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Antiinfectives for Systemic Use

Rofluzol (Capsules)
(Fluconazole)



CONTENT:
Capsules. Capsule contains fluconazole 50 mg/100 mg/150 mg/200 mg.
 
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS. Fluconazole is triazole-derivative antifungal agent. Fluconazole exerts its antifungal activity by altering cellular membranes resulting in increased membrane permeability, leakage of essential elements (e.g. amino acids, potassium), and impaired uptake of precursor molecules (e.g. purine and pyrimidine precursors to DNA). The drugs inhibit cytochrome P-450 14-a-desmethylase in susceptible fungi, which leads to accumulation of C-14 methylated sterols (e.g. lanosterol) and decreased concentrations of ergosterol. Fluconazole usually is fungistatic in action. Fluconazole is active against some strains of Candida, including some strains of C. albicans, C. dubliniensis, C. guilliermondii, C. kefyr, C. glabrata, C. parapsilosis, C. lusitaniae, and C. tropicalis. Fluconazole has in vitro activity against some strains of Cryptococcus neoformans. Fluconazole is active in vitro against some strains of Blastomyces dermatitidis, Histoplasma capsulatum (including in immunosupressed persons). PHARMACOKINETICS. The drug is rapidly and almost completely absorbed from the Gl tract. Oral bioavailability of fluconazole exceeds 90%. Fluconazole is only 11 -12% bound to plasma proteins. Concentrations attained in saliva, sputum, nails, blister fluid, blister skin, and vaginal tissue are approximately equal to plasma concentrations. CSF concentrations may be 50-94% of plasma concentrations. The plasma elimination half-life of fluconazole is approximately 30 hours. Fluconazole is eliminated principally by renal excretion.
 
THERAPEUTIC INDICATIONS:
candidosis of mucosa membrane of mouth, faring, esophagus; non-invasive candidosis of respiratory tract, candiduria; generalized candidosis, including candidemia, disseminated candidiosis; uncomplicated and complicated vulvovaginal candidiasis; criptococcosis, including meningitis caused byC. neoformans; prophylaxis of fungal infections in cancer patients; dermatomycoses, onichomycoses, invasive endemic mycoses.
 
CONTRAINDICATIONS:
Fluconazole is contraindicated in patients with known hypersensitivity to the drug. Concomitant intake of drugs prolonging QT-interval (e.g. terphenadine, astemizole).
 
SIDE EFFECTS:
From GIT: mild to moderate nausea, vomiting, abdominal pain, diarrhea, elevation of hepatic enzymes. From CNS: headache, dizziness, fatigue, seizures. From blood system: leucopenia, thrombocytopenia, neutropenia, agranulocytosis. Allergy: skin rash, multiform ecssudative dermatitis, epidermal necrosis, anaphylactic reactions. Other: renal damage, alopecia, dislipidemia, hypokaliemia.
 
DOSAGEAND ADMINISTRATION:
Capsules should be taken as a whole, regardless of food Intake. 0000000000000 Vaginal candidosis: 150 mg single dose. For prophylaxis It can be administered 150 mg once a month. Oropharlngeal and esophageal candidosis: 200 mg at first day and 100 mg in following days. Duration of course of therapy is 7-14 days. Candidemia, dissiminated candidosis and other invasive variants of candidosis: 400 mg in first day and 200 mg during following days. Duration of course of therapy depends on clinical situation. Prophylaxis of candidosis: dose range 50-400 mg per day depending on degree of risk. Cryptococcal meningitis and cryptococcal infections of other localization: 400 mg in first day and 200 mg during following days. Duration of therapy should be 10-12 weeks after confirmation of sterility of CSF. Mycoses of skin: 150 mg in a week or 50 mg daily. Course of therapy 2-4 weeks. Onichomycoses: 150 mg in a week. Duration of cours of therapy up to the complete replacement of infected nail. Dosing in children. Oropharingeal and esophageal candidosis: 6 mg/kg of body weight at first day and 3 mg/kg of body weight in following days. Duration of course of therapy is 7-14 days. Generalized candidosis and cryptococcosis: 12 mg/kg of body weight at first day and 6 mg/kg of body weight in following days. Prophylaxis of candidosis: dose range 3-12 mg/kg of body weight depending on degree of risk. In patients with compromised renal function dose should be corrected according to the instruction.
 
PACKAGING:
4 or 7 capsules with 50 mg of fluconazole in blister. One blister with leaflet in carton box. 7 capsules with 100 mg of fluconazole in blister. One blister with leaflet in carton box. 1 capsule with 150 mg of fluconazole in blister. One blister with leaflet in carton box. 7 capsules with 200 mg of fluconazole in blister. One blister with leaflet in carton box.
 
 
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