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Therapeutic Category
- ANTIFUNGAL DRUGS
- ANTI-INFECTIVE DRUGS
- Pharmaceutical Form : Oral Solution
- Composition : Nystatin 100000 IU / 1 ml
- Active Substance : Nystatin
Pharmacological Classifications: Antifungal drug.
Mechanism of action:
Nystatin interferes with the permeability of the cell membrane of sensitive fungi by binding to sterols, chiefly ergosterol.
Its main action is against Candida spp.
Pharmacokinetics:
Nystatin is poorly absorbed from the gastrointestinal tract. It is not absorbed through the skin or mucous membranes when applied topically.
Indications:
Nystatin-Oral Suspension: 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.
Contraindications:
Nystatin is contraindicated in patients with a history of hypersensitivity to any of product components.
Side Effects:
Nausea, vomiting, diarrhea, and gastrointestinal upset have occasionally been reported after oral use of Nystatin.
Oral irritation or sensitisation may occur.
Rashes, including urticaria, have occurred and Stevens-Johnson syndrome has been reported rarely.
Precautions:
Nystatin oral preparations should not be used for treatment of systemic mycoses.
Discontinue treatment if sensitization or irritation is reported during use.
Use in pregnancy and Lactation:
Nystatin preparations should be prescribed for a pregnant woman only if the potentialbenefit to the mother outweighs the potentialrisk to the fetus.
It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
Drug and Food Interactions:
No interactions have been reported.
Dosage and Administration:
- Nystatin- Oral Suspension:
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 candidasalbicans. 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.
Overdoses:
Oral doses of nystatin in excess of 5 million units daily have caused nausea and gastrointestinal upset.
STORAGE:
Store in a dry place below 25°C.
PACKAGE:
Oral suspension: 100 mL.