Mildralex (meldonium) ampoules 10% 5 ml. №10

Description

Mildralex composition
active substance: meldonium;
5 ml of solution (1 ampoule) contain 0.5 g of meldonium dihydrate;
auxiliary substances: water for injection.

Dosage form
Injection.

Pharmacological properties
Mildralex is a metabolic drug. It is a structural analogue of a substance present in every human cell – gamma-butyrobetaine. Under conditions of increased stress, the drug restores the balance between the need for oxygen and its delivery to cells, and also eliminates the accumulation of toxic products of cellular metabolism, protecting them from damage. Also, the medicine has a tonic effect. When applied, the human body acquires the ability to quickly restore energy reserves, to withstand heavy loads. Due to these properties, this drug can be used to treat disorders of cardiovascular activity, blood supply to the brain, as well as to increase mental and physical performance. Due to a decrease in the concentration of carnitine, gamma-butyrobetaine, which has vasodilating properties, is intensively produced. In the case of acute oxygen deficiency of the heart muscle (ischemic myocardial damage), the drug slows down the formation of a zone of tissue death, shortens the rehabilitation period. In the case of heart failure, the drug increases the contractility of the myocardium, reduces the incidence of angina (angina pectoris) attacks, and increases exercise tolerance. In acute / chronic disorders (ischemic) of cerebral circulation, it improves blood flow in the ischemic focus, contributes to the redistribution of blood volume in favor of the area suffering from a lack of oxygen. The drug is effective for vascular (vascular) and degenerative changes in the fundus. It relieves functional disorders of the nervous system in people with chronic alcoholism with withdrawal symptoms (disorders caused by alcohol withdrawal).

Indications
In the complex therapy of the following diseases:

• diseases of the heart and vascular system: stable exertional angina, chronic heart failure (NYHA I – IIІ functional class), cardiomyopathy, functional disorders of the heart and vascular system;
• acute and chronic ischemic disorders of cerebral circulation;
• decreased performance, physical and psycho-emotional overstrain;
• during the recovery period after cerebrovascular disorders, head trauma and encephalitis.

Contraindications:

• hypersensitivity to meldonium and / or to any excipient of the drug;
• increased intracranial pressure (in violation of venous outflow, intracranial tumors);
• severe hepatic and / or renal failure (there is insufficient data on the safety of use).

Children
There is no data on the safety and efficacy of using meldonium in children (under the age of 18), therefore the use of meldonium in this category of patients is contraindicated.

Application during pregnancy and lactation
The safety of use during these periods has not been proven.

Method of administration and dosage
Intravenously. The use of Mildralex does not require any special preparation before administration.
Due to the possible stimulating effect, the drug is recommended to be used in the morning.
Adults
The dose is 500-1000 mg (5-10 ml) into a vein, it is administered at one time or divided into two doses. The duration of treatment is usually 10-14 days, after which treatment is continued with an oral dosage form.
The duration of the course of treatment is 4-6 weeks. The course of treatment can be repeated 2-3 times a year.

Overdose
No cases of meldonium overdose have been reported. The drug is low-toxic and does not cause threatening side effects.
With low blood pressure, headaches, dizziness, tachycardia, and general weakness are possible. Treatment is symptomatic.
In case of severe overdose, it is necessary to monitor liver and kidney function.
Hemodialysis is not essential in case of an overdose of meldonium due to the pronounced binding to blood proteins.

Side effects
Possible changes in blood pressure, dyspeptic symptoms, tachycardia, agitation, development of an allergic reaction, manifested by skin irritation, allergic rhinitis (runny nose), hyperemia (redness) of the skin, itching, urticaria (urticaria), shortness of breath. Severe manifestations of allergies are not excluded: Quincke’s edema (rapidly developing edema of the face or part of it, larynx, eyes, lips with impaired breathing), anaphylactic shock (rapidly spreading severe itching of the skin, a sharp drop in blood pressure, noisy and difficult breathing, vomiting, loose stools , laryngeal edema, pallor or cyanosis of the skin, a sharp narrowing of the bronchi, larynx, leading to acute difficulty in breathing, disruption of vital organs, loss of consciousness).

Shelf life
5 years.
Do not use after the expiration date printed on the package.

Storage conditions
Store Mildralex at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of the reach of children.