Universal reference book for medicines
Product name: DEPRENORM ® MB (DEPRENORM MR)

Active ingredient: trimetazidine

Type: A drug that improves the metabolism of the myocardium and neurosensory organs under conditions of ischemia

Manufacturer: КАНОНФАРМА ПРОДАКШН (Russia)
Composition, form of production and packaging
Tablets of prolonged action, covered with a film membrane of
pink color, round, biconcave;
on a cross-section of almost white color.
1 tab.

trimetazidine dihydrochloride 70 mg

Excipients: hypromellose (hydroxypropyl methylcellulose) 171 mg, carbomer 2 mg, silicon colloidal dioxide 6 mg, magnesium stearate 3 mg, vegetable hydrogenated water 3 mg, microcrystalline cellulose 195 mg.

The composition of the film shell: opedrai II pink - 15 mg (polyvinyl alcohol - 6 mg, polyethylene glycol (macrogol) - 3.03 mg, talc - 2.22 mg, titanium dioxide - 2.8395 mg, dye sunset yellow 0.381 mg, indigo carmine dye 0.2175 mg, dye crimson (ponso 4R) - 0.312 mg).

7 pcs.
- packings cellular planimetric (2) - packs cardboard.
7 pcs.
- packings cellular planimetric (4) - packs cardboard.
10 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (6) - packs cardboard.
14 pcs.
- packings of cellular contour (1) - packs cardboard.
14 pcs.
- packings cellular planimetric (2) - packs cardboard.
14 pcs.
- packings cellular planimetric (4) - packs cardboard.
15 pcs.
- packings of cellular contour (1) - packs cardboard.
15 pcs.
- packings cellular planimetric (2) - packs cardboard.
15 pcs.
- packings cellular planimetric (4) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

A drug that improves myocardial metabolism.
Has antihypoxic effect.
Trimetazidine prevents a decrease in the intracellular concentration of ATP by maintaining the energy metabolism of cells in a state of hypoxia.
Thus, the drug ensures the normal functioning of membrane ion channels, transmembrane transfer of potassium and sodium ions and preservation of cellular homeostasis.
Trimetazidine slows the oxidation of fatty acids due to selective inhibition of the enzyme 3-ketoacyl-CoA-thiolase (3-CAT), which leads to increased glucose oxidation, glycolysis acceleration with glucose oxidation, and causes myocardial protection from ischemia.
Switching energy metabolism from the oxidation of fatty acids to glucose oxidation underlies the pharmacological properties of trimetazidine.
It has been experimentally confirmed that trimetazidine has the following properties: it supports the energy metabolism of the heart and neurosensory tissues during ischemia;
reduces the intensity of intracellular acidosis and the degree of changes in the transmembrane ion flow that occur with ischemia; reduces the level of migration and infiltration of polynucleated neutrophils in ischemic and reperfusion tissues of the heart; reduces the size of myocardial damage; does not directly affect the parameters of hemodynamics.
In patients with angina, trimetazidine increases the coronary reserve, thereby slowing the onset of ischaemia caused by physical exertion, starting from the 15th day of therapy;
limits blood pressure fluctuations caused by physical activity, without significant changes in heart rate; reduces the incidence of angina attacks and the need for short-acting nitroglycerin; improves the contractile function of the left ventricle in patients with ischemic dysfunction.
PHARMACOKINETICS

Suction

After oral administration, trimetazidine is absorbed from the digestive tract.
C max in blood plasma is reached after approximately 5 hours. For more than 24 hours, the concentration in the blood plasma remains at a level exceeding 75% of the concentration, determined after 11 hours. Food intake does not affect the bioavailability of trimetazidine.
Distribution

C ss is reached after 60 h. V d is 4.8 l / kg, which indicates a good distribution of trimetazidine in tissues.
The degree of binding to blood plasma proteins is quite low (about 16% in vitro).
Excretion

Trimetazidine is excreted mainly by the kidneys, mainly in unchanged form.
The renal clearance of trimetazidine directly correlates with QC.
Pharmacokinetics in special clinical cases

Hepatic clearance decreases with the age of the patient.

INDICATIONS

- IHD: prevention of attacks of stable angina pectoris (as part of a combination therapy).

DOSING MODE

The drug is taken orally, with food.

The recommended dose is 1 tablet.
(70 mg) 1 time / day, preferably in the morning.
The duration of the course of treatment is determined by the doctor.

SIDE EFFECT

The frequency of side effects noted when taking trimetazidine is given in the following gradation: very often (> 1/10);
often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10 000, <1/1000); very rarely (<1/10 000, including individual reports); frequency (frequency can not be calculated from available data).
From the side of the central nervous system: often - dizziness, headache;
unspecified frequency - sleep disturbances (insomnia, drowsiness), symptoms of parkinsonism (tremor, akinesia, tone increase), instability in Romberg's posture and gait unsteadiness, restless leg syndrome, other associated motor disorders, usually reversible after cessation of therapy .
From the cardiovascular system: rarely - orthostatic hypotension, "tides" of blood to the skin of the face, a feeling of palpitations, extrasystole, tachycardia, marked decrease in blood pressure.

On the part of the hematopoiesis system: unspecified frequency - agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

From the digestive system: often - abdominal pain, diarrhea, dyspepsia, nausea, vomiting;
Unspecified frequency - constipation, hepatitis.
Allergic reactions: often - skin rash, itching, urticaria;
Unspecified frequency - acute generalized exanthematous pustulosis, angioedema.
Other: often - asthenia.

CONTRAINDICATIONS

- renal failure of severe degree (QC less than 30 ml / min);

- Parkinson's disease, symptoms of parkinsonism, tremor, restless legs syndrome and other associated motor disorders;

- Pregnancy;

- the period of lactation (breastfeeding);

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

- Hypersensitivity to any of the components of the drug.

Caution should be given to patients with severe hepatic impairment (limited clinical data), impaired renal function (QC greater than 30 mL / min), age over 75 years.

PREGNANCY AND LACTATION

Data on the use of the drug Deprenorm ® MB in pregnant women are absent.
Experimental studies in animals showed no direct or indirect reproductive toxicity.Studies have shown no effect of trimetazidine on reproductive function in rats of both sexes. The drug is contraindicated in pregnancy due to the lack of clinical data on the safety of its use.
Data on the release of trimetazidine or its metabolites with breast milk are not available.
The risk to a newborn / child can not be ruled out. Do not use Deprenorm ®CF during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER

With adiposity, the drug should be given to patients with impaired renal function (QC more than 30 ml / min).

The use of the drug in patients with severe renal insufficiency (CC less than 30 ml / min) is contraindicated.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With the severity of the drug should be prescribed for patients with severe hepatic insufficiency (clinical data are limited).

APPLICATION FOR CHILDREN

The use of the drug in children and adolescents under the age of 18 is contraindicated.

APPLICATION IN ELDERLY PATIENTS

Caution should be used in patients aged over 75 years.

SPECIAL INSTRUCTIONS

Deprenorm® MF is not intended to stop angina attacks, for an initial course of therapy for unstable angina or myocardial infarction, or when preparing for hospitalization or in the first days.

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

The drug can cause or worsen symptoms of parkinsonism (tremor, akinesia, tone increase), therefore, regular monitoring of patients, especially the elderly, should be carried out.

When motor disorders such as Parkinsonism symptoms, restless legs syndrome, tremor, Romberg pose instability and gait unsteadiness occur, Deprenorm® CF preparation should be finally abolished.
Such cases are rare and symptoms usually go away after discontinuation of therapy, in most patients for 4 months after drug discontinuation. If the symptoms of parkinsonism persist for more than 4 months after the drug is discontinued, the patient should consult a neurologist.
There may be cases of falls associated with instability in the Romberg pose and "gait" gait or arterial hypotension, especially in patients taking antihypertensive drugs.

Impact on the ability to drive vehicles and manage mechanisms

In connection with the possible development of dizziness and other side effects with the use of the drug Deprenorm® CF, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

OVERDOSE

There is only limited information on the overdose of trimetazidine.

Treatment: In case of overdose, symptomatic therapy should be given.

DRUG INTERACTION

There are no data on the interaction of the drug with other drugs.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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