Trimetazidine MB-Teva - instructions for use, dose, side effects, contraindications

1 tablet contains: active substance: trimetazidine dihydrochloride 35.00 mg; auxiliary substances (core): hypromellose 90.00 mg, calcium hydrogen phosphate dihydrate 141.00 mg, magnesium stearate 3.00 mg, silicon dioxide colloid 1.00 mg, auxiliary substances (shell): water gloss pink * 7.00 mg.

* - hypromellose 60.00%, stearic acid 5.00%, macrogol-6000 3.00%, glycerol 5.00%, titanium dioxide 26.75%, iron dye oxide red 0,25%.

Description:

Round biconvex tablets, covered with a film coating of pink color.

On a cross-section of a tablet - a kernel of white or almost white color.

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 prevents the intracellular decrease in the activity of adenosine triphosphatase (ATP), preserving the energy metabolism of cells subjected to hypoxia or ischemia, thereby ensuring the normal functioning of the ion channels of cell membranes and the transmembrane sodium-potassium flow, maintaining cell homeostasis.

Trimetazidine inhibits beta-oxidation of fatty acids, blocking the long-chain 3-ketoacyl CoA-thiolase, which enhances the oxidation of glucose. A cage in a state of ischemia requires less oxygen for the process of glucose oxidation than in the process of beta oxidation of fatty acids.Potentiation of glucose oxidation optimizes cellular energy production processes, thereby maintaining the proper energy metabolism of the cell in ischemia.

Have patients with ischemic heart disease trimetazidine acts as a metabolic agent, retaining in the myocardium sufficient intracellular activity of high-energy phosphates. The anti-ischemic effect is achieved without affecting hemodynamics.

Pharmacokinetics:

Ingestion trimetazidine quickly absorbed in the gastrointestinal tract (GIT) and reaches a maximum concentration in blood plasma on average for 5 hours. For more than 24 hours, the concentration of trimetazidine in the blood plasma is maintained at concentrations greater than or equal to 75% of the maximum concentration determined within 11 hours.

The equilibrium state is reached after 60 hours. Admission to the diet does not affect the pharmacokinetic properties of trimetazidine. The volume of distribution is 4.8 l / kg. The association with plasma proteins is low and in vitro is 16%.

Trimetazidine is excreted mainly by the kidneys, mainly in an unchanged form. When administered orally at a dose of 35 mg, the half-life period in young healthy volunteers averages 7 hours, in patients older than 65, 12 hours.

The total renal clearance of trimetazidine directly correlates with creatinine clearance (CC). hepatic clearance decreases with age.

In elderly patients with a daily dose of 2 tablets in 2 doses, an increase in the exposure of trimetazidine in blood plasma is observed.

Indications:

Symptomatic treatment of stable angina pectoris with insufficient therapeutic effect or intolerance of antianginal first-line therapy in adult patients (as adjunctive therapy).

Contraindications:

- increased sensitivity to trimetazidine and other components of the drug;

- severe renal failure (CC less than 30 ml / min);

- Parkinson's disease, Parkinson's symptoms, tremor, restless legs syndrome and other symptoms associated with movement disorders:

- children under 18 years of age (efficacy and safety not established).

Carefully:

Severe hepatic insufficiency, moderate renal dysfunction, and elderly patients over 75 years of age (possibly an increase in trimetazidine exposure).

Pregnancy and lactation:

There are no data on the use of trimetazidine in pregnant women. Insufficient data on application in animals.Potential risk of use in pregnant womenNot known. Preparation Trimetazidine MB-Thava should not be used during pregnancy, if there is no obvious need.

It is not known whether trimstazidine is excreted in breast milk, so if it is necessary to administer the drug Trimetazidine MB-Tev during lactation should stop breastfeeding.

In experimental studies, the teratogenic effect of trimetazidine has not been established.

Dosing and Administration:

Inside, during a meal.

1 tablet (35 mg) 2 times a day (morning and evening).

The duration of treatment is determined by the attending physician. The result of treatment is evaluated after three months. If there is no effectiveness of treatment, taking the drug Trimetazidine MB- Yours must be stopped.

Patients with impaired renal function

In patients with mild disruption of the function of the night (QC 30-60 ml / min), the recommended dose is 35 mg (1 tablet) in the morning during breakfast.

Elderly patients

In elderly patients, there may be an increased exposure of trimetazidine due to age-related decline in kidney function. In patients with moderate renal dysfunction (CK 30-60 ml / min), the recommended dose is 35 mg (1 tablet) in the morning during breakfast.

Care should be taken when choosing a dose in elderly patients.

Side effects:

To assess the incidence of side effects, the following criteria were used: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100): rarely (≥1/10000, <1/1000); very rarely (<1/10000), unknown frequency - based on the available data, it is not possible to estimate the frequency.

From the nervous system: often dizziness, headache: unknown frequency - symptoms of parkinsonism (tremor, akinesia, increased muscle tone), gait instability, restless legs syndrome, other symptoms related to motor disorders, usually reversible after discontinuation of treatment, sleep disorder (insomnia, drowsiness).

From the cardiovascular system: rarely - flutter, extrasystole, tachycardia, arterial hypotension, orthostatic hypotension, which can be associated with malaise, dizziness or falling, especially in patients receiving anti-hypertensive medication, "tides" of blood to the face.

From the digestive tract: often - abdominal pain, diarrhea, dyspepsia, nausea, vomiting; unknown frequency - constipation.

From the liver and bile ducts: unknown frequency - hepatitist.

From the skin and subcutaneous fat: often - skin rash, itching, hives; unknown frequency - acute generalized exandark pustulous eruption (AGEP), angioedema.

From the side of the kroen and lymphatic system: unknown frequency - agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

Other: often - asthenia.

Overdose:

There is limited information on the overdose of trimetazidine. In case of an overdose, symptomatic therapy should be given.

Interaction:

Trimetazidine can be used simultaneously with heparin kaltsiparinom, indirect anticoagulant agents, drugs used in violation of lipid metabolism, of salicylic acid, beta-blockers, blockers "slow" calcium channel blockers, cardiac glycosides.

Special instructions:

If you miss one or more medications Trimetazidine MB-This should not take a higher dose to the next dose.

A drug Trimetazidine MB-Tev is not intended for relief of angina attacks, nor is it indicated as an initial treatment for unstable angina or myocardial infarction. It should not be taken before hospitalization and in the first days of hospitalization.

In angina attacks, the pathology of the coronary vessels should be reassessed, and the treatment applied is adjusted (medication and possibly revascularization).

A drug Trimetazidine MB-Tev can cause symptoms of parkinsonism (tremor, akinesia, increased muscle tone) or worsen their course. It is necessary to regularly monitor the condition of patients, especially in old age. In case of doubt, the patient should be referred to a neurologist for an appropriate examination.

The development of motor disorders, such as Parkinson's symptoms, restless leg syndrome, tremor, unsteadiness in walking, can lead to the elimination of trimetazidine.

The frequency of motor disorders is low. Usually it is reversible, it is allowed when the drug is discontinued. In most cases, after stopping the administration of trimetazidine, patients recovered within 4 months.If the symptoms of parkinsonism persist for more than 4 months after drug withdrawal, neurologist consultation is necessary.

With unstable walking or low muscle tone, especially with the use of antihypertensive therapy, the patient may fall.

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

In clinical trials trimetazidine did not demonstrate haemodynamic effects, however, post-marketing experience reported cases of dizziness and drowsiness that could affect the ability to drive vehicles and mechanisms.

Form release / dosage:

Tablets of prolonged action, film-coated, 35 mg.

Packaging:

For 10 tablets in the blister PVC / PVDC / Al-foil.

2, 6 or 12 blisters with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002986

Date of registration:07.05.2015

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

MERCKLE, GmbH Germany

Representation: & nbspTeva Teva Israel

Information update date: & nbsp24.10.2015

Illustrated instructions

Instructions

Trimetazidine MB-Teva (Trimetazidine MV-Teva)