Trimetazidine MB-Teva sustained release pills 35mg 60pcs

Composition

1 tablet of prolonged action, film-coated, contains:

Active ingredient: trimetazidine dihydrochloride 35 mg.

Auxiliary substances:

calcium hydrophosphate dihydrate,

microcrystalline cellulose,

colloidal silicon dioxide (aerosil),

hydroxypropylcellulose Klucel LF,

hydroxypropylmethylcellulose,

plasdon S-630,

magnesium stearate.

Composition of the film shell:

Selekout (hydroxypropylmethylcellulose, plasdon S-630, polyethylene glycol, talc, iron oxide red, titanium dioxide).

Pharmacological action

Antihypoxic agentath:

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

C. 01. E. B. 15 Trimetazidine

Pharmacodynamics :

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

Trimetazidine inhibits beta-oxidation of fatty acids by blocking long-chain 3-ketoacyl CoA thiolase, which increases glucose oxidation. A cell in a state of ischemia requires less oxygen to produce energy during the oxidation of glucose than during the beta-oxidation of fatty acids. Potentiation of glucose oxidation optimizes the cellular processes of energy production, thereby maintaining the correct energy metabolism of the cell during ischemia.

In patients with coronary artery disease, trimetazidine acts as a metabolic agent, preserving sufficient intracellular activity of high-energy phosphates in the myocardium. The anti-ischemic effect is achieved without affecting hemodynamics. Pharmacokinetics: When taken orally, trimetazidine is rapidly absorbed in the gastrointestinal tract (GIT) and reaches its maximum plasma concentration in an average of 5 hours. For more than 24 hours, the concentration of trimetazidine in blood plasma is maintained at concentrations exceeding or equal to 75% of the maximum concentration determined within 11 hours.

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

Trimetazidine is mainly excreted by the kidneys, mainly in unchanged form. When taken orally at a dose of 35 mg, the half-life in young healthy volunteers averages 7 hours, in patients over 65 years of age – 12 hours.

Total renal clearance of trimetazidine is directly correlated with creatinine clearance (CC). hepatic clearance decreases with age.

In elderly patients, when taking a daily dose of 2 tablets in 2 divided 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 to first-line antianginal therapy in adult patients (as an additional therapy).

Use during pregnancy and lactation

There are no data on the use of trimetazidine in pregnant women. There are insufficient data on animal use. The potential risk of use in pregnant women is well known. Trimetazidine MB-Teva should not be used during pregnancy unless it is clearly necessary.

It is not known whether trimstazidine is excreted in breast milk, so if necessary, use the drug Trimetazidine MB-Teva should be discontinued during lactation.

The teratogenic effect of trimetazidine has not been established in experimental studies.

Contraindications

-hypersensitivity to trimetazidine and other components of the drug;

– severe renal failure (creatinine clearance less than 30 ml / min);

– Parkinson’s disease, Parkinsonism symptoms, tremor, restless legs syndrome and other symptoms associated with movement disorders:

– children under 18 years of age (efficacy and safety have not been established).

With caution:

Severe hepatic insufficiency, moderate renal impairment, and elderly patients over 75 years of age (possibly increased exposure to trimetazidine).

Side effects

The frequency of side effects reported when taking trimetazidine is given in the following gradation:

• very common (more than 1/10);
• common (more than 1/100, less than 1/10);
• infrequent (more than 1/1000, less than 1/100);
• rare (more than 1/10000, less than 1/1000);
• very rare (less than 1/10000, including individual messages);
• unspecified frequency (frequency cannot be calculated from available data).

From the central nervous system: often – dizziness, headache. Unspecified frequency – symptoms of Parkinsonism (tremor, akinesia, increased tone), instability in the Romberg position and “shaky” gait, restless legs syndrome, and other associated motor disorders, usually reversible after discontinuation of therapy. Sleep disorders (insomnia, drowsiness).

From the cardiovascular system: rarely-orthostatic hypotension, “flushes” of blood to the skin of the face, palpitation, extrasystole, tachycardia, marked decrease in blood pressure.

From the circulatory and lymphatic system: unspecified frequency-agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

From the digestive system: often – abdominal pain, diarrhea, dyspepsia, nausea, vomiting. Unspecified frequency-constipation.

Liver and biliary tract disorders: unspecified frequency – hepatitis.

From the side of the skin: often – skin rash, pruritus, urticaria. Unspecified frequency – acute generalized exanthematous pustulosis, angioedema.

General violations: often-asthenia.

Interaction

Trimetazidine can be used simultaneously with heparin, calciparin, indirect anticoagulants, drugs used for lipid metabolism disorders, salicylic acid, beta-blockers, slow calcium channel blockers, cardiac glycosides.

How to take, course of use and dosage

Inside, during a meal.

Take 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. In the absence of effective treatment, taking the drug Trimetazidine MB-Teva should be discontinued.

Patients with impaired renal function

In patients with moderate renal impairment (creatinine clearance 30-60 ml / min), the recommended dose is 35 mg (1 tablet) in the morning with breakfast.

Elderly patients

Elderly patients may experience increased exposure to trimetazidine due to age-related decline in renal function. In patients with moderate renal impairment (creatinine clearance 30-60 ml / min), the recommended dose is 35 mg (1 tablet) in the morning with breakfast.

Caution should be exercised when selecting the dose in elderly patients.

Overdose

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

Special instructions

If you miss one or more doses of the drug Trimetazidine MB-Teva should not be taken at the next higher dose. Medication Trimetazidine MB-Teva is not intended for the 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 during the first days of hospitalization.

In the event of an angina attack, the pathology of the coronary vessels should be re-evaluated, and the treatment used should be adjusted (drug treatment, etc. ). possibly revascularization).

Medication Trimetazidine MB-Teva may cause symptoms of Parkinsonism (tremor, akinesia, increased muscle tone) or worsen their course. Patients should be monitored regularly, especially in the elderly. In case of doubt, the patient should be referred to a neurologist for an appropriate examination.

The development of motor disorders, such as Parkinsonism symptoms, restless legs syndrome, tremor, unsteadiness when walking, can lead to the withdrawal of trimetazidine.

The frequency of motor disorders is low. It is usually reversible and resolves upon discontinuation of the drug. In most cases, patients recovered within 4 months after discontinuation of trimetazidine. If the symptoms of parkinsonism persist for more than 4 months after discontinuation of the drug, a neurologist should be consulted.

If you walk unsteadily or have low muscle tone, especially when using antihypertensive therapy, the patient may fall.

Effects on the ability to drive vehicles and vehicles: In clinical studies, trimetazidine has not demonstrated hemodynamic effects, but in post-marketing experience, cases of dizziness and drowsiness have been reported, which may affect the ability to drive vehicles and mechanisms.

Form of production

Long-acting film-coated tablets,35 mg.

Storage conditions

 In a dry place, protected from light, at a temperature not exceeding +25 ° C, in places inaccessible to children.

Shelf life

2 years

Active ingredient

Trimetazidine

Conditions of release from pharmacies

By prescription

Dosage form

long-acting tablets

Purpose

For adults as directed by your doctor

Indications

Angina, Vascular diseases of the eyes