Deprenorm CF, 35 mg 60 pcs

Antianginal drug that improves myocardial metabolism.

It has antihypoxic and antianginal action. It directly improves metabolism and function of cardiomyocytes and brain neurons. Cytoprotective effect is due to increased energy potential, activation of oxidative decarboxylation and rationalization of oxygen consumption (by enhancing aerobic glycolysis and inhibition of fatty acid oxidation). Maintains normal myocardial contractility, prevents intracellular depletion of ATP and creatine phosphate.

Under acidosis it normalizes membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, and normalizes intracellular potassium ions. Reduces intracellular acidosis and phosphate content caused by myocardial ischemia and reperfusion. Prevents damaging effects of free radicals, maintains the integrity of cell membranes, increases the duration of electrical potential, prevents the activation of neutrophils in the ischemic zone, reduces the output of CPK from cells and the severity of ischemic myocardial damage. With angina reduces the frequency of attacks and reduces the need for nitrates.

In 2 weeks of treatment the tolerance to exercise increases, BP fluctuations decrease. Against the background of using the drug, hearing and the results of vestibular tests improve, dizziness and tinnitus decrease. In case of vascular eye pathology, the functional state of the retina improves.

Indications

IHD: prevention of angina attacks (as part of complex therapy);
chorioretinal vascular disorders;
dizziness of vascular origin;
cochleo-vestibular disorders of ischemic nature (tinnitus, hearing impairment).

Pharmacological effect

Antianginal drug that improves myocardial metabolism.

Has antihypoxic and antianginal effects. Directly improves the metabolism and function of cardiomyocytes and neurons in the brain. The cytoprotective effect is due to an increase in energy potential, activation of oxidative decarboxylation and rationalization of oxygen consumption (due to increased aerobic glycolysis and inhibition of fatty acid oxidation). Maintains normal myocardial contractility, prevents intracellular depletion of ATP and creatine phosphate.

In conditions of acidosis, it normalizes the state of membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, and normalizes the intracellular content of potassium ions. Reduces intracellular acidosis and phosphate content caused by myocardial ischemia and reperfusion. Prevents the damaging effects of free radicals, preserves the integrity of cell membranes, increases the duration of the electrical potential, prevents the activation of neutrophils in the ischemic zone, reduces the release of CPK from cells and the severity of ischemic damage to the myocardium. For angina pectoris, it reduces the frequency of attacks and reduces the need for nitrates.

After 2 weeks of treatment, exercise tolerance increases and blood pressure changes decrease. With the use of the drug, hearing and the results of vestibular tests improve, dizziness and tinnitus decrease. In case of vascular pathology of the eyes, the functional state of the retina improves.

Special instructions

Deprenorm® MB is not intended for the relief of angina attacks, for the initial course of treatment of unstable angina or myocardial infarction, as well as in preparation for hospitalization or in its first days.

If an attack of angina occurs, treatment (drug therapy or revascularization) should be reviewed and adapted.

The drug may cause or worsen symptoms of parkinsonism (tremor, akinesia, increased tone), so patients should be regularly monitored, especially the elderly. If movement disorders appear, such as symptoms of parkinsonism, restless legs syndrome, tremor, instability in the Romberg position and unsteadiness of gait, the drug Deprenorm® MB should be permanently discontinued.

Such cases are rare and symptoms usually resolve after discontinuation of therapy, in most patients within 4 months after discontinuation of the drug. If symptoms of parkinsonism persist more than 4 months after discontinuation of the drug, you should consult a neurologist. Falls associated with unsteadiness in the Romberg position and unsteady gait or arterial hypotension may occur, especially in patients taking antihypertensive drugs (see section “Side effects”).

Impact on the ability to drive vehicles and other mechanisms that require increased concentration

Due to the possible development of dizziness and other side effects when using the drug Deprenorm® MB, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Trimetazidine

Composition

1 extended-release film-coated tablet contains:

Active ingredient:

trimetazidine dihydrochloride 35 mg.

Excipients:

calcium hydrogen phosphate dihydrate,

microcrystalline cellulose,

colloidal silicon dioxide (Aerosil),

Hydroxypropyl cellulose Klucel LF,

hydroxypropyl methylcellulose,

Plasdon S-630,

magnesium stearate.

Film shell composition:

Selekote (hydroxypropyl methylcellulose, plasdon S-630, polyethylene glycol, talc, red iron oxide, titanium dioxide).

The blister contains 15 tablets. There are 4 blisters in a cardboard package.

Pregnancy

There are no data on the use of Deprenorm® MB in pregnant women. Animal studies have not shown any direct or indirect reproductive toxicity. Reproductive toxicity studies have shown no effect of trimetazidine on reproductive function in rats of either sex. The drug is contraindicated during pregnancy due to the lack of clinical data on the safety of its use.

There are no data on the excretion of trimetazidine or its metabolites into breast milk. Risk to the newborn/child cannot be excluded. Deprenorm® MB should not be used during breastfeeding.

Contraindications

renal failure (creatinine clearance < 15 ml/min); severe liver dysfunction; children and adolescents under 18 years of age (efficacy and safety have not been established); pregnancy; lactation (breastfeeding); hypersensitivity to the components of the drug.

Side Effects

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

very often (more than 1/10);
often (more than 1/100, less than 1/10);
uncommon (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 “wobbly” gait, restless legs syndrome, and other associated motor disorders, usually reversible after cessation of therapy. Sleep disorders (insomnia, drowsiness).

From the cardiovascular system: rarely – orthostatic hypotension, “flushes” of blood to the skin of the face, palpitations, 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.

From the liver and biliary tract: unspecified frequency – hepatitis.

From the skin: often – skin rash, itching, urticaria. Unspecified frequency – acute generalized exanthematous pustulosis, Quincke’s edema.

General disorders: often – asthenia.

Interaction

There are no data on interactions with other drugs.

Overdose

There is only limited information on trimetazidine overdose.

In case of overdose, symptomatic therapy should be carried out.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Manufacturer

Kanonpharma production CJSC, Russia