(and dosage form):
Each lozenge contains 10 mg amphotericin B.
Category A 20.1.7 Antifungal antibiotics.
FUNGIZONE is a polyene antifungal antibiotic obtained from Streptomyces nodosus.. It is effective in vitro against a wide range of yeasts and yeast-like fungi, including Candida albicans.
The antifungal activity of FUNGIZONE is, at least in part, dependent on its binding to a sterol moiety, primarily ergosterol, present in the membrane of sensitive fungi. This results in an increase in the permeability of the membrane which allows leakage of the intra-cellular components.
Pharmacokinetic: absorption from the gastrointestinal tract is negligible.
Treatment of candidiasis (thrush) in the oral and perioral areas, and non-specific oral infections, complicated by candida (denture stomatitis, angular cheilitis, antibiotic stomatitis).
Patients who have shown hypersensitivity to amphotericin B.
Orally administered amphotericin B is not to be used for the treatment of systemic fungal infections.
DOSAGE AND DIRECTIONS FOR USE:
The dosage regimen depends primarily on the severity of the infection; good results can be expected in most cases with the administration of 4 lozenges per day until at least 48 hours after clinical cure. The lozenge should be administered after meals and at bedtime; it should be sucked slowly to prolong the effect. Patients wearing dentures should be especially careful to cleanse them thoroughly and should remove them while sucking the lozenge to allow the active material to reach all tissues.
Other contributing factors (poor oral hygiene, ill-fitting dentures, drugs or medications, other infections or disease states, etc.) should be corrected if necessary.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Amphotericin B is not appreciably absorbed when taken orally. However the following may occur:
Rash, glossitis, and gastrointestinal distress, including nausea, vomiting, and diarrhoea. Urticaria, angioedema, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. Transient yellowing of the teeth may occur, which can easily be removed by brushing.
Headache, nausea, vomiting, chills, fever, malaise, muscle and joint pains, rash, anorexia, diarrhoea and gastrointestinal cramp may occur with systemic therapy. Although amphotericin B is poorly absorbed when administered orally, the possibility that these side-effects may occur are not excluded.
Sensitivity is rare, but should it develop, treatment should be discontinued.
There are no adequate and well-controlled studies in pregnant women. Oral forms of amphotericin B should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether amphotericin B is excreted in human milk. Through gastrointestinal absorption is insignificant, caution should be exercised when amphotericin B is prescribed for a nursing woman.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There is little information available regarding overdose with oral dosage forms of amphotericin B. Absorption of amphotericin B from the gastrointestinal tract is negligible, even in high doses.
Treatment of overdosage should be symptomatic and supportive.
Round pale yellow flat faced, bevelled edge tablets, 16 mm in diameter, printed SQUIBB on one face; having an orange odour and flavour.
Bottles of 20 lozenges.
Store at room temperature not exceeding 25°C, in a dry place and avoid excessive heat.
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 Fungizone
Updated on this site: January 2000
Current: March 2005
Source: Hospital Pharmacy
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