Trimetazidine mv - Teva coated pills prolonged 35mg N60
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Description
Tablets of prolonged action, film-coated pink, round, biconvex; on the cross-section - the core is white or almost white.
Active ingredients
Trimetazidine
Release form
Pills
Composition
Per 100 grams: liquid extract of the roots of pelargonium sidovidnoy EPs 7630 (1: 8-10) * 80 g. * Extractant: ethanol 11% (mass / mass). Excipients: glycerol 85% - 20 g.
Pharmacological effect
A tool that normalizes the energy metabolism of cells subjected to hypoxia or ischemia. Prevents a decrease in the intracellular content of ATP, ensures the normal functioning of membrane ion channels, transmembrane transfer of potassium and sodium ions and preservation of cellular homeostasis. Trimetazidine slows down fatty acid oxidation by selectively inhibiting long-chain 3-ketoacetyl-CoA thiolase, which leads to an increase in glucose oxidation and restoration of the conjugation between glycolysis and oxidative decarboxylation and, as has been shown, protects myocardium from ischemia. Switching fatty acid oxidation to glucose oxidation underlies the antianginal action of trimetazidine.
Pharmacokinetics
After ingestion, trimetazidine is rapidly absorbed and reaches its maximum plasma concentration in approximately 5 hours. Over 24 hours the concentration in the blood plasma remains at a level exceeding 75% of the concentration determined after 11 hours. The equilibrium state is reached after 60 hours. Eating does not affect the bioavailability of trimetazidine.
Indications
Long-term treatment of coronary artery disease: prevention of strokes (monotherapy or as part of combination therapy) treatment of cochleo-vestibular disorders of ischemic nature (including dizziness, tinnitus, hearing loss) chorioretinal vascular disorders with an ischemic component.
Contraindications
Hypersensitivity to any of the components of the drug, Parkinson’s disease, parkinsonism symptoms, tremor, restless legs syndrome and other related motor disorders, severe renal failure (creatinine clearance less than 30 ml / min). Due to the lack of a sufficient amount of clinical data for patients under 18 years of age, prescribing the drug is not recommended.With care: patients with severe hepatic impairment (clinical data are limited), patients with moderate renal insufficiency.
Use during pregnancy and lactation
Data on the use of the drug Deprenorm® MV in pregnant women are not available. Animal studies have not revealed direct or indirect reproductive toxicity. Reproductive toxicity studies did not show the effect of trimetazidine on reproductive function in rats of both sexes. The drug is contraindicated in pregnancy due to the lack of clinical data on the safety of its use. Data on the allocation of trimetazidine or its metabolites in breast milk are not available. The risk for a newborn / child cannot be excluded. Do not use the drug Deprenorm® MV during breastfeeding.
Dosage and administration
Tablets should be taken whole without chewing, drinking water. Inside, on 1 tablet 2 times a day, in the morning and in the evening, during food. The duration of treatment is determined by the doctor.
Side effects
Adverse reactions, defined as adverse events, at least having a possible relation to treatment with trimetazidine, are given in the following grades: very often (? 1/10), often (? 1/100, <1/10), infrequently (& ge1 / 1000 , <1/100), rarely (? 1/10000, <1/1000), very rarely (<1/10000), unspecified frequency (frequency cannot be calculated from the available data). Of the digestive system Often: abdominal pain, diarrhea, dyspepsia, nausea, vomiting. Unspecified frequency: constipation. Common disorders Often: asthenia. From the side of the central nervous system Often: dizziness, headache. Unspecified frequency: symptoms of parkinsonism (tremor, akinesia, increased tone), instability in the Romberg position and "shaky" gait, restless legs syndrome, and other motor disturbances associated with them, usually reversible after cessation of therapy. Sleep disturbances (insomnia, drowsiness). Of the skin and subcutaneous fat Often: skin rash, pruritus, urticaria. Unspecified frequency: acute generalized exantmatous pustus, angioedema. Cardiovascular Rare: palpitations, extrasystoles, tachycardia, marked reduction in blood pressure, orthostatic hypotension, which may be accompanied by general weakness, dizziness or loss of balance, especially while taking antihypertensive drugs, "flushes" of blood to the skin of the face.On the part of the circulatory and lymphatic systems. Unspecified frequency: agranulocytosis, thrombocytopenia, thrombocytopenic purpura. Liver and biliary tract Unspecified frequency: hepatitis.
special instructions
Trimetazidine MV is not intended for the relief of angina attacks and is not indicated for the initial course of therapy for unstable angina or myocardial infarction in the prehospital or in the first days of hospitalization. In the case of an attack of angina, treatment should be reviewed and adapted (drug therapy or revascularization). Trimetazidine MV can cause or worsen parkinsonism symptoms (tremor, akinesia, increased tone), therefore, patients should be regularly monitored, especially in the elderly. In doubtful cases, patients should be referred to a neurologist for appropriate examination. When motor disorders such as parkinsonism symptoms, restless legs syndrome, tremor, instability in the Romberg position and shakiness of the gait, Trimetazidine MB should be permanently reversed.