Nystatin Ready Mix

/ Taro

Neonates (from birth to 1 month): Clinical studies of limited size in neonates, including preterm and babies of low weight at birth, indicate that 1 ml (100,000 U) four times daily is an effective regimen.
Infants (1 month to 5 years): 2 ml (200,000 U) 4 times daily (1 ml for each side of the mouth).
Children (over 5 years) and adults: 4 – 6 ml (400,000 – 600,000 U) 4 times daily (half dose in each side of the mouth). It is recommended to keep the medication in contact with the affected areas as long as possible.
Older people: No specific dosage recommendations or precautions.
The preparation should be retained in the mouth as long as possible before swallowing. The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.
In the prevention and treatment of candidiasis, the dosage regimen for Nystatin 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.

For the treatment of oral fungal infections.

Hypersensitivity to the active substance(s) or to any of the excipients.

This preparation contains sucrose and sodium.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltaseinsufficiency should not take this medicine.
This medicinal product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). Nystatin oral preparations should not be used for treatment of systemic mycoses.

Nystatin is generally well tolerated by all age groups, even during prolonged use. If irritation or sensitisation develops, treatment should be discontinued. 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.
Hypersensitivity and angioedema, including facial oedema have been reported.
See prescribing information for full details.

None known.

Pregnancy: Animal reproductive studies have not been conducted with nystatin. It is not known whether nystatin can cause foetal harm when administered to a pregnant woman or can affect reproductive capacity, however absorptionof nystatin from the gastro-intestinal tract is negligible. Nystatin should be prescribed during pregnancy only if thepotential benefits to be derived outweigh the potential risk to the foetus.
Lactation: It is not known whether nystatin is excreted in human milk. Although gastrointestinal absorption is insignificant, caution should be exercised when nystatin is prescribed for a nursing woman.

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.

Storage: Do not store above 25°C.