Oraf 150 mg (Capsule)
Medicine Details
| Category | Details |
|---|---|
| Generic | Fluconazole |
| Company | Hallmark 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
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 (Vaginal Candidiasis)
- 200 mg in 1st day followed by 100 mg daily for 14 days (Oropharyngeal Candidiasis)
- 200 mg in 1st day followed by 100 mg daily for 14-30 days (Oesophageal Candidiasis)
- 150 mg weekly for 4-6 weeks (Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea)
- 50 mg daily for 20 days (Kerion)
- 400 mg as a single dose (Pityriasis versicolor)
- 150 mg weekly for 12 months (Onychomycosis)
- Orally or by IV infusion, 400 mg on first day then 200-400 mg daily (Invasive candidal infections and cryptococcal infections)
- Orally or by IV infusion, 200 mg daily (Prevention of cryptococcal meningitis)
- Orally or by IV infusion, 50-400 mg daily (Prevention of fungal infections in immunocompromised patients)
- Child over 1 year:
- 1-2 mg/kg daily (Superficial Candidiasis)
- 3-6 mg/kg daily (Systemic Candidiasis & Cryptococcal infection)
- Up to 12 mg/kg daily for children aged 5-13 years
- 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 may interact with medications such as warfarin, sulphonylureas, hydrochlorothiazide, phenytoin, rifampicin, combined oral contraceptives, cyclosporin, theophyline, cimetidine, antacids, and the effect of food and total body irradiation on absorption.
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 rare adverse events may include rash and anaphylaxis.
Pregnancy & Lactation
Fluconazole should not be used in pregnancy or in women of childbearing potential unless adequate contraception is employed. Its use in nursing mothers is not recommended.
Precautions & Warnings
- Underlying Diseases: Abnormalities of hepatic, renal, haematological, and other biochemical function tests have been observed in some patients, particularly those with serious underlying diseases such as AIDS and cancer.
- Cutaneous Reactions: Patients have rarely developed exfoliative cutaneous reactions during treatment, and monitoring for the development of severe cutaneous reactions is advised.
- Lactation: Its use in nursing mothers is not recommended.
- Driving/Use of Machinery: Experience with fluconazole indicates that therapy is unlikely to impair a patient's ability to drive or use machinery.
Use in Special Populations
- 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 based on creatinine clearance.
- Renal Impairment: No adjustments in single dose therapy are required, but in multiple dose therapy, the 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 and haemodialysis may also be considered.
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.