PREDUKTAL MV

Active material: Trimetazidine
When ATH: C01EB15
CCF: Preparation, improving myocardial metabolism, and neurosensory organs in ischemia
ICD-10 codes (testimony): H34, H35.0, H81, H93.0, i20
When CSF: 01.12.09
Manufacturer: Servier Laboratories (France)

Pharmaceutical form, composition and packaging

The modified-release tablet, coated Pink colour, round, lenticular.

Excipients: calcium hydrogen phosphate dihydrate, povidone, magnesium stearate, Titanium dioxide (E171), iron oxide red (E172), glycerol, Colloidal anhydrous silica, macrogol, gipromelloza.

20 PC. – blisters (2) – packs cardboard.
30 PC. – blisters (2) – packs cardboard.

Pharmacological action

Antianginal drug. Preductal^® CF prevents a decrease in intracellular ATP content by saving energy metabolism of cells in hypoxic. Thus, preparation ensures the normal functioning of membrane ion channels, transmembrane transport of potassium ions and sodium and preservation of cellular homeostasis.

Trimetazidine slows the oxidation of fatty acids by selective inhibition of the long-chain 3-ketoatsetil-CoA thiolase, which leads to increased oxidation of glucose and rehabilitation conjugation between glycolysis and oxidative decarboxylation causes myocardial protection against ischemia. Switching oxidation of fatty acids on glucose oxidation underlies antianginalnogo trimetazidine.

Trimetazidine has the following properties: It supports the energy metabolism of the heart and neurosensory organs during periods of ischemia; It reduces the amount of intracellular acidosis and extent of changes in the transmembrane ion flux, arising during ischemia; It lowers the level of the migration and infiltration of polynuclear neutrophils in ischemic and reperfusion heart tissue, It reduces the size of myocardial damage. These effects of trimetazidine observed in the absence of any direct hemodynamic effect.

Patients, angina pectoris, trimetazidine uvelichivaet koronarnыy reserve, thus slowing the development of ischemia, exercise-induced, starting from the 15th day of therapy; limit swings in blood pressure without any significant changes in heart rate; significantly reduces the frequency of angina attacks, significantly reduces the need for nitroglycerine, improves left ventricular function in patients with ischemic dysfunction.

Pharmacokinetics

Absorption

After taking the drug is rapidly absorbed into the trimetazidine. FROM_max achieved through 5 no. More 24 h plasma concentration remains at, exceeding 75% concentration, determined by 11 no. Eating does not affect the pharmacokinetic properties of the drug.

Distribution

FROM_ss achieved through 60 no. V_d is 4.8 l / kg, suggesting good diffusion in tissue.

Plasma protein binding is low, about 16% (in vitro).

Deduction

Excreted mainly kidneys unchanged. T_1/2 – about 7 no, in patients over 65 years – about 12 no.

Renal clearance of trimetazidine is directly correlated with CC, hepatic clearance decreases with age.

It has been shown, that elderly patients at a daily dose 2 tab. in 2 admission, increase plasma concentration does not lead to any marked effect.

Testimony

- Cardiology: long-term treatment of CHD, prevention of angina attacks (monotherapy or in combination therapy);

- ENT diseases: cochle-treatment of vestibular disorders ischemic nature (such as dizziness, noise in ears, hearing disorder);

- ophthalmology: chorioretinal vascular disorders with an ischemic component.

Dosage regimen

Preductal^® CF appoint 35 mg (1 tab.) 2 times / day at mealtime morning and evening. Daily dose – 70 mg (2 tab.). The duration of therapy is determined individually.

Side effect

From the digestive system: rarely – mild nausea, vomiting.

Contraindications

- Pregnancy;

- breast-feeding;

- Up to 18 years;

- Hypersensitivity to the drug.

Pregnancy and lactation

The drug is contraindicated in pregnancy because of the lack of clinical data on the safety of its use.

Unknown, whether trimetazidine is released in breast milk. Therefore, if necessary, the appointment during lactation should stop breastfeeding.

IN experimental studies ustanovleno not teratogenic action trimetazidine.

Cautions

It will be appreciated, that Preductal^® CF is not intended for the relief of angina attacks and is not indicated for the initial course of therapy of unstable angina or myocardial infarction, and in preparation for hospitalization or in the first days of its.

In the case of an attack of angina pectoris should be reviewed and adapted treatment (drug therapy or revascularization).

Due to lack of relevant clinical data, use of the drug Preductal^® CF is not recommended for patients with renal insufficiency (CC < 15 ml / min), as well as patients with severe hepatic impairment.

Use in Pediatrics

Due to the lack of sufficient clinical data should not be given the drug children and adolescents under the age of 18 years.

Effects on ability to drive vehicles and management mechanisms

Preductal^® CF does not affect the ability to drive a car and perform work, requiring a high rate of psychomotor reactions.

Overdose

Currently, cases of drug overdose Preductal^® MB has not been reported.

Drug Interactions

Drug Interactions drug Preductal^® CF is not described.

Conditions of supply of pharmacies

The preparation is available on medical prescription.

Conditions and terms

No special storage conditions requires. Keep out of the reach of children. Shelf life – 3 year.