Since the absorption of Nystatin filmcoated tablets from the gastro-intestinal tract is negligible, overdosage or accidental ingestion causes no systemic toxicity. Oral doses of Nystatin filmcoated tablets in excess of 5 million units daily have caused nausea and gastrointestinal upset.
Not applicable.
Nystatin filmcoated tablets 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 filmcoated tablets 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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard.
No long-term animal studies have been performed to evaluate the carcinogenic potential of Nystatin filmcoated tablets. No studies have been performed to determine the mutagenicity of Nystatin filmcoated tablets or its effect on male or female fertility.
Indications
The prevention and treatment of candidal infections of the oral cavity, oesophagus and intestinal tract.
The suspension also provides effective prophylaxis against oral candidosis in those born of mothers with vaginal candidosis.
Pharmacotherapeutic group: Antifungals for topical use, ATC code: D01AA01
Nystatin filmcoated tablets 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 filmcoated tablets A1.
Nystatin filmcoated tablets is active against a wide range of yeasts and yeast-like fungi, including Candida albicans.
Nystatin filmcoated tablets 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.
Nystatin filmcoated tablets Oral Suspension BP contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This should also be taken into account in patients with diabetes mellitus.
Nystatin filmcoated tablets Oral Suspension contains 0.3 mmol (or 1.3 mg) sodium per 1 ml dose. To be taken into consideration by patients on a controlled sodium diet.
Nystatin filmcoated tablets Oral Suspension contains sodium metabisulphite (E223) which may rarely cause severe hypersensitivity reactions and bronchospasm.
Nystatin filmcoated tablets Oral Suspension contains propyl p-hydroxybenzoate and methyl p-hydroxybenzoate which may cause allergic reactions (possibly delayed).
Nystatin filmcoated tablets oral preparations should not be used for treatment of systemic mycoses.
Not relevant.
Posology
Oral Candidiasis
Infants (1 month to 2 years)
1ml should be dropped into the mouth four times a day.
Children (> 2 years) and adults
For the treatment of denture sores, and oral infections in children (> 2 years) and 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.
Intestinal candidiasis
Infants (1 month to 2 years)
1ml should be dropped into the mouth four times a day.
Adults
For the treatment of intestinal candidosis 5ml of the suspension should be dropped into the mouth four times daily.
Paediatric population (> 2 years)
1ml should be dropped into the mouth four times a day.
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.
For prophylaxis in the newborn the suggested dose is 1ml once daily.
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.
Older people
No specific dosage recommendations or precautions.
If signs and symptoms worsen or persist (beyond 14 days of treatment), the patient should be reevaluated, and alternate therapy considered.
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.
