Meldonium: Optimize Cellular Energy and Ischemic Protection
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Synonyms | |||
Meldonium is a cardioprotective and anti-ischemic agent belonging to the class of fatty acid oxidation inhibitors. Its primary mechanism of action involves the modulation of carnitine biosynthesis, shifting cellular energy production from fatty acid β-oxidation to the less oxygen-intensive glycolysis. This pharmacological profile makes it a significant therapeutic option for managing conditions associated with compromised oxygen supply, particularly in cardiovascular and neurological contexts. It is recognized for its role in enhancing physical capacity and functional recovery in patients under ischemic stress.
Features
- Active Pharmaceutical Ingredient: Meldonium (Mildronāts)
- Pharmacotherapeutic Group: Other cardiac preparations, ATC code: C01EB22
- Standard Dosage Forms: Oral capsules (250 mg, 500 mg) and solution for intravenous/peritoneal infusion or parabulbar injection (100 mg/mL)
- Mechanism of Action: Selective inhibitor of gamma-butyrobetaine hydroxylase, reducing L-carnitine synthesis and shifting energy metabolism to glycolysis
- Bioavailability: Approximately 78% following oral administration
- Plasma Protein Binding: Minimal
- Metabolism: Not extensively metabolized
- Elimination Half-life: Approximately 3-6 hours
- Excretion: Primarily renal (95% as unchanged drug)
Benefits
- Enhanced Cellular Tolerance to Ischemia: Protects cells from damage caused by insufficient oxygen supply by optimizing energy metabolism under hypoxic conditions.
- Improved Physical and Mental Performance: Increases work capacity and reduces symptoms of physical and psychological overstrain, such as fatigue and functional asthenia.
- Cardioprotective Effects: Supports cardiac function in various pathologies, including chronic heart failure, by improving myocardial contractility and reducing anginal episodes.
- Neuroprotective Properties: Helps restore functions after cerebrovascular accidents and improves microcirculation in retinal and choroidal vessels in ocular pathologies.
- Stimulation of Central Nervous System Function: Can lead to improved cognitive function, concentration, and overall central nervous system activity.
- Promotion of Functional Recovery: Aids in the rehabilitation process and accelerates recovery of functional capacity following periods of ischemic insult or excessive exertion.
Common use
Meldonium is clinically indicated for a range of conditions where improved cellular energy metabolism and protection against ischemia are therapeutic goals. Its primary use is in the field of cardiology for the treatment of chronic heart failure (Stage II and III, according to the classification of N.D. Strazhesko and V.Kh. Vasilenko) and coronary artery disease, including stable angina pectoris and post-infarction states. It is also employed in the complex therapy of cerebrovascular disorders, such as recovery from ischemic stroke and chronic cerebral ischemia. In ophthalmology, it is used for retinal vascular pathologies and hemorrhages into the vitreous body. Furthermore, it is utilized to reduce functional impairments associated with physical and psychoemotional overload in otherwise healthy individuals.
Dosage and direction
Dosage is individualized based on the patient’s condition, severity of disease, and the chosen route of administration. Always follow the precise instructions of the prescribing physician.
- Oral Administration (Capsules): The usual adult dose is 500 mg - 1 g (2-4 capsules of 250 mg) once or twice daily. The total daily dose should not exceed 2 g. The course of treatment is typically 4-6 weeks, which may be repeated 2-3 times per year.
- Intravenous/Parabulbar Administration (Solution): Used for more acute conditions. The typical dose is 5-10 mL of a 100 mg/mL solution, injected once daily. The intravenous course usually lasts 10-14 days, after which a switch to oral maintenance therapy is common.
- General Direction: The medication is best taken in the first half of the day, before 16:00, to avoid potential effects on sleep due to its activating properties. Capsules should be swallowed whole with a sufficient amount of water.
Precautions
Exercise caution when prescribing meldonium. Use with caution in patients with chronic liver and/or kidney disease due to the primary renal route of excretion; dosage adjustment may be necessary in cases of severe renal impairment. Caution is advised in patients with a history of hypotension, as the drug may cause a decrease in blood pressure. Due to its stimulating effect on the central nervous system, it should be used carefully in patients with heightened nervous excitability. The safety and efficacy of meldonium in children and adolescents under 18 years of age have not been established. Its use during pregnancy and lactation is not recommended unless the potential benefit justifies the potential risk to the fetus or infant, as human data is insufficient.
Contraindications
Meldonium is contraindicated in patients with known hypersensitivity to the active substance or any of the excipients in the formulation. Its use is prohibited in cases of severely elevated intracranial pressure, including intracranial tumors and acute disturbances of cerebrovenous outflow. It should not be used in patients with severe hepatic or renal impairment where dosage adjustment is not feasible. Concomitant use with other products containing meldonium or structurally similar compounds is contraindicated.
Possible side effect
Meldonium is generally well-tolerated; however, like all pharmacological agents, it can cause adverse reactions. Side effects are typically mild to moderate and transient.
- Cardiovascular System: Tachycardia (palpitations), blood pressure fluctuations (most commonly hypotension), a feeling of hot flushes.
- Central and Peripheral Nervous System: Psychomotor agitation, emotional lability, headache, dizziness.
- Gastrointestinal System: Dyspepsia, nausea, a feeling of heaviness in the epigastric region.
- Allergic Reactions: Skin rash, pruritus (itching), urticaria, angioedema, and in rare cases, anaphylactoid reactions.
- Other: General weakness, a feeling of fatigue, or, paradoxically, drowsiness in some individuals.
Drug interaction
Clinically significant pharmacokinetic interactions are unlikely due to meldonium’s minimal protein binding and lack of extensive metabolism. However, pharmacodynamic interactions should be considered.
- Antihypertensive Drugs, Vasodilators (e.g., nitrates, calcium channel blockers, ACE inhibitors): Meldonium may potentiate their blood pressure-lowering effect, increasing the risk of hypotension. Blood pressure should be monitored closely.
- Other Cardiotonic and Anti-anginal Agents: Concomitant use is common and may have additive therapeutic effects in the management of cardiac conditions.
- Substances with Stimulating Effects on the CNS (e.g., theophylline, caffeine): May lead to excessive nervous system stimulation, agitation, or tachycardia.
- Diuretics: May enhance the potential for hypotension. Caution is advised.
Missed dose
If a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Do not take a double dose to make up for a missed one. Due to the recommendation to avoid evening doses to prevent sleep disturbances, a dose missed late in the day should generally be omitted.
Overdose
Cases of overdose are rare. Symptoms are likely to be an extension of the drug’s known side effects and may include pronounced hypotension, dizziness, tachycardia, headache, general weakness, and nausea. In case of suspected overdose, discontinue the medication immediately. Treatment is symptomatic and supportive. There is no specific antidote. Hemodialysis may be considered due to the drug’s high renal excretion.
Storage
Store in the original packaging at a temperature not exceeding 25°C (77°F). Protect from light and moisture. Keep the medication out of the sight and reach of children. Do not use after the expiration date printed on the packaging. Do not dispose of medication via wastewater or household waste; consult a pharmacist on proper disposal methods.
Disclaimer
This information is provided for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information presented is based on the typical profile of the drug and may not encompass all available data, including the latest research or regional prescribing variations.
Reviews
- “As a cardiologist, I have incorporated meldonium into the rehabilitation protocols for post-MI patients. The improvement in exercise tolerance and reduction in anginal symptoms in my patient cohort has been notable compared to standard therapy alone.” – Dr. Elena V., Cardiologist
- “Prescribed for chronic fatigue and functional asthenia following a period of intense professional stress. The difference in my energy levels and mental clarity within two weeks was significant. No side effects experienced.” – Patient M., 42
- “Used in our neurology department for patients recovering from ischemic stroke. We observe a positive trend in faster recovery of motor and cognitive functions as part of a comprehensive rehabilitation program.” – Dr. Igor S., Neurologist
- “Noticed a dramatic improvement in my physical endurance during training. However, it’s crucial to note this was under strict medical supervision for a diagnosed cardiac condition, not for athletic enhancement.” – Patient A., 38