Meldonium (Mildronate) pills, ampoules - Instructions for Use, Dosage, Side Effects

Pharmacological group: Other metabolic.

Synonyms: Idrinol, Cardionate, Medatern, Melfor, Midolat, Mildronat, Mildronats, Mildronats-Grindeks, Mildroxyn, Neomildronat, Midolat.

Active substance: Meldonium.

ATC - C01EB Drugs for treatment of other diseases of the heart.

Nosological classification (ICD- 10)

E63 Physical and mental overload;

F10.3 abstinence;

G46 Vascular syndromes of brain in cerebrovascular diseases;

H34.8 Other retinal vascular occlusion;

H35.0 Background retinopathy and retinal vascular changes;

H35.6 Retinal hemorrhage;

H36.0 Diabetic retinopathy (E10-E14 + with common fourth character.3);

H44.8 Other disorders of eyeball;

I20 Angina [ angina ];

I21 Acute myocardial infarction;

I42.8 Other cardiomyopathy;

I50.0 Congestive heart failure;

I63 Cerebral infarction;

R53 Malaise and fatigue;

Z73.0 Overwork;

Z73.2 Lack of rest and relaxation;

Z73.6 Restrictions on activity, caused by reduced disability.

Composition, structure and packing of Meldonium

Meldnonium tablets hard gelatin capsules, size number 00, white contents of capsules - white crystalline powder with a faint odor, hygroscopic.

Other ingredients: potato starch, colloidal silicon dioxide, calcium stearate.

The composition of the capsule shell: gelatin, titanium dioxide (E171).

Meldonium tablets 250 mg, N40

Meldonium tablets 500 mg, N60

Solution for injection transparent, colorless.

Excipients: water for injections.

Meldonium ampoules 100 mg/ml, 5 ml, N10

Pharmacological action of Meldonium

The drug Meldonium, that improves metabolism. Meldonium is a structural analog of gamma-butyrobetaine, a substance that is found in every cell of the human body.

Under conditions of high load Meldonium restores the balance between the delivery and the need for oxygen cells, eliminates the accumulation of toxic products of metabolism in the cells, protecting them from damage, also has a tonic effect. As a result of its use of the organism acquires the ability to withstand stress and to quickly restore energy reserves. Because of these properties Meldonium is used to treat a variety of disorders of the cardiovascular system, the blood supply to the brain, as well as enhance physical and mental performance.

As a result of reducing the concentration of carnitine is synthesized hard gamma-butyrobetaine, which has vasodilatory properties. In acute ischemic myocardial injury - Meldonium slows the formation of necrotic area, shorten the rehabilitation period.

In heart failure, the drug increases myocardial contractility, increases exercise tolerance, reduces the frequency of angina attacks.

Acute and chronic ischemic cerebrovascular disorders improves blood circulation in the ischemic focus, promotes redistribution of blood in favor of ischemic area.

Effective with vascular pathology and dystrophic retina.

The drug eliminates the functional disorders of the nervous system in patients with chronic alcoholism with abstinence syndrome.

Pharmacokinetics of Meldonium

Absorption of Meldonium

After oral administration, the drug is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 78%. C max in plasma is reached after 1–2 hours after ingestion.

After IV the bioavailability is 100%. Cmax in plasma is reached immediately after its introduction.

Metabolism and excretion

It is metabolized in the body into two major metabolites are excreted by the kidneys. T 1/2 is 3 - 6 hours and was dose-dependent.

Meldonium Dosage

In connection with the possibility of stimulating effect of the drug Meldonium is recommended in the first half of the day.

Cardiovascular diseases in the complex therapy drug Meldonium is prescribed oral dose of 0.5–1 g/day or IV (of 5–10 ml of solution for injections at a concentration of 500 mg/5 ml), the multiplicity of application 1–2 times/day. The course of treatment - 4–6 weeks.

When cardialgia on background dyshormonal myocardial dystrophy Meldonium designate the interior of 250 mg 2 times/day. The course of treatment - 12 days.

In case of violation of cerebral circulation in the acute phase of drug Meldonium administered IV (in the appropriate dosage form - 500 mg 1 time/day for 10 days), then move on to receive the drug orally 0.5–1 g/day. The general course of therapy - 4–6 weeks.

In chronic cerebrovascular disorders drug Meldonium is taken orally 0.5–1 g/day. The general course of therapy - 4–6 weeks. Repeated courses administered individually 2–3 times a year.

When mental and physical stress Meldonium is prescribed orally 250 mg 4 times/day. The treatment course - 10–14 days. If necessary, repeat the treatment after 2–3 weeks.

Athletes are recommended to use 0.5–1 g 2 times/day before workouts. Duration of the Meldonium course during the preparatory period - 14–21 days, in Season - 10–14 days.

In chronic alcoholism Meldonium drug designate the interior of 500 mg 4 times/day. The course of Meldonium treatment - 7–10 days.

Meldonium Overdose

Overdoses Meldonium is not described, the drug has low toxicity and does not cause side effects that are dangerous to the health of patients.

Meldonium Interactions

In a joint application Meldonium enhances the effect of antianginal drugs, some antihypertensive drugs, cardiac glycosides.

Meldonium can be combined with antianginal drugs, anticoagulants and antiplatelet agents, antiarrhythmic agents, diuretics, bronchodilators.

In a joint application with Meldonium nitroglycerin, nifedipine, alpha-blockers, antihypertensives and peripheral vasodilators may develop mild tachycardia, hypotension (use caution when using this combination.)

Meldonium -Pregnancy and lactation

Safety for use during pregnancy has not Meldonium proved. To avoid potential adverse effects on the fetus drug should not be administered during pregnancy.

It is not known whether the drug in breast milk. If necessary, use Meldonium lactation breastfeeding should be discontinued.

Meldonium Side effects

With the cardiovascular system: rarely - tachycardia, changes in blood pressure.

CNS: rarely - psychomotor agitation.

Digestive system: rarely - diarrhea symptoms.

Allergic reactions: rarely - itching, redness, rash, swelling.

Indications for Meldonium Usage

• In the complex therapy of coronary heart disease (angina, myocardial infarction), congestive heart failure, cardiomyopathy dyshormonal;
• In the complex treatment of acute and chronic cerebrovascular events (stroke and cerebrovascular disease);
• Reduced performance;
• Physical stress (including athletes);
• Abstinence syndrome in chronic alcoholism (in combination with specific therapy for alcoholism);
• Hemophthalmus, retinal hemorrhages of different etiologies;
• Thrombosis of the central retinal vein and its branches;
• Retinopathy of different etiology (diabetic, hypertension).

Contraindications for Meldonium Usage

Increased intracranial pressure (including the violation of the venous outflow, intracranial tumors);

Children and teens under 18 years old;

Hypersensitivity to the drug.

Be wary of diseases of the liver and/or kidney disease, especially in a long time.

With careful use of the drug for a long time in patients with chronic liver disease and kidney failure.

Years of experience in the treatment of acute myocardial infarction and unstable angina in cardiology departments shows that Meldonium is not the drug of choice in acute coronary syndrome.

Meldonium Use in Pediatrics

In children and adolescents under the age of 18 years the efficacy and safety of Meldonium in the form of capsules and solution for injection has not been established.

Effects on ability to drive vehicles and management mechanisms

Information on adverse effects Meldonium for psychomotor speed of reaction is not available.