Mildronate, 500 mg capsules 60 pcs

Meldonium is a synthetic analogue of gamma-butyrobetaine, a substance found in every cell of the human body. It inhibits gamma-butyrobetaine hydroxinase, reduces the synthesis of carnitine and transport of long-chain fatty acids through cell membranes, prevents the accumulation of activated forms of non-oxidized fatty acids in cells – derivatives of acylcarnitine and acylcoenzyme A.

Cardioprotective agent that normalizes myocardial metabolism. Under the conditions of ischemia Meldonium restores equilibrium between the processes of oxygen delivery and its consumption in cells, prevents violation of adenosine triphosphate (ATP) transport; simultaneously it activates glycolysis which proceeds without additional oxygen consumption. As a result of a decrease in the concentration of carnitine, gamma-butyrobetaine, which has vasodilatory properties, is synthesized intensively. The mechanism of action determines the diversity of its pharmacological effects: increase of work capacity, reduction of symptoms of mental and physical overexertion, activation of tissue and humoral immunity, cardioprotective effect.

In case of acute ischemic myocardial injury, meldonium slows down the formation of the necrotic zone and shortens the rehabilitation period.

In cases of heart failure, it increases myocardial contractility, increases exercise tolerance, and decreases the frequency of angina attacks. In acute and chronic ischemic disorders of cerebral circulation, it improves blood circulation in the focus of ischemia and promotes redistribution of blood in favor of the ischemic area.

It is effective in cases of vascular and dystrophic pathology of the fundus vessels.

The tonic effect on the central nervous system, elimination of functional disorders of the somatic and vegetative nervous system in patients with chronic alcoholism with withdrawal syndrome is also characteristic.

Pharmacological action

Pharmacological action

Cardioprotective agent which normalizes myocardial metabolism and has vasodilator properties.

Pharmacokinetics

Meldonium is rapidly absorbed after oral administration with a bioavailability of 78%. Time of reaching maximum concentration in blood plasma – 1 to 2 hours after ingestion. It is metabolized mainly in the liver to form two major metabolites, which are eliminated by the kidneys. Period of half-life (T1/2) when taken orally depends on the dose, is 3 – 6 hours.

Indications

Myocardial infarction, Stenocardia, Stroke aftermath, Intense physical activity, Low performance, Heart failure, Weakness and fatigue, Hangover In complex therapy of ischemic heart disease (angina, myocardial infarction), chronic heart failure and dyshormonal cardiomyopathy, and in complex therapy of subacute and chronic brain blood supply disorders (after stroke, cerebrovascular failure).
Reduced performance; mental and physical overload (including in athletes).
Withdrawal syndrome in chronic alcoholism (in combination with specific therapy).

Active ingredient

Meldonium

Composition

1 capsulemeldonium dihydrate500 mg

Ancillary substances:

Potato starch – 27.2 mg,

colloidal silicon dioxide – 10.8 mg,

calcium stearate – 5.4 mg.

Capsule shell composition:

titanium dioxide (E171) – 2%,

gelatin – 98%.

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How to take, the dosage

In connection with the possibility of development of excitatory effect the drug is recommended to be used in the morning and not later than 17.00 (when taking several times a day).

In CHD (angina pectoris, myocardial infarction), chronic heart failure in complex therapy the drug is prescribed orally in dose of 0.5-1 g/day, frequency of use 1-2 times/day. The course of treatment is 4-6 weeks.

In case of dyshormonal cardiomyopathy Mildronate in complex therapy is prescribed orally in dose of 500 mg/day. The course of treatment is 12 days.

In case of subacute cerebrovascular disorders (stroke and cerebrovascular failure) after the end of the course of injection therapy with the preparation Mildronate is still taken as part of complex therapy orally in 0.5-1 g/day with a single dose or by dividing it into 2 doses. The course of treatment is 4-6 weeks.

In chronic disorders of cerebral circulation the drug is taken as part of complex therapy orally at 0.5 g/day. The total course of therapy is 4-6 weeks. The repeated courses are possible after consulting the doctor (usually 2-3 times a year).

With reduced performance, mental and physical stress (including athletes) is prescribed orally at 500 mg 2 times a day. The course of treatment is 10-14 days. If necessary the therapy is repeated in 2-3 weeks.

In athletes it is recommended to use 0.5-1 g 2 times a day before training. The course duration is 14-21 days during the preparatory period and 10-14 days during the competition period.

In case of withdrawal syndrome in chronic alcoholism (in combination with specific alcohol therapy) the drug is prescribed orally 500 mg 4 times a day. The course of treatment is 7-10 days.

Interaction

Mildronate enhances the effect of coronadilators, some hypotensive drugs, cardiac glycosides.

Mildronate may be combined with prolonged forms of nitrates, other antianginal drugs, anticoagulants and antiaggregants, antiarrhythmic agents, diuretics and bronchodilators.

Because of the possible development of tachycardia and arterial hypotension, caution should be exercised when combining with nitroglycerin (for sublingual use) and antihypertensive agents (especially alpha-adrenoblockers and short-acting forms of nifedipine).

Special Instructions

Patients with chronic liver and kidney disease should use the drug with caution over long term.

Pediatric use

There are insufficient data on the use of Mildronate in children and adolescents under 18 years of age.

Influence on driving and operating ability

There are no data on adverse effects of Mildronate on driving and operating ability.

Synopsis

Mildronate® is an original metabolic corrector with dual mechanism of action, for patients with cardiovascular diseases, providing multifactorial protection of organs and tissues.
Mildronate® increases myocardial contractility, increases tolerance to physical stress, reduces the frequency of angina attacks.1
Mildronate® improves cerebral hemodynamics and cognitive functions, reduces asthenic status. 2,3
Mildronate® increases physical and mental performance.4

1. V.J. Dzerve, I.J. Kalvinsh. “Mildronate® in Cardiology”, research review, Riga 2013.
2. I.P. Logina, I.J. Kalvinsh, “Mildronate® in Neurology”, research review, Riga 2012.
3. StatsenkoM. E. at al. Possibilities of Mildronate in correction of cognitive impairment in patients with elderly arterial hypertension. Russian Journal of Cardiology ¹ 4 (90) / 2011
4.N. Belokopytova, E.A. Antipenko, A.V. Gustov, V.A. Abarenova. Efficacy of the nonspecific cytoprotector Mildronate in chronic cerebrovascular insufficiency. NMJ, 2007, No.6
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Contraindications

Hypersensitivity to the active substance and other ingredients of the drug, increased intracranial pressure (with impaired venous outflow, intracranial tumors), age under 18 years (effectiveness and safety has not been established), pregnancy, breast-feeding.

Side effects

Rarely – allergic reactions (redness and itching of the skin, skin rash, urticaria, angioedema), as well as – dyspeptic symptoms, tachycardia, decreased or increased blood pressure, increased excitability.
Very rarely – eosinophilia, general weakness.

Overdose

Symptoms: decreased BP accompanied by headache, tachycardia, dizziness and general weakness.

Treatment: symptomatic therapy.

Pregnancy use

The safety of using the drug in pregnancy has not been established. To avoid possible adverse effects on the fetus, Mildronate should not be prescribed during pregnancy.

It is not known whether meldonium dihydrate is excreted with breast milk. Breast-feeding should be stopped if it is necessary to use Mildronate during lactation.

Similarities

Mildronate, Cardionate, Idrinol, Meldonium, Meldonium-Solofarm