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Drug Details

CAMPRAL EC

• Drug Class Description
  GABA analogues.
• Generic Name
  Acamprosate
• Presentation
  Enterocoated tablets.
• Description
  Each tablet contains acamprosate (I.N.N.) calcium 333.0 mg as the active ingredient.
• Indications
  Acamprosate is indicated as therapy to maintain abstinence in alcohol-dependent patients. It should be combined with counselling.
• Adult Dosage
  

  Adults within the age range 18-65 years:

  - 2 tablets three times daily with meals (2 tablets morning, noon and night) in subjects weighing 60kg or more.

  - In subjects weighing less than 60kg, 4 tablets divided into three daily doses with meals (2 tablets in the morning, 1 at noon and 1 at night).

• Child Dosage
  

  Children and the Elderly:

  Acamprosate should not be administered to children and the elderly.

  The recommended treatment period is one year. Treatment with acamprosate should be initiated as soon as possible after the withdrawal period and should be maintained if the patient relapses.

• Elderly Dosage
  Acamprosate should not be administered to the elderly.
• Contra Indications
  

  Acamprosate is contraindicated:

  − in patients with a known hypersensitivity to the drug

  − in pregnant women and lactating women

  − in cases of renal insufficiency (serum creatinine >120 micromol/L)

  − in cases with severe hepatic failure (Childs- Pugh Classification C)

• Special Precautions
  

  Acamprosate does not constitute treatment for the withdrawal period.

  Acamprosate does not prevent the harmful effects of continuous alcohol abuse. Continued alcohol abuse negates the therapeutic benefit, therefore acamprosate treatment should only be initiated after weaning therapy, once the patient is abstinent from alcohol.

  Because the interrelationship between alcohol dependence, depression and suicidality is well-recognised and complex, it is recommended that alcohol-dependent patients, including those treated with acamprosate, be monitored for such symptoms.

• Interactions
  

  The concomitant intake of alcohol and acamprosate does not affect the pharmacokinetics of either alcohol or acamprosate. Administering acamprosate with food diminishes the bioavailability of the drug compared with its administration in the fasting state. Pharmacokinetic studies have been completed and show no interaction between acamprosate and diazepam, disulfiram or imipramine. There is no information available on the concomitant administration of acamprosate with diuretics.

• Adverse Drug Reactions
  

  The following definitions apply to the frequency terminology used hereafter: very common ( 1/10), common ( 1/100, < 1/10), uncommon ( 1/1,000, < 1/100), rare ( 1/10,000, < 1/1,000), very rare (< 1/10,000, including isolated cases), frequency not known (cannot be estimated from the available data)

  Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

  Gastrointestinal disorders:

  Very common: Diarrhoea

  Common: Abdominal pain, nausea, vomiting

  Skin and subcutaneous tissue disorders:

  Common: Pruritus, maculo-papular rash

  Rare: Bullous skin reactions

  Immune system disorders:

  Very rare: Hypersensitivity reactions including urticaria, angio-oedema or anaphylactic reactions.

  Reproductive system and breast disorders:

  Common: Frigidity or impotence.

  Psychiatric disorders:

  Common: Decreased libido

  Uncommon: Increased libido