Flugal Powder for Suspension- 35 ml bottle

Fluconazole is indicated in

• 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

Drugs for cutaneous mycoses, Drugs for subcutaneous and systemic mycoses

Fluconazole is the first of a new subclass of synthetic triazole antifungal agent 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.

Oral-

Adults: 

• Oropharyngeal Candidiasis: 200 mg on the first day, followed by 100 mg once daily for 7-14 days.
• Esophageal Candidiasis: 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.

Children:

• Oropharyngeal Candidiasis: 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: 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.

Intravenous-

Adult & child: Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by IV, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis); Child 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily.

Prevention of relapse of cryptococcal meningitis, by IV, 100-200 mg daily.

Since oral absorption is rapid and almost complete, the daily dose of Fluconazole is the same for oral and intravenous administration.

Rifampicin reduces plasma concentration of Fluconazole. Fluconazole enhances the effect of nicoumalone, warfarin and phenytoin. It also increases the plasma concentration of sulphonylureas & theophlline.

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

Therapy with Fluconazole is well tolerated. The common adverse effects are nausea. abdominal pain, vomiting, diarrhoea, headache and skin rash.

Use in pregnancy: Fluconazole should be used in pregnancy only if the potential benefit justifies the possible risk to the foetus.

Use in lactation: Fluconazole is secreted in human milk at concentrations similar to plasma. Therefore, the use of Flouconazole in nursing mother is not recommended.

Caution should be taken in renal impairment, pregnancy and breast feeding and in raised liver enzymes. The use of Fluconazole
in lactating mothers is not recommended.

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

Store below 30° C. Protect from light & moisture. Remaining reconstituted suspension should not be used after 7 days. If it is kept under freezing temperature (2- 8° C) , it can be used for 14 days. Keep out of the reach of children.