MYCOSTATIN ORAL SUSPENSION
(and dosage form)
MYCOSTATIN ORAL SUSPENSION
MYCOSTATIN ORAL SUSPENSION contains 100 000 units nystatin per mL, preserved with methylparaben 0,1% m/v and propylparaben 0,02% m/v.Contains 0,5% v/v ethyl alcohol.
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 moeity, 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.
Treatment of candidal (monilial) infections of the oral cavity.
Patients with a history of hypersensitivity to any component.
Safety in pregnancy and lactation has not been established. It is not known whether nystatin is excreted in human milk.
DOSAGE AND DIRECTIONS FOR USE
INFANTS: The usual dose is 1 mL to 2 mL (100 000 to 200 000 units) four times daily, dropped into the mouth.
CHILDREN AND ADULTS: The usual dose is 1 mL to 2 mL (100 000 to 200 000 units) four times daily, dropped into the mouth and held for some time before swallowing. This dose may be increased to 4 mL to 6 mL (400 000 to 600 000 units) four times daily for more severe infections.
(On administration by dropper, the suspension readily disperses throughout the mouth, and is compatible with commonly used antimicrobial agents, and may be given concomitantly with these agents).
The suspension should be retained in the mouth for as long as possible (e.g., several minutes) before swallowing. In infants and young children, apply one-half of dose in each side of mouth.
The dosage regimen for nystatin for oral suspension should be continued for at least 48 hours after symptoms have disappeared.
NOTE: If significant regenerations or repair of oral tissue has not occurred in seven days, additional investigation into the etiology of the oral lesion is advised.
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 SUSPENSION 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.
Light creamy yellow suspension, flavoured with cherry mint.
Bottle containing 30 mL suspension.
Store at room temperature not exceeding 25°C.
KEEP OUT OF REACH OF CHILDREN.
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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