Fluconal 50 mg Tablet

Fluconal 50 mg Tablet

DESCRIPTION

FLUCONAL (Fluconazole) is a triazole antifungal drug which is a highly selective inhibitor of the fungal cell membrane. FLUCONAL (Fluconazole) acts by inhibiting the synthesis of ergosterol, a major component of the cell membrane of yeasts and fungi. It has a broad spectrum of activity. Oral administration of FLUCONAL (Fluconazole) leads to rapid and almost complete absorption. Administration of the drug with food does not affect absorption.

COMPOSITION

FLUCONAL 50 : Each tablet contains Fluconazole BP 50 mg.

FLUCONAL 150 : Each tablet contains Fluconazole BP 150 mg. Powder for Suspension : After reconstitution each 5 ml suspension contains Fluconazole BP 50 mg.

INDICATIONS

FLUCONAL (Fluconazole) is indicated for the treatment of :

1. Vaginal candidiasis/candidal balanitis

2.Mucosal candidiasis : Oropharyngeal candidiasis, oesophagitis, candiduria. FLUCONAL is also effective for the treatment of systemic candidal infections (including candidaemia and disseminated candidiasis).

3. Cryptococcal infections (including meningitis).

4. Tinea pedis, tinea corporis, tinea cruris, tinea versicolor, dermal candidiasis and onychomycosis.

DOSAGE AND ADMINISTRATION

Use in adult :

 Vaginal candidiasis/candidal balanitis : 150 mg as a single dose.

 Mucosal candidiasis (except vaginal) : 50 mg daily (100 mg daily in unusually difficult infections) for 7-14 days in oropharyngeal candidiasis and 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.

 Tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candidiasis : 50 mg daily for 2-4 weeks (for up to 6 weeks in tinea pedis); maximum duration of treatment 6 weeks.

 Onychomycosis : 150 mg 1 day per week for 6 months.

Use in children :

 Mucosal candidiasis : Children 3-6 mg/kg on first day then 3 mg/kg daily.

Neonate :

0-2 weeks : Every 72 hours

2-4 weeks : Every 48 hours

 Systemic candidiasis and cryptococcal infections (including meningitis) : 6-12 mg/kg daily.

Neonate :

0-2 weeks : Every 72 hours

2-4 weeks : Every 48 hours

OR AS DIRECTED BY THE PHYSICIAN

CONTRAINDICATIONS

Fluconazole is contraindicated for patients hypersensitive to this drug.

Use in Pregnancy & lactation

Pregnancy category C. Fluconazole may be used in pregnancy only if the potential benefit justifies the possible risk to the fetus. Caution should be taken during lactation.

PRECAUTIONS

In patients with renal impairment the dosage schedule should be reduced in accordance with the degree of renal impairment.

SIDE EFFECTS

Nausea, abdominal discomfort, diarrhoea, and flatulence may occur which is very rare, mild and transient.

SUPPLY

FLUCONAL 50 : Each box contains 2 x 10 tablets in alu-alu blister strips.

FLUCONAL 150 : Each box contains 3 x 4 tablets in alu-alu blister strips.

Powder for Suspension : Dry powder in a glass bottle for reconstitution to 35 ml of suspension with a measuring cup and a calibrated dropper.