PMS-Nystatin

Nystatin.

Nystatin is an antifungal antibiotic produced by Streptomyces noursei. Each mg of nystatin contains not less than 4400 units of activity. Nystatin deteriorates on exposure to heat, light, moisture, or air.
Each mL of yellow, cherry-flavored suspension contains 100,000 units of nystatin.
Excipients/Inactive Ingredients: the following non-medicinal ingredients: alcohol, artificial raspberry flavor, artificial wild cherry flavor, citric acid anhydrous (to adjust pH), dibasic potassium phosphate (to adjust pH), D&C yellow n*10, FD&C red n*40, glycerine, methylparaben, microcrystalline cellulose and carboxymethyl cellulose sodium, propylene glycol, propylparaben, purified water and sucrose.

Pharmacology: Nystatin exerts its antifungal activity by binding to sterols in the fungal cell membrane. The drug is not active against organisms (e.g., bacteria) that do not contain sterols in their cell membrane. As a result of this binding, the membrane is no longer able to function as a selective barrier, and potassium and other cellular constituents are lost.
Pharmacokinetics: Nystatin is poorly absorbed from the gastrointestinal tract, and detectable blood concentrations are not obtained after usual doses. Following oral administration, nystatin is excreted almost entirely in feces as unchanged drug. The drug is not absorbed from intact skin or mucous membranes.
Microbiology: Spectrum: Nystatin has fungistatic or fungicidal activity against a variety of pathogenic or nonpathogenic yeasts and fungi. In vitro, nystatin concentrations of approximately 3 μm/mL inhibit Candida albicans and C. guilliermondi. Concentrations of 6.25 μg/mL are required to inhibit C. krusei and Geotrichum lactis. It is also effective against Aspergillus spp., Coccidioides immitis, Cryptococcus neoformans, Histoplasma, Capsulatum, Blastomyces dermatidis, and other yeasts and fungi. In general, there is little difference between minimum inhibitory and fungicidal concentrations for a particular organism. Nystatin is not active against bacteria, protozoa, or viruses.
Resistance: Candida rarely becomes resistant in vivo. When resistant strains appear, they frequently are also resistant to other polyene antifungal antibiotics.

Prevention and treatment of candidal infections of the oral cavity and esophagus, for intestinal candidiasis and for protection against candidal overgrowth during antimicrobial or corticosteroid therapy.

Newborn: For prophylaxis, 100,000 units once daily may be given by dropper directly into the mouth.
Infants: Usual prophylactic and therapeutic dosage is 100,000 units 4 times daily, dropped into the side of the mouth and swallowed. Dosage may be increased if necessary.
Children and adults: Usual therapeutic dose is 100,000 units 4 times daily dropped into the mouth and held or swished throughout the mouth for as long as possible, then gargled and swallowed.
Missed Dose: If the patient missed a dose, take the missed dose as soon as possible, unless it is almost time for the next dose. Skip the missed dose if it is almost time for the next regular dose. Do not take two doses at the same time.

For management of a suspected drug overdose, contact your regional Poison Control Centre immediately.

Hypersensitivity to nystatin or any components of pms-NYSTATIN SUSPENSION. If irritation or sensitization occurs, pms-NYSTATIN SUSPENSION should be discontinued.

Nystatin exhibits no appreciable activity against bacteria, protozoa or viruses.
Fertility: Studies have not been done to evaluate the effect of nystatin on fertility in either males or females.
Dental: Patients with full or partial dentures who have symptomatic oral candidiasis may need to soak their dentures nightly in reconstituted nystatin for oral suspension to eliminate Candida species from the dentures. In rare cases when this does not eliminate the fungus, it may be necessary to have new dentures made.
Use in Pregnancy: Studies in humans have not shown that nystatin causes adverse effect on the fetus.
Use in Lactation: It is not known whether oral nystatin is excreted in breast milk. However, problems in humans have not been documented. The drug should be used with caution in nursing women.
Use in the Elderly: No information is available on the relationship of age to the effects of oral nystatin in geriatric patients.

Fertility: Studies have not been done to evaluate the effect of nystatin on fertility in either males or females.
Pregnancy: Studies in humans have not shown that nystatin causes adverse effect on the fetus.
Breast-feeding: It is not known whether oral nystatin is excreted in breast milk. However, problems in humans have not been documented. The drug should be used with caution in nursing women.

Large doses have occasionally produced diarrhea, gastrointestinal distress, nausea and vomiting.

Store between 15°C and 30°C. Store in a tight, light resistant container. Protect from freezing.

Antifungals

A07AA02 - nystatin ; Belongs to the class of antibiotics. Used in the treatment of intestinal infections.

POM