Nystan Oral Suspension (Ready -Mixed )

1. Name Of The Medicinal Product

NYSTAN ORAL SUSPENSION (READY-MIXED)

2. Qualitative And Quantitative Composition

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

3. Pharmaceutical Form

Oral suspension

4. Clinical Particulars

4.1 Therapeutic Indications

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.

4.2 Posology And Method Of Administration

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.

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.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

Nystan Oral Suspension contains sugar.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Animal reproductive studies have not been conducted with nystatin.

It is not known whether nystatin can cause foetal harm when administered to a 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.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Nystatin is generally well tolerated by all age groups, even during prolonged use. Rarely hypersensitivity,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, and face oedema has been reported rarely. Steven-Johnson Syndrome has been reported very rarely.

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

No further relevant information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethanol, flavours, glycerin, methyl parahydroxybenzoate, pH adjusters (hydrochloric acid, sodium hydroxide), propyl parahydroxybenzoate, sodium carboxymethylcellulose, sodium phosphate, sucrose, water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

30ml amber glass bottle, packed in a cardboard carton with a graduated, polyethylene dropper.

6.6 Special Precautions For Disposal And Other Handling

Shake well before use.

Dilution is not recommended as this may reduce therapeutic efficacy.

7. Marketing Authorisation Holder

E. R. Squibb & Sons Limited

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex UB8 1DH

8. Marketing Authorisation Number(S)

PL 0034/0130R

9. Date Of First Authorisation/Renewal Of The Authorisation

08/02/2010

10. Date Of Revision Of The Text

08/02/2010