Omastin 150 mg (Capsule)
Medicine Details
| Category | Details |
|---|---|
| Generic | Fluconazole |
| Company | Beximco 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 and a potent inhibitor of fungal cytochrome P-450 dependent enzymes responsible for ergosterol synthesis in the fungal cell membrane.
Dosage & Administration
- 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
- 400 mg on first day then 200-400 mg daily for Invasive candidal infections and cryptococcal infections (including meningitis)
Interactions
- Increased prothrombin time with warfarin administration
- Prolonged serum half-life of concomitantly administed oral sulphonyl ureas
- Increased plasma concentrations of fuconazole by 40% when co-administered with hydrochlorothiazide
- Increase in the level of phenytoin and decrease in AUC and shorter half-life with rifampicin administration
- Increased 40% AUC of ethinyl estradiol and 4% AUC of levonorgestrel with combined oral contraceptive use
- Slowly increased cyclosporin concentrations in renal transplant patients
- No clinically significant impairment of fuconazole absorption when co-administered with food, cimetidine, antacids, or following total body irradiation for bone marrow transplantation
- 18% decrease in mean plasma clearance of theophyline when administered for 14 days
Contraindications
Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.
Side Effects
- Nausea
- Abdominal discomfort
- Diarrhoea
- Fatulence
- Rarely encountered rash
- Rare cases of anaphylaxis
Pregnancy & Lactation
Fluconazole adverse fetal effects seen in animals only at dose levels associated with maternal toxicity; should not be used in pregnancy or in women of child bearing potential unless adequate contraception is employed.
Precautions & Warnings
- Abnormalities of hepatic, renal, haematological and other biochemical function tests in some patients, particularly those with serious underlying diseases such as AIDS and cancer
- Rare development of exfoliative cutaneous reactions such as Stevens Johnson Syndrome and toxic epidermal necrolysis
- Omastin found in human breast milk at concentrations similar to plasma, hence its use in nursing mothers is not recommended
Use in Special Populations
Normal dose should be used if no evidence of renal impairment; dosage intervals or daily dosage should be adjusted based on creatinine clearance in patients with renal impairment
Overdose Effects
Supportive measures and symptomatic treatment with gastric lavage if necessary may be adequate; forced volume diuresis would probably increase the elimination rate; haemodialysis decreases 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