Indications

Fluconazole is indicated in- Vaginal Candidiasis Oropharyngeal Candidiasis Esophageal Candidiasis Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea Kerion Pityriasis versicolor Onychomycosis Invasive candidal infections and cryptococcal infections (including meningitis) ... Read more Fluconazole is indicated in- Vaginal Candidiasis Oropharyngeal Candidiasis Esophageal Candidiasis Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea Kerion Pityriasis versicolor Onychomycosis Invasive candidal infections and cryptococcal infections (including meningitis) Prevention of cryptococcal meningitis Prevention of fungal infections in immunocompromised patients Systemic Candidiasis and Cryptococcal infection In Superficial Candidiasis In Systemic Candidiasis & Cryptococcal infection Other indications- Fungal urinary tract infections Disseminated candidiasis Prophylaxis for fungal infection in neutropenic cancer patients. Acute treatment of other systemic fungal infections such as coccidioidomycosis and histoplasmosis.

Composition

Pharmacology

Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.

Dosage & Administration

Adults: Vaginal Candidiasis : 150 mg as a single dose. Oropharyngeal Candidiasis : 200 mg in 1st day followed by 100 mg daily for 14 days. Oesophageal Candidiasis : 200 mg in 1st day followed by 100 mg daily for 14-30 days. Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea : 150 mg weekly for 4-6 weeks. Kerion : 50 mg daily for 20 days. Pityriasis versicolor : 400 mg as a single dose. Onychomycosis : 150 mg weekly for 12 months. Invasive candidal infections and cryptococcal infections (including meningitis) : Orally or by IV infusion, 400 mg on first day then 200-400 mg daily. Prevention of cryptococcal meningitis : Orally or by IV infusion 200 mg daily. Prevention of fungal infections in immunocompromised patients : Orally or by IV infusion, 50-400 mg daily. Child over 1 year- In Superficial Candidiasis : 1-2 mg/kg daily. In Systemic Candidiasis & Cryptococcal infection :3-6 mg/kg daily. In serious life threatening infections upto 12 mg/kg daily has been given to children aged 5-13 years (Maximum 400 mg daily) 1 year: 9 kg : 1/2 measuring spoonful 1-2 years: 12 kg : 1 measuring spoonful 2-3 years: 14 kg : 1½ measuring spoonful 3-4 years: 16 kg : 2 measuring spoonful 4-6 years: 20 kg : 2½ measuring spoonful Use in Specific Population- Elderly patient : The normal dose should be used if there is no evidence of renal impairment. Renal Impairment : No adjustment in single dose therapy is required. In multiple dose therapy of patients with renal impairment, normal doses should be given on days 1 and 2 of treatment and there after the dosage intervals should be modified as follows: Creatinine clearance (>41 ml/min): Dosage interval (hours) 24 Creatinine clearance (21-40 ml/min): Dosage interval (hours) 48 Creatinine clearance (10-20 ml/min): Dosage interval (hours) 72 Patients receiving regular dialysis: One dose after every dialysis session Children : Renal clearance in children may be proportionately more rapid than in adults and doses up to 12 mg/kg is recommended.

Contraindications

Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.

Side Effects

Fluconazole is generally well tolerated. The commonest side-efects associated Fluconazole are symptoms associated with the gastrointestinal tract; these include nausea, abdominal discomfort, diarrhoea and fatulence. Other adverse events such as rash are rarely encountered (Incidence less than 1%). In rare cases, as with other azoles, anaphylaxis has been reported.

Pregnancy & Lactation

Fluconazole adverse fetal efects have been seen in animals only at dose levels associated with maternal toxicity. These levels are many times in excess of those recommended for therapeutic use. There has been little use during human pregnancy. Accordingly, fuconazole should not be used in pregnancy or in women of child bearing potential unless adequate contraception is employed.

Precautions & Warnings

in some patients, particularly those with serious underlying diseases such as AIDS and cancer, abnormalities of hepatic, renal, haematological and other biochemical function tests have been observed during treatment with fuconazole, but the clinical signifcance and relationship to treatment is uncertain. Very rarely. patients who died with severe underlying disease and who had received multiple dose fuconazole, had post-mortem fndings which included hapatic necrosis. These patients were receiving multiple concomitant medications, some known to be potentially hepatotoxic, and/or had underlying diseases, which could have caused the hepatic necrosis. Consequently, because a causal relationship with fuconazole cannot be excluded, the risk-beneft ratio of continued fuconazole treatment should be assessed in those patients in whom a signifcant rise of liver enzymes occurs. Patients have rarely developed exfoliative cutaneous reactions, such pa Stevens Johnson Syndrome and toxic epidermal necrolysis, during treatment with fuconazole. AIDS patients are more prone to the development of severe cutaneous reactions to many drugs. If a rash develops in a patients treated for a superfaclal fungal infection which is considered attributable to fuconazole further therapy with this agent should be discontinued. In patients with invasive/ systemic fungal infections who develop rashes, they should be monitored closely and fuconazole should be discontinued if bolbous lesions or erythema multiform develop. Use during lactation: Fluconazole is found in human breast milk at concentrations similar to plasma. hence its use in nursing mothers is not recommended. Driving/Use of machinery: Experience with fuconazole indicates that therapy a unlikely to impair a patient's ability to drive or use machinery.

Therapeutic Class

Drugs for subcutaneous and mycoses

Storage Conditions

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