NILSTAT

What it is

NILSTAT ORAL is a medicine containing nystatin 500,000 I.U. available as tablets and capsules. Nystatin is 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 a relapse.

Key safety warnings

NILSTAT ORAL tablets or capsules should not be used in the treatment of systemic fungal infections since it is not absorbed from the gastrointestinal tract. NILSTAT ORAL tablets or capsules should not be used in infants and children up to 5 years of age. Nausea, vomiting, and diarrhoea have occasionally been reported after oral use of nystatin. Oral irritation or sensitisation may occur, and rashes, including urticaria, have occurred and Stevens-Johnson syndrome has been reported rarely.

Contraindications

Nystatin is contraindicated in individuals who are hypersensitive to the drug.

PBS listing

NILSTAT tablets 500,000 units are listed on the PBS with 2 items, unrestricted access, at an ex-manufacturer price of A$8.53. NILSTAT capsules 500,000 units are listed on the PBS with 2 items, unrestricted access, at an ex-manufacturer price of A$8.53.

Regulatory history

NILSTAT ORAL tablets and capsules were first listed on the Australian Register of Therapeutic Goods on 9 September 1991. The product was first approved on 10 November 1999.