Trimetazidine

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,

colloidal silicon dioxide 0.5 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. 

Pharmacological action  - antianginal, antihypoxic, cytoprotective, metabolic.

Directly affects cardiomyocytes and neurons in the brain, optimizing their metabolism and function. Cytoprotection is due to the provision of sufficient energy potential, activation of oxidative decarboxylation and rationalization of oxygen consumption (increased aerobic glycolysis and blockade of fatty acid oxidation). Supports myocardial contractility, prevents intracellular depletion of ATP and phosphocreatinine. Under conditions of acidosis, it normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, and normalizes the intracellular potassium content.

Reduces intracellular acidosis and phosphate levels caused by myocardial ischemia and reperfusion. It prevents the damaging action 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 release of creatine phosphokinase from cells and the severity of ischemic damage to the myocardium.

With angina pectoris, it reduces the frequency of attacks (the consumption of nitrates decreases), after 2 weeks of treatment, exercise tolerance increases, and blood pressure drops decrease.

Improves hearing and results of vestibular tests in patients with pathology of ENT organs, reduces dizziness and tinnitus. In case of vascular pathology, the eye restores the functional activity of the retina.

Completely and quickly absorbed from the gastrointestinal tract, bioavailability - 90%. Tmax - 2 hours Cmax after a single oral dose of 20 mg of trimetazidine is 55 ng / ml. Plasma protein binding - 16%. The volume of distribution is 4.8 l / kg. Easily passes through histohematogenous barriers. Almost half of the introduced amount undergoes biotransformation. T1 / 2 about 6 hours 51% is excreted unchanged by the kidneys.

• treatment of cochleo-vestibular disorders of an ischemic nature (such as: dizziness, tinnitus, hearing impairment);
• long-term therapy of ischemic heart disease: prevention of angina attacks (monotherapy or as part of combination therapy);
• chorioretinal vascular disorders with an ischemic component.

Trimetazidine is contraindicated in 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.

• hypersensitivity to the drug Trimetazidine-Teva.
• severe liver dysfunction;
• renal failure (creatinine clearance below 15 ml / min.);
• pregnancy;
• breast-feeding;
• age up to 18 years (efficacy and safety have not been established).

From the digestive system: rarely - nausea, vomiting.

Allergic reactions: skin rash, itching and other manifestations are possible.

The drug is taken with meals.

Prescribed in a dose of 40-60 mg / day.

Frequency rate of admission 2-3 times / day.

The duration of therapy is set individually, depending on the clinical situation.

It is not used to relieve angina attacks!

The use of the drug does not affect the ability to drive and perform work that requires a high speed of mental and physical reactions.

film-coated tablets