Product Monograph - Jamp-Nystatin Oral Suspension USP
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 JAMP-Nystatin Oral Suspension USP. If irritation or sensitization occurs, JAMP-Nystatin Oral Suspension USP 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. Tachycardia, bronchospasm, facial swelling, urticarial and non-specific myalgia have been reported rarely.
DOSAGE AND ADMINISTRATION
SHAKE WELL BEFORE USE.
Dosing Considerations
Therapy should generally be continued for at least 48 hours after clinical cure to prevent relapse. When oral nystatin is given concomitantly with an oral antibacterial agent, oral nystatin should be continued at least as long as the antibacterial agent.
Administration
For oral (thrush) and intestinal monilial infections:
Infants and children: 100 000 units 3 to 4 times daily;
Adults: 100,000 units 4 times daily.
Dosage may be increased if necessary.
For treatment of infections of the oral cavity, the medication should be dropped directly on the tongue by means of a calibrated dropper and retained in the mouth for as long as possible before swallowing.
For treatment of intestinal infections, may be dropped directly on the tongue by means of a calibrated dropper or may be mixed with milk, lukewarm formula, or other non-acid vehicles, or incorporated in honey, jelly or peanut butter.
OVERDOSAGE
SUPPLIED
Each mL of banana-flavored suspension contains 100 000 units of nystatin and the following non-medicinal ingredients: Anhydrous dibasic sodium phosphate, ammonium glycyrrhizinate, banana flavour, citric acid anhydrous, carboxymethylcellulose sodium, D&C Yellow No. 10, ethyl vanillin, glycerin, maltol, methylparaben, propylene glycol, propylparaben, purified water, sucrose.
JAMP-Nystatin Oral Suspension USP is available in 100 mL and 500 mL high density polyethylene bottles with a polypropylene cap.
STORAGE
Store: 15-30°C.
JAMP-Nystatin Oral Suspension USP should not be used beyond 30 days after opening.
Keep bottle tightly closed. Protect from light.
Keep out of reach and sight of children.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).