Europe — EMA
Mildronate (Meldonium Dihydrate)
GNH USA supplies Mildronate (Meldonium), a cardiovascular anti‑ischemic agent for ischemic heart disease, angina and chronic heart failure.
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What is Meldonium Dihydrate?
Meldonium, the active ingredient in Mildronate, is an anti‑ischemic agent presented as an oral tablet for oral administration. It is used to enhance myocardial energy metabolism by shifting substrate utilization toward glucose, thereby improving oxygen efficiency in patients with ischemic heart disease, angina, chronic heart failure and related vascular conditions.
GNH USA supplies Mildronate as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, pharmacies, and clinics across global markets while adhering to EU quality standards and regulatory requirements.
What is Meldonium Dihydrate used for?
Mildronate (meldonium) is indicated for several cardiovascular conditions where myocardial oxygen demand exceeds supply.
- Ischemic heart disease: improves cardiac efficiency and reduces frequency of angina episodes in patients with reduced coronary blood flow. - Angina pectoris: alleviates chest pain by enhancing myocardial energy utilization during periods of increased demand. - Chronic heart failure: supports ventricular function and exercise tolerance, helping to mitigate symptoms of reduced cardiac output. - Peripheral arterial disease: promotes blood flow in compromised limbs, aiding in symptom relief and walking capacity. - Exercise intolerance: increases stamina by optimizing skeletal muscle metabolism and reducing fatigue during physical activity.
What are the side effects of Meldonium Dihydrate?
Meldonium may be associated with a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Headache - Nausea or gastrointestinal discomfort - Dizziness
Serious or Rare Side Effects: - Allergic reactions (rash, angioedema) - Hypotension or significant blood pressure changes - Cardiac arrhythmias
What precautions apply to Meldonium Dihydrate?
When prescribing Meldonium, clinicians should consider several precautionary measures to ensure safe use. - Cardiovascular monitoring: assess blood pressure and heart rate before and during therapy. - Renal or hepatic impairment: use with caution and adjust if organ function is compromised. - Concomitant anti‑arrhythmic drugs: monitor for additive effects on cardiac rhythm. - Pregnancy and lactation: avoid use unless benefits clearly outweigh potential risks. - Elderly patients: start at lower dose and observe for tolerance. - Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture.
What does Meldonium Dihydrate interact with?
Meldonium can interact with other medicines, influencing its efficacy or safety profile.
Major Interactions (Avoid): - Strong CYP450 inducers: may reduce Meldonium plasma levels, diminishing therapeutic effect. - Concurrent use with other anti‑ischemic agents: risk of excessive cardiovascular depression.
Moderate Interactions (Monitor Closely): - Antihypertensive drugs: potential additive blood pressure lowering. - Diuretics: may exacerbate electrolyte disturbances. - Anticoagulants: monitor for altered bleeding risk.



