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Tradename

Ripronate

International nonproprietary name

Meldonium

Dosage form

Capsules 250 mg, 500 mg

Compound

1 capsule contains

active substance - meldonium 250 mg or 500 mg,

excipients: modified corn starch, anhydrous colloidal silicon, calcium stearate,

shell composition: titanium dioxide E171, iron (III) yellow oxide E172, yellow quinoline E104, azorubine E122, crimson 4 RE124, gelatin.

Description

Ripronate 250 m - shiny cream-colored capsules.

Ripronate 500 mg - shiny capsules with a red cap and a cream-colored body.

Contents of the capsule

White or almost white powder.

Pharmacotherapeutic group

Other drugs for the treatment of heart diseases.

Pharmacological properties

Pharmacokinetics

After oral administration, the drug is rapidly absorbed from the gastrointestinal tract. its bioavailability is about 78%. The maximum concentration in blood plasma is achieved 1 to 2 hours after administration. The half-life is 3 – 6 hours.

Pharmacodynamics

Ripronate is a structural analogue of gamma-butyrobetaine, a precursor of carnitine. Performing the functions of gamma-butyrobetaine, it is able to accelerate the transmission of nerve impulses in the body, as a result, all responses are accelerated, overall metabolism improves, a tonic effect is observed - memory improves, thinking processes accelerate, dexterity of movements increases, the body's resistance to adverse circumstances increases, mental and physical stress is weakened .

The drug, by inhibiting γ-butyrobetaine hydroxylase, reduces the biosynthesis of carnitine and the transport of long-chain fatty acids through cell membranes, prevents the accumulation in cells of activated forms of unoxidized fatty acids - derivatives of acylcarnitine and acyl coenzyme A, thus preventing their harmful effects. In conditions of ischemia, it restores the balance between the delivery and the need of cells for oxygen. As a result of a decrease in carnitine concentration, u-butyrobetaine, which has vasodilating properties, is intensively synthesized.

In acute myocardial infarction, it slows down tissue necrosis and shortens the rehabilitation period. In case of heart failure, it improves myocardial contractility and increases exercise tolerance.

The drug is able to eliminate functional disorders of the somatic and autonomic nervous system in patients with chronic alcoholism during the abstinence period.

Indications for use

IHD (angina pectoris, myocardial infarction), chronic heart failure, cardialgia against the background of dishormonal myocardial dystrophy and dishormonal cardiomyopathy as part of complex therapy

acute and chronic cerebrovascular accidents (cerebral strokes and cerebrovascular insufficiency) as part of complex therapy

decreased performance, physical stress (including among athletes)

withdrawal syndrome in chronic alcoholism (in combination with specific therapy for alcoholism)

Directions for use and doses

Due to the possible development of an exciting effect, it is recommended to use it in the first half of the day.

For adults:

For cardiovascular diseases, as part of complex therapy, the drug is prescribed at 500–1000 mg/day in 1 or 2 doses. Course of treatment: 4 – 6 weeks.

For cardialgia against the background of dyshormonal myocardial dystrophy, Ripronate is prescribed 250 mg 2 times a day. Course of treatment: 12 days.

In case of acute cerebrovascular accident, take the drug orally at 500–1000 mg/day. General course of therapy: 4 – 6 weeks.

For chronic cerebrovascular accidents, the drug is taken at a dose of 500 mg/day. General course of therapy: 4 – 6 weeks. Repeated courses are prescribed individually 2–3 times a year.

For mental and physical stress, 250 mg is prescribed orally 4 times a day. Course of treatment: 10 – 14 days. If necessary, therapy is repeated after 2–3 weeks.

Athletes are recommended to use 500–1000 mg 2 times/day before training. The duration of the course during the preparatory period is 14–21 days, during the competition period – 10–14 days.

For chronic alcoholism, the drug is prescribed 500 mg 4 times a day. Course of treatment: 7 – 10 days.

Children over 12 years old:

For functional disorders of the cardiovascular system, Ripronate is prescribed at a rate of 12.5 - 25 mg/kg body weight, but not more than 1 g per day. The daily dose must be divided into 2 doses.

For mental and physical stress, the drug is prescribed 250 mg 4 times a day.

The course of treatment is determined by the doctor.

Side effects

Rarely

– tachycardia, changes in blood pressure

psychomotor agitation

dyspeptic symptoms

skin itching, redness, rash, swelling

Contraindications

hypersensitivity to the drug

increased intracranial pressure (due to impaired venous outflow, intracranial tumors)

pregnancy and lactation

children's age up to 12 years

Drug interactions

Enhances the effect of coronary dilating drugs, some antihypertensive drugs, cardiac glycosides. Due to the possible development of moderate tachycardia and arterial hypotension, caution should be exercised when combined with nitroglycerin, nifedepine, alpha-blockers, antihypertensive agents and peripheral vasodilators.

Can be combined with antianginal drugs, anticoagulants, antiplatelet agents, antiarrhythmic drugs, diuretics, bronchodilators.

special instructions

Ripronate is not a first-line drug for acute coronary syndrome.

Patients with chronic liver and kidney diseases should be careful with long-term use of the drug.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Considering the side effects of the drug, care should be taken when driving a vehicle or potentially dangerous mechanisms.

Overdose

Symptoms: sudden changes in blood pressure are possible, mainly towards hypotension.

Treatment is symptomatic and drug withdrawal.

Release form and packaging

Hard gelatin capsules 250 mg

10 capsules in a blister pack, 4 or 6 packs along with instructions for medical use in a cardboard box.

Hard gelatin capsules 500 mg

15 capsules in a blister pack, 4 packs along with instructions for medical use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25°C in a dry place.

Keep out of the reach of children!

Shelf life

3 years

Do not use after the expiration date.
Attention! The description of the drug on this page is simplified. Before purchasing and using the drug, consult your doctor or pharmacist, and also read the instructions approved by the manufacturer. Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. ATTENTION! This section is provided for informational purposes only and is not a catalog or price list of our company. To obtain information about the availability of drugs, call + 99871 202 0999 Pharmacy Network Helpline 999.

Ripronate 10%/5 ml No. 10 solution d/in.amp.

Instructions for medical use of the drug RIPRONAT Trade name Ripronate International nonproprietary name Meldonium Dosage form Solution for injection 10% Composition 1 ml of solution contains the active substance - Meldonium (3-(2,2,2-trimethylhydrazinium) propionate dihydrate) (meldonium) 100 mg , excipient - water for injection up to 1 ml. Description Transparent colorless liquid Pharmacotherapeutic group Other drugs for the treatment of heart diseases. Meldonium ATC code C01EB22 Pharmacological properties Pharmacokinetics Metabolized in the body to form two main metabolites, which are excreted by the kidneys. The half-life is 3-6 hours. The bioavailability of the drug after intravenous administration is 100%. The maximum concentration in blood plasma is achieved immediately after its administration. Pharmacodynamics Ripronate is a structural analogue of γ-butyrobetaine, a precursor of carnitine. As a result of a decrease in carnitine concentration, γ-butyrobetaine, which has vasodilating properties, is intensively synthesized. In the case of acute ischemic damage to the myocardium, the use of the drug slows down the formation of the necrotic zone, shortens the rehabilitation period, improves blood circulation in the ischemic area, and promotes the redistribution of blood in favor of the ischemic area. In heart failure, Ripronate increases myocardial contractility, increases exercise tolerance, and reduces the frequency of angina attacks. Under conditions of increased stress, the drug restores the balance between the delivery and the need of cells for oxygen, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage. As a result of use, the body acquires the ability to withstand stress and quickly restore energy reserves. Ripronate has a tonic effect. The drug is able to eliminate functional disorders of the somatic and autonomic nervous system in patients with chronic alcoholism during the period of abstinence. Indications for use: coronary heart disease (angina pectoris, myocardial infarction), chronic heart failure and dyshormonal cardiomyopathy (as part of complex therapy) - acute and chronic cerebrovascular accidents (cerebral strokes and cerebrovascular insufficiency) (as part of complex therapy). Method of administration and dosage Due to the possible development of an stimulating effect, it is recommended to use it in the first half of the day. Recommended doses of ripronate for adults. As part of complex therapy for coronary artery disease, chronic heart failure, dishormonal cardiopathy, 500 mg-1 g/day is prescribed intravenously (iv), administering the entire dose at once or dividing it by 2 times for 10 days, then switching to taking the tablet form of the drug. In case of acute cerebrovascular accident, the drug is prescribed intravenously at 500 mg/day for 10 days, then switched to taking the drug in tablet form. For chronic cerebrovascular accidents - intramuscularly (IM) 500 mg x 1 time / day, then switch to taking the drug in tablet form. The total duration of treatment is determined by the attending physician. Repeated courses are prescribed individually 2-3 times a year. Elderly patients: Elderly patients with liver and/or kidney disease should have their dose of meldonium reduced. Patients with Renal Impairment Since the drug is eliminated from the body through the kidneys, patients with mild to moderate renal impairment should use a lower dose of meldonium. Patients with hepatic impairment Patients with mild to moderate hepatic impairment should use a lower dose of meldonium. Pediatric population There is no data on the safety and effectiveness of meldonium in children and adolescents under the age of 18 years, therefore the use of this drug in children and adolescents is contraindicated. Side effects Often - allergic reactions (hypersensitivity, allergic dermatitis, urticaria, angioedema, anaphylactic reaction) - headaches - dyspepsia (feeling of heaviness, bloating, fullness, pain and discomfort in the epigastrium, nausea) Rarely - agitation, feeling of fear, obsessiveness thoughts, sleep disturbance - paresthesia, tremor, hypoesthesia, tinnitus, vertigo, dizziness, gait disturbance, lightheadedness, loss of consciousness - tachycardia/sinus tachycardia, atrial fibrillation, arrhythmia, chest discomfort/chest pain - blood pressure fluctuations , hypertensive crisis, hyperemia, pallor of the skin - sore throat, cough, dyspnea, apnea - dysgeusia (metallic taste in the mouth), loss of appetite, nausea, vomiting, gas accumulation, diarrhea, abdominal pain - rashes (general / macular / papular), itching - back pain, muscle weakness, muscle spasms - pollakiuria - general weakness, tremor, asthenia, general swelling, swelling of the face, swelling of the legs, feeling hot, feeling cold, cold sweat - abnormalities in the electrocardiogram (ECG), acceleration heart function, eosinophilia Contraindications - hypersensitivity to meldonium dihydrate - severe liver and/or renal failure, due to the lack of data on the safety of use - pregnancy and lactation - children under 18 years of age, due to the lack of data on clinical use during this period Drug interactions Strengthens the effect of coronary dilatants, some antihypertensive drugs, cardiac glycosides. Due to the possible development of moderate tachycardia and arterial hypotension, caution should be exercised when combined with nitroglycerin, nifedipine, alpha-blockers, antihypertensive agents and peripheral vasodilators. Can be combined with antianginal drugs, anticoagulants, antiplatelet agents, antiarrhythmic drugs, diuretics, bronchodilators. Special instructions Ripronate is not a first-line drug for acute coronary syndrome. Patients with chronic liver and kidney diseases should be careful with long-term use of the drug. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Care should be taken when driving vehicles or potentially dangerous mechanisms. Overdose Symptoms: increased severity of side effects. In particular, there is excitement and a decrease in blood pressure. Treatment is symptomatic. Release form and packaging 5 ml of the drug in colorless glass ampoules. A self-adhesive label is placed on the ampoule or the text is applied with quick-fixing paint for glass products. 5 ampoules are placed together in a blister pack. 2 contour packages together with instructions for medical use in the state and Russian languages are placed in a cardboard box. Storage conditions Store at a temperature not exceeding 25ºС. Do not freeze. Keep out of the reach of children! Shelf life: 3 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription, Otopeni, st. Eroilor 1A, Romania (“Rompharm Company SRL”, Otopeni, Eroilor Street 1A, Romania) for ROTAPHARM, UK Registration certificate holder Rotapharm, London/UK. Address of the organization that accepts claims from consumers on the quality of products (goods) of the Republic of Kazakhstan on the territory of the Republic of Kazakhstan, Almaty, st. Suyunbaya 222 B Tel/fax: 8(7272)529090