Derma 50 mg (Capsule)
Medicine Details
| Category | Details |
|---|---|
| Generic | Fluconazole |
| Company | Alco pharma 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
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:
- 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
- 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 thereafter the dosage intervals should be modified based on creatinine clearance.
Interaction
Fuconazole interacts with a number of medications such as warfarin, oral sulphonyl ureas, hydrochlorothiazide, phenytoin, rifampicin, combined oral contraceptives, cyclosporin, theophyline, cemetidine, antacids, 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, such as nausea, abdominal discomfort, diarrhea, and flatulence. Other adverse events are rare, with an incidence less than 1%. 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. Accordingly, fuconazole should not be used in pregnancy or in women of childbearing potential unless adequate contraception is employed.
Precautions & Warnings
Abnormalities of hepatic, renal, hematological, and other biochemical function tests have been observed during treatment with fuconazole in some patients, particularly those with serious underlying diseases such as AIDS and cancer.
Use in Special Populations
- Elderly: The normal dose should be used if there is no evidence of renal impairment.
- Renal Impairment: No adjustments in single dose therapy are required. In multiple dose therapy of patients with renal impairment, normal doses should be given on days 1 and 2 of treatment and thereafter the dosage intervals or daily dosage should be modified based on 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 would probably increase the elimination rate. Haemodialysis has been shown to decrease 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.