Deprenorm mV Table n / a film about prolong. 70 mg 30 pcs

Description

Composition
Active substance:
1 tablet contains: 70 mg of trimetazidine dihydrochloride ;.
Excipients:
Hypromellose (hydroxypropyl methylcellulose) 171 mg; 2 mg carbomer; Colloidal silica 6 mg; Magnesium stearate 3 mg; Hydrogenated vegetable oil 3 mg; microcrystalline cellulose 195 mg; composition of the film coating: Opadry II pink 15mg, including: polyvinyl alcohol 6mg, polyethylene glycol (macrogol) 3.03 mg talc 2.22 mg, 2.8395 mg of titanium dioxide, dye sunset yellow 0.381 mg, indigo dye 0.2175 mg carmine dye [Ponceau 4R] 0,312 mg.
Description:
The tablets are round, biconvex, film-coated pink. The cross sectional almost white color.
Product form:
Prolonged action tablets, film-coated, 70 mg.
At 7, 10, 14 or 15 tablets in blisters of PVC film and aluminum foil printed patent.
At 2, 4 blisters of 7 tablets or 1, 3, 6 contour cell packs of 10 pills, or 1, 2, 4 blisters 14 pills, or 1, 2, 4 blisters 15 tablets together with instructions for use placed in a pile of cardboard.
Contraindications
– hypersensitivity to any component of the drug; – severe renal impairment (creatinine clearance less than 30 mL / min); – Parkinson’s disease, parkinsonism, tremor, a syndrome of “restless” legs and other related movement disorders. – pregnancy; – the period of breast-feeding; – the age of 18 years (effectiveness and safety have been established).
Precautions: Patients with severe hepatic insufficiency (clinical data are limited); Patients with impaired renal function (creatinine clearance of 30 ml / min.); Patients older than 75 years.
Dosage
70 mg
Indications
Ischemic heart disease: prevention of attacks of stable angina (in combination therapy).
Interaction with other drugs
Data on the interaction with other drugs is not.
Overdose
There is only limited information on the overdose of trimetazidine. In the case of an overdose should be symptomatic therapy.
pharmachologic effect
Pharmacological group:
Antihypoxanth means.
Pharmacodynamics:
It provides anti-hypoxic action. Trimetazidine prevents a decrease in the intracellular concentration of adenosine triphosphate (ATP) by maintaining the energy metabolism of the cells in a state of hypoxia. Thus, the preparation ensures normal functioning of membrane ion channels, transmembrane transport of potassium ions and sodium and maintaining cellular homeostasis.
Trimetazidine inhibits oxidation of fatty acids due to selective inhibition of the enzyme 3-ketoacyl-CoA thiolase (3-KAT) mitochondrial isoform long chain fatty acids, which leads to increased oxidation of glucose and acceleration of glycolysis to glucose oxidation, which is responsible for protecting the myocardium from ischemia. Switching energy metabolism from fatty acid oxidation to glucose oxidation is based on the pharmacological properties of trimetazidine.
Experimentally confirmed that trimetazidine has the following properties: -supports energy metabolism of the heart and neurosensory tissues during ischemia; It reduces the severity of intracellular acidosis and changes of transmembrane ion flux arising during ischemia; -ponizhaet level of migration and infiltration of polynuclear neutrophils in ischemic and reperfused heart tissue; It reduces the size of myocardial injury; It does not have a direct impact on the hemodynamic parameters.
In patients with angina, trimetazidine: -uvelichivaet coronary flow reserve, thereby delaying the onset of ischemia, exercise-induced, starting from the 15th day of treatment; -ogranichivaet fluctuation of blood pressure caused by physical activity, without significant changes in heart rate; -Reduces frequency of angina attacks and the need for short-acting nitroglycerin; -improves contractile function of the left ventricle in patients with coronary dysfunction.
Pharmacokinetics:
After oral administration of trimetazidine absorbed from the gastrointestinal tract, and reaches a maximum concentration in plasma after about 5 hours. Over 24 hours the concentration in the blood plasma remains at levels above 75% concentration, determined by 11 hours. The equilibrium state is reached after 60 hours. Eating does not affect the bioavailability of trimetazidine.
The volume of distribution of 4.8 l / kg, indicating that the trimetazidine good tissue distribution (the degree of binding to plasma proteins is quite low, about 16% in vitro).
Trimetazidine displayed in the kidney primarily in the unchanged form.
Renal clearance of trimetazidine is directly correlated with creatinine clearance (CC), hepatic clearance decreases with patient age.
Pregnancy and breast-feeding
Data on the use of the drug in pregnant Deprenorm® MB available. Animal studies have not revealed the presence of the direct or indirect reproduction toxicity. Reproductive toxicity studies showed no effect of trimetazidine on reproductive function in rats of both sexes. The drug is contraindicated in pregnancy because of the lack of clinical data on the safety of its use.
Data on the allocation of trimetazidine or its metabolites in breast milk are not available. Risk can not be ruled out for the infant / child. You should not use the drug Deprenorm® MW during breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
The frequency of adverse effects reported when receiving trimetazidine, refer to the following gradation: very often (1/10); frequently (more than 1/100, less than 1/10); infrequently (more than 1/1000, 1/100 less); slowly (over 1/10000, 1/1000 less); very rare (less than 1/10000, including isolated reports); unspecified frequency (frequency can not be calculated from the available data).
On the part of the central nervous system
Common: dizziness, headache.
Unspecified frequency: the symptoms of parkinsonism (tremor, akinesia, body toning), instability in the Romberg and “precariousness” gait, the syndrome of “restless” legs, other related movement disorders, usually reversible upon discontinuation of therapy. sleep disorders (insomnia, somnolence).
Cardio-vascular system
Rare: Orthostatic hypotension, “tides” of blood to the facial skin, palpitations, arrythmia, tachycardia, marked reduction in blood pressure.
On the part of the circulatory and lymphatic system
Unspecified frequency: agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
From the digestive system
Common: abdominal pain, diarrhea, dyspepsia, nausea, vomiting.
Unspecified frequency: constipation.
Liver and Biliary
Unspecified frequency: hepatitis.
For the skin
Common: skin rash, pruritus, urticaria.
Unspecified frequency acute generalized exanthematous pustulosis, angioedema.
General disorders
Common: asthenia.
special instructions
Deprenorm® MB is not intended for the relief of angina attacks, for the initial course of therapy of unstable angina or myocardial infarction, as well as in preparation for hospitalization or in its first days.
In the case of angina attack should review and adapt the treatment (drug therapy or revascularization).
The drug can cause or worsen the symptoms of parkinsonism (tremor, akinesia, body toning), therefore it is necessary to carry out regular monitoring of patients, particularly the elderly.
When the movement disorders such as parkinsonism symptoms, a syndrome of “restless” legs, tremors, instability in the Romberg and “precariousness” gait, Deprenorm® CF drug should be completely abolished.
Such cases are rare, and symptoms usually resolve after discontinuation of therapy, most patients within 4 months after discontinuation of the drug. If parkinsonian symptoms persist for more than 4 months after discontinuation of the drug should consult a neurologist.
Cases may occur drop associated with instability in Romberg and “unsteadiness” gait or hypotension, especially in patients taking antihypertensive drugs (see. the section “Side effect”).
The effect on the ability to drive vehicles and carry out work requiring high speed psychomotor reactions
In connection with the possible development of dizziness and other side effects when using the drug Deprenorm® MB Caution should be exercised when driving and busy with other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside, during a meal time.
Deprenorm® MB take 1 tablet of 70 mg 1 time per day (in the morning). The course of treatment – on the advice of a doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist