Trimetazidine, 20 mg 60 pcs

Pharmacological action – antianginal, antihypoxic, cytoprotective, metabolic.

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

Limits intracellular acidosis and phosphate content caused by myocardial ischemia and reperfusion. Prevents damaging action of free radicals, maintains integrity of cell membranes, prevents activation of neutrophils in ischemic area, increases duration of electric potential, decreases release of creatine phosphokinase from cells and intensity of ischemic myocardial damage.

In angina pectoris it reduces the frequency of attacks (nitrates consumption decreases), after 2 weeks of treatment the tolerance to physical load increases, BP fluctuations decrease.

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

It is completely and quickly absorbed from the gastrointestinal tract, the bioavailability is 90%. Tmax – 2 hours. Cmax after single oral administration of 20 mg trimetazidine is 55 ng/ml. Binding to plasma proteins is 16%. The volume of distribution is 4.8 l/kg. Easily passes through histohematic barriers. Almost half of the administered amount undergoes biotransformation. T1/2 is about 6 hours. 51% is excreted unchanged by the kidneys.

Indications

Active ingredient

Composition

1 film-coated tablet contains:

the active ingredient:

trimetazidine dihydrochloride – 20 mg

excipients:

Hyprolose (hydroxypropyl cellulose) 0.7 mg,

Corn starch 16 mg,

Colloidal silica (aerosil) 3.13 mg,

Lactose monohydrate (milk sugar) 89.47 mg,

Magnesium stearate 0.7 mg.

composition of the film coating:

Selecoate AQ-01673 – 6 mg: hypromellose (hydroxypropylmethylcellulose) 2.4 mg, macrogohl-400 (polyethylene glycol-400) 0.6 mg, macrogohl-6000 (polyethylene glycol-6000) 0.6 mg, crimson dye [Ponceau 4 R] 0.6 mg, titanium dioxide 1.8 mg

How to take, the dosage

Overly, with meals.

The recommended dosing regimen is (40-60 mg) per day, in 2-3 doses.

The course of treatment is according to the doctor’s recommendation.

Special Instructions

Do not use to control angina attacks. Not indicated for initial therapy of unstable angina or myocardial infarction. If an angina attack develops, the treatment should be reconsidered and adapted.

Impact on driving and operating machinery. Trimetazidine does not affect the ability to drive vehicles and perform work requiring increased speed of psychomotor reactions.

Contraindications

Side effects

The incidence of side effects noted when taking trimetazidine is given in the following gradation: very frequently (more than 1/10); frequently (more than 1/100, less than 1/10); infrequently (more than 1/1000, less than 1/100); rarely (more than 1/10000, less than 1/1000); very rarely (less than 1/10000), including individual reports.

Digestive system disorders:
Often: abdominal pain, diarrhea, dyspepsia, nausea, vomiting.

General disorders:
Often: asthenia.

Actually: dizziness, headache.
Very rare: extrapyramidal disorders (tremor, rigidity, akinesia), reversible after discontinuation of the drug.

Skin disorders:
Often: skin rash, itching, urticaria.

Cardiovascular system disorders:
Rarely: orthostatic hypotension, “rushes” of blood to the face.

Overdose

The data on cases of overdose are limited. In case of overdose symptomatic therapy should be administered.

Pregnancy use

Trimetazidine is contraindicated in pregnancy due to the lack of clinical data on the safety of its use. Breast-feeding should be discontinued if the drug has to be administered during lactation.

It is unknown whether trimetazidine is excreted with breast milk.

The teratogenic effects of trimetazidine have not been established in experimental studies.

Similarities