Presentation
Fluconazole 50 : Each capsule contains Fluconazole USP 50 mg
Fluconazole 150 : Each capsule contains Fluconazole USP 150 mg
Fluconazole Powder for Suspension: After reconstitution according to direction each 5 ml of suspension contains Fluconazole USP 50 mg.

Description
Fluconazole is a synthetic triazole antifungal drug that inhibits the biosynthesis of ergosterol, a major component of the cell membrane of yeast and fungal cells, leading to abnormalities in membrane permeabilities, inhibition of growth, abnormal cell wall formation and accumulation of intracellular lipids and membranous vesicles. It is active against a broad spectrum of yeast and other fungal pathogens. Following oral administration, absorption is rapid with > 90% of the dose being absorbed. Bioavailability is the same whether taken during fasting or with food, as the pharmacokinetics of Fluconazole is relatively insensitive to physiological changes in the GIT. Unlike other azole drugs, the bioavailability of Fluconazole is unaffected by gastric pH so it can be given during treatment with antiulcer drugs including PPI. 80% of a dose of Fluconazole is excreted unchanged and 11% is excreted as inactive metabolites in the urine, presumably as a result of metabolism in the liver. A further 2% of a dose is recovered unchanged in the feces, and the fate of the remaining is unknown.

Indications and Uses
Superficial candidal infections such as oral or vaginal thrush
Esophagitis caused by Candida or other susceptible species
Maintenance therapy of cryptococcal meningitis
Disseminated candidiasis
Prophylaxis for fungal infection in neutropenic cancer patients
Acute treatment of other systemic fungal infections
Dermatophyte and Candida skin infections
Fungal UTIs

Contraindications
Known hypersensitivity
Advanced liver disease

Dosage And Administration
Fluconazole is usually given orally. Generally the total daily dose is given at once unless nausea supervenes, in which case the dose may be divided.

Precautions
Cautions should be taken in renal impairment; in hepatic disease liver function should be monitored and should be discontinued if signs or symptoms of hepatic disease appear.

Side Effects
Nausea, abdominal discomfort, diarrhoea, flatulence, headache, rash; less frequently dyspepsia, vomiting, abnormalities in liver enzymes, seizures, alopecia and Stevens Johnson syndrome reported.

Use in pregnancy & lactation
There are limited data on the use of Fluconazole in pregnant woman. However Fluconazole should be used in pregnancy only when the benefit clearly outweighs the risk.

Fluconazole is excreted in breast milk in levels about half of those found in plasma; therefore the drug should be avoided during lactation

Overdosage
In the case of an overdose, supportive measures should be instituted.

Storage
Shake the bottle well to loosen the powder. Add 20 ml (4 measuring spoonful) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation add water to the bottle in two portions. Shake the bottle well after each addition of water until all the powder is in suspension.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 14 days.

Commercial Pack
Fluconazole 50 : Each box contains 3 blister strips of 10 capsules.
Fluconazole 150 : Each box contains 1 blister strip of 10 capsules.
Fluconazole Powder for Suspension: Bottle containing dry powder to produce 35 ml suspension when reconstituted.