Diflazon capsules 50mg №7×1

Name:
Diflazon capsules 50mg in blister packs №7×1
Description:
Diflazon belongs to a group of medicines called “antifungal medicines”. The active substance is fluconazole. The drug is used to treat fungal infections, as well as to prevent candidal infections. The most common causative agents of fungal infections are yeast-like fungi – Candida. The main active substance Fluconazole Release form capsules Dosage 50 mg Special instructions Treatment can be started in the absence of culture results or other laboratory tests, but if they are available, an appropriate correction of fungicidal therapy is recommended. Pharmacological action Diflazon is an antifungal drug. Fluconazole, a member of the triazole antifungal class, is a potent selective inhibitor of sterol synthesis in fungal cells. Active against pathogens of opportunistic mycoses, incl. caused by Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp. Fluconazole has also been shown to be active in models of endemic mycoses, including infections caused by Blastomyces dermatitidis, Coccidioides immitis, and Histoplasma capsulatum. Pharmacodynamics Absorption After oral administration, fluconazole is well absorbed. Bioavailability is 90%. After taking the drug orally on an empty stomach at a dose of 150 mg Cmax is 90% of the content in plasma when administered intravenously at a dose of 2.5-3.5 mg / l. Simultaneous ingestion of food does not affect absorption when taken orally. Cmax is achieved 0.5-1.5 hours after taking fluconazole. Plasma concentration is directly proportional to the dose taken. The distribution of 90% Css is achieved by 4-5 days of treatment with the drug (when taken 1 time / day). The introduction of a loading dose (on the 1st day), 2 times the average daily dose, allows you to reach 90% Css level by the 2nd day. The apparent Vd approaches the total body water content. Protein binding – 11-12%. Fluconazole penetrates well into all body fluids. Fluconazole concentrations in saliva and sputum are similar to those in plasma. In patients with fungal meningitis, fluconazole levels in the cerebrospinal fluid are about 80% of its plasma levels. In the stratum corneum, epidermis, dermis and sweat fluid, high concentrations are achieved that exceed serum levels. Excretion Fluconazole is excreted mainly by the kidneys; Approximately 80% of the administered dose is found in the urine unchanged. Fluconazole clearance is proportional to CC. Fluconazole metabolites were not found in the blood. Indications for use Cryptococcosis, including cryptococcal meningitis and other localizations of this infection (including lungs, skin), both in patients with a normal immune response and in patients with various forms of immunosuppression (including in patients with AIDS, with organ transplants); prevention of cryptococcal infection in AIDS patients; generalized candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidal infections (infections of the peritoneum, endocardium, eyes, respiratory and urinary tract). Treatment can be carried out in patients with malignant neoplasms, patients in intensive care units and undergoing a course of cytostatic or immunosuppressive therapy, as well as in the presence of other factors predisposing to the development of candidiasis; candidiasis of the mucous membranes, incl. oral cavity and pharynx (including atrophic candidiasis of the oral cavity associated with wearing dentures), esophagus, non-invasive bronchopulmonary candidiasis, candiduria, skin candidiasis; prevention of recurrence of oropharyngeal candidiasis in patients with AIDS; genital candidiasis: vaginal candidiasis (acute and chronic recurrent), prophylactic use to reduce the frequency of recurrence of vaginal candidiasis (3 or more episodes per year); candidal balanitis; prevention of fungal infections in patients with malignant neoplasms who are predisposed to such infections as a result of chemotherapy with cytostatics or radiation therapy; mycoses of the skin, including mycoses of the feet, body, inguinal region; pityriasis versicolor; onychomycosis; skin candidiasis; deep endemic mycoses, including coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis in patients with normal immunity. Dosage and administration Adults with cryptococcal meningitis and cryptococcal infections of other localization are prescribed 400 mg on the first day, and then continue treatment at a dose of 200-400 mg 1 time per day. The duration of treatment for cryptococcal infections depends on clinical efficacy, confirmed by mycological examination; in cryptococcal meningitis, therapy is usually continued for at least 6-8 weeks. To prevent the recurrence of cryptococcal meningitis in AIDS patients, after completion of the full course of primary treatment, fluconazole therapy at a dose of 200 mg / day can be continued for a very long period of time. With candidemia, disseminated candidiasis and other invasive candidal infections, the dose is an average of 400 mg on the first day, and then 200 mg / day. With insufficient clinical efficacy, the dose may be increased to 400 mg / day. The duration of therapy depends on clinical efficacy. With oropharyngeal candidiasis, the drug is prescribed on average 50-100 mg 1 time per day; duration of therapy – 7-14 days. If necessary, in patients with a pronounced decrease in immunity, treatment may be longer. With atrophic candidiasis of the oral cavity associated with the wearing of dentures, the drug is prescribed at an average dose of 50 mg 1 time per day for 14 days in combination with local antiseptic agents for the treatment of the prosthesis. For other candidal infections (with the exception of genital candidiasis), such as esophagitis, non-invasive bronchopulmonary lesions, candiduria, candidiasis of the skin and mucous membranes, the effective dose is an average of 50-100 mg / day with a duration of treatment of 14-30 days. To prevent recurrence of oropharyngeal candidiasis in patients with AIDS, after completing the full course of primary therapy, fluconazole can be prescribed 150 mg once a week. With vaginal candidiasis, fluconazole is taken once orally at a dose of 150 mg. To reduce the frequency of recurrence of vaginal candidiasis, the drug can be used at a dose of 150 mg once a month. The duration of therapy is determined individually; it varies from 4 to 12 months. Some patients may require more frequent use. For balanitis caused by Candida, fluconazole is prescribed as a single dose of 150 mg orally. For the prevention of candidiasis, the recommended dose of fluconazole is 50-400 mg 1 time per day, depending on the risk of developing a fungal infection. In the presence of a high risk of generalized infection, for example, in patients with expected severe or long-lasting neutropenia, the recommended dose is 400 mg 1 time per day. Fluconazole is prescribed a few days before the expected onset of neutropenia; after an increase in the number of neutrophils more than 1000/μl, treatment is continued for another 7 days. For skin mycoses, including mycoses of the feet, smooth skin, inguinal region and skin candidiasis, the recommended dose is 150 mg 1 time per week or 50 mg 1 time per day. The duration of therapy in normal cases is 2-4 weeks, however, with mycoses of the feet, longer therapy (up to 6 weeks) may be required. With pityriasis versicolor, the recommended dose is 300 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 the drug at a dose of 300-400 mg is sufficient. An alternative treatment regimen is the use of the drug 50 mg 1 time per day for 2-4 weeks. For onychomycosis, the recommended dose is 150 mg once a week. Treatment should be continued until replacement of the infected nail (growth of an uninfected nail). It takes 3-6 months and 6-12 months, respectively, for the re-growth of fingernails and toenails. With deep endemic mycoses, it may be necessary to use the drug at a dose of 200-400 mg / day for up to 2 years. The duration of therapy is determined individually; it is 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 exceeding that in adults. Diflazon is used daily 1 time / day. For mucosal candidiasis, the recommended dose of fluconazole is 3 mg/kg/day. On the first day, a loading dose of 6 mg/kg may be given in order to more quickly achieve constant equilibrium concentrations. For the treatment of generalized candidiasis and cryptococcal infections, the recommended dose is 6-12 mg / kg / day, depending on the severity of the disease. For the prevention of fungal infections in children with reduced immunity, in whom the risk of developing an infection is associated with neutropenia that develops as a result of cytotoxic chemotherapy or radiation therapy, the drug is prescribed at 3-12 mg / kg / day, depending on the severity and duration of induced neutropenia. In children with impaired renal function, the daily dose of the drug should be reduced (in the same proportional relationship as in adults), in accordance with the severity of renal failure. In elderly patients, in the absence of signs of renal insufficiency, the usual dosing regimen of the drug should be followed. Patients with renal insufficiency (CC Fluconazole is excreted mainly in the urine unchanged. With a single dose, a dose change is not required. When re-appointed to patients with impaired renal function, a loading dose of 50 mg to 400 mg should be administered. With CC> 50 ml / min, the average recommended dose of the drug is applied; with a CC of 11 to 50 ml / min, a dose of 50% of the recommended dose is applied. Patients who are regularly on hemodialysis, one dose of the drug is administered after each hemodialysis session. during pregnancy it is impractical, except for severe or life-threatening forms of fungal infections, if the intended benefit to the mother outweighs the possible risk to the fetus.Fluconazole is found in breast milk at the same concentration as in plasma, so the drug is not recommended during lactation.Measures precautionsBefore taking Diflazon, tell your doctor about that: you have problems with your liver or kidneys you suffer from cardiovascular diseases, including heart rhythm disturbances you have a violation of the content of potassium, calcium and magnesium in the blood you have experienced the development of severe skin reactions (itching, redness of the skin) or trouble breathing. If you are not sure if the above applies to you, talk to your doctor before taking this medicine. In some cases, the doctor may order an examination to determine the type of bacteria that caused the disease. Depending on the results obtained, different dosages of Diflazon® or another drug may be prescribed. Interaction with other drugs When using fluconazole with warfarin, an increase in prothrombin time by 12% was noted. In this regard, it is recommended to control the prothrombin time in patients receiving Diflazon in combination with coumarin anticoagulants. With simultaneous use, fluconazole increases T 1/2 of oral hypoglycemic drugs – sulfonylurea derivatives (chlorpropamide, glibenclamide, glipizide and tolbutamide) in healthy volunteers. Co-administration of fluconazole and oral hypoglycemic drugs is allowed, but the possibility of developing hypoglycemia should be taken into account. The simultaneous use of fluconazole and phenytoin may be accompanied by an increase in the concentration of phenytoin to a clinically significant extent. If the combined use of two drugs is required, it is necessary to monitor the level of phenytoin and select its dose to ensure therapeutic serum concentrations. The simultaneous use of fluconazole and rifampicin leads to a decrease in AUC by 25% and a shortening of T 1/2 of fluconazole by 20%. In patients receiving concomitant rifampicin, it is necessary to consider the advisability of increasing the dose of fluconazole. It is recommended to monitor the concentration of cyclosporine in the blood in patients receiving fluconazole, because. when using fluconazole and cyclosporine in patients with a transplanted kidney, taking fluconazole at a dose of 200 mg / day slowly increased the concentration of cyclosporine. 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, tk. simultaneous administration of fluconazole leads to a decrease in the average clearance rate of theophylline from plasma. With the simultaneous use of fluconazole and cisapride, cases of adverse reactions from the heart, including paroxysms of ventricular tachycardia (pirouette-type arrhythmia), have been described. There are reports of the interaction of fluconazole and rifabutin, accompanied by an increase in serum levels of the latter. With the simultaneous use of fluconazole and rifabutin, cases of uveitis have been described. It is necessary to carefully monitor patients who simultaneously receive rifabutin and fluconazole. With the simultaneous use of zidovudine and fluconazole, there is an increase in the concentration of zidovudine in plasma, which is caused by a decrease in the conversion of the latter into the main metabolite, so an increase in the side effects of zidovudine should be expected. Contraindications Hypersensitivity to fluconazole, other components of Diflazon or other azole compounds; simultaneous use of terfenadine (against the background of continuous use of fluconazole at a dose of 400 mg / day or more), cisapride or astemizole and other drugs that prolong the QT interval and increase the risk of developing severe arrhythmias; lactation period. Composition Each capsule of Diflazon® 50 mg contains 50 mg of fluconazole. Each capsule of Diflazon® 150 mg contains 150 mg of fluconazole. List of excipients Corn starch, lactose monohydrate, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silicon dioxide, shell: gelatin EP, titanium dioxide (E171), patent blue V (E131). OverdoseSymptoms: hallucinations, paranoid behavior. Treatment: gastric lavage and symptomatic therapy are recommended. Since fluconazole is excreted in the urine, forced diuresis increases its excretion. Carrying out hemodialysis for 3 hours reduces the concentration of fluconazole in plasma by 50%. Side effect On the part of the digestive system: nausea, diarrhea, flatulence, vomiting, abdominal pain, taste changes, rarely – increased activity of liver enzymes and impaired liver function (jaundice, hyperbilirubinemia, increased activity of ALT, ACT and alkaline phosphatase, hepatitis, hepatocellular necrosis, in including fatal). From the nervous system: headache, dizziness; rarely – convulsions. On the part of the hematopoietic organs: rarely – agranulocytosis, neutropenia. Patients with severe fungal infections may experience hematological changes (leukopenia and thrombocytopenia). From the side of the cardiovascular system: an increase in the duration of the QT interval on the electrocardiogram (ECG), ventricular fibrillation / flutter. Allergic reactions: skin rash, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), bronchial asthma (more often with intolerance to acetylsalicylic acid), anaphylactoid reactions (including angioedema, swelling of the face, urticaria, pruritus). Storage conditions Keep out of the reach of children at a temperature not exceeding 25 ° C. Buy Diflazon capsules 50 mg No. 7×1 Price for Diflazon capsules 50 mg No. 7×1