Composition:

Fuze 50 mg capsules: Each capsule contains Fluconazole BP 50 mg

Description: Fluconazole is a triazole antifungal drug, which acts by inhibition of the ergosterol component of the fungal cell membrane. It is active against a broad spectrum of fungal pathogens and is available for oral use. Fluconazole acts by inhibiting the synthesis of ergosterol, a major component of the cell membrane of yeast and fungi. Fluconazole is normally administered orally. Following oral administration, absorption is rapid and extensive, with > 90% of the dose being absorbed. Bioavailability is the same in fasting and fed states. The bioavailability of Fluconazole is unaffected by gastric pH. The plasma half-life is approximately 30 hrs. The plasma protein binding of Fluconazole is low, at 11% and the drug is widely distributed throughout the body. Most of the dose of Fluconazole is excreted unchanged in the urine, the remainder of the dose being eliminated in the urine as metabolites.

Indications and Uses: It is indicated in the treatment of acute or recurrent vaginal candidiasis, mucosal candidiasis (as oropharyngeal candidiasis, oesophagitis, candiduria), systemic candidiasis and cryptococcal infections (including meningitis).

Dosage and Administration: Acute or recurrent vaginal candidiasis: a single dose of 150 mg. Mucosal candidiasis: (except vaginal): 50 mg daily (100 mg daily in unusually difficult infections) given for 7-14 days in ropharyngeal candidiasis; for 14-30 days in other mucosal infections (e.g. oesophagitis, candiduria). Systemic candidiasis and cryptococcal infections (including meningitis): 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily; treatment continued according to response

Child over 1 year: superficial candida infections, 1- 2 mg/ kg daily; systemic candidiasis and cryptococcal infections (including meningitis) 3- 6 mg/kg daily (in serious life threatening infections up to 12 mg/ kg daily has been given to children aged 5- 13 years – max. 400 mg daily).

Contraindications: Fuze is contraindicated to patients hypersensitive to Fluconazole and in advanced liver.

Warning & Precautions: Caution should be taken in renal impairment, pregnancy and breast feeding and in raised liver enzyme. The use of Fluconazole in children below the age of one year is not recommended. Side-effects: Nausea, abdominal discomfort, diarrhoea and flatulence, occasionally abnormalities of liver enzyme, rarely rash, angioedema and anaphylaxis reported. Use in pregnancy and lactation: Caution should be taken in pregnancy. Use of Fluconazole in nursing mother is not recommended. Use in children and adolescents: Fluconazole should not be used by girls less than 12 years of age unless advised by a physician. Drug interactions: Rifampicin reduce plasma concentration of Fluconazole. Effect of warfarin is enhanced. Plasma concentrations of sulphonylureas and theophylline is possibly increased. Effect of phenytoin is enhanced.

Overdose: In case of accidental overdose there is a need to consult with a doctor immediately, even if there are no symptoms. Storage: Do not store above 30°C, protect from light & moisture. Keep the medicine reach out of children. Pack Size: Fuze 50 capsule: Each box contains 3 x 10’s capsules in Alu-Alu blister pack