MYCOSTATIN ORAL TABLETS
(and dosage form):
MYCOSTATIN ORAL TABLETS
MYCOSTATIN ORAL TABLETS each contain 500 000 units nystatin.
Category A 20.1.7 Antifungal antibiotics.
Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool.
Nystatin is an antibiotic with antifungal activity against a wide variety of yeasts and yeast-like fungi. The antifungal activity of nystatin is at least in part dependent on its binding to a sterol moiety, primarily ergosterol, present in the membrane of sensitive fungi, which results in an increase in the permeability of the membrane and leakage of intra-cellular components.
Nystatin exhibits no appreciable activity against bacteria, protozoa or viruses.
MYCOSTATIN ORAL TABLETS are indicated for the treatment of intestinal candidiasis.
Patients with a history of hypersensitivity to any component.
Pregnancy and Lactation
Safety of use during pregnancy has not been established. It is not known whether nystatin is excreted in human milk.
DOSAGE AND DIRECTIONS FOR USE
The usual dose is one tablet (500 000 units) three times daily. This dosage may be increased to two tablets (1 000 000 units) three times daily if intestinal fungi are not adequately suppressed. The treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Nystatin may produce diarrhoea and gastro-intestinal disturbance, nausea and vomiting. Rash, including urticaria, has been reported. Stevens-Johnson syndrome has been reported very rarely.
MYCOSTATIN ORAL TABLETS should not be used for the treatment of systemic mycoses.
If irritation or sensitization develops, treatment should be discontinued.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Treatment of overdosage should be symptomatic and supportive.
Round, biconvex, chocolate coloured tablets.
Bottles of 20 and 100 tablets.
Store at room temperature not exceeding 25°C.
KEEP OUT OF REACH OF CHILDREN.
A 155 (Act 101 of 1965).
NAME AND BUSINESS ADDRESS OF APPLICANT
BRISTOL-MYERS SQUIBB (PTY) LTD*
47 Van Buuren Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT
*Authorised user of the TM MYCOSTATIN.
Updated on this site: June 2005
Source: Pharmaceutical Industry
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