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Funazol

Al-Tinez Pharmaceuticals Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-4826452; 0802-307-7320, 0803-305-7978

Brand Name

Funazol

Manufacturer

Baroque Pharmaceuticals Pvt. Ltd, Sokhada-388 620, Ta. Khambhat, Gujarat, India. Mfg. Lic. No G/1217.

Therapeutic Class

Antifungals, Systemic

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsule (NRN: 04-7375): Fluconazole 50 mg.

How to Identify the Product: Light blue-coloured hard capsule is filled with white or light brown powder.

Pack size: 50 mg capsules in a blister pack.

funazol

Pharmacology

Funazole is an antifungal drug with fluconazole as the active ingredient.

Fluconazole is used to treat infections caused by fungi and may also be used against candidal infection. The most common cause of fungal infections is a yeast called Candida.

Indications

Acute or recurrent vaginal candidiasis. Oropharyngeal and esophageal candidiasis, nonpenetrant bronchitis and pneumonia, candida polyurea, mucosal candidiasis including mucocutaneous and chronic atrophic oropharyngeal candidiasis.

Systemic candidiasis including candidemia and disseminated candidiasis, peritonitis, pneumonia, urinary tract infection, patient with malignant tumor, candida infection in patient receiving antibody or immunodepressant therapy.

Cryptococcal meningitis in patient undergoing organ transplantation, patient who receive other immunosuppressive therapy, patient with AIDS or not.

Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.

Dermatomyces infection including onychomycosis, tinea pedis, tinea cruris.

Contra-indications

Patients with known hypersensitivity to fluconazole or to related triazole compound. Patients taking triazolam.

Precautions/Warnings

In some patients, particularly those with serious underlying diseases such as AIDS and cancer, abnormalities of hepatic, renal and haematological function have been observed during treatment with fluconazole. In the treatment of systemic infections, multiple doses of fluconazole have been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions.

Fluconazole hepatotoxicity has usually, but not always been reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more severe hepatic injury.

Patients have rarely developed exfoliative skin disorders during treatment with fluconazole. In patients with serious underlying diseases (predominantly AIDS and malignancy), these have rarely resulted in a fatal outcome.

Patients who develop rashes during treatment with fluconazole should be monitored closely and the drug discontinued if lesions progress.

Interactions

Fluconazole has been shown to prolong prothrombin times in subjects receiving warfarin. In concomitant treatment with fluconazole and coumarin drugs the dose of anticoagulant should be carefully adjusted.

Fluconazole has been shown to prolong the serum half life of concomitantly administered oral sulphonylureas. Co-administration of multiple doses of hydrochlorothiazide may increase the plasma concentrations of fluconazole.

Fluconazole increases the plasma concentrations of phenytoin. Careful monitoring of phenytoin concentrations in patients receiving fluconazole and phenytoin is recommended.

No clinically significant interactions have been seen with coadministration of oral contraceptives, cyclosporin A, or cimetidine.

No adverse effect has been seen, no endogenous steroid levels or on ACTH stimulated cortisol response. Concomitant administration of other azole compounds and terfenadine has been shown to result in QT-prolongation, ventricular arrhythmia, cardiac arrest, therefore adverse effects related to cardiovascular system should be carefully monitored.

Concomitant administration of fluconazole and tacirolimus hydrate, cyclosporin, or zidovudine has been shown to result in increased plasma concentrations of these drug, therefore, concomitant administration of these drugs should be carefully monitored.

Adverse Effects

Generally, fluconazole has been shown good tolerant.

Dermatologic: Exfoliative skin disorder including Stevens-Johnson Syndrome and toxic epidermal necrosis.

Hematologic: Agranulocytosis.

Others: Nausea, vomiting, diarrhoea, headache, dizziness, eruption.

Dosage & Administration

Use in Adults:

Vaginal candidiasis: The recommended dosage for vaginal candidiasis is 150 mg as a single dose

Mucosal candidiasis: Oropharyngeal candidiasis: The recommended dosage is 50 mg once daily for 7-14 days.

Atrophic candidiasis related denture: The recommended dosage is 50 mg once daily for 14 days.

Others (esophageal candidiasis, nonpenetrant bronchitis, pneumonia, candida polyurea, mucocutaneous candidiasis): The recommended dosage is 50 mg once daily for 14-30 days. Doses up to 400 mg/day may be used in severe cases.

Systemic candida infections including candidemia and disseminated candidiasis: The recommended dosage is 400 mg on the first day, followed by 200 mg once daily. Doses up to 400 mg/day may be used, based on medical judgement of patient's response to therapy.

Cryptococcal meningitis: The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgement of the patient's response to therapy.

The recommended duration of treatment for initial therapy of cryptococcal meningitis is 6-8 weeks after the cerebrospinal fluid becomes culture negative.

The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is at least 100 mg once daily.

Prophylaxis in patients undergoing bone marrow transplantation: The recommended fluconazole daily dosage for the prevention of candidiasis of patients undergoing bone marrow transplantation is 400 mg once daily. Patients who are anticipated to have severe granulocytopenia should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu.mm

Onychomycosis: For tinea ungium, the recommended dosage is 150 mg once weekly. Treatment should be continued until infected nail is replaced (uninfected nail grows in). Regrowth of fingernails and toenails normally require 3 to 6 months and 6 to 12 months, respectively. However, growth rates may vary widely in individuals and by age.

After successful treatment of long term chronic infections, nails occasionally remain disfigured.

For dermal infections including tinea pedis, corporis, cruris and candida infections: The recommended dosage is 50 mg once daily or 150 mg once weekly. Duration of treatment is normally 2 to 4 weeks but tinea pedis may require treatment for up to 6 weeks. For tinea versicolor, the recommended dosage is 50 mg once daily for 2-4 weeks.

Use in children:

Insufficient evidence is available to establish safety and efficacy of fluconazole in the above indications for use in children. Specially, efficacy of fluconazole has not been established in infants less than 6 months of age.

Oropharyngeal Candidiasis: The recommended dosage is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.

Esophageal candidiasis: The recommended dosage of fluconazole in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used based on medical judgement of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of 3 weeks or at least 2 weeks following the resolution of symptoms.

Systemic candida infections: For the treatment of candidemia and disseminated candida infections, daily doses of 6-12 mg/kg/day have been used in an open, noncomparative study of a small number of children.

Cryptococcal Meningitis: For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgement of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of fluconazole is 6 mg/kg daily.

Use in elderly:

Where there is no evidence of renal impairment, normal dosage recommendations should be adopted.

Storage/Handling Recommendations

Store below 30oC protected from light and children.

Review Date

2016-12-02 07:16:19