Trimektal mV Table n / a film about modif.vysv. 35mg 60 pcs vertex

Description

Composition
Active substance:
1 tablet contains: trimetazidine dihydrochloride – 35.0 mg ;.
Excipients:
Kollidon SR [80% polyvinyl acetate, 19% povidone, sodium lauryl sulfate, 0.8%, 0.2% silicon dioxide] – 137.5 mg Calcium hydrogen phosphate dihydrate – 73.8 mg, colloidal silicon dioxide – 1.2 mg Magnesium stearate – 2.5 mg; film coating: [hypromellose – 4.80 mg talc – 1.60 mg titanium dioxide – 0.88 mg macrogol 4000 (polyethylene glycol 4000) – 0.72 mg] or [dry film coating mixture comprising hypromellose (60 %), talc (20%), titanium dioxide (11%), macrogol 4000 (polyethylene glycol 4000) (9%)] – 8.0 mg.
Description:
Tablets, film-coated, white or almost white color with a yellowish shade, round, biconvex.
Product form:
The modified-release tablet, film-coated, 35 mg.
10, 20 or 30 tablets in blisters of PVC film and aluminum foil. The bank of HDPE, 60 pcs. 3 or 6, the contour of cellular packages for Table 10. 2, 3, 5 or 6, the contour of cellular packages for Table 20., Or 1, 2 or 4 blisters Table 30., Or Bank 1 of Table 60. in the stack of cardboard.
Contraindications
Hypersensitivity to any component of the drug; Parkinson’s disease, the symptoms of Parkinson’s disease, tremor, a syndrome of “restless legs” and others associated with them, movement disorders; severe renal impairment (creatinine clearance less than 30 mL / min); age 18 years (effectiveness and safety have been established).
Carefully
Patients with severe hepatic insufficiency; with moderate renal impairment (creatinine clearance of 30-60 ml / min); the use in elderly patients (older than 75 years).
Dosage
35 mg
Indications
Ischemic heart disease: prevention of attacks of stable angina (as adjuvant therapy).
Interaction with other drugs
In clinical studies, trimetazidine shown that it increases the anti-ischemic activity of other antianginal drugs, other interactions were not observed.
Overdose
There is only limited information on the overdose of trimetazidine. In the case of an overdose should be symptomatic therapy.
pharmachologic effect
Pharmacological group:
Antihypoxanth means.
Pharmacodynamics:
It provides anti-hypoxic action.
Directly affecting the cardiomyocytes and neurons in the brain, the drug to optimize their metabolism and function. Cytoprotective effect is due to an increase in potential energy, the activation of the oxidative decarboxylation and the rationalization of oxygen consumption (increasing aerobic glycolysis and fatty acid oxidation blockade).
Trimetazidine supports myocardial contractility, prevents the decrease in intracellular adenosine triphosphate (ATP) and phosphocreatine. In acidosis conditions normalize the functioning of ionic channels membranes, prevents the accumulation of sodium and calcium ions in cardiomyocytes normalizes the intracellular content of potassium ions.
Reduces intracellular acidosis and increased phosphate content caused by myocardial ischemia and reperfusion. Prevents the damaging action of free radicals, preserves the integrity of cellular membranes, prevents activation of neutrophils in the ischemic area, increases the electrical potential, reduces yield creatine kinase (CK) cells and the severity of ischemic myocardial injury.
Trimetazidine reduces the frequency of angina attacks, reduce the need for taking nitrates, after 2 weeks of treatment improves exercise capacity, reduced blood pressure sharp fluctuations (BP). Reduces dizziness and tinnitus. When vascular eye disease improves the functional activity of the retina eyes.
Pharmacokinetics:
After taking the drug inside Trimetazidine is rapidly and almost completely absorbed in the gastrointestinal tract. Bioavailability – 90%.
The time to reach maximum plasma concentration – 3 hours.
The steady state is reached after 60 hours. The volume of distribution of 4.8 l / kg, suggesting good diffusion distribution in tissues.
Communication with plasma proteins – 16%.
Trimetazidine is excreted mainly by the kidneys (approximately 60% – unchanged). The half-life of about 7 hours, in patients older than 65 years – about 12 hours.
Renal clearance of trimetazidine is directly correlated with creatinine clearance (CC), hepatic clearance decreases with age.
Easily penetrates the blood-tissue barriers.
Pregnancy and breast-feeding
Data on the use of trimetazidine in pregnant women are not available. As a precaution, not recommended Trimektal® MW during pregnancy.
Data on the allocation of trimetazidine or its metabolites in breast milk are not available. Risk can not be ruled out for the infant / child. Do not use Trimektal® MW during breastfeeding.
Conditions of supply of pharmacies
Prescription.
side effects
Adverse reactions that are defined as unwanted phenomena at least having a potential relevance to the treatment of trimetazidine are shown in the following gradation: very often (1/10); frequently (more than 1/100 and less than 1/10); infrequently (more than 1/100 to 1/1000 or less); rare (more or less 1/1000 1/10000); very rare (less than 1/10000); unknown frequency (frequency can not be calculated from the available data).
From the digestive system: often – abdominal pain, diarrhea, dyspepsia, nausea, vomiting; the frequency is unknown – constipation.
General disorders: often – fatigue.
Central nervous system: often – dizziness, headache; the frequency is unknown – the symptoms of parkinsonism (tremor, akinesia, body toning), instability in the Romberg and “precariousness” gait, the syndrome of “restless legs”, while others related movement disorders, usually reversible upon discontinuation of therapy; sleep disorders (insomnia, somnolence).
For the skin and subcutaneous fat: often – skin rash, itching, hives; frequency is unknown – acute generalized exanthematous pustulosis, angioedema.
With the cardiovascular system: rarely – palpitations, arrythmia, tachycardia, marked reduction in blood pressure, orthostatic hypotension, which may be accompanied by general weakness, dizziness or loss of balance, especially while receiving antihypertensive drugs, “tides” of blood to the skin.
On the part of the circulatory and lymphatic system: the frequency is unknown – agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
Of the liver and biliary tract: unknown frequency – hepatitis.
special instructions
Trimektal® MB is not intended for the relief of angina attacks and is not indicated for the initial course of therapy of unstable angina or myocardial infarction in the prehospital or in the first days of hospitalization.
In the case of angina attack should review and adapt the treatment (drug therapy or revascularization).
Trimetazidine can cause or worsen the symptoms of parkinsonism (tremor, akinesia, body toning), therefore it is necessary to carry out regular monitoring of patients, particularly the elderly. In doubtful cases, patients should be referred to a neurologist for appropriate examination.
When the movement disorders such as parkinsonism symptoms, a syndrome of “restless legs”, tremor, unsteadiness in Romberg and “precariousness” gait, trimetazidine should be completely abolished.
Such cases are rare, and symptoms usually resolve after discontinuation of therapy: Most patsientov- for 4 months after discontinuation of the drug. If parkinsonian symptoms persist for more than 4 months after discontinuation of the drug should consult a neurologist. Cases may occur drop associated with instability in Romberg and “unsteadiness” gait or a marked reduction in blood pressure, particularly in patients taking antihypertensive drugs.
It should be used with caution Trimektal® CF patients who may increase its exposure: with moderate renal failure; in elderly patients older than 75 years.
In view of the dosage form Trimektal® CF drug, tablets with modified release film-coated tablet can not dissolve in the intestine and faeces stand that does not affect the therapeutic efficacy of the drug.
Impact on the management of vehicles and mechanisms
Given the possibility of adverse reactions of the CNS when receiving trimetazidine (cm. “Side effects”), caution should be exercised in the management of vehicles and other technical devices, require high concentration and psychomotor speed reactions. Trimektal® CF does not affect the ability to drive vehicles and perform work requiring high rate of psychomotor reactions.
Storage conditions
In the dark place at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside, during a meal.
Trimektal® CF prescribed 1 tablet 2 times a day (morning and evening).
The course of treatment – on the advice of a doctor.
When applied in patients with moderate renal impairment (creatinine clearance of 30-60 ml / min) and elderly patients need to reduce the dosing frequency to 1 times a day (morning, lunch in time).
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist