Product Monograph - PMS-Nystatin Suspension 100000 Unit/mL
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.
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.
INDICATIONS
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.
CONTRAINDICATIONS
Hypersensitivity to nystatin or any components of pms-NYSTATIN SUSPENSION. If irritation or sensitization occurs, pms-NYSTATIN SUSPENSION should be discontinued.
PRECAUTIONS
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.
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.
Geriatrics:
No information is available on the relationship of age to the effects of oral nystatin in geriatric patients.
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.
ADVERSE EFFECTS
Large doses have occasionally produced diarrhea, gastrointestinal distress, nausea and vomiting.
DOSAGE
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.
Shake the bottle well before use.
OVERDOSAGE
For management of a suspected drug overdose, contact your regional Poison Control Centre immediately.
SUPPLIED
Each mL of yellow, cherry-flavored suspension contains 100 000 units of nystatin and 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 nº 10, FD&C red nº 40, glycerine, methylparaben, microcrystalline cellulose and carboxymethyl cellulose sodium, propylene glycol, propylparaben, purified water and sucrose.
pms-NYSTATIN SUSPENSION is available in white plastic unit dose bottles of 5 mL with screw caps, white plastic bottles of 24 mL or 48 mL (with graduated droppers). It is also available in 100 mL and 500 ml graduated amber Pet-G bottles.
STORAGE
Store between 15°C and 30°C. Store in a tight, light- resistant container. Protect from freezing.