Omastin 50

Generic

Fluconazole

 

Indications

Vaginal candidiasis, oropharyngeal & esophageal candidiasis, and cryptococcal meningitis are all treated with fluconazole. It can also be used to treat candida infections in the urinary tract, peritonitis, and systemic candida infections (including candidemia, disseminated candidiasis and pneumonia).

 

Pharmacology

Fluconazole is a triazole antifungal that is used to treat fungal infections. It's a strong inhibitor of cytochrome P-450-dependent enzymes in fungi. The ergosterol synthesis is carried out by the Cytochrome P-450 enzyme system, which is an important component of the fungal cell membrane..

 

Dosage & Administration

Adult (oral)-

• Vaginal candidiasis: 150 mg as a single dose.
• Oropharyngeal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of this infection generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
• Esophageal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used. Patients should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
• Systemic candida infections: Optimal therapeutic dosage and duration of therapy have not been established. Sometimes, doses of up to 400 mg daily have been used.
• Urinary tract infections caused by candida and peritonitis: 50-200 mg daily have been used.
• Cryptococcal meningitis: 400 mg on the first day, followed by 200 mg once daily.
• Prophylaxis in patients undergoing bone marrow transplantation: 400 mg once daily.

Child (oral):

• Doses of 3-6 mg/kg daily have been used. Doses up to 12 mg/kg is recommended.

Intravenous-

• Adult: Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by IV, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis)
• Child: 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily. Prevention of relapse of cryptococcal meningitis, by IV, 100-200 mg daily.

 

Interaction

When cyclosporin or phenytoin is used with Fluconazole, the plasma level of cyclosporin or phenytoin rises. The prothrombin time is prolonged when Fluconazole and warfarin are taken together. When Fluconazole is used with Rifampicin, the level of Rifampicin is reduced.

 

Contraindications

Patients who have a known hypersensitivity to fluconazole or comparable triazole drugs should avoid taking it.

 

Side Effects

Fluconazole is a drug that is well tolerated. Nausea, vomiting, abdominal pain, diarrhoea, headache, and skin rash are the most common Fluconazole side effects.

 

Pregnancy & Lactation

Fluconazole is classified as a category C drug by the US Food and Drug Administration (FDA) for use during pregnancy. Fluconazole should therefore be avoided during pregnancy and lactation unless the potential advantages outweigh the potential dangers to the fetus.

 

Precautions & Warnings

General: If hepatic and renal functions deteriorate and drug clearance diminishes, buildup may occur, and cessation should be considered against the therapeutic benefit obtained. When considering the use of topical proteolytic enzymes in conjunction with it, keep in mind that silver has the potential to inactivate these enzymes.

 

Therapeutic Class

Drugs for subcutaneous and mycoses

 

Storage Conditions

Protect from light and moisture by storing in a cool, dry place below 30°C. Keep out of children's reach.

 

Pharmaceutical Name

Beximco Pharmaceuticals Ltd.