 10th Street; Indianapolis, IN 46202
Pediatric dosage forms and strengths
Safety and efficacy have not been established
Campral (acamprosate) adverse (side) effects
>10%
Diarrhea (16%)
1-10%
Accidental injury (3%)
Anorexia (3%)
Anxiety (6%)
Asthenia (6%)
Depression (5%)
Dizziness (3%)
Dry mouth (2%)
Flatulence (3%)
Insomnia (7%)
Nausea (4%)
Pain (3%)
Paresthesia (2%)
Pruritus (4%)
Sweating (2%)
Frequency not defined
Hypertension
Chest-pain
Edema
Syncope
Vasodilation
Abnormal vision
Cough
Pharyngitis
Dyspnea
Rhinitis
Warnings
Contraindications
Hypersensitivity
Severe renal impairment
Cautions
Does not diminish withdrawal symptoms
May impair ability to operate heavy machinery or drive
Efficacy not established in promoting abstinence in non-abstinent patients
Check for suicidal tendencies
Use as part of a conprehensive to treat alcohol dependence
Possibility of acute renal failure (ARF)
Pregnancy and lactation
Pregnancy category: C
Lactation: Excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Campral (acamprosate)
Mechanism of action
Not fully understood; may act by interacting with glutamate & GABA neurotransmitter systems
Does not cause alcohol aversion or a disulfiram-like reaction on ethanol ingestion
Pharmacokinetics
Protein Bound: Negligible
Vd: 1 L/kg
Peak PlasmaTime: 3-8 hr
Concentration: 350 ng/mL for a dose of 666 mg TId
Bioavailability: 11%, decreased by food
Metabolism: None
Excretion: Urine
Half-life: 20-33 hr
