NYSTAN ORAL SUSPENSION (READY-MIXED)

Ready mixed oral suspension containing 100,000 units nystatin per ml.

Oral suspension

The prevention and treatment of candidal infections of the oral cavity, oesophagus and intestinal tract. The suspension provides effective prophylaxis against oral candidosis in those born of mothers with vaginal candidosis.

Adults:

For the treatment of denture sores, and oral infections in adults caused by C.albicans, 1ml of the suspension should be dropped into the mouth four times daily; it should be kept in contact with the affected areas as long as possible.

Administration should be continued for 48 hours after clinical cure to prevent relapse.

Children:

In intestinal and oral candidosis (thrush) in infants and children, 1ml should be dropped into the mouth four times a day. The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.

For prophylaxis in the newborn the suggested dose is 1ml once daily.

Elderly:

No specific dosage recommendations or precautions.

Contra-indicated in patients with a history of hypersensitivity to any of the components.

Nystan Oral Suspension contains sugar.

Nystan oral preparations should not be used for treatment of systemic mycoses.

None known.

Animal reproductive studies have not been conducted with nystatin.

It is not known whether nystatin can cause foetal harm when administered to pregnant women; however absorption of nystatin from the gastro-intestinal tract is negligible. Nystatin should be prescribed during pregnancy only if the potential benefits to be derived outweigh the possible risks involved.

Nursing Mothers:

Though gastro-intestinal absorption is insignificant, it is not known whether nystatin is excreted in human breast milk and caution should be exercised when nystatin is prescribed for nursing women.

None known.

Nystatin is generally well tolerated by all age groups, even during prolonged use. Rarely, oral irritation or sensitisation may occur. Nausea has been reported occasionally during therapy.

Large oral doses of Nystatin have occasionally produced diarrhoea, gastrointestinal distress, nausea and vomiting. Rash, including urticaria, has been reported rarely. Steven-Johnson Syndrome has been reported very rarely.

Since the absorption of nystatin from the gastro-intestinal tract is negligible, overdosage or accidental ingestion causes no systemic toxicity.

Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including Candida albicans.

Nystatin is formulated in oral and topical dosage forms and is not systemically absorbed from any of these preparations.

No further relevant information.

None known.

Do not store above 25°C

Shake well before use.

Dilution is not recommended as this may reduce therapeutic efficacy.

E.R. Squibb & Sons Limited

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex UB8 1DH

24 June 2005