Fluconazole, 150 mg capsules 4 pcs.
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- cryptococcosis, including cryptococcal meningitis and other localizations of this infection (including lung, skin), both in patients with normal immune response, and in patients with various forms of immunosuppression (including AIDS patients, organ transplant patients). In AIDS patients, in organ transplant patients); the drug may be used for prevention of cryptococcal infection in AIDS patients;
- Generic candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidiasis infections (infections of the peritoneum, endocardium, eyes, respiratory and urinary tract). Treatment may be carried out in patients with malignant tumors, patients in intensive care unit, patients undergoing cytostatic or immunosuppressive therapy, as well as in the presence of other factors predisposing to the development of candidiasis;
- candidosis of mucous membranes, including. Oral and pharyngeal candidiasis (including atrophic oral candidiasis associated with the wearing of dentures), esophagus, non-invasive bronchopulmonary candidiasis, candiduria, skin candidiasis; prevention of relapse of oropharyngeal candidiasis in AIDS patients;
- Genital candidiasis: Vaginal candidiasis (acute and chronic recurrent), prophylactic use to reduce the recurrence of vaginal candidiasis (3 or more episodes per year); Candida balanitis;
- Prevention of fungal infections in patients with malignancies who are predisposed to such infections due to cytostatic chemotherapy or radiation therapy;
- dermal mycoses, including mycoses of the feet, body, groin; pityriasis, onychomycosis; candidiasis of the skin;
- deep endemic mycoses, including coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis in patients with normal immunity.
Active ingredient
Fluconazole
Composition
1 capsule contains:
Active substance: fluconazole150 mg;
Ancillary substances: lactose monohydrate; pregelatinized starch; colloidal anhydrous silicon dioxide; magnesium stearate; sodium lauryl sulfate.
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How to take, the dosage
Internal.
Adults and children over 15 years of age (body weight over 50 kg) To prevent relapse of cryptococcal meningitis in AIDS patients, after completion of a complete course of initial therapy, fluconazole is prescribed at a dose of 200 mg (4 50 mg capsules) daily for an extended period of time. In candidemia, disseminated candidiasis, and other invasive candidiasis infections, the dose is 400 mg (8 50 mg capsules) the first day and then 200 mg (4 50 mg capsules) daily. If clinical efficacy is insufficient, the drug dose may be increased to 400 mg (8 50 mg capsules) per day. The duration of therapy depends on clinical effectiveness. In oropharyngeal candidiasis the drug is usually prescribed by 150 mg once daily, duration of treatment – 7-14 days. If necessary, in patients with a marked decrease in immunity, treatment may be longer. For prevention of relapses of oropharyngeal candidiasis in AIDS patients after completion of the full course of initial therapy, 150 mg once weekly. In atrophic oral candidiasis associated with denture wear, 50 mg once daily for 14 days in combination with topical antiseptic medications for denture treatment. In other localizations of candidiasis (except genital, such as esophagitis, noninvasive bronchopulmonary lesions, candiduria, candidiasis of the skin and mucous membranes, etc., the effective dose is usually 150 mg/day with a treatment duration of 14-30 days. For vaginal candidiasis, fluconazole is taken once orally in a dose of 150 mg. To reduce the recurrence rate of vaginal candidiasis, the drug may be used in a dose of 150 mg once a month. The duration of therapy is determined individually and varies from 4 to 12 months. Some patients may require more frequent use. For balanitis caused by Candida, fluconazole is given orally in a single dose of 150 mg/day. For prevention of candidiasis, the recommended dose is 50-400 mg once daily, depending on the risk of fungal infection. For prevention of candidiasis in patients with malignant tumors, the recommended dose of fluconazole is 150-400 mg 1 time per day, depending on the degree of risk of fungal infection. If there is a high risk of generalized infection, such as in patients with expected severe or long-lasting neutropenia, the recommended dose is 400 mg/day. Fluconazole is prescribed several days before the expected appearance of neutropenia; after increasing neutrophil counts above 1,000/µl, the treatment is continued for another 7 days. In mycoses of the skin, including mycoses of the feet, skin of the groin, and candidiasis of the skin, the recommended dose is 150 mg once weekly or 50 mg once daily, the dosing regimen depends on the clinical and mycological effect. The duration of therapy in normal cases is 2-4 weeks, but longer therapy (up to 6 weeks) may be required for foot mycoses. In pityriasis, 300 mg (2 capsules of 150 mg) once a week for 2 weeks; some patients require a third dose of 300 mg per week, while in some cases a single dose of 300-400 mg is sufficient; an alternative therapy regimen is 50 mg once a day for 2-4 weeks. In onychomycosis, the recommended dose is 150 mg once weekly. Treatment should be continued until the infected nail is replaced (the uninfected nail grows back). It normally takes 3-6 months and 6-12 months, respectively, for the nails on the fingers and toes to grow back. Deep endemic mycosis may require use of the drug at a dose of 200 mg (4 50 mg capsules) to 400 mg (8 50 mg capsules) daily for up to 2 years. The duration of therapy is determined individually; it may be 11-24 months for coccidioidomycosis, 2-17 months for paracoccidioidomycosis, 1-16 months for sporotrichosis, and 3-17 months for histoplasmosis. In children, as in similar infections in adults, the duration of treatment depends on the clinical and mycological effect. In children, the drug should not be used in a daily dose that would exceed that of adults, i.e., not more than 400 mg/day. The drug is used daily once a day.
Interaction
The use of fluconazole with warfarin increases PV (by 12% on average). In this regard, it is recommended to carefully monitor the PV in patients receiving the drug in combination with coumarin anticoagulants.
Fluconazole increases plasma elimination half-life of oral hypoglycemic agents – sulfonylurea derivatives (chlorpropamide, glibenclamide, glipizide, tolbutamide) in healthy subjects. Concomitant use of fluconazole and oral hypoglycemic agents in diabetic patients is allowed, but the physician should take into account the possibility of hypoglycemia.
The concomitant use of Fluconazole and phenytoin may increase plasma concentrations of phenytoin to a clinically significant degree. Therefore, if co-administration of these drugs is necessary, phenytoin concentrations should be monitored with dose adjustments to maintain drug levels within the therapeutic interval.
Combination with rifampicin decreases AUC by 25% and shortens plasma elimination half-life of fluconazole by 20%. Therefore, in patients receiving rifampicin concomitantly, it is reasonable to increase fluconazole dose.
The monitoring of cyclosporine blood concentrations in patients receiving fluconazole is recommended, because the use of fluconazole and cyclosporine in patients with renal transplantation (administration of fluconazole at a dose of 200 mg/day) leads to a slow increase of cyclosporine plasma concentration.
Patients who receive high doses of theophylline or who are likely to develop theophylline intoxication should be monitored for early detection of symptoms of theophylline overdose, because fluconazole administration leads to a decrease in the average plasma clearance rate of theophylline.
In concomitant use of fluconazole with terfenadine and cisapride, adverse cardiac reactions, including paroxysms of ventricular tachycardia (torsades de points) have been described.
The concomitant use of fluconazole and hydrochlorothiazide may increase fluconazole plasma concentrations by 40%.
There have been reports of interaction of fluconazole and rifabutin with increased serum levels of the latter. There have been cases of uveitis during concomitant use of Fluconazole and rifabutin. Patients receiving rifabutin and fluconazole concomitantly should be closely monitored.
In patients receiving a combination of fluconazole and zidovudine an increase in concentration of zidovudine is observed, which is caused by a decrease in conversion of the latter to its main metabolite, therefore an increase in side effects of zidovudine should be expected.
Enhances concentrations of midazolam, due to which the risk of psychomotor effects increases (more pronounced when using fluconazole orally than intravenously).
Enhances tacrolimus concentrations, due to which the risk of nephrotoxic effects increases.
Special Instructions
Treatment must be continued until clinical and hematological remission occurs. Premature discontinuation of treatment leads to relapses.
By treatment, blood parameters, renal and hepatic function should be monitored. If renal and hepatic function abnormalities occur, the drug should be discontinued.
In rare cases the use of fluconazole has been accompanied by toxic liver changes, including with fatal outcome, mainly in patients with severe comorbidities. In the case of hepatotoxic effects associated with fluconazole, no clear dependence on the total daily dose, duration of therapy, sex and age of the patient was noted. Hepatotoxic effects of fluconazole were usually reversible; their signs disappeared after discontinuation of therapy. If clinical signs of liver damage appear, which may be associated with fluconazole, the drug should be discontinued.
AIDS patients are more prone to develop severe skin reactions with many drugs. In cases where patients with superficial fungal infections develop a rash and it is considered definitely related to fluconazole, the drug should be discontinued. If a rash develops in patients with invasive/systemic fungal infections, they should be closely monitored and fluconazole should be discontinued if bullous changes or erythema multiforme appear.
Caution should be exercised if fluconazole is taken concomitantly with cisapride, rifabutin or other drugs metabolized by the cytochrome P 450 system.
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Contraindications
- hypersensitivity to the drug (including.
- Hypersensitivity to the drug (including history of other azole antifungals);
- concurrent use of terfenadine (with continuous use of fluconazole at a dose of 400 mg/day or more) or astemizole, or other QT interval prolonging drugs;
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Side effects
Digestive system disorders: decreased appetite, changes in taste, abdominal pain, vomiting, nausea, diarrhea, flatulence, rarely – disorders of liver function (jaundice, hepatitis, hepatonecrosis, hyperbilirubinemia, increased alanine aminotransferase activity, aspartate aminotransferase activity, increased alkaline phosphatase activity, hepatocellular necrosis), incl.including severe.
Nervous system disorders:headache, dizziness, excessive fatigue, rarely – seizures.
Hematopoietic organs: rarely – leukopenia, thrombocytopenia (bleeding, petechiae), neutropenia, agranulocytosis.
Allergic reactions: skin rash, rarely – erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), anaphylactoid reactions (including angioedema, facial edema, urticaria, skin itching).
Cardiovascular disorders:increased QT interval duration, ventricular fibrillation/thrash.
Others: Rarely – impaired renal function, alopecia, hypercholesterolemia, hypertriglyceridemia, hypokalemia.
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Overdose
Symptoms:Hallucinations, paranoid behavior.
Treatment:symptomatic – gastric lavage, forced diuresis. Hemodialysis for 3 h reduces plasma concentrations by approximately 50%.
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Similarities
Diflucan, Flucostat, Mycosist, Mycomax, Fluconazole-Teva, Fluconazole, Fluconazole Stada, Fluconazole Sandoz
Weight | 0.010 kg |
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Shelf life | 2 years. |
Conditions of storage | In a dry, light-protected place at 15-25 °C. |
Manufacturer | Ozon, Russia |
Medication form | capsules |
Brand | Ozon |
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