Fludex 50 mg (Capsule)
Medicine Details
| Category | Details |
|---|---|
| Generic | Fluconazole |
| Company | Medicon pharmaceuticals ltd |
| Also available as |
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
- Superficial Candidiasis
- 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
Triazole antifungal agent. Potent inhibitor of fungal cytochrome P-450 dependent enzymes. Essential component of fungal cell membrane responsible for the synthesis of ergosterol.
Dosage & Administration
- Adults:
- 150 mg as a single dose for Vaginal Candidiasis
- 200 mg in 1st day followed by 100 mg daily for 14 days for Oropharyngeal Candidiasis
- 200 mg in 1st day followed by 100 mg daily for 14-30 days for Oesophageal Candidiasis
- 150 mg weekly for 4-6 weeks for Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea
- 50 mg daily for 20 days for Kerion
- 400 mg as a single dose for Pityriasis versicolor
- 150 mg weekly for 12 months for Onychomycosis
- Orally or by IV infusion, 400 mg on first day then 200-400 mg daily for Invasive candidal infections and cryptococcal infections (including meningitis)
- Orally or by IV infusion 200 mg daily for Prevention of cryptococcal meningitis
- Orally or by IV infusion, 50-400 mg daily for Prevention of fungal infections in immunocompromised patients
- Child over 1 year:
- 1-2 mg/kg daily for Superficial Candidiasis
- 3-6 mg/kg daily for Systemic Candidiasis & Cryptococcal infection
- Use in Specific Population: Dosing modifications based on creatinine clearance for renal impairment. Elderly patients use normal dose if no evidence of renal impairment.
Interaction
Potential interactions with warfarin, sulphonyl ureas, hydrochlorothiazide, phenytoin, rifampicin, oral contraceptives, cyclosporin, theophyline, cimetidine, antacids, and food.
Contraindications
Not to be used in patients with known hypersensitivity to Fluconazole or related triazole compounds.
Side Effects
Common side-effects include symptoms associated with the gastrointestinal tract, such as nausea, abdominal discomfort, diarrhea, and flatulence. Rare adverse events include rash and anaphylaxis.
Pregnancy & Lactation
Adverse fetal effects seen only at dose levels associated with maternal toxicity. Should not be used in pregnancy or in women of child bearing potential without adequate contraception.
Precautions & Warnings
Abnormalities in hepatic, renal, haematological and other biochemical function tests have been observed, particularly in patients with serious underlying diseases. Rarely, exfoliative cutaneous reactions observed. Use during lactation not recommended.
Use in Special Populations
- Elderly: Normal dose should be used if no evidence of renal impairment.
- Renal Impairment: Dosing modifications based on creatinine clearance. No adjustments in single dose therapy required.
Overdose Effects
Supportive measures and symptomatic treatment with gastric lavage if necessary. Forced volume diuresis may increase elimination rate. Haemodialysis decreases plasma levels by approximately 50% during a three hour session.
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.