Mildronate 250

Mildronate Capsules, 250 mg No. 40 (10x4)

Composition
Active ingredient: meldonium.
One capsule contains 250 mg of meldonium dihydrate.
Excipients: potato starch, silicon dioxide, calcium stearate.
Capsule shell: titanium dioxide (E 171), gelatin.

Pharmaceutical Form
Hard capsules.
Physical properties: White gelatin capsules containing a white crystalline, slightly odorous, and hygroscopic powder.

Pharmacological Group
Other cardiological drugs. ATC Code: C01E B22.

Pharmacodynamics
Meldonium, a precursor of carnitine, is a structural analogue of gamma-butyrobetaine (GBB). It influences the body through two primary mechanisms:

1. Carnitine Biosynthesis Regulation
   Meldonium reversibly inhibits gamma-butyrobetaine hydroxylase, reducing carnitine synthesis. This inhibits the accumulation of activated, non-oxidized fatty acids, protecting cell membranes during ischemia. It improves oxygen utilization, stimulates glucose oxidation, and restores ATP transportation from mitochondria to the cytosol.

2. Role as a Mediator
   Meldonium acts as a potential mediator in a hypothesized GBB-ergic system, supporting cellular response mechanisms and enhancing metabolic activity, including within the central nervous system (CNS).

CNS Effects
Studies on animals have shown that meldonium possesses anti-hypoxic and cerebrovascular effects, optimizing blood flow to ischemic areas and enhancing neuron resilience under hypoxia. It also stimulates CNS activity, increasing physical endurance and motor activity while exhibiting anti-stress properties.

Efficacy in Neurological Disorders
Meldonium aids in the rehabilitation of neurological patients, improving physical endurance, restoring intellectual functions, and reducing neurological deficits.

Pharmacokinetics

• Absorption: Meldonium achieves peak plasma concentration within 1–2 hours post-administration.
• Distribution: Rapidly distributed in tissues; binds to plasma proteins.
• Metabolism and Excretion: Metabolized mainly in the liver and excreted via the kidneys.

Indications

• Reduced work capacity, physical and mental stress.
• Recovery after cerebrovascular events, brain trauma, or encephalitis.

Contraindications

• Hypersensitivity to meldonium or excipients.
• Intracranial pressure increases.
• Severe hepatic or renal impairment.
• Pregnancy, lactation, and children under 18 years old.

Dosage and Administration
For oral use. Capsules should be swallowed with water, taken in the morning due to potential stimulating effects. The usual course of treatment is 4–6 weeks, repeatable 2–3 times annually.

Side Effects
Common: headaches, respiratory infections.
Rare: allergic reactions, tachycardia, blood pressure fluctuations.

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