CAMPRAL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CAMPRAL (CAMPRAL).
Acamprosate (calcium acetylhomotaurinate) is thought to stabilize the chemical balance in the brain that is altered by alcohol dependence. Its exact mechanism is unknown, but it is believed to restore the balance of inhibitory (GABA) and excitatory (glutamate) neurotransmission, reducing the physiological symptoms of alcohol withdrawal and craving.
| Metabolism | Acamprosate is not metabolized by the liver; it is excreted unchanged by the kidneys through glomerular filtration. |
| Excretion | Renal: approximately 90% as unchanged drug; biliary/fecal: minimal (<10%) |
| Half-life | Terminal elimination half-life is 20-30 hours (mean 23 hours), supporting twice-daily dosing; steady-state achieved after 5-7 days |
| Protein binding | Negligible (<5%); primarily binds to albumin |
| Volume of Distribution | Approximately 1.0 L/kg (53 L in 70 kg adult); reflects distribution into total body water |
| Bioavailability | Oral: approximately 11% (low due to poor absorption); bioavailability is proportional to dose over therapeutic range |
| Onset of Action | Oral: clinical effects (reduced craving, abstinence maintenance) typically observed within 5-7 days of consistent dosing |
| Duration of Action | 12 hours per dose; sustained abstinence effects require continuous therapy; some clinical benefit may persist for weeks after discontinuation but not reliably |
666 mg (three 333 mg tablets) orally three times daily.
| Dosage form | TABLET, DELAYED RELEASE |
| Renal impairment | Contraindicated if creatinine clearance <30 mL/min. No dose adjustment specified for 30-50 mL/min; use with caution. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C); use cautiously. |
| Pediatric use | Safety and efficacy not established; no recommended dose. |
| Geriatric use | No specific dose adjustment; use standard adult dosing with monitoring due to potential age-related renal impairment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CAMPRAL (CAMPRAL).
| Breastfeeding | Unknown whether excreted in human milk. M/P ratio not available. Caution advised due to potential adverse effects in nursing infants. |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: Limited human data; animal studies show increased fetal resorptions and delayed ossification at high doses. Second/third trimester: No controlled human studies; potential risks based on neurodevelopmental effects in animals. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Severe renal impairment (creatinine clearance ≤30 mL/min)","Hypersensitivity to acamprosate or any component of the formulation"]
| Precautions | ["Renal impairment: Contraindicated in patients with severe renal impairment (CrCl ≤30 mL/min). Dose adjustment required for moderate impairment (CrCl 30-50 mL/min).","Suicidality: Monitor for depression and suicidal ideation, as alcohol dependence and acamprosate use have been associated with these events.","Alcohol withdrawal: Not indicated for detoxification or treatment of withdrawal symptoms.","Pregnancy: Category C; use only if potential benefit justifies risk to the fetus."] |
| Food/Dietary | Take acamprosate with food to improve tolerability, as gastrointestinal side effects are common. Avoid alcohol completely while on therapy. |
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| Monitor maternal withdrawal symptoms, adherence, and hepatic function. Fetal ultrasound for growth and development if significant exposure. |
| Fertility Effects | Animal studies: No adverse effects on fertility at therapeutic doses. Human data lacking. |
| Clinical Pearls | Campral (acamprosate) is a medication used to maintain abstinence in alcohol-dependent patients. It should be initiated after detoxification and while the patient is abstinent. Renal function must be assessed before starting therapy; it is contraindicated in severe renal impairment (CrCl ≤30 mL/min). Dosage adjustment is required for moderate renal impairment (CrCl 30-50 mL/min). Common side effects include diarrhea, which may be dose-limiting. The drug does not treat withdrawal symptoms and is not effective if the patient continues to drink. Psychiatric monitoring is recommended due to potential suicidal ideation. |
| Patient Advice | Take Campral exactly as prescribed, usually 3 times daily with meals. · Do not drink alcohol while taking this medication; it is meant to support abstinence. · Inform your doctor if you have kidney problems, as dose adjustment may be needed. · Common side effects include diarrhea, especially in the first few weeks; contact your doctor if it is severe or persistent. · It may take several weeks to feel the full benefit; continue treatment even if you feel well. · Seek immediate medical help if you experience thoughts of self-harm or depression. · Store at room temperature away from moisture and heat. |