Mildronate injection solution ampoules 10% 5ml N10
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Active ingredients
Meldonius
Composition
Meldonia dihydrate 100 mg per 1 ml. Excipients: water d / i.
Pharmacological effect
Meldonium (Mildronate) is a structural analogue of gamma-butyrobetaine - a substance that is found in every cell of the human body. Under the conditions of increased load, Mildronate restores the balance between the delivery and the need of cells for oxygen, eliminates the accumulation of toxic metabolic products in the cells, protecting them from damage; also has a tonic effect. As a result of its use, the body acquires the ability to withstand the load and quickly restore energy reserves. Due to these properties, Mildronate is used to treat various disorders of the cardiovascular system, the blood supply to the brain, as well as to increase physical and mental performance. As a result of reducing the concentration of carnitine, gamma-butyrobetaine with vasodilating properties is intensively synthesized. In case of acute ischemic damage to the myocardium, Mildronate slows down the formation of a necrotic zone, shortens the rehabilitation period. In heart failure, it increases myocardial contractility, increases exercise tolerance, and reduces the frequency of strokes. In acute and chronic ischemic disorders of cerebral circulation, Mildronate improves blood circulation in the ischemia, promotes the redistribution of blood in favor of the ischemic area. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal syndrome.
Pharmacokinetics
Bioavailability of the drug after intravenous administration is 100%. The maximum plasma concentration is reached immediately after its administration. Metabolized in the body to form two major metabolites that are excreted by the kidneys. T1 / 2 is 3-6 hours.
Indications
- In the treatment of coronary heart disease (angina, myocardial infarction); - chronic heart failure and dyshormonal cardiomyopathy; - in the treatment of acute and chronic disorders of the blood supply to the brain (stroke and cerebrovascular insufficiency); - hemophthalmus and retinal hemorrhage of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (diabetic, hypertensive); - reduced performance; - mental and physical overload (includingathletes); - withdrawal syndrome in chronic alcoholism (in combination with a specific therapy of alcoholism).
Contraindications
- hypersensitivity to the drug; - increased intracranial pressure (in violation of the venous outflow, intracranial tumors); - age up to 18 years (efficacy and safety have not been established); - pregnancy; - breastfeeding period. With care: at diseases of a liver and / or kidneys.
Use during pregnancy and lactation
Safety of use in pregnant women has not been studied, therefore, in order to avoid possible adverse effects on the fetus, its use is contraindicated. The release of the drug Mildronate with milk and its effect on the health of the newborn have not been studied, therefore, if necessary, use breastfeeding should be prepared.
Dosage and administration
Due to the possible development of the exciting effect, it is recommended to apply in the morning. Mildronate is administered intramuscularly (IM), intravenously (IV) and parabulbarno. The route of administration, the dose and the duration of the course of treatment are set individually, depending on the indications, the severity of the condition, etc. Cardiovascular diseases As part of complex therapy: - coronary heart disease (myocardial infarction) in / in the stream of 0.5-1.0 g per day (5-10 ml of Mildronat), applying the entire dose immediately or dividing it into 2 doses; - ischemic heart disease (stable angina); chronic heart failure and dyshormonal cardiomyopathy in / in the jet of 0.5-1.0 g per day (5-10 ml of Mildronate), applying the entire dose immediately or dividing it into 2 administrations, or intramuscularly 0.5 g 1-2 times a day, the course of treatment is 10-14 days, with the subsequent transition to ingestion. The general course of treatment is 4-6 weeks. Violation of cerebral circulation As part of complex therapy in the acute phase of 0: 5 g (5 ml of Mildronate) 1 time per day IV for 10 days, turning into oral administration of 0.5-1 g. General course of treatment - 4 -6 weeks. In chronic cerebrovascular insufficiency (dyscirculatory encephalopathy) 0.5 g (5 ml of the drug Mildronate) in / m or / in 1 time per day for 10 days, then 0.5 g orally. The general course of treatment is 4-6 weeks. Repeated courses (usually 2-3 times a year) are possible after consulting a doctor.Ophthalmopathology (hemophthalmus and retinal hemorrhages of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (diabetic, hypertensive)) 0.05 g (0.5 ml of Mildronate) is parabulbar and lasts 10 days. Including used in combination therapy. Mental and physical overloads At 0.5 g (5 ml of the drug Mildronate) in / m or / in 1 time per day. The course of treatment is 10-14 days. If necessary, repeat the treatment after 2-3 weeks. Chronic alcoholism At 0.5 g (5 ml of the drug Mildronate) in a / m or / 2 times a day. The course of treatment is 7-10 days.
Side effects
Rarely - allergic reactions (redness, rash, itching, swelling), as well as dyspepsia, tachycardia, decrease or increase in blood pressure, agitation. Very rarely - eosinophilia, general weakness.
Overdose
Symptoms: decrease in blood pressure, accompanied by headache, tachycardia, dizziness and general weakness. Treatment: symptomatic. Mildronate is low toxic and does not cause side effects that are hazardous to patients.
Interaction with other drugs
Can be combined with antianginal agents, anticoagulants, antiplatelet agents, antiarrhythmic agents, diuretics, bronchodilators. Enhances the action of cardiac glycosides. Due to the possible development of moderate tachycardia and hypotension, caution should be exercised when combined with nitroglycerin, nifedipine, alpha-blockers, other antihypertensive drugs and peripheral vasodilators, as Mildronate enhances their action.
special instructions
Long-term experience in the treatment of acute myocardial infarction and unstable angina in the cardiology departments shows that Mildronate is not a first-line drug for acute coronary syndrome and its use is not acutely necessary. Impact on the ability to drive vehicles and control mechanisms There is no data on the adverse effects of Mildronate on the speed of the psychomotor reaction.