FALCON ® – Fluconazole USP
COMPOSITION
Available in 2 different Capsule Content:
FALCON-50: Each capsule contains Fluconazole USP 50 mg.
FALCON-150: Each capsule contains Fluconazole USP 150 mg.
PHARMACOLOGY
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.
INDICATION
FALCON (Fluconazole) is indicated in the treatment of:
• Onychomycosis
• Vaginal candidiasis.
• Mucosal candidiasis: Oropharyngeal, Candidiasis, Oesophagitis, Candiduria. FALCON is also effective for the treatment of systemic candidal infections (including candidaemia and disseminated candidiasis).
• Cryptococcal infection (including meningitis), Timeapedis, Tineacorporis, Tineacruris, Tineaversicolor, Dermal candidiasis and Onycho- mycosis.
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).
Use in Adult:
Vaginal candidiasis: 150mg as a single dose.
Use in Children:
Children aged above 1 year with normal renal function
Superficial candidal infections: The daily dose is 1-2mg/kg body weight.
Systemic candidal/dose is 3-6 mg/kg body weight. In serious life threatening infections up to 12 mg/kg daily has been given to children aged 5-13 years. The maximum approved daily dose of 400 mg should not be exceeded.
SIDE EFFECTS
Fluconazole is generally well tolerated. Nausea is the most frequently observed side effect. Vomiting and gastrointestinal discomfort have also been reported. Hepatic enzymes may also be raised.
PRECAUTION
In patients with renal impairment, the dosage schedule should be reduced in accordance with the degree of renal impairment. Children below the age of 1 year, the use of Fluconazole is not recommended.
CONTRAINDICATION
Fluconazole is contra-indicated for nursing mothers, in patients hypersensitive to this drug and patients with advanced liver disease
DRUG INTERACTION
Rifampicin reduces plasma concentration of Fluconazole enhances the effect of warfare & phenytoin. It also increases the plasma concentration of Sulphonylureas & Theophyline. Effect of Phenytoin is enhanced.
USE IN PREGNANCY AND LACTATION
Pregnancy: There are no adequate studies in pregnant women. There are reports of harmful effects to the fetus when high dose fluconazole was administered to pregnant women for a few months. Use of fluconazole during pregnancy is not recommended.
Nursing mothers: Fluconazole is secreted in breast milk at concentrations similar to the mother’s blood level.
STORAGE
Store below 30o C in a cool and dry place, protected from light. Keep all medicines out of reach of children.
PACKAGING
FALCON 150mg. Capsule: Box contains 2×6 capsules in Alu-Alu blister strip pack.
FALCON 50mg. Capsule: Box contains 3×10 capsules in Alu-Alu blister strip pack.
