MILDRONAT (Solution for injection)

Active material: Meldonium
When ATH: C01EB
CCF: Preparation, improves metabolism and energy supply of tissues
ICD-10 codes (testimony): F10.3, H34, H35.0, H35.6, H36.0, H44.8, i20, I21, I25.1, I42, I50.0, I61, I63, I67.2, I69, Z73.0, Z73.3
When CSF: 01.12.11.05
Manufacturer: GRINDEX AO (Latvia)

Pharmaceutical form, composition and packaging

Solution for injection clear, colorless.

1 ml1 amp.
meldonium (trimetilgidraziniya propionate)100 mg500 mg

Excipients: water d / and.

5 ml – ampoule (5) – packings Valium plastic (2) – packs cardboard.

 

Pharmacological action

Preparation, improves metabolism. Meldonium is a structural analog of gamma-butyrobetaine, substances, It is found in every cell of the human body.

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

As a result of reducing the concentration of carnitine is synthesized hard gamma-butyrobetaine, vasodilating properties. In acute ischemic myocardial injury Mildronat® It slows down the formation of necrotic zone, shortens the rehabilitation period.

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

In acute and chronic ischemic cerebrovascular disorders improves blood circulation in the ischemic focus, It promotes redistribution of blood to the ischemic area.

Effective with vascular and dystrophic pathology of the fundus.

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

 

Pharmacokinetics

After the on / in the bioavailability of 100%. Cmax plasma levels achieved immediately after its introduction.

It is metabolized in the body into two major metabolites, that the kidneys. T1/2 is 3-6 no.

 

Testimony

- In the complex treatment of coronary artery disease (angina, myocardial infarction), chronic heart failure;

- In the complex treatment of acute and chronic disorders of cerebral circulation (strokes and cerebrovascular insufficiency);

- Impaired performance;

- Abstinence syndrome in chronic alcoholism (in combination with a specific treatment of alcoholism);

- Hemophthalmus, retinal hemorrhages of different etiologies;

- Thrombosis of the central retinal vein and its branches;

- Retinopathy of different etiology (Diabetic, hypertension).

 

Dosage regimen

Due to the possibility of the exciting effect of the drug is recommended in the first half of the day.

At cardiovascular diseases in the complex therapy of drug administered in a dose 0.5-1 g / day / in (by 5-10 ml solution for injections at a concentration of 500 mg / 5ml), multiplicity of application 1-2 times / day. A course of treatment – 4-6 weeks.

At violation of cerebral circulation in the acute phase of the drug is prescribed in / on 500 mg 1 times / day for 10 days, then go to the reception of the drug inside (the appropriate dosage form – by 0.5-1 g / day). The total course of therapy – 4-6 weeks.

At vascular pathology, and degenerative diseases of the retina Mildronat® administered by parabulbarno 0.5 ml injection solution with a concentration of 500 mg / 5 ml for 10 days.

At mental and physical exertion administered in / on 500 mg 1 time / day. A course of treatment – 10-14 days. If necessary, repeat the treatment after 2-3 of the week.

At alcoholism the drug is prescribed in / on 500 mg 2 times / day. A course of treatment 7-10 days.

 

Side effect

Cardio-vascular system: rarely – tachycardia, changes in blood pressure.

CNS: rarely – psychomotor agitation.

From the digestive system: rarely – dyspeptic symptoms.

Allergic reactions: rarely – itching, redness, rash, edema.

 

Contraindications

- Increased intracranial pressure (incl. in violation of the venous outflow, intracranial tumors);

- Hypersensitivity to the drug.

FROM caution used for diseases of the liver and / or kidney, especially for a long time.

 

Pregnancy and lactation

Safety of Mildronate® during pregnancy has not been proven. To avoid possible adverse effects on the fetus drug should not be administered during pregnancy.

Unknown, whether the drug is released in breast milk. If necessary, use Mildronate® lactation breastfeeding should be discontinued.

 

Cautions

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

Many years of experience in the treatment of acute myocardial infarction and unstable angina in the cardiology departments shows, that Mildronat® not a first-line drug for acute coronary syndrome.

Effects on ability to drive vehicles and management mechanisms

Data on adverse effects Mildronate® psychomotor speed not available.

 

Overdose

Cases of overdose Mildronate® not disclosed, the drug has low toxicity and does not cause side effects, hazardous to the health of patients.

 

Drug Interactions

In a joint application Mildronat® enhances the effect of antianginal drugs, Some antihypertensive drugs, cardiac glycosides.

Mildronat® It can be combined with antianginal drugs, anticoagulants and antiplatelet, antiarrhythmics, diuretic, bronholitikami.

In a joint application with Mildronate® nitroglycerin, Nifedipine, alpha-blockers, antihypertensives and peripheral vasodilators may develop mild tachycardia, hypotension (Caution should be exercised when using this combination).

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C; Do not freeze. Shelf life – 4 year.

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