FLUKNAZOL (susp)
-
Chemical Name:
Fluconazole -
Therapeutic Category:
Antifungal drugs & Antiviral drugs -
Pharmacologic Category:
Antifungal Agent, Oral - Antifungal Agent, Parenteral -
Pharmaceutical Form:
Dry powder for suspension -
Composition:
Fluconazole 50mg/5ml
FLUKNAZOL
Capsules - Dry powder for Oral Suspension -Solution for IV Infusion
1. CLINICAL PHARMACOLOGY:
Fluconazole is an antifungal drug, it inhibits fungal cytochrome P-450 dependent enzymes resulting in blocked ergosterol synthesis.
2. INDICATIONS:
Fluconazole is used in the treatment of:
- Oropharyngeal, oesophageal, vaginal or systemic candidiasis.
- Acute cryptococcal meningitis and other cryptococcal infections.
- Fluconazole is used for the prophylaxis of fungal infections in immuno-compromised patients or in patients undergoing bone marrows transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
3. CONTRAINDICATIONS:
Fluconazole is contraindicated in patients who have shown hypersensitivity to Fluconazole or to any of its excipients.
4. SIDE EFFECTS:
Fluconazole may cause: Nausea, vomiting, abdominal pain, headache, and elevated liver-function values.
Dermatologic: Skin disorders including Stevens-Johnson Syndrome (specially AIDS patients).
Central Nervous System: Seizures.
5. PRECAUTIONS:
- Patients who develop abnormal liver function tests during Fluconazole therapy should be monitored for the development of more severe hepatic injury. Fluconazole should be discontinued if necessary.
- In rare cases, anaphylaxis has been reported.
- Patients have rarely developed exfoliative skin disorders during treatment with Fluconazole. Patients who develop rashes during the treatment should be monitored closely and the drug discontinued if lesions progress.
- Pregnancy: Category C. Fluconazole should be used in pregnancy only if the potential benefit justifies the possible risk to the fetus.
- Nursing Mothers: Fluconazole is secreted in human milk at concentrations similar to plasma. Therefore, the use of Fluconazole in nursing mothers is not recommended.
6. DRUG INTERACTIONS:
- The concomitant administration of Fluconazole with cisapride or terfenadine should be avoided because of the risk of cardiac arrhythmias.
- Fluconazole may increase serum concentrations of oral sulphonylureas, ciclosporin, midazolam, warfarin, zidovudine, theophylline, oral anticoagulants, and phenytoin.
- Concomitant oral administration of Fluconazole and hydrochlorothiazide increase serum concentrations of Fluconazole.
- Rifampicin and Cimetidine decreases serum concentrations of Fluconazole.
- The efficacy of oral contraceptives may be affected with concomitant administration of Fluconazole.
7. DOSAGE AND ADMINISTERATION:
Oropharyngeal candidiasis: 200 mg, followed by 100 mg for 14 days.
Oesophageal candidiasis: 200 mg, followed by 100 mg for a minimum of 3 weeks.
Vaginal candidiasis: 150 mg, as a single dose.
Systemic candidiasis: 400 mg, followed by 200 mg daily based on clinical response.
Acute cryptococcal meningitis and other cryptococcal infections: 400 mg, followed by 200 mg to 400 mg daily. During of treatment is depending on clinical response. Treatment should be continued for 10 - 12 weeks after negative culture of cerebrospinal fluid.
Preventing relapse following a primary course of antifungal treatment for acute cryptococcal meningitis in AIDS-patients: 200 - 400 mg orally or intravenously.
Prophylaxis in patients undergoing bone marrow transplantation: The recommended daily dosage for the prevention of candidiasis is 400 mg once daily.
Children 1 month to 13 years: 3 - 6 mg per kg/24 hours.
Neonates 0-2 weeks: 3 - 6 mg/kg/72 hours.
Neonates 2 weeks to 1 month: 3 - 6 mg/kg/48 hours.
FLUKNAZOL is used safely for 14 days by intravenous infusion in a dose of 200 mg/h.
The dose should be reduced in patients with renal impairment.
8. OVERDOSAGE:
In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if clinically indicated) should be instituted.
Fluconazole is largely excreted in urine. A three hour hemodialysis session decreases plasma levels by approximately 50%.
9. PACKAGING & COMPOSITION:
- FLUKNAZOL 50 - Capsules: A pack of 10 capsules in blister. Each capsule contains Fluconazole 50 mg.
- FLUKNAZOL 200 - Capsules: A pack of 10 capsules in blister. Each capsule contains Fluconazole 200 mg.
- FLUKNAZOL - Dry Powder for Oral Suspension: A pack of glass bottle of 60 mL. After reconstitution, each 1 mL of suspension contains Fluconazole 10 mg.
- FLUKNAZOL – Solution for IV Infusion: A pack of 1 vial of 100 mL. Each 100 mL contains Fluconazole 200 mg.
10. STORAGE CONDITIONS:
Store FLUKNAZOL – Capsules, Dry Powder for Oral Suspension and Solution for IV Infusion at temperature below 30°C.
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