Predysin, tablets 35 mg 60 pcs

Predisine is an antihypoxant.

Pharmacodynamics

Trimetazidine has an antihypoxic effect. Directly affecting cardiomyocytes and brain neurons, it optimizes their metabolism and function. Cytoprotective effect is due to increase of energetic potential, activation of oxidative decarboxylation and rationalization of oxygen consumption (increase of aerobic glycolysis and blockade of fatty acids oxidation).

Maintains myocardial contractility, prevents the decrease of intracellular ATP and phosphocreatine. Under acidosis, it normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium ions in cardiomyocytes and normalizes the intracellular content of potassium ions.

Limits intracellular acidosis and increased 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 KFC output from cells and severity of ischemic myocardial damage.

In angina patients it reduces the frequency of attacks and the necessity of using nitroglycerin; after 2 weeks of treatment the tolerance to physical load increases, the left ventricular contractile function of patients with ischemic dysfunction improves, BP fluctuations decrease. It reduces dizziness and tinnitus. In vascular eye disease improves the functional activity of the retina.

Pharmacokinetics

After oral administration, trimetazidine is rapidly and almost completely absorbed in the GI tract, bioavailability is 90%. T_max in plasma is approximately 5 h. After 24 h, the plasma concentration remains at a level exceeding 75% of the concentration determined after 11 h. The equilibrium state is reached after 60 h.

Eating does not affect the pharmacokinetic properties of trimetazidine. Visible V_d is 4.8 (l/kg), which explains the good diffusion in tissues (binding to blood plasma proteins is low, about 16%); easily penetrates through histohematic barriers. Trimetazidine is excreted mainly by the kidneys (about 60% – unchanged).

T_1/2 in healthy volunteers is about 7 h, in patients older than 65 years – about 12 h. Renal clearance of trimetazidine directly correlates with creatinine clearance, hepatic clearance decreases with age. Increased T_1/2 trimetazidine in elderly patients is not clinically relevant.

Indications

Ischemic heart disease – prevention of angina attacks (in combination therapy); cochleovestibular disorders of ischemic nature (dizziness, tinnitus, hearing loss).

Active ingredient

Composition

Active substance:

Trimetazidine dihydrochloride 35 mg;

Ancillary substances:

MCC – 88.22 mg;

Hypromellose – 36.04 mg;

Pregelatinized starch – 88.22 mg;

Colloidal silica – 1.26 mg;

Magnesium stearate – 1.26 mg;

Film film sheath:

Opadry II 85G24057 (polyvinyl alcohol – 3.3 mg, talc – 1.5 mg, titanium dioxide – 1.46025 mg, macrogol 3350 – 0.92625 mg, soy lecithin – 0.2625 mg, iron oxide red dye – 0.02775 mg, iron oxide yellow dye – 0.0195 mg, iron oxide black dye – 0.00375 mg) – 7.5 mg;

How to take, the dosage

Overly, 1 tablet of 35 mg 2 times a day, morning and evening with meals.

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

Special Instructions

Do not use Predysin® to control angina pectoris attacks. The drug is not indicated for initial therapy of unstable angina or myocardial infarction.

In case of development of an angina attack, the therapy should be reviewed and adapted.

Impact on the ability to drive vehicles and operate machinery.The use of Predysin® has no effect on the ability to drive vehicles and perform work requiring high speed psychomotor reactions.

Contraindications

Side effects

Digestive system: often – abdominal pain, diarrhea, dyspepsia, nausea, vomiting.

General disorders: often – asthenia.

CNS disorders: common – dizziness, headache; very rare – extrapyramidal disorders (tremor, rigidity, akinesia), reversible after discontinuation of the drug.

The skin and subcutaneous fatty tissue: often – skin rash, itching, urticaria.

Systemic system disorders: rare – orthostatic hypotension, blood rushes to the skin.

Overdose

There is limited information about trimetazidine overdose.

Treatment: symptomatic therapy.

Similarities