Antisten MV tablets 35mg, No. 60

• IHD: prevention of angina attacks (in combination therapy);

• cochleovestibular disorders of an ischemic nature, such as dizziness, tinnitus, hearing impairment;

• choreoretinal vascular disorders.

Inside, during meals.

Antisten MV is prescribed 1 tab. 2 times / day (morning and evening). The course of treatment is determined by the doctor individually.

Sustained-release tablets, film-coated, creamy pink, biconvex; the cross section shows two layers, the inner layer (core) is white or white with a yellowish tinge.

1 tab. trimetazidine dihydrochloride 35 mg

Excipients : hypromellose - 93 mg, microcrystalline cellulose - 178.9 mg, colloidal silicon dioxide - 1.55 mg, magnesium stearate - 1.55 mg.

The composition of the film shell: opadry II 85F240012 Pink (polyvinyl alcohol - 4 mg, macrogol 3350 - 2.438 mg, iron oxide red oxide - 0.04 mg, iron oxide yellow oxide - 0.022 mg, talc - 1.48 mg, titanium dioxide - 2.02 mg).

• hypersensitivity to any component of the drug;

• renal failure (CC less than 15 ml / min);

• severe liver dysfunction;

• age up to 18 years (efficacy and safety have not been established).

Release form, packaging and composition of the drug Antisten MV

Sustained-release tablets, film-coated, creamy pink, biconvex; the cross section shows two layers, the inner layer (core) is white or white with a yellowish tinge.

1 tab. trimetazidine dihydrochloride 35 mg

Excipients : hypromellose - 93 mg, microcrystalline cellulose - 178.9 mg, colloidal silicon dioxide - 1.55 mg, magnesium stearate - 1.55 mg.

The composition of the film shell: opadry II 85F240012 Pink (polyvinyl alcohol - 4 mg, macrogol 3350 - 2.438 mg, iron oxide red oxide - 0.04 mg, iron oxide yellow oxide - 0.022 mg, talc - 1.48 mg, titanium dioxide - 2.02 mg).

Clinical and pharmacological group: A drug that improves the metabolism of the myocardium and neurosensory organs in ischemic conditions

Pharmaco-therapeutic group: Antihypoxic agent

pharmachologic effect

Has antihypoxic effect. By directly affecting the cardiomyocytes and neurons of the brain, the drug optimizes their metabolism and function. The cytoprotective effect is due to an increase in energy potential, activation of oxidative decarboxylation and rationalization of oxygen consumption (increased glycolysis and blockade of fatty acid oxidation).

Trimetazidine maintains myocardial contractility, prevents a decrease in the intracellular content of ATP and phosphocreatinine. Under conditions of acidosis, it normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium ions in cardiomyocytes, and normalizes the intracellular content of potassium ions.

Reduces intracellular acidosis and increased phosphate levels caused by myocardial ischemia and reperfusion. It prevents the damaging action of free radicals, preserves the integrity of cell membranes, prevents the activation of neutrophils in the ischemic zone, increases the duration of the electric potential, reduces the release of CPK from cells and the severity of ischemic damage to the myocardium.

Trimetazidine reduces the frequency of angina attacks, reduces the need to take nitrates, after 2 weeks of admission it increases exercise tolerance, and sharp fluctuations in blood pressure decrease. Reduces dizziness and tinnitus of ischemic etiology. In case of vascular pathology of the eye, it restores the functional activity of the retina.

Pharmacokinetics

Absorption and distribution

After taking the drug inside, trimetazidine is rapidly and almost completely absorbed in the gastrointestinal tract. Bioavailability is 90%. The time to reach Cmax in blood plasma is 3-5 hours. The equilibrium state is reached after 60 hours. Vd is 4.8 l / kg. Plasma protein binding - 16%. Easily penetrates histohematogenous barriers.

Withdrawal

Trimetazidine is excreted from the body mainly by the kidneys (about 60% - unchanged). T1 / 2 about 7 hours

Pharmacokinetics in special clinical situations

T1 / 2 in patients over 65 years of age - about 12 hours. Renal clearance of trimetazidine directly correlates with CC, hepatic clearance decreases with age.

Indications of the drug Antisten MV

• IHD: prevention of angina attacks (in combination therapy);

• cochleovestibular disorders of an ischemic nature, such as dizziness, tinnitus, hearing impairment;

• choreoretinal vascular disorders.

Dosage regimen

Inside, during meals.

Antisten MV is prescribed 1 tab. 2 times / day (morning and evening). The course of treatment is determined by the doctor individually.

Side effect

Frequency: very often - more than 1/10; often - more than 1/100 and less than 1/10; infrequently - more than 1/1000 and less than 1/100; rarely - more than 1/10000 and less than 1/1000; very rarely - less than 1/100000, including individual messages.

From the digestive system: often - abdominal pain, diarrhea, dyspepsia, nausea, vomiting.

From the side of the cardiovascular system: rarely - orthostatic hypotension, hot flashes to the skin of the face.

From the side of the central nervous system: often - dizziness, headache; very rarely - extrapyramidal disorders (tremor, rigidity, akinesia), reversible after drug withdrawal.

Dermatological reactions: often - skin rash, itching, urticaria.

Others: often - asthenia.

Contraindications for use

• hypersensitivity to any component of the drug;

• renal failure (CC less than 15 ml / min);

• severe liver dysfunction;

• age up to 18 years (efficacy and safety have not been established).

Application during pregnancy and lactation

Animal studies have not revealed a teratogenic effect, however, due to the lack of clinical data on the safety of the drug during pregnancy, the risk of fetal malformations cannot be excluded. Use during pregnancy is contraindicated.

It is not known whether Antisten MV is excreted in breast milk. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be resolved.

Application for violations of liver function

Contraindication: severe liver dysfunction.

Application for impaired renal function

Contraindication: renal failure (CC less than 15 ml / min).

Application in children

Contraindication: age up to 18 years (efficacy and safety have not been established).

Use in elderly patients

T1 / 2 in patients over 65 years old - about 12 hours.

special instructions

Do not use to relieve angina attacks!

The drug is not indicated for the initial course of therapy for unstable angina pectoris or myocardial infarction.

In the event of an attack of angina pectoris, treatment should be reviewed and adapted.

If you miss one or more doses of the drug, you should not take a higher dose in the next dose.

Influence on the ability to drive vehicles and use mechanisms

The drug Antisten MV does not significantly affect the ability to drive vehicles and perform other work requiring a high speed of psychomotor reactions.

Overdose

Currently, no cases of drug overdose have been reported.

Drug interactions

There is no information on the drug interaction of the drug.

Storage conditions of the drug Antisten MV

The drug should be stored in a dry, dark place, out of reach of children, at a temperature not exceeding 25 ? C.

Shelf life of the drug Antisten MV

Shelf life is 3 years. Do not use after the expiration date.

Terms of sale

The drug is available with a prescription.