Adult Dosing

Alcohol dependence

• Adults: 666 mg PO tid

• Initiate therapy after period of alcohol withdrawal, when the patient has achieved abstinence, and maintain if the patient relapses
• Use in association with comprehensive psychosocial treatment program

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Maintenance of abstinence from alcohol in patients with alcohol dependence

• Hypersensitivity to any of the ingredients of the product
• Sever renal impairment (CrCl 30 mL/min)

• N/A

Renal Dose Adjustment (Based on CrCl)

• 30-50 (mL/min): 333 mg PO tid
• <30 (mL/min): Contraindicated

Hepatic Dose Adjustment

• Mild to moderate hepatic impairment: No dose adjustments
• Several hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Therapy does not eliminate or diminish withdrawal symptoms
• Perform dose reduction in patients with moderate renal impairment (CrCl 30-50 mL/min). Avoid using in patients with severe renal function impairment (CrCl <30 mL/min)
• Adverse events such as suicide events, and depression have occurred while on therapy

Cautions: Use cautiously in

• Renal impairment
• History of depression or suicide attempt
• Elderly patients

Supplemental Patient Information

• Advise families and caregivers of patients being treated with this drug to remain alert to the need for monitoring patients for the emergence of symptoms of depression or suicidality, and to communicate such symptoms to the patient's health care provider
• Advise patient not to operate hazardous machinery, including automobiles while on therapy

Pregnancy Category:C

Breastfeeding: Safety Unknown; It is unknown whether acamprosate is excreted in human milk. Manufacturer advises caution.

• CNS: insomnia, anxiety, dizziness, asthenia, headache, somnolence, amnesia, abnormal thinking, tremor
• NEURO: Paresthesia
• GI: Diarrhea, anorexia, flatulence, nausea, dry mouth, vomiting, dyspepsia, constipation, abdominal pain
• CV: Palpitation, syncope, peripheral edema, vasodilatation, hypertension, chest pain, cardiomyopathy, thrombophlebitis, mesenteric arterial occlusion, heart failure, shock
• RESP: Pharyngitis, rhinitis, cough increased, dyspnea, bronchitis
• METABOLIC: Weight gain, increased appetite
• PSYCHIATRY: Suicide, depression
• DERM; Pruritus, sweating, rash
• GU: Libido decreased, impotence
• EENT: Abnormal vision, taste perversion
• MUSC: Myalgia, arthralgia, pain, back pain
• MISC: Accidental Injury, flu syndrome, chills, infection, renal failure

• CNS agent (Antialcoholic agent); precise mechanism of action is unknown; interacts with glutamate and GABA neurotransmitter systems, leading to the hypothesis and restoration of balance between neuronal excitation and inhibition
• Absolute bioavailability: 11%
• Not metabolized
• Primarily excreted in urine
• Half-life: 20-33 hrs

US Trade Name(s)

• Campral

US Availability

acamprosate (generic)

• Delayed Release TABS: 333 mg

Campral

• Delayed Release TABS: 333 mg

Canadian Trade Name(s)

• Campral

Canadian Availability

Campral

• Enteric Coated TABS: 333 mg

UK Trade Name(s)

• Campral EC

UK Availability

Campral EC

• Enteric Coated TABS: 333 mg

Australian Trade Name(s)

• Campral

Australian Availability

Campral

• TABS: 333 mg

[Outline]

Psychiatric

Alcohol Dependence Drugs

Gastrointestinal

Alcohol Dependence Drugs

Pricing data from www.DrugStore.com in U.S.A.

• Campral 333 MG TBEC [Bottle] (FOREST)
  180 mg = $162.99
  540 mg = $463.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Campral Dose Pak

Pill Image:

[
See full size image]

Ingredient(s): Acamprosate

Imprint: 333

Color(s): White

Shape: Round

Size (mm): 10.00

Score: 1

Inactive Ingredient(s): crospovidone / microcrystalline cellulose / magnesium silicate / sodium starch glycolate / colloidal anhydrous silica / magnesium stearate / talc / propylene glycol / eudragit l 30 d

Drug Label Author:
FOREST PHARMACEUTICALS, Inc.

DEA Schedule:
Non-Scheduled