Trade Name: FLUJALE

Generic Name: Fluconazole 50 mg

Description:

FLUJALE (Fluconazole) is a broad-spectrum antifungal of Triazole subclass. Fluconazole exerts its antifungal activity by inhibiting the synthesis of ergosterol, a major component of the cell membrane of yeast and fungi. Fluconazole is used for superficial mucosal candidiasis, fungal skin infections, systemic fungal infections and has been tried in blastomycosis, chromoblastomycosis, histoplasmosis, sporotrichosis, and cutaneous leishmaniasis.

Composition:

FLUJALE Capsule: Each capsule contains Fluconazole USP 50 mg.

Indication:

FLUJALE (Fluconazole) is indicated for the treatment of the following infections:

◘ Vaginal candidiasis and candidal balanitis

◘ Mucosal candidiasis including oropharyngeal candidiasis, atrophic oral candidiasis associated with dentures.

◘ Other mucosal infections (e.g. oesophagitis, candiduria, non-invasive bronchopulmonary infections)

◘ Tenia pedis, corporis, cruris, pityriasis versicolor and dermal candidiasis

◘ Systemic/Invasive candidal infections (including candidaemia and disseminated candidiasis) and cryptococcal infections (including meningitis)

◘ Prevention of relapse of cryptococcal meningitis in AIDS patients

◘ Prevention of fungal infections in immunocompromised patients

◘ Urinary tract infection and peritonitis

◘ Cutaneous leishmaniasis

Dosage and Administration:

Adults:

Higher dose are recommended in the USA where an initial dose of Fluconazole 200 mg is followed by 100 mg daily and doses up to 400 mg daily may be used if necessary. In the USA 10-12 weeks.

Children (over 4 weeks): Mucosal candidiasis: 6 mg/kg on first day

then 3 mg/kg daily. Systemic/Invasive candidal infections (including candidaemia and disseminated candidiasis) and cryptococcal infections (including meningitis): 12 mg/kg on first day then 6 mg/kg daily.

Prevention of fungal infections in immunocompromised patients: according to extent and duration of neutropenia, 3-12 mg/kg daily.

Infant (2-4 weeks): Same dose of older children (over 4 weeks) but every 48 hours.

Infant (under 2 weeks): Same dose of older children (over 4 weeks) but every 72 hours.

A maximum dose of 400 mg daily should not be exceed in children or 12 mg/kg at appropriate intervals in infants.

In renal impairment: Normal loading or initial doses of Fluconazole should be given on the first day of treatment and subsequent doses should be adjusted according to Creatinine Clearance (CC). CC >50 ml/min: standard dose; CC <50 mg/min: and the patient is not receiving dialysis: ½ the standard dose; patients on regular haemodialysis: standard dose after every dialysis session. No dosage adjustment is needed in single dose therapy.

Contraindication:

FLUJALE is contraindicated in known hypersensitivity to Fluconazole or other Azole antifungal agents and in advanced liver disease.

Precaution:

FLUJALE (Fluconazole) should be used with caution in renal or hepatic impairment, arrhythmic conditions.

In Pregnancy and Lactation:

Pregnancy: Pregnancy category C. There are no adequate and well controlled studies of Fluconazole in pregnant women. Fluconazole should be considered only if the expected benefit to the mother is greater than any possible risk to the fetus.

Lactation: Fluconazole is secreted in breast-milk at concentrations similar to plasma. Because of the potential for adverse reactions in nursing infants, decide whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Side Effect:

Nausea and vomiting, abdominal discomfort, diarrhoea, flatulence, taste disturbance, headache, dizziness, leucopenia, thrombocytopenia, hyperlipidaemia, rash, anaphylaxis, pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome, alopecia, hypokalemia, QT prolongation, hepatic toxicity.

Drug Interaction:

Oral hypoglycemics (Tolbutamide, Glyburide, Glipizide, Nateglinide): plasma concentration of these agents are increased, therefore hypoglycemia may be precipitated. Cumarin-type anticoagulants (Warfarin): prothrombin-time may be increased. Cyclosporine, Phenytoin, Rifabutin, Tacrolimus, Zidovudine: plasma concentration of these agents is increased. Benzodiazepines (Midazolam, Triazolam), Nortriptylin: plasma concentration of these agents is increased. Astemizole, Cisapride,

Terfenadine: risk of cardiac arrhythmias. Rifampicin: reduces plasma concentration of Fluconazole. Theophylline: may reduce the clearance of theophylline.

Oral contraceptives: the efficacy of oral contraceptives may be affected.

Storage:

Store in a cool dry place and away from light. Keep out of the reach of children.

How Supplied:

FLUJALE Capsule: Each box containing 3 x 10’s capsule in Alu-PVC blister strips.