NYSTAN Oral suspension Ref.[7711] Active ingredients: Nystatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Vygoris Limited, 930 High Road, London N12 9RT, United Kingdom

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.

Posology and method of administration

Posology

Adults

For the treatment of denture sores, and oral infections in adults caused by C.albicans, 1 ml 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, 1 ml 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 1 ml once daily.

Older people

No specific dosage recommendations or precautions.

In the prevention and treatment of candidiasis, the dosage regimen for Nystan should be continued for at least 48 hours after symptoms have disappeared. If signs and symptoms worsen or persist (beyond 14 days of treatment), the patient should be reevaluated, and alternate therapy considered.

Overdose

Since the absorption of nystatin from the gastro-intestinal tract is negligible, overdosage or accidental ingestion causes no systemic toxicity. Oral doses of nystatin in excess of 5 million units daily have caused nausea and gastrointestinal upset.

Shelf life

2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

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

Special precautions for disposal and other handling

Shake well before use.

Dilution is not recommended as this may reduce therapeutic efficacy.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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