Fluconazole 150 mg (Capsule)

Indications

• Vaginal Candidiasis
• Oropharyngeal Candidiasis
• Oesophageal 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
• 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

Pharmacology

Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes 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
• Pediatric Dosing:
  • In Superficial Candidiasis: 1-2 mg/kg daily
  • In Systemic Candidiasis & Cryptococcal infection: 3-6 mg/kg daily
  • For children aged 5-13 years: doses up to 12 mg/kg daily have been given (Maximum 400 mg daily)

Interaction

Fluconazole interacts with various medications such as warfarin, sulphonylureas, hydrochlorothiazide, phenytoin, rifampicin, combined oral contraceptives, cyclosporin, theophylline, and food.

Contraindications

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

Side Effects

Common side effects include symptoms associated with the gastrointestinal tract, nausea, abdominal discomfort, diarrhea, flatulence, and rarely encountered rash. Anaphylaxis has been reported in rare cases.

Pregnancy & Lactation

Fluconazole adverse fetal effects have been seen in animals only at dose levels associated with maternal toxicity. Its use in pregnancy or in women of childbearing potential is not recommended unless adequate contraception is employed.

Precautions & Warnings

• Abnormalities in hepatic, renal, haematological, and biochemical function tests have been observed in some patients, particularly those with serious underlying diseases such as AIDS and cancer
• Patients with severe underlying diseases and receiving multiple doses of fluconazole should be assessed for liver enzyme rise
• Exfoliative cutaneous reactions such as Stevens Johnson Syndrome and toxic epidermal necrolysis have been rarely encountered, particularly in AIDS patients
• Use in lactation is not recommended, as fluconazole is found in human breast milk at concentrations similar to plasma
• Therapy is unlikely to impair a patient's ability to drive or use machinery

Use in Special Populations

• Use in the elderly: The normal dose should be used if there is no evidence of renal impairment. In patients with renal impairment, the dosage intervals or daily dosage should be adjusted according to creatinine clearance

Overdose Effects

In the event of overdosage, supportive measures and symptomatic treatment with gastric lavage if necessary may be adequate. Forced volume diuresis could increase the elimination rate. Haemodialysis decreases plasma levels by approximately 50%

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.

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