Product Dossier

CAMPRAL

Product Dossier for CAMPRAL (acamprosate calcium, Alphapharm). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

CAMPRAL is an enteric coated tablet containing acamprosate calcium 333 mg as the active ingredient.

Approved indications

— Therapy to maintain abstinence in alcohol dependent patients.

Dosing overview

Treatment with acamprosate calcium should be initiated as soon as possible after the withdrawal period and should be maintained if the patient relapses. The recommended period of treatment is 1 year. CAMPRAL tablets should be taken with meals, and swallowed whole. For adults weighing 60 kg or more, the dose is 2 tablets taken three times daily (2 tablets in the morning, at midday and at night). In adults weighing less than 60 kg, the dose is 2 tablets in the morning, 1 tablet at midday and 1 tablet at night.

Key safety warnings

Acamprosate does not constitute treatment for the withdrawal period. 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 respective symptoms. Diarrhoea is a very common adverse effect. Common gastrointestinal effects include abdominal pain, nausea, vomiting, and flatulence. Very rare hypersensitivity reactions including urticaria, angioedema or anaphylactic reactions have been reported.

Contraindications

CAMPRAL is contraindicated in patients with a known hypersensitivity to the medicine, pregnant or breastfeeding women, renal insufficiency (serum creatinine > 120 micromol/L), and severe hepatic failure (Child-Pugh Classification C). CAMPRAL should not be administered to the elderly. CAMPRAL should not be administered to children.

PBS listing

CAMPRAL tablet (enteric coated) containing acamprosate calcium 333 mg is listed on the PBS as 1 item with streamlined restriction at an ex-manufacturer price of A$61.19.

Regulatory history

CAMPRAL was first listed on the ARTG on 6 August 1999 as acamprosate calcium 333 mg enteric coated tablet blister pack. The product information was first approved on 6 March 2018 for ACAMPROSATE VIATRIS (the current variant), with the most recent revision dated 18 July 2023.