Deprenorm MV tabs 35mg #60

Instruction for Deprenorm MV

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Deprenorm MV is an antihypoxic drug that improves the metabolism of the myocardium and neurosensory organs in ischemic conditions.

Release form and composition

Dosage form of the drug Deprenorm MV - tablets of prolonged action, film-coated:
    dosage 35 mg: round, biconvex, slight surface roughness is allowed, a pink-colored shell and an almost white core stand out in a cross-section (10 pcs. in blister contour packages, in a cardboard box 1, 2, 3 or 6 packages; 30 pcs. . in contoured cell packs, in a cardboard box 1, 2, 3 or 4 packages);
    dosage of 70 mg: round, biconvex, a pink-colored sheath and an almost white-colored core stand out on the cross section (7 pcs. in contoured cell packs, in a cardboard box 2 or 4 packs; 10 pcs. in contour cell packs, in a cardboard box 1, 3 or 6 packs; 14 or 15 pcs. In blister strip packs, in a cardboard box 1, 2 or 4 packs).
Composition of 1 tablet at a dosage of 35 mg:
    active ingredient: trimetazidine dihydrochloride - 35 mg;
    auxiliary components: calcium hydrogen phosphate dihydrate, magnesium stearate, hydroxypropyl cellulose (hyprolose), hydroxypropyl methylcellulose (hypromellose), aerosil (colloidal silicon dioxide), copovidone, microcrystalline cellulose;
    film casing: selecoat AQ-01673 [polyethylene glycol 400 (macrogol 400), hypromellose (hydroxypropyl methylcellulose), macrogol 6000 (polyethylene glycol 6000), aluminum varnish based on crimson dye (ponceau 4R) (E124), titanium dioxide].
Composition of 1 tablet at a dosage of 70 mg:
    active ingredient: trimetazidine dihydrochloride - 70 mg;
    auxiliary components: hydroxypropyl methylcellulose (hypromellose), carbomer, magnesium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, microcrystalline cellulose;
    film casing: pink opadry II [polyethylene glycol (macrogol), polyvinyl alcohol, titanium dioxide, talc, indigo carmine dye, sunset yellow dye, crimson dye (ponceau 4R)].

Pharmacodynamics

The active ingredient of Deprenorm MV is trimetazidine. Thanks to its action, the drug improves myocardial metabolism and exhibits an antihypoxic effect in patients with stable angina pectoris.
By maintaining the energy metabolism of cells in a state of hypoxia, trimetazidine prevents a decrease in the intracellular concentration of adenosine triphosphates (ATP), ensuring the maintenance of cellular homeostasis, normal function of meMVrane ion channels and transmeMVrane transport of sodium and potassium ions.
Slowing down the oxidation of fatty acids due to the selective inhibition by trimetazidine of the enzyme 3-ketoacyl-CoA-thiolase (3-CAT) leads to increased glucose oxidation, accelerated glycolysis with glucose oxidation, and also protects the heart muscle from ischemia. The pharmacological properties of trimetazidine are based on the transfer of energy metabolism to glucose oxidation from fatty acid oxidation.
Experimentally confirmed pharmacodynamic properties of trimetazidine:
    maintenance of energy metabolism of the heart and neurosensory tissues during ischemia;
    a decrease in the severity of intracellular acidosis and the degree of changes in the transmeMVrane ion flow occurring during ischemia;
    decrease in the level of migration and infiltration in reperfusion and ischemic heart tissues of polynuclear neutrophils;
    reducing the size of the damage to the heart muscle;
    lack of direct influence on hemodynamic parameters;
    an increase in coronary reserve in patients with angina pectoris with a delay in the onset of exercise-induced ischemia, starting from the 15th day of therapy;
    limiting fluctuations in blood pressure (BP) caused by physical activity, without significant changes in heart rate (HR);
    reducing the frequency of angina attacks and the need to take short-acting nitroglycerin;
    improvement of the contractile function of the left ventricle in patients with ischemic dysfunction.
In vascular pathology of the eyes, trimetazidine improves the functional activity of the retina.

Pharmacokinetics

The main pharmacokinetic parameters of trimetazidine:
    absorption: after oral administration, trimetazidine is absorbed from the gastrointestinal tract (GIT). The maximum concentration (Cmax) in blood plasma is reached after 5 hours. For more than 24 hours, the level of the substance in the blood plasma exceeds 75% of the value determined 11 hours after taking the tablets. Concomitant food intake does not affect the bioavailability of trimetazidine;
    distribution: steady-state concentration of the drug in the blood (Css) is achieved after 60 hours. The volume of distribution (Vd) is 4.8 l / kg, which demonstrates a good distribution of trimetazidine in tissues. According to in vitro studies, the degree of binding of trimetazidine to blood plasma proteins is low, about 16%;
    elimination: trimetazidine is eliminated mainly by the kidneys, mainly unchanged, its renal clearance directly correlates with creatinine clearance (CC).
With the age of the patient, the hepatic clearance of trimetazidine decreases.

Indications for use

According to the instructions, Deprenorm MV is recommended to be used as part of the complex therapy of coronary heart disease (IHD) to prevent attacks of stable angina pectoris.
Tablets in a dosage of 35 mg are also used for chorioretinal disorders with an ischemic component and cochleo-vestibular disorders of an ischemic nature (tinnitus, dizziness, hearing impairment).

Contraindications

    severe renal failure with CC less than 15 ml / min (35 mg tablets);
    severe renal failure with CC less than 30 ml / min (70 mg tablets);
    severe liver failure (35 mg tablets);
    parkinsonism symptoms, Parkinson's disease, restless legs syndrome (RLS), tremors, other movement disorders associated with them (70 mg tablets);
    period of pregnancy;
    lactation (breastfeeding);
    children and adolescents under 18 years of age;
    increased individual sensitivity to any component of the drug.
With caution, Deprenorm MV tablets at a dosage of 70 mg should be taken in severe hepatic insufficiency (clinical data on safety and efficacy are limited), impaired renal function with a CC of more than 30 ml / min, as well as elderly patients over 75 years old.

Instructions for the use of Deprenorm MV: method and dosage

Deprenorm MV is intended for oral administration. The tablets are taken with meals.
Recommended dosage regimen:
    tablets 35 mg: 1 pc. 2 times a day (in the morning and in the evening);
    tablets 70 mg: 1 pc. 1 time per day, preferably in the morning.
The duration of the course of therapy is determined by the doctor.

Side effects

The frequency of side effects recorded when taking Deprenorm MV is determined in accordance with the gradation of the nuMVer of cases: very often - more than 0.1; often 0.01–0.1; infrequently 0.001–0.01; rarely 0.0001-0.001; extremely rare - less than 0.0001 (including individual messages); frequency unknown - it is impossible to calculate the frequency from the available data.
Adverse reactions from systems and organs when taking tablets at a dosage of 35 mg:
    central nervous system (CNS): often - dizziness, headaches; extremely rarely - extrapyramidal disorders (rigidity, tremor, akinesia), which disappear on their own after discontinuation of the drug;
    cardiovascular system: rarely - flushing of the face, orthostatic hypotension;
    digestive system: often - abdominal pain, dyspepsia, diarrhea, nausea / vomiting;
    hypersensitivity reactions: often - itching, skin rash, urticaria;
    other reactions: often - asthenia.
Adverse reactions from systems and organs when taking tablets at a dosage of 70 mg:
    CNS: often - dizziness, headaches; the frequency is unknown - sleep disorders (drowsiness / insomnia), parkinsonism symptoms (akinesia, tremor, increased tone), instability in the RoMVerg position, unsteadiness of gait, RLS, other movement disorders associated with them, usually disappearing on their own after stopping the course;
    cardiovascular system: rarely - orthostatic hypotension, marked decrease in blood pressure, flushing, extrasystole, palpitations, tachycardia;
    hematopoietic system: frequency is unknown - agranulocytosis, throMVocytopenic purpura, throMVocytopenia;
    digestive system: often - indigestion, abdominal pain, diarrhea, nausea / vomiting; frequency unknown - constipation, hepatitis;
    hypersensitivity reactions: often - itching, skin rash, urticaria; frequency unknown - acute generalized exanthematous pustulosis (OGEP), Quincke's edema;
    other reactions: often - asthenia.

Overdose

Data on trimetazidine overdose are limited.
If an overdose is suspected, symptomatic treatment is recommended.

Special instructions

Deprenorm MV is not intended for the initial course of treatment of unstable angina pectoris or myocardial infarction, for relieving angina attacks, or for admission during preparation for hospitalization or in its early days.
With the development of an attack of angina pectoris, the treatment regimen should be reviewed and adapted to the patient's condition (prescribe additional drug therapy or conduct myocardial revascularization).
Deprenorm MV tablets can cause or worsen the symptoms of parkinsonism (akinesia, tremor, increased tone), and therefore requires regular monitoring of patients, especially the elderly.
The appearance of movement disorders, such as tremors, symptoms of parkinsonism, instability in the RoMVerg position and unsteadiness when walking, restless legs syndrome, requires immediate and final discontinuation of the drug. Such disorders are quite rare and their symptoms usually disappear after stopping therapy on their own in most cases within 4 months after discontinuation of the drug. If the symptoms of parkinsonism persist for more than 4 months from the date of discontinuation of the drug, the patient should seek advice from a neurologist.
In connection with the instability of the patient in the RoMVerg position, unsteadiness of gait or with arterial hypotension, especially in patients taking antihypertensive drugs, there may be cases of falling.

Influence on the ability to drive vehicles and complex mechanisms

Since the development of dizziness and other side effects that affect the speed of psychomotor reactions and the ability to concentrate as a result of therapy with Deprenorm MV, patients should be careful when engaging in potentially hazardous activities, including when driving.

Application during pregnancy and lactation

There are no data on the safety of the use of Deprenorm MV by pregnant women, as well as on the release of trimetazidine or its metabolites in breast milk, and therefore the drug is contraindicated for use during gestation and breastfeeding (lactation).

Childhood use

In pediatric practice, the use of the drug for the treatment of children and adolescents under 18 years of age is contraindicated due to the lack of clinical observation data on its effectiveness and safety in this age group.

With impaired renal function

Tablets Deprenorm MV 35 mg are contraindicated for use in severe renal failure with CC less than 15 ml / min.
Tablets Deprenorm MV 70 mg are prescribed with caution in renal failure with CC more than 30 ml / min; the use of 70 mg tablets with CC less than 30 ml / min is contraindicated.

For violations of liver function

Tablets 35 mg are contraindicated in severe liver dysfunction.
Tablets 70 mg are prescribed with caution in severe hepatic insufficiency due to the limited data of clinical studies.

Use in the elderly

The tablets at a dosage of 70 mg are used with caution in elderly patients over 75 years of age.

Drug interactions

There is no data on the interaction of Deprenorm MV with other medicinal substances / drugs.

Terms and conditions of storage

Store at temperatures up to 25 ° C in a place protected from moisture and light. Keep out of the reach of children.
Shelf life: 35 mg tablets - 3 years; 70 mg tablets - 2 years.

Reviews

According to reviews, Deprenorm MV with stable angina has a positive effect on health. Regular intake of pills improves well-being, reduces the frequency, and in some cases even eliminates the attacks of angina pectoris and increases the threshold of acceptable physical activity. There is no need to use more toxic drugs. It is noted that adverse reactions as a result of therapy are rare.
Doctors remind that Deprenorm MV is not an emergency drug and requires long-term systematic use.

Terms of sell

A prescription is not required to buy Deprenorm MV.