Derma 150 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:
- 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
- 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
Fluconazole can interact with various medications including warfarin, sulphonyl ureas, hydrochlorothiazide, phenytoin, rifampicin, oral contraceptives, cyclosporin, cimetidine, antacids, theophylline, and other medications. Careful monitoring and dose adjustment may be necessary when co-administering with these medications.
Contraindications
Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.
Side Effects
- Nausea
- Abdominal discomfort
- Diarrhoea
- Flatulence
- Rash
Pregnancy & Lactation
Fluconazole adverse fetal effects have been seen in animals only at dose levels associated with maternal toxicity, hence its use in pregnancy or in women of child-bearing potential is not recommended unless adequate contraception is employed.
Precautions & Warnings
Patients with serious underlying diseases such as AIDS and cancer may experience abnormalities in hepatic, renal, haematological and other biochemical function tests during treatment with fluconazole. Hepatic necrosis, exfoliative cutaneous reactions, and anaphylaxis have been rarely reported. Its use during lactation is not recommended.
Use in Special Populations
- Use in the elderly: The normal dose should be used if there is no evidence of renal impairment.
- Use in 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. The dosage intervals or daily dosage should be modified in accordance with 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 and haemodialysis may also help in reducing plasma levels of fluconazole.
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.