Fluzamed
(Fluconazole)




COMPOSITION

Each hard gelatin capsule contains fluconazole 50 mg, 150 mg, or 200 mg.

THERAPEUTIC INDICATIONS

- Cryptococcosis, including cryptococcal meningitis and other localizations of the infection (lungs, skin, etc.);
- Systemic candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidal infections (abdominal infections, endocarditis, eye, respiratory and urinary tracts infections).;
- Candidiasis of skin and mucous membranes, including oral cavities and gullet cavities, noninvasive bronchopulmonary candidiases, candiduria, and also atrophic candidiasis of oral cavity;
- Genital candidiasis: vulvovaginal candidiasis (acute and chronic recurrent).
- Preventive maintenance of fungal infections for patients with cancer, predisposed to such infections as a result of cytostatic chemotherapy or radio therapy;
- Skin mycosises, including feet mycosises, inguinal region; branny lichen; onychomycosis;
- Deep endemic mycosises, including coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis at patients with normal immunity.

CONTRAINDICATIONS

Hypersensitivity to any drug component or structurally close azole compounds, period of lactation, children age (up 6 months).

ADVERSE REACTIONS

Fluzamed, as a rule, it is well tolerated.
More often reported adverse reactions: from GIT – nausea, pain in a stomach, diarrhea, meteorism, from CNS – headache, dermatological reactions – skin rash.

DOSAGE AND ADMINISTRATION

In cryptococcal meningitis and cryptococcal infections of other localizations in the first day usually 400 mg, and then 200-400 mg once a day. The treatment duration of cryptococcal infections depends on clinical efficiency confirmed by mycological research; in case of cryptococcal meningitis the treatment is carried out for at least 6-8 weeks
For preventive maintenance of cryptococcal meningitis relapse in patients with AIDS, after end of a full term of primary treatment, Fluzamed is prescribed in a dose of 200 mg/day during the long period of time.
For candidemia, disseminated candidiasis and other invasive candidal infections the dose usually is 400 mg in the first day, and then – 200 mg.
For preventive maintenance of oropharyngeal candidiasis relapses in patients with AIDS after end of full term of primary therapy Fluzamed can be prescribed as 150 mg once a week.
For vaginal candidiasis Fluzamed is taken orally in a single dose of 150 mg. For decrease of frequency of vaginal candidiasis relapses the medicine can be used in a dose of 150 mg once a month.
For preventive maintenance of a candidiasis it is recommended 50-400 mg of Fluzamed once a day depending on risk of development of fungal infection.
For skin mycosises, including foot mycosises, skin of inguinal region and skin candidiases, the recommended dose is 150 mg once a week.

PREGNACY AND LACTATION

The drug should be prescribed during pregnancy only if treatment efficacy justifies potential risk for fetus.
The breast-feeding should be ceased during treatment as Fluzamed is found in breast milk in the same concentration as in plasma.

MANUFACTURED FORM

4 hard gelatin capsules 50 mg in a box.
1 hard gelatin capsule 150 mg in a box.
7 hard gelatin capsules 200 mg in a box.

Anti-İnfectives for Systemic Use

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