Nystatin Oral Suspension BP

Nystatin Dome

Infestat (Opus Pharmaceuticals)

Each ml contains 100,000 I.U. Nystatin BP.

For a full list of excipients, see section 6.1.

Oral Suspension.

Indications

Suspension for the prevention and treatment of candidal infections of the oral cavity, oesophagus and intestinal tract. It 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 candidas 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.

For the treatment of intestinal candidosis 5ml of the suspension should be dropped into the mouth four times daily.

For prophylaxis a total daily dosage of 1 million units has been found to suppress the overgrowth of candidas albicans in patients receiving broad-spectrum antibiotic therapy.

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.

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

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

Elderly: No specific dosage recommendations or precautions.

Route of administration

Oral.

Contraindicated in patients with a history of hypersensitivity to the active substance or excipients.

Nystatin Oral Suspension BP contains sugar.

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

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

The label states the following warnings:-

Shake well before use.

Do use if seal is broken.

This product should not be diluted.

Store in a cool place. Avoid freezing.

Protected from light.

Not known.

Pregnancy:

Animal reproductive studies have not been conducted with nystatin.

It is not known whether nystatin can cause foetal harm when taken by 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.

Breastfeeding:

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 breast-feeding mothers.

No known 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.

There have been reports of rash (including urticaria) and rarely Stevens-Johnson syndrome has been reported.

Large doses of nystatin could cause face oedema, vomiting, diarrhoea and gastrointestinal distress.

Since the absorption of Nystatin from the gastro-intestinal tract is negligible, overdosage causes no systemic toxicity.

Nystatin is a mixture of antifungal polyenes produced by the growth of certain strains of Streptomyces noursei, or by any other means. It consists largely of Nystatin A₁.

Nystatin is a tetraene macrolide. There is no data available on the pharmacokinetics as it is not absorbed from the gastro-intestinal tract, skin or vagina and most of the use is topical. Microbial growth-inhibiting concentrations have been shown to be in the range 3-6mg/l.

Not required.

Sodium carboxymethylcellulose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium metabisulphite, sucrose, saccharin sodium, sodium citrate, permaseal aniseed flavour, purified water.

Not known.

36 months.

Store in a cool place - avoid freezing.

30g amber glass bottle fitted with a:

i) phenolic resin plastic cap and tin-foil covered melinex liner or

ii) child-resistant cap.

Pack size: 30ml

Shake well before use.

Sandoz Ltd

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR.

United Kingdom

PL 4416/0161

13 February 1990 / 11 October 2005

06/2011