Meldoreb

Meldoreb

INTERNATIONAL NONPROPRIETARY NAME:

Meldonium

DRUG FORM: solution for intravenous injection 100 mg/ml.

COMPOSITION:

1 ampule with the drug contains:

Active substance: Meldonium dihydrate – 500.00 mg.

Excipients: water for injections

PHARMACOTHERAPEUTIC GROUP:

Other agents for the treatment of heart diseases

ATC CODE: C01EB22

PHARMACOLOGICAL PROPERTIES:

PHARMACODYNAMICS:

Meldonium is a structural analogue of γ-butyrobetaine, carnitine precursor. As a result of decrease in carnitine concentration γ-butyrobetaine (with vasodilating properties) is synthesized. In case of acute ischemic damage of myocardium the drug slows down necrotic zone formation and shortens rehabilitation period. In case of heart failure meldonium increases myocardial contractility, increases tolerance to physical activity and reduces the frequency of angina attacks.

Under increased physical activity the drug restores balance between oxygen delivery and its demand in cells, eliminates accumulation of toxic metabolites in cells protecting them from the damage. Meldonium possesses the tonic effect.

In case of neurological disorders (after cerebrovascular accident, brain surgery, head injuries, tick-borne encephalitis) meldonium positively effects the recovery process of physical and intellectual functions.

PHARMACOKINETICS:

Maximal Meldonium plasma concentration (C_max) is reached in 11-2 hrs.

Meldonium is mainly metabolized in the liver.

The drug half-life is 4 hours. The drug excretion rate is increased at doses up to 400 mg; at doses higher than 400 mg the excretion rate practically does not change. Food in the stomach delays Meldonium absorption rate of a single dose 400 mg.

INDICATIONS TO USE:

Meldoreb is used as a part of combination therapy in the following cases:

- cardiovascular diseases (stable angina pectoris, chronic heart failure (NYHA I-III functional class), cardiomyopathy, functional disorders of cardiovascular system);

- acute and chronic ischemic disorders of cerebral circulation;

- reduced work performance, physical and psycho-emotional stress;

- cerebrovascular disorders, head injuries and encephalitis recovery period.

DOSAGE AND ADMINISTRATION:

Meldoreb is administered intravenously in a form of injection.

Adult patients: the recommended dose is 500 mg – 1000 mg once a day or divided into two portions twice a day. Maximal daily dose is 1000 mg.

Patients with impaired liver and/or kidney function: reduced doses are required.

Elderly patients with normal liver and/or kidney function: dose adjustment is not required.

Children: Meldonium is contraindicated. Meldonium safety and efficacy in this patients’ category has not been established.

Due to the possible excitory effect Meldoreb is recommended to be taken in the morning.

SIDE EFFECT

The side effects listed below are classified according to the group of organs and the degree of incidence MedDRA: very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100), rarely (≥1/10,000 to <1/1000), very rare (<1/10000), unknown (cannot be determined from the data available).

Blood and Lymphatic system disorders

Unknown: eosinophilia.

Immune System Disorders

Often: allergic reactions.

Cardiac disorders

In some cases: tachycardia.

Blood Circulation disorders

In some cases: low blood pressure.

Nervous system disorders

Often: headache.

Unknown: agitation.

Respiratory system, chest and mediastinum diseases

Unknown: dyspnoea.

General disorders and administration site conditions

Unknown: fatigue.

CONTRAINDICATIONS:

- hypersensitivity to the drug components;

- renal and hepatic insufficiency (due to the lack of the drug safety information);

- increased intracranial pressure (in case of venous outflow disturbance, intracranial tumors);

- pregnancy;

- lactation (breastfeeding);

- children and teenagers up to 18 years old;

OVERDOSE:

No cases of Meldonium overdose have been reported. The drug is low toxic and does not cause life threatening side effects. In case of severe overdose it is necessary to control the liver and kidneys function.

Symptoms: in case of low blood pressure headache, dizziness, tachycardia and fatigue are possible.

Treatment: symptomatic.

PRECAUTIONARY MEASURES

Meldoreb is not the first-line drug for the treatment of acute coronary syndrome.

In treatment of patient with a history of chronic liver and kidney diseases caution should be exercised and liver and kidney function monitored.

Effect on ability to drive and operate machinery

There is no data on the drug adverse effects on ability to drive and operate machinery.

Use in pregnancy and lactation.

Meldonium safety in pregnancy has not been established. To avoid possible adverse effects on the fetus the drug is not prescribed in pregnancy.

There is no evidence of whether Meldonium is excreted into breast milk. In necessity to take the drug breastfeeding should be stopped.

Pediatric use

The drug safety and efficacy in children and teenagers under 18 years has not been established.

INTERACTION WITH OTHER DRUGS

Meldoreb can be used in combination with prolonged nitrates and other antianginal drugs (stable angina pectoris), cardiac glycosides and diuretic drugs (heart failure). Also Meldoreb can be combined with anticoagulants, antiplatelet agents, antiarrhythmic drugs and other drugs that improve microcirculation.

It should be considered that Meldoreb can enhance the effect of glyceryl trinitrate, nifedipine, beta-blockers other antihypertensive drugs and peripheral vasodilators.

Do not use with other drugs contained Meldonium (capsules, tablets) as the risk of side effects may increase.

STORAGE CONDITIONS:

Store in a place protected from moisture at a temperature not above 25°C.

Keep out of reach of children!

SHELF LIFE:

Shelf life is 3 years. Should not be uses after the expiration date indicated on the label.

PRESCRIPTION STATUS

By prescription

PACKAGING

5 ml ampoules made of clear glass of class I.

5 ampoules placed into a separator made of polyvinyl chloride film.

2 separators made of polyvinyl chloride film with a leaflet in a cardboard pack.

Manufacturer Information

Foreign production and trade unitary enterprise “Reb-Pharma”, 223216, Republic of Belarus, Minsk region, Chervensky district, Smilovichi, Sadovaya st., 1, tel./fax: (+375) 17 240 26 35,

e-mail: rebpharma@rebpharma.by, http://www.rebpharma.by