[Fluconazole USP] Antifungal
Composition
Fungicap 50 capsule: Each capsule contains Fluconazole USP 50 mg.
Fungicap 150 capsule: Each capsule contains Fluconazole USP 150 mg.
Pharmacology
Fluconazole is a triazole antifungal drug that 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. Following oral administration, absorption is rapid and extensive (>90%). Bioavailability is the same in the fasting and fed states. The bioavailability of Fluconazole is unaffected by gastric pH. The plasma half life is approximately 30h. The plasma portein 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 remain of the dose being eliminated in the urine as metabolites.
Indication
Fluconazole is indicated for the treatment of acute or recurrent vaginal candidiasis, mucosal candidiasis (as oropharyngeal candidiasis, oesophagistis, candiduria), systemic candidiasis and cryptococcal infections (including meningitis).
Dosage & administration
Adults
Oropharyngeal Candidiasis: The recommended dosage of Fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily for 7-14 days. Esophageal Candidiasis: The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily for 2-3 weeks. Systemic Candidiasis and Cryptococcal Meningitis: 400 mg daily followed by 200 mg once daily. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks. Acute or recurrent vaginal candidiasis: Single dose of 150 mg. Urinary Tract Infections and Peritonitis: 50 to 200 mg once daily. Prophylaxis in Patients Undergoing Bone Marrow Transplantation: 400 mg once daily.
Contra-indication
Fluconazole is contraindicated to patients hypersensitive to this drug and in advanced liver disease.
Warning & precaution
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 and flatulence, occasionally abnormalities of liver enzymes; rarely rash; angioedema and anaphylaxis reported.
Use in pregnancy & lactation
Fluconazole should be used in pregnancy only if the potential benefit justifies the possible risk to the fetus. Fluconazole is secreted in human milk at concentrations similar to plasma. Therefore, the use of Fluconazole in nursing mother is not recommended.
Use in children & adolescents
Oropharyngeal Candidiasis: The recommended dosage of Fluconazole for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse. Esophageal Candidiasis: Recommended dosage of Fluconazole in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Cryptococcal meningitis: Initial therapy should be started with 6 to 12 mg/kg daily. Doses up to 12 mg/kg/day may be used for three weeks and treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks.
Drug interaction
Rifampicin reduces plasma concentration of Fluconazole. Effects of Nicoumalone, Phenytoin and Warfarin are enhanced. Plasma concentrations of Sulphonylureas & theophylline are possibly increased.
Overdose
In the case of an overdose, supportive measures should be instituted.
Storage
Keep out of the reach of children. Keep below 300 C, protect from light.
Packing
Fungicap 50 capsule: Each box contains 3x10 capsules in blister pack.
Fungicap 150 capsule: Each box contains 2x10 capsules in blister pack.
