MYCOSTATIN

What it is

MYCOSTATIN contains nystatin, an antifungal antibiotic active against yeasts and sensitive yeast-like fungi, including Candida albicans. The antifungal activity is due to the binding of sterols, chiefly ergosterol, in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components, so the membrane is no longer able to function as a selective barrier and potassium and other cellular constituents are lost.

Approved indications

— Treatment of intestinal infections caused by Candida albicans and other candida species.

Dosing overview

The usual adult and adolescent dosage is 500,000 to 1 million units (1 to 2 tablets or capsules) 3 times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

Key safety warnings

MYCOSTATIN should not be used in the treatment of systemic fungal infections since it is not absorbed from the gastrointestinal tract. Nausea, vomiting, and diarrhoea have occasionally been reported after oral use, oral irritation or sensitisation may occur, and rashes including urticaria have occurred with Stevens-Johnson syndrome reported rarely. MYCOSTATIN should not be used in infants and children up to 5 years of age. MYCOSTATIN should be used during pregnancy only when clearly needed. Since it is not known whether nystatin is distributed into human milk, the drug should be used with caution in nursing women.

Contraindications

MYCOSTATIN is contraindicated in individuals with hypersensitivity to the drug.

Regulatory history

MYCOSTATIN was first approved on 10 November 1999. MYCOSTATIN has two registered variants on the ARTG: a cream formulation first listed on 30 September 1991, and oral drops first listed on 7 September 2012.