Campral (acamprosate calcium) Full Prescribing Information

Written by HealthyPlace.com Staff Writer

Brand Name: Campral
Generic Name: Acamprosate calcium

Pronounced: a-kam-PROE-sate cal-cium

Campral (acamprosate calcium) is an alcohol dependence medication used in treatment of Alcoholism. Detailed info on uses, dosage and side-effects of Campral below.

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Campral Patient Information (in plain English)

Description

CAMPRAL (acamprosate calcium) is supplied in an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid General homotaurine, which is a structural analogue of the amino acid neurotransmitter -aminobutyric acid and the amino Renal Impairment: Treatment with CAMPRAL in patients with moderate renal impairment (creatinine clearance acid neuromodulator taurine. Its chemical name is calcium acetylaminopropane sulfonate. Its chemical formula of 30-50 mL/min) requires a dose reduction. Patients with severe renal impairment (creatinine clearance of is C ₁₀H ₂₀N ₂O ₈S ₂Ca and molecular weight is 400.48. Its structural formula is: 30 mL/min) should not be given CAMPRAL (see also CONTRAINDICATIONS).

Campral structural formula

Acamprosate calcium is a white, odorless or nearly odorless powder. It is freely soluble in water, and practically insoluble in absolute ethanol and dichloromethane.

Each CAMPRAL tablet contains acamprosate calcium 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in CAMPRAL tablets include: crospovidone, microcrystalline cellulose, magnesium silicate, sodium ® starch glycolate, colloidal anhydrous silica, magnesium stearate, talc, propylene glycol and Eudragit L 30 D or equivalent. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be pres- ent in the drug product.

Clinical Pharmacology

Pharmacodynamics

The mechanism of action of acamprosate in maintenance of alcohol abstinence is not completely understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition. In vitro and in vivo studies in animals have provided evidence to suggest acamprosate may interact with glutamate and GABA neurotransmitter systems centrally, and has led to the hypothesis that acamprosate restores this balance. Pharmacodynamic studies have shown that acamprosate calcium reduces alcohol intake in alcohol-dependent animals in a dose-dependent manner and that this effect appears to be specific to alcohol and the mechanisms of alcohol dependence.

Pharmacodynamic studies have shown that acamprosate calcium reduces alcohol intake in alcohol-dependent animals in a dose-dependent manner and that this effect appears to be specific to alcohol and the mechanisms of alcohol dependence.

Acamprosate calcium has negligible observable central nervous system (CNS) activity in animals outside of its effects on alcohol dependence, exhibiting no anticonvulsant, antidepressant, or anxiolytic activity.

The administration of acamprosate calcium is not associated with the development of tolerance or dependence in animal studies.

CAMPRAL is not known to cause alcohol aversion and does not cause a disulfiram-like reaction as a result of ethanol ingestion.

Pharmacokinetics

Absorption
The absolute bioavailability of CAMPRAL after oral administration is about 11%. Steady-state plasma concentrations of acamprosate are reached within 5 days of dosing. Steady-state peak plasma concentrations after CAMPRAL doses of 2 Ã— 333 mg tablets three times daily average 350 ng/mL and occur at 3-8 hours post-dose. Coadministration of CAMPRAL with food decreases bioavailability as measured by C max and AUC, by approximately 42% and 23%, respectively. The food effect on absorption is not clinically significant and no adjustment of dose is necessary.

Distribution
The volume of distribution for acamprosate following intravenous administration is estimated to be 72-109 liters (approximately 1 L/kg). Plasma protein binding of acamprosate is negligible.

Metabolism
Acamprosate does not undergo metabolism.

Elimination
After oral dosing of 2 Ã— 333 mg of CAMPRAL , the terminal half-life ranges from approximately 20-33 hours. Following oral administration of CAMPRAL , the major route of excretion is via the kidneys as acamprosate.

Special Populations

Gender: CAMPRAL does not exhibit any significant pharmacokinetic differences between male and female subjects.

Age: The pharmacokinetics of CAMPRAL have not been evaluated in a geriatric population. However, since renal function diminishes in elderly patients and acamprosate is excreted unchanged in urine, acamprosate plasma concentrations are likely to be higher in the elderly population compared to younger adults.

Pediatrics: The pharmacokinetics of CAMPRAL have not been evaluated in a pediatric population.

Renal Impairment: Peak plasma concentrations after administration of a single dose of 2 Ã— 333 mg CAMPRAL tablets to patients with moderate or severe renal impairment were about 2-fold and 4-fold higher, respectively, compared to healthy subjects. Similarly, elimination half-life was about 1.8-fold and 2.6-fold longer, respectively, compared to healthy subjects. There is a linear relationship between creatinine clearance values and total apparent plasma clearance, renal clearance and plasma half-life of acamprosate. A dose of 1 Ã— 333 mg CAMPRAL , three times daily, is recommended in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min, see also PRECAUTIONS ).

Patients with severe renal impairment (creatinine clearance

Precautions

Use of CAMPRAL does not eliminate or diminish withdrawal symptoms.

General

Renal Impairment: Treatment with CAMPRAL in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) requires a dose reduction. Patients with severe renal impairment (creatinine clearance of