Included in the formulation
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):VED
АТХ:J.04.A.K Other antituberculous drugs
Pharmacodynamics:The drug belongs to the class of anti-tuberculosis drugs - diarylquinolines. It has a bactericidal effect due to inhibition of the mycobacterium adenosine triphosphate synthase pump, thus detaching the processes of cellular respiration of mycobacterium tuberculosis (Mycobacterium tuberculosis) and leading to the death of a microbial cell.
Pharmacokinetics:Oral intake, full absorption, the maximum concentration of the drug in the blood is observed after 5 hours after admission. Does not penetrate the blood-brain barrier. The greatest bioavailability is achieved when taken with food (up to 95%), which is about 2 times higher than bioavailability when taken on an empty stomach. Thus, to increase the bioavailability of Bedakville, the drug should be taken with food. Binding to plasma proteins is> 99.9%. Bedakvilin is metabolized primarily by oxidation. Excretion mainly through the gastrointestinal tract. The half-life of the drug and its metabolites is 5.5 months.
Indications:In the treatment of pulmonary tuberculosis in adults, which is caused by strains Mycobacterium tuberculosis multidrug-resistant.
I.A15-A19.A15 Tuberculosis of respiratory organs, confirmed bacteriologically and histologically
Contraindications:Lactation.
Severe kidney failure.
Severe hepatic insufficiency (due to the lack of clinical safety data for the drug in this group).
Lactose intolerance, glucose-lactose malabsorption, lactose deficiency.
Pregnancy.
Hypersensitivity.
Children and adolescence under 18 years.
Carefully:Interval lengthening QT (including with simultaneous use with drugs that extend the QT interval, antibiotics of the group of fluoroquinolones, macrolides, clofazimine), the presence of decompensated heart failure, the development of arrhythmias of the "torsade de points" type; bradycardia, hypocalcemia, hypokalemia, hypomagnesemia, hypothyroidism (including in the anamnesis), age over 65 years, when combined with lopinavir / ritonavir.
Pregnancy and lactation:The drug is not classified Food and Drug Administration (US Food and Drug Administration). Safety of the drug in pregnancy is not established, so the drug is contraindicated for use in pregnant women.
Data on the use of Bedakville in women during lactation are absent, therefore, the use of the drug during breastfeeding is contraindicated.
Dosing and Administration:Orally with meals. 400 mg once a day for 2 weeks, then 200 mg 3 times a week (with a break of at least 48 hours between doses) for 22 weeks.
Side effects:From the musculoskeletal system: pain in the muscles and / or joints.
From the liver and bile ducts: increased activity of transaminases.
From the nervous system: headache, dizziness.
Disorders from the gastrointestinal tract: vomiting, nausea, diarrhea.
From the cardiovascular system: lengthening of the interval QT on an electrocardiogram.
Overdose:There is no information. Treatment is symptomatic. In case of overdose, general measures should be taken to support the basic vital functions and monitor the electrocardiogram of the QT interval. Non-sucked Bedakvilin can be removed by washing the stomach and taking activated charcoal.As Bedakvilin is largely associated with proteins, the effectiveness of dialysis to remove the drug from the plasma will be low. If possible, clinical follow-up should continue.
Interaction:The effectiveness of the drug may decrease with simultaneous reception with inducers CYP3A4, including antibiotics of the rifampicin group. The reverse effect is observed with simultaneous administration with ketoconazole and other inhibitors CYP3A4, antiretroviral drugs (lopinavir / ritonavir).
Special instructions:Treatment should be done under the supervision of a physician.
In the second phase of treatment, the risk of a lethal outcome significantly increases, in connection with this, this drug is prescribed only in the absence of the effectiveness of alternative therapy.
Before the beginning of therapy with the drug and after 2, 12 and 24 weeks of treatment, an electrocardiographic study is needed to dynamically monitor the QT interval.
Before the beginning of therapy with the drug it is necessary to assess the concentration of potassium, magnesium and calcium of blood serum and adjust the indicators in case of deviation from normal values.
The drug is not used to treat people under the age of 18.