Fluconal 50 mg/5 ml (Powder for Suspension)
Medicine Details
| Category | Details |
|---|---|
| Generic | Fluconazole |
| Company | Acme laboratories 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)
OtherIndications
- 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
Triazole antifungal agent, potent inhibitor of fungal cytochrome P-450 dependent enzymes
DosageAdministrationAdults
- 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
DosageAdministrationChildren
1-2 mg/kg daily for Superficial Candidiasis, 3-6 mg/kg daily for Systemic Candidiasis & Cryptococcal infection, up to 12 mg/kg daily for serious life-threatening infections in children aged 5-13 years
Interaction
- Increased prothrombin time after warfarin administration
- Prolonged serum half-life of concomitantly administered oral sulphonylureas
- Co-administration with hydrochlorothiazide increases plasma concentrations by 40%
- May increase the level of phenytoin and decrease the AUC of fluconazole with rifampicin co-administration
- No relevant effects on hormone levels in the 50 mg fluconazole study, increased AUCs of ethinyl estradiol and levonorgestrel at 200 mg daily
- Slowly increases cyclosporine concentrations in renal transplant patients
- No clinically significant impairment of fluconazole absorption when co-administered with food, cimetidine, antacids or following total body irradiation
- May result in an 18% decrease in the mean plasma clearance of theophylline
Contraindications
Not to be used in patients with known hypersensitivity to Fluconazole or related triazole compounds
SideEffects
- Nausea
- Abdominal discomfort
- Diarrhea
- Flatulence
- Rarely encountered rash with incidence less than 1%
- Rare reports of anaphylaxis
PregnancyLactation
Adverse fetal effects seen in animals only at dose levels associated with maternal toxicity, not recommended for use in pregnancy or in women of childbearing potential unless adequate contraception is employed, found in human breast milk at concentrations similar to plasma
PrecautionsWarnings
- Abnormalities of hepatic, renal, hematological, and other biochemical function tests observed in some patients
- Rare occurrences of severe cutaneous reactions including exfoliative cutaneous reactions in patients, particularly those with AIDS
- Use in lactation not recommended, unlikely to impair a patient's ability to drive or use machinery
UseSpecialPopulations
Normal dose should be used in the elderly if no evidence of renal impairment, dosage intervals or daily dosage should be modified in patients with renal impairment based on creatinine clearance
OverdoseEffects
Supportive measures and symptomatic treatment with gastric lavage if necessary may be adequate, forced volume diuresis may increase elimination rate, haemodialysis can decrease plasma levels by approximately 50%
TherapeuticClass
Drugs for subcutaneous and mycoses
StorageConditions
Keep in a dry place away from light and heat, keep out of the reach of children