Fungican 150 mg 2 capsules

Tradename

Fungican

Composition

Each hard gelatin capsule contains:

Fluconazole 150mg

Auxiliary components: microcrystalline cellulose, dibasic calcium phosphate, Povidone K30, croscarmellose sodium, magnesium stearate, purified talc, gelatin, titanium dioxide.

Properties

Fluconazole is an antifungal triazole. It is a potent and selective inhibitor of fungal enzymes required for the synthesis of ergosterol. Active against opportunistic mycoses such as infections caused by Candida spp. including systemic candidiasis in animals with weakened immunity; with Cryptococcus neoformans, including intracranial infections, with Microsporum spp. and with Trichophyton spp. Fluconazole is very specific for fungal cytochrome P450-dependent enzymes. It has been shown that fluconazole does not affect plasma testosterone concentration in men or steroid concentration in women of childbea age when taken 50 mg daily for up to 28 d No clinically significant effect was observed on endogenous steroid levels or on ACTH

stimulated response in healthy male volunteers. taking fluconazole 200-400 mg per day. Interaction studies with antipyrine show that a single or multiple dose of fluconazole 50 mg does not affect metabolism.

Indications

For the treatment of cryptococcal meningitis, coccidioidomycosis, invasive candidiasis. Treatment of vaginal candidiasis, acute or recurrent; candidal balanitis, when local therapy is not suitable. To prevent a decrease in the frequency of relapses of vaginal candidiasis (4 or more episodes per year). Prevention of candidal infections in patients with long-term neutropenia (for example, in patients with hematologic malignancies receiving chemotherapy or in patients receiving hematopoietic stem cell transplantation).

Mode of application:

The capsules should be swallowed whole and taken with or without food. The dose should be based on the nature and severity of the fungal infection. Treatment for multiple-dose infections should be continued if clinical parameters or laboratory tests indicate that active fungal infection has subsided. An

Contraindications

Hypersensitivity to fluconazole, related azole compounds or any of the excipients in the composition. Fluconazole should not be taken with terfenadine, cisapride or ergot derivatives.

Precautions:

Use with caution in patients with renal and hepatic dysfunction. The drug has been associated with rare cases of severe liver toxicity. In cases of hepatotoxicity associated with fluconazole, there was no clear relationship with the total daily dose, durati of therapy, gender or age of the patient. It is reversible upon discontinuation of therapy. The patient should be informed of the symptoms of a serious hepatic effect (asthenia, anorexia, persistent nausea, vomiting and jaundice are important). Fluconazole treatment should be stopped immediately and the patient should see a doctor.

Side effects

Most common: headache, abdominal pain, diarrhea, nausea, vomiting, elevated alkaline phosphatase levels, and rash. Diseases of the blood and lymphatic system: anemia. Rarely: agranulocytosis, leukopenia, thrombocytopenia, neutropenia. Immune system disorders: rare anaphylaxis. Metabolism and nutritional disorders: infrequently: decreased appetite. Rarely:

hypercholesterolemia, hypertriglyceridemia, hypokalemia. Mental disorders: drowsiness, insomnia. Nervous system disorders: infrequently: convulsions, paresthesia, dizziness, taste perversion. Rare: tremors. Gastrointestinal disorders: infrequently:

constipation, dyspepsia, flatulence, dry mouth. Rare: liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage. Diseases of the skin and subcutaneous tissue: general: rash. Uncommon: drug rash, urticaria, itching, increased sweating. Rare: angioedema, facial edema, alopecia. Musculoskeletal system and connective tissue: infrequently: myalgia. General disorders: fatigue, malaise, astheni fever.

Storage

Store at a temperature not exceeding 30C in a dry place out of the reach of children.

Packaging:

The cardboard box contains 1,2,3 blisters of 1 capsule each and paper instructions.