Neostatin

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.

Nystatin topical preparations are indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

These preparations are not indicated for systemic, oral, intravaginal or ophthalmic use.

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.

Very moist lesions are best treated with the topical dusting powder.

Neostatin (nystatin) ® Cream

Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.

Neostatin (nystatin) ® Topical Powder

Adults and Pediatric Patients (Neonates and Older): Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

Nystatin topical preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

Neostatin 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.

Neostatin 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.

Neostatin Oral Suspension contains sodium metabisulphite (E223) which may rarely cause severe hypersensitivity reactions and bronchospasm.

Neostatin Oral Suspension contains propyl p-hydroxybenzoate and methyl p-hydroxybenzoate which may cause allergic reactions (possibly delayed).

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

WARNINGS

No information provided.

PRECAUTIONS

General

Nystatin, topical preparations should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

Laboratory Tests

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.

Pregnancy: Teratogenic Effects

Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION.)

Geriatric Use

Clinical studies with Neostatin (Nystatin) Cream and Neostatin (Nystatin) Topical Powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Neostatin 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 Neostatin 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.

The frequency of adverse events reported in patients using Neostatin (nystatin) ® preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General.)

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

No information provided.

Neostatin 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 is not absorbed from intact skin or mucous membrane.