CLONAC

What it is

CLONAC is a modified release tablet containing diclofenac sodium, available in 25 mg and 50 mg strengths.

Approved indications

— Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis and osteoarthritis. — Relief of acute or chronic pain states in which there is an inflammatory component. — Symptomatic treatment of primary dysmenorrhoea.

Dosing overview

For adults, initial dosage is 75 to 150 mg daily, with 75 to 100 mg daily usually sufficient for long-term therapy. The daily dosage should generally be prescribed in 2 or 3 fractional doses. In primary dysmenorrhoea, the daily dosage is generally 50 to 150 mg, with an initial dose of 50 to 100 mg which may be raised up to a maximum of 200 mg per day.

Key safety warnings

Non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events including myocardial infarction and stroke, which may increase with dose or duration of use, particularly in patients with cardiovascular disease or cardiovascular risk factors. Treatment with CLONAC is generally not recommended in patients with established cardiovascular disease or uncontrolled hypertension; if needed, patients with these conditions should be treated only after careful consideration and at doses of 100 mg daily or less when treatment continues for more than 4 weeks. Upper gastrointestinal ulcers, gross bleeding or perforation occur in approximately 1% of patients treated for 3–6 months and about 2–4% of patients treated for one year, with risk increasing with higher NSAID doses, longer duration of use, and in patients with a history of ulcer or in the elderly. Gastric or duodenal ulceration, perforation or gastrointestinal bleeding, which can be fatal, have been reported in patients receiving CLONAC. Serious skin reactions, some fatal, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely with NSAIDs and appear to be idiosyncratic; patients are at highest risk early in therapy, with onset typically occurring within the first month of treatment. NSAIDs may lead to new hypertension or worsening of pre-existing hypertension, and patients on anti-hypertensives may have impaired response.

Contraindications

Gastric or duodenal ulcer, gastrointestinal bleeding or perforation. Hypersensitivity to diclofenac or any of the excipients. Third trimester of pregnancy, severe hepatic impairment. Renal failure, severe cardiac failure, treatment of perioperative pain in coronary artery bypass surgery, or patients in whom diclofenac, aspirin or other NSAIDs induce asthma, angioedema, urticaria or other allergic-type reactions.

Regulatory history

CLONAC diclofenac sodium 25 mg and 50 mg modified release tablets were first listed on the ARTG on 4 April 2017.