Description
Release form
film-coated tablets
Packing
30 pcs.
Pharmacological action
Pharmacological action – antianginal, antihypoxic, cytoprotective, metabolic.
Directly affects cardiomyocytes and brain neurons, optimizing their metabolism and function. Cytoprotection is due to the provision of sufficient energy potential, the activation of oxidative decarboxylation and the rationalization of oxygen consumption (increased aerobic glycolysis and blockade of fatty acid oxidation). It supports myocardial contractility, prevents intracellular depletion of ATP and phosphocreatinin. Under conditions of acidosis, it normalizes the functioning of the ion channels of membranes, prevents the accumulation of calcium and sodium in cardiomyocytes, and normalizes the intracellular potassium content.
Reduces intracellular acidosis and phosphate levels due to myocardial ischemia and reperfusion. Prevents the damaging effect of free radicals, preserves the integrity of cell membranes, prevents the activation of neutrophils in the ischemic zone, increases the duration of the electric potential, reduces the yield of creatine phosphokinase from the cells and the severity of ischemic damage to the myocardium.
With angina pectoris it reduces the frequency of seizures (nitrate consumption decreases), after 2 weeks of treatment, exercise tolerance increases, blood pressure drops decrease.
Improves hearing and results of vestibular tests in patients with ENT pathology, reduces dizziness and tinnitus. With vascular pathology, the eye restores the functional activity of the retina.
Completely and rapidly absorbed from the digestive tract, bioavailability – 90%. Tmax – 2 hours. Cmax after a single oral administration of 20 mg of trimetazidine is 55 ng / ml. Binding to plasma proteins – 16%. Distribution volume – 4.8 l / kg. It easily passes through histohematological barriers. Almost half of the administered amount undergoes biotransformation. T1 / 2 about 6 hours 51% is excreted unchanged by the kidneys.
Indications
treatment of cochleo-vestibular disorders of ischemic nature (such as dizziness, tinnitus, hearing impairment)
long-term therapy for coronary heart disease: prevention of angina attacks (monotherapy or as part of combination therapy)
chorioretinal disorders and vascular components.
Contraindications
hypersensitivity to the drug Trimetazidine-Teva.
severe hepatic impairment
renal failure (creatinine clearance below 15 ml / min.)
pregnancy
breastfeeding
age 18 years (efficacy and safety not established).
Use during pregnancy and lactation
Trimetazidine is contraindicated during pregnancy due to the lack of clinical data on the safety of its use. If necessary, the appointment of the drug during lactation should stop breastfeeding. It is not known whether trimetazidine is excreted in breast milk. In experimental studies, the teratogenic effect of trimetazidine has not been established.
Special instructions
Not applicable for relief of angina attacks!
The use of the drug does not affect the ability to drive a car and perform work that requires a high speed of mental and physical reactions.
Composition
1 film-coated tablet contains:
active substance: trimetazidine dihydrochloride 20 mg
excipients: microcrystalline cellulose 20.0 mg, mannitol 44.5 mg, copolyvidone 4.0 mg, silicon dioxide, colloid 0, silicon dioxide 5 mg, magnesium stearate 1.0 mg, hypromellose 2.3 mg, macrogol 6000 (polyethylene glycol) 0.23 mg, dye-iron oxide red (E 172) 0.1 mg, titanium dioxide (E 171) 0.49 mg .
Dosage and administration of
The drug is taken with food.
Assign in a dose of 40-60 mg / day. Multiplicity of administration is 2-3 times / day. The duration of therapy is set individually, depending on the clinical situation.
Side effects
From the digestive system: rarely – nausea, vomiting.
Allergic reactions: skin rash, itching and other manifestations are possible.
Storage conditions
At a temperature not exceeding 25 ° C.
Pharmacy Conditions
Prescription
Dosage form
tablets
Indications
Angina
Teva Pharmaceutical Enterprises Co., Ltd. Israel
