Description
Latin name
Mildronate
Release form
Capsules.
Packing
10 pcs – blister packagings (4) – packs of cardboard.
Pharmacological action
Pharmacotherapeutic group
Metabolic agent.
ATX code: C01EB
Pharmacological action
Pharmacodynamics
Meldonium is a precursor to carnitine, a structural analogue of gamma-butyrobetaine (GBB), a substance that is found in every cell in the human body.
Under conditions of increased load, meldonium restores the balance between delivery and oxygen demand of cells, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage also has a tonic effect. As a result of its use, the body’s resistance to stresses and the ability to quickly restore energy reserves increase.
The drug has a stimulating effect on the central nervous system (CNS) – an increase in motor activity and physical endurance. Thanks to these properties, MILDRONAT ® is also used to increase physical and mental performance.
Pharmacokinetics
After oral administration, the drug is rapidly absorbed, bioavailability is 78%. The maximum concentration (Cmax) in blood plasma is achieved 1-2 hours after ingestion. It is metabolized in the body mainly in the liver with the formation of two major metabolites that are excreted by the kidneys. The half-life (T1 / 2) when taken orally depends on the dose, is 3-6 hours.
Indications
Reduced performance, mental and physical overload.
Contraindications
Hypersensitivity to meldonium or any other component of the drug.
Increased intracranial pressure (in violation of the venous outflow, intracranial tumors).
Pregnancy and the period of breastfeeding.
Age under 18 years (security not confirmed).
Precautions: for diseases of the liver and / or kidneys.
Use during pregnancy and lactation
The safety of use in pregnant women has not been studied, therefore, in order to avoid possible adverse effects on the fetus, the use of the drug in pregnant women is contraindicated.
Excretion with milk and the effect on the health of the newborn have not been studied, therefore, if you need to use the drug, you should stop breastfeeding.
Ingredients
1 capsule contains:
active ingredient
meldonium dihydrate 250 mg
excipients
starch potassium chloride, srdl, potassium chloride, srd dioxide (E 171),
gelatin.
Dosage and Administration
Inside.
The daily dose for adults is 500 mg (2 capsules). The entire dose is used in the morning in one dose or dividing it into 2 doses.
The course of treatment is 10-14 days.
If necessary, treatment is repeated after 2-3 weeks.
In connection with a possible stimulating effect, the drug is recommended to be used in the morning.
Side effects
Meldonium is generally well tolerated. However, in susceptible patients, as well as in cases of exceeding the recommended dose, undesirable reactions may occur.
Adverse drug reactions are grouped into organ-system classes according to the following gradation of frequency: very often ( 1/10), often ( 1/100 and
from the blood and lymphatic systems
Frequency unknown: eosinophilia.
from the immune side
systems Often: allergic reactions (redness of the skin, rashes, itching, swelling)
From the heart
Very rarely: tachycardia
From the vessels
Very rarely: lowering blood pressure
From the gastrointestinal tract srdlkc Often: dyspepsia symptoms of
From the nervous system
Often: headaches
Frequency unknown: agitation
General disorders
Frequency unknown: general weakness
If any of the side effects indicated in the instructions are aggravated, or if you notice any other side effects not listed in the instructions, notify your doctor.
Drug Interaction
Meldonium may be used concurrently with prolonged-action nitrates and other anti-anginal agents, cardiac glycosides, and diuretics. It can also be combined with anticoagulants, antiplatelet agents, antiarrhythmic agents and other microcirculatory drugs.
Meldonium may potentiate the action of nitroglycerin, nifedipine, beta-blockers, other antihypertensive agents and peripheral vasodilators.
The concomitant use of the drug with other medicines of meldonium is not allowed as it may increase the risk of adverse reactions.
Overdose
No cases of overdose with meldonium have been reported. The drug is low-toxic and does not cause serious adverse reactions.
Symptoms: lowering of blood pressure accompanied by headache, tachycardia, dizziness and general weakness.
Treatment: symptomatic.
In severe overdose, liver and kidney function must be monitored.
Storage conditions
Store in a dry place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Expiration
4 years.
Do not use after the expiry date stated on the package.
Deystvuyuschee substances
meldonium
dosage form
dosage form
capsules
Grindeks, Latvia
