PRODUCT DETAILS
Fluconazole USP.

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.

Presentation:

Candidal® 50 capsule: Each capsule contains Fluconazole USP 50 mg.

  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 oropharyngeal 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 candidal 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).

  Side Effects

Nausea, abdominal discomfort, diarrhoea and flatulence, occasionally abnormalities of liver enzyme, rarely rash, angioedema and anaphylaxis reported.

  Contraindications

It is contraindicated to patients hypersensitive to this drug and in advanced liver disease. 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.

  Use in Pregnancy and Lactation

Caution should be taken in pregnancy. Use of in nursing mother is not recommended.

  Drug Interaction

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.

  Storage

Store in a cool and dry place at a temperature below 30°C, keep away from sunlight.
Keep out of reach of children.

  Commercial Pack

Candidal® 50 capsule: Each box contains 5 x 6\\\'s capsules in Alu-Alu blister pack.
Candidal® 150 capsule: Each box contains 2 x 6\\\'s capsules in Alu-Alu blister pack.

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