Predizin - instructions for use, doses, side effects, contraindications

Excipients: cellulose microcrystalline 88.22 mg, hypromellose 36.04 mg, pregelatinized starch 88.22 mg, silicon dioxide colloid 1, 26 mg, magnesium stearate 1, 26 mg; shell: Opadrai II 85G24057 - 7.50 mg (polyvinyl alcohol 3.30000 mg, talc 1.50000 mg, titanium dioxide 1.46025 mg, macrogol 3350 - 0.92625 mg, soy lecithin - 0.26250 mg, iron oxide dye red 0,02775 mg, iron oxide oxide yellow 0.01950 mg, iron oxide dye black 0.00375 mg).

Description:Pink, round biconvex tablets covered with a film membrane, without the inscription.

Pharmacotherapeutic group:antihypoxic agent

ATX: & nbsp

C.01.E.B Other drugs for the treatment of heart disease

C.01.E.B.15 Trimetazidine

Pharmacodynamics:

Trimetazidine has an antihypoxic effect. Directly affecting the cardiomyocytes and neurons of the brain, it optimizes their metabolism and function. The cytoprotective effect is due to an increase in the energy potential, activation of oxidative decarboxylation, and rationalization of oxygen consumption (enhancement of aerobic glycolysis and fat oxidation blockade).

Supports contractility of the myocardium, prevents the reduction of intracellular content of adenosine triphosphate (ATP) and phosphocreatine. In conditions of acidosis normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium ions in cardiomyocytes, normalizes the intracellular content of potassium ions.

Reduces intracellular acidosis and increased phosphate content, 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 ischemia zone, prolongs the duration of the electrical potential, reduces the yield of creatine phosphokinase from cells and the severity of myocardial ischemic damage.

With angina reduces the frequency of seizures and the need for nitroglycerin, after 2 weeks of treatment, tolerance to exercise increases, improves contractile function of the left ventricle in patients with ischemic dysfunction, and decreases in blood pressure (BP).

Reduces dizziness and tinnitus. In vascular pathology, the eye improves the functional activity of the retina.

Pharmacokinetics:

After oral administration trimetazidine quickly and almost completely absorbed in the gastrointestinal tract, bioavailability - 90%.

The time to reach the maximum concentration in the blood plasma is approximately 5 hours. After 24 hours the concentration in the blood plasma remains at a level exceeding 75 % concentration, determined after 11 hours. The equilibrium state is reached after 60 hours. Eating does not affect the pharmacokinetic properties of trimetazidine.

The apparent volume of distribution is 4.8 (l / kg-1), which explains the good diffusion in the tissues (the connection with plasma proteins is low, about 16%); easily penetrates through gistogematicheskie barriers.

Trimetazidine is excreted from the body mainly by the kidneys (about 60% - unchanged). Half-life in healthy volunteers is about 7 hours, in patients older than 65 years - about 12 hours. Renal clearance of trimetazidine directly correlates with the clearance of creatinine (CC), the hepatic clearance decreases with age. The increase in the half-life of trimetazidine in elderly patients has no clinical significance.

Indications:

Ischemic heart disease: prevention of angina attacks (in complex therapy).

Cohleo-vestibular disorders of ischemic nature (dizziness, tinnitus, hearing impairment).

Contraindications:

- hypersensitivity to any component of the drug;

- renal failure (CC less than 15 ml / min);

- severe liver dysfunction;

- age under 18 years (effectiveness and safety not established);

- pregnancy, lactation.

Pregnancy and lactation:

Pregnancy

Data on the safety of the use of the drug in pregnancy are absent, and therefore, the use of the drug Predizin® in pregnancy should be discarded.

Lactation period

There is no data on the excretion of trimetazidine into breast milk. If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.

Dosing and Administration:

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

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

Side effects:

The frequency of side effects noted with the administration of trimetazidine is given in accordance with the WHO classification: very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥1 / 1000 and <1/100) , rarely (≥ 1/10000 and <1/1000), very rarely (<1/10000), including individual messages.

From the digestive system

Often: abdominal pain, diarrhea, indigestion, nausea, vomiting.

Common violations Often: asthenia.

From the central nervous system

Often: dizziness, headache.

Very rarely: extrapyramidal disorders (tremor, rigidity, akinesia),reversible after withdrawal of the drug.

From the skin and subcutaneous fat

Often: skin rash, itching, hives.

From the side of the cardiovascular system

Rarely: orthostatic hypotension, "hot flashes" of blood to the skin of the face.

Overdose:There is only limited information about an overdose of trimetazidine, symptomatic therapy should be given in case of an overdose.

Interaction:

There is no information.

Special instructions:

Do not use Predizin® to stop angina attacks! The drug is not indicated for the initial course of therapy for unstable angina or myocardial infarction.

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

Effect on the ability to drive transp. cf. and fur:

The use of Predisin® does not affect the ability to drive vehicles and perform work that requires a high rate of psychomotor reactions.

Form release / dosage:Tablets of prolonged actionfilm coating, 35 mg.

Packaging:For 10 tablets in a blister of PVC - aluminum foil. 6 blisters each in a cardboard box together with the instructionapplication.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children!

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006244/10

Date of registration:01.07.2010

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER POLAND, Co. Ltd. Poland

GEDEON RICHTER ROMANIA, S.A. Romania

GEDEON RICHTER-RUS, CJSC Russia

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp25.10.2015

Illustrated instructions

Instructions

Predisin® (Predizin®)