FALCON ® – Fluconazole USP

Chemical Name: 2-(2,4-difluorophenyl)-1,3-bis(1,2,4-triazol-1-yl)propan-2-ol

Description: Fluconazole is an antifungal drug used for the treatment of both systemic and superficial fungal infections in a variety of tissues. Fluconazole is an Antifungal from the Azole family, a triazole to be specific. Fluconazole has many advantages over the other antifungal drugs including the option of oral administration.

— 50 mg 3×10 capsules
— 150 mg 2×6 capsules

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FALCON ® – Fluconazole USP

COMPOSITION

Available in two dosage forms:

FALCON®-50 Capsule: Each capsule contains Fluconazole USP 50 mg. FALCON®-150 Capsule: Each capsule contains Fluconazole USP 150 mg.

FALCON® Powder For Suspension: After reconstitution each 5 ml contains Fluconazole USP 50 mg.

MODE OF ACTION

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
  • 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.

CONTRAINDICATION

Fluconazole is contra-indicated for nursing mothers, in patients hypersensitive to this drug and patients with advanced liver disease

SIDE EFFECT

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.

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® 150 Capsule: Box contains 2×6 capsules in Alu-Alu blister strip pack.

FALCON® 50 Capsule: Box contains 3×10 capsules in Alu-Alu blister strip pack.

FALCON® Powder for Suspension: Pet bottle contains 35 ml Powder for Suspension.