Fluconazole Sandoz capsules 150 mg 1 pc. (Fluconazole)

Pharmacological action

Pharmacological action - antifungal.

Indications

Cryptococcosis, including cryptococcal meningitis and infections of a different location (e.g., lungs, skin), including in patients with a normal immune response and in patients with AIDS, recipients of transplanted organs and patients with other forms of immunodeficiency, maintenance therapy to prevent relapse of cryptococcosis in AIDS patients.

Generalized candidiasis, including candidaemia, disseminated candidiasis and other forms of invasive candidiasis infection, such as infections of the peritoneum, endocardium, eyes, respiratory and urinary tracts, including in patients with malignant tumors located in the ICU and receiving cytotoxic or immunosuppressive drugs, as well as in patients with other factors predisposing to the development of candidiasis.

Candidiasis of the mucous membranes, including mucous membranes of the oral cavity and pharynx, esophagus, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic atrophic candidiasis of the oral cavity (associated with wearing dentures), including in patients with normal and suppressed immune function, prevention of recurrence of oropharyngeal candidiasis in AIDS patients.

Genital candidiasis acute or recurrent vaginal candidiasis prophylaxis to reduce the recurrence rate of vaginal candidiasis (3 or more episodes per year) candidiasis balanitis.

Mycoses of the skin, including mycoses of the feet, body, inguinal region, pityriasis versicolor, onychomycosis and skin candidiasis.

Deep endemic mycoses in patients with normal immunity, coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis.

Prevention of fungal infections in patients with malignant tumors predisposed to the development of such infections as a result of cytotoxic chemotherapy or radiation therapy.

Contraindications

The simultaneous use of terfenadine during repeated use of fluconazole at a dose of 400 mg / day and more simultaneous use of cisapride increased sensitivity to fluconazole increased sensitivity to azole derivatives with a similar structure to fluconazole.

Pregnancy and lactation

There have been no adequate and well-controlled studies of the safety of fluconazole in pregnant women. The use of fluconazole during pregnancy should be avoided, except in cases of severe and potentially life-threatening fungal infections, when the expected benefits of the treatment outweigh the potential risk to the fetus.

Women of childbearing age should use reliable contraceptives during the treatment period.

Fluconazole is determined in breast milk at concentrations close to plasma, so use during lactation (breastfeeding) is not recommended.

Composition of

Capsules: 1 capsule contains fluconazole - 150 mg

Side effects

From the nervous system: headache, dizziness, cramps, taste change.

From the digestive system: abdominal pain, diarrhea, flatulence, nausea, dyspepsia, vomiting, hepatotoxicity (including rare cases with fatal outcome), increased levels of alkaline phosphatase, bilirubin, serum aminotransferases (ALT and AST), impaired liver function, hepatitis , hepatocellular necrosis, jaundice.

From the cardiovascular system: increased QT interval on the ECG, ventricular fibrillation / flutter.

Dermatological reactions: rash, alopecia, exfoliative skin diseases, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

From the hemopoietic system: leukopenia, including neutropenia and agranulocytosis, thrombocytopenia.

Metabolism: increased cholesterol and triglycerides in plasma, hypokalemia.

Allergic reactions: anaphylactic reactions (including angioedema, swelling of the face, urticaria, pruritus).

Drug interaction

When used simultaneously with warfarin, fluconazole increases prothrombin time (by 12%), and bleeding (hematomas, nose and gastrointestinal bleeding, hematuria, melena) is possible. In patients receiving coumarin anticoagulants, it is necessary to constantly monitor prothrombin time.

After oral administration of midazolam, fluconazole significantly increases the concentration of midazolam and psychomotor effects, moreover, this effect is more pronounced after taking fluconazole orally than when it is used iv. If concomitant therapy with benzodiazepines is necessary, patients taking fluconazole should be monitored with a view to correspondingly reducing the dose of benzodiazepine.

With the simultaneous use of fluconazole and cisapride, undesirable reactions from the heart are possible, including ventricular fibrillation / flutter (pirouette type arrhythmia). The use of fluconazole at a dose of 200 mg 1 time / day and cisapride at a dose of 20 mg 4 times / day leads to a marked increase in plasma concentrations of cisapride and an increase in the QT interval on the ECG. Concomitant use of cisapride and fluconazole is contraindicated.

In patients after kidney transplantation, the use of fluconazole at a dose of 200 mg / day leads to a slow increase in the concentration of cyclosporine. However, with repeated administration of fluconazole at a dose of 100 mg / day, changes in the concentration of cyclosporin in bone marrow recipients were not observed. With the simultaneous use of fluconazole and cyclosporine, it is recommended to monitor the concentration of cyclosporin in the blood.

Repeated use of hydrochlorothiazide simultaneously with fluconazole leads to an increase in the concentration of fluconazole in plasma by 40%. The effect of this severity does not require a change in the dosage regimen of fluconazole in patients receiving diuretics at the same time, but this should be taken into account.

With the simultaneous use of a combined oral contraceptive with fluconazole in a dose of 50 mg, a significant effect on the level of hormones has not been established, whereas with a daily intake of 200 mg of fluconazole, the AUC of ethinyl estradiol and levonorgestrel increase by 40% and 24%, respectively, and with 300 mg of fluconazole once a week, the AUC of ethinyl estradiol and norethindrone increase by 24% and 13%, respectively. Thus, repeated use of fluconazole in the indicated doses is unlikely to affect the effectiveness of combined oral contraceptives.

The simultaneous use of fluconazole and phenytoin may be accompanied by a clinically significant increase in the concentration of phenytoin. With this combination, the concentration of phenytoin should be monitored and its dose adjusted accordingly to ensure a therapeutic concentration in the blood serum.

The simultaneous use of fluconazole and rifabutin can lead to an increase in serum concentrations of the latter. With the simultaneous use of fluconazole and rifabutin, cases of uveitis have been described. Patients receiving rifabutin and fluconazole at the same time should be carefully monitored.

The simultaneous use of fluconazole and rifampicin leads to a decrease in AUC by 25% and a duration T1 / 2 of fluconazole by 20%. In patients taking rifampicin at the same time, the feasibility of increasing the dose of fluconazole should be considered.

Fluconazole, when taken concomitantly, leads to an increase in T1 / 2 of the oral sulfonylurea preparations (chlorpropamide, glibenclamide, glipizide and tolbutamide). Patients with diabetes can be prescribed fluconazole and oral sulfonylureas, but the possibility of hypoglycemia should be considered.

The simultaneous use of fluconazole and tacrolimus leads to an increase in plasma concentrations of the latter. Cases of nephrotoxicity are described. With this combination, the condition of the patients should be carefully monitored.

With the simultaneous use of azole antifungal agents and terfenadine, serious arrhythmias may occur as a result of an increase in the QT interval. When taking fluconazole at a dose of 200 mg / day, an increase in the QT interval has not been established, however, the use of fluconazole in doses of 400 mg / day and higher causes a significant increase in the concentration of terfenadine in plasma. The simultaneous administration of fluconazole in doses of 400 mg / day or more with terfenadine is contraindicated. Treatment with fluconazole in doses less than 400 mg / day in combination with terfenadine should be monitored closely.

With simultaneous use with fluconazole at a dose of 200 mg for 14 days, the average plasma clearance rate of theophylline decreases by 18%. When prescribing fluconazole to patients taking theophylline in high doses, or to patients with an increased risk of developing the toxic effects of theophylline, the appearance of symptoms of theophylline overdose should be monitored and, if necessary, adjust therapy accordingly.

With simultaneous use with fluconazole, an increase in the concentration of zidovudine is observed, which is probably due to a decrease in the metabolism of the latter to its main metabolite. Before and after therapy with fluconazole at a dose of 200 mg / day for 15 days, patients with AIDS and ARC (the complex associated with AIDS) found a significant increase in the AUC of zidovudine (20%).

When using zidovudine at a dose of 200 mg every 8 hours in HIV-infected patients for 8 days in combination with fluconazole at a dose of 400 mg / day or without it with an interval of 21 days between the two regimens, a significant increase in the AUC of zidovudine was found (74% ) with simultaneous use with fluconazole. Patients receiving this combination should be observed in order to identify side effects of zidovudine.

The simultaneous use of fluconazole with astemizole or other drugs, the metabolism of which is carried out by isoenzymes of the cytochrome P450 system, may be accompanied by an increase in serum concentrations of these agents. With such combinations, the condition of the patients should be carefully monitored.

Shelf life

3 years

active substance

Fluconazole

Conditions of release from drugstores

Without prescription

lekarstvennaja form

kapsul

Prescribing

For children over 3 years old, Adults, For children prescribed by a doctor

Indications

From thrush

Sandoz, Switzerland



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