OUR PRODUCTS
Each 5 ml of the suspension after preparation contains 50 mg or 200 mg fluconazole.
- Hypersensitivity to the active substance, to related azoles, or to any of the excipients
- Coadministration of terfenadine is contraindicated in patients receiving fluconazole in multiple doses of 400 mg daily or higher based on the results of a multiple dose interaction study.
- Other drugs known to prolong the QT interval that are metabolized by cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin are contraindicated in patients receiving fluconazole
- Cisapride: Increased plasma concentration of cisapride, therefore concomitant therapy is contraindicated.
- Terfenadine: Fluconazole at doses of 400 mg or more is contraindicated with terfenadine. Co-administration of fluconazole at doses less than 400 mg per day with terfenadine should be carefully monitored.
- Astemizole: administration of fluconazole with astemizole may increase serum levels/decrease clearance of astemizole.
- Pimozide: Concomitant administration of fluconazole with pimozide may lead to inhibition of pimozide metabolism.
- Quinidine: Fluconazole combined with quinidine may inhibit the metabolism of quinidine.
- Erythromycin: Concomitant use of fluconazole and erythromycin has the potential to increase the risk of cardiotoxicity (prolonged QT interval) and, consequently, sudden cardiac death.
- Rifampicin: Simultaneous administration leads to a decrease in the effectiveness of fluconazole and therefore the dose of fluconazole must be increased.
- Amitriptyline and Nortriptyline: Fluconazole increases the pharmacological effect of both compounds.
- Carbamazepine: Fluconazole inhibits the metabolism of carbamazepine and increases its serum levels
- Phenytoin: Fluconazole inhibits the hepatic metabolism of phenytoin and increases its serum levels.
Fluconazole is used in the treatment of onychomycosis caused by Candida, cryptococcus and other susceptible yeasts, in particular:
1- Mucosal candidiasis: includes oropharyngeal candidiasis, esophageal infections, non-invasive bronchopulmonary infections, candidiasis, mucocutaneous candidiasis, and chronic atrophic oral candidiasis (inflammation of the oral teeth).
2- Systemic candidiasis (including deep disseminated infection and peritonitis).
3- Acute malignant meningitis in adults, including AIDS patients, transplanted patients, or other patients with other causes of immunosuppression.
4- A genital candidiasis. Acute or recurrent vaginal candidiasis. Candida balanoposthitis.
5- Prevention of fungal infections for patients exposed to such infections as a result of chemotherapy or radiotherapy, including bone transplant patients.
6- Dermatophytosis, including infections such as tinea pedis, tinea corporis, tinea pedis, tinea versicolor.
- Fluconazole is not indicated for the treatment of nail infections and ringworm of the head
Dosage:
- The daily dose of fluconazole depends on the nature and severity of the fungal infection.
- Inadequate treatment period may cause relapses of active infection.
- Adults:
Candida vaginitis: 150 mg as a single daily dose.
Mucosal candidiasis: 50 mg as a single dose daily for 7-14 days
- Renal impairment: Fluconazole is mainly excreted in the urine as an unchanged drug. No adjustments are required in treatment with a single dose. In patients (including children) with impaired renal function who will receive multiple doses of fluconazole, the normal recommended dose should be administered on Day 1, followed by a daily dose based on creatinine clearance.
- Children: The maximum dose of 400 mg per day should not be exceeded
- Mucosal candidiasis: the daily dose is 3 mg/kg once daily
- Systemic candidiasis, cryptococcal infection: 6-12 mg/kg daily
- Prevention of fungal infections in immunocompromised patients considered at risk of neutropenia after cytotoxic chemotherapy or radiotherapy: 3-12 mg/day
Anemia, agranulocytosis, facial edema, anorexia, hypertriglyceridemia, hypokalemia, headache, insomnia and drowsiness, arrhythmia, increase in serum activity of hepatic enzymes, cholestasis, pruritus, urticaria, exfoliative skin disorders, myalgia