Europe — EMA
Mildronate (Meldonium Dihydrate)
GNH USA supplies Mildronate (Meldonium), a modulator for ischemic heart disease, angina and heart failure. Request a quote for supply to hospitals worldwide.
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What is Meldonium Dihydrate?
Meldonium, the active ingredient in Mildronate, is a metabolic modulator presented as an oral tablet for oral use. It improves cardiac efficiency under ischemic conditions and is used to treat ischemic heart disease and related cardiovascular disorders in adult patients.
GNH USA supplies Mildronate as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on reliable quality and regulatory compliance for EU‑approved medicines. The product meets European Union pharmacopeia standards and is available for export.
What is Meldonium Dihydrate used for?
Mildronate acts on cardiac metabolism and is indicated for several ischemic cardiovascular conditions.
- Ischemic heart disease: improves myocardial oxygen utilization and reduces angina episodes. - Angina pectoris: alleviates chest pain by enhancing cardiac energy efficiency. - Chronic heart failure: supports ventricular function and may improve exercise tolerance. - Peripheral arterial disease: helps relieve intermittent claudication by improving peripheral blood flow.
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: - Nausea: mild to moderate stomach upset, may be accompanied by loss of appetite, usually resolves without treatment. - Headache: tension‑type headache, often mild, can be alleviated with simple analgesics if needed. - Dizziness: occasional light‑headedness, particularly when changing posture, generally transient and self‑limiting. - Fatigue: persistent sense of tiredness or reduced energy that does not improve with rest.
Serious or Rare Side Effects: - Severe allergic reaction (anaphylaxis): rapid development of rash, facial swelling, difficulty breathing, and hypotension requiring immediate medical care. - Cardiac arrhythmia: emergence of irregular heart rhythm, palpitations, or syncope that may necessitate cardiac monitoring.
What precautions apply to Meldonium Dihydrate?
When prescribing Meldonium, clinicians should consider several precautionary measures to ensure safe use. - Renal impairment: adjust dosing and monitor renal function regularly. - Hepatic dysfunction: evaluate liver enzymes before initiation and during therapy. - Pregnancy: avoid use unless potential benefit justifies potential risk to the fetus. - Elderly patients: start with lower dose and observe for increased sensitivity. - Concomitant anti‑ischemic agents: monitor for additive cardiovascular effects. - Store at room temperature: keep tablets in original packaging, protect from moisture and light.
What does Meldonium Dihydrate interact with?
Meldonium can interact with other medicines, influencing its efficacy or safety profile.
Major Interactions (Avoid): - Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis due to overlapping metabolic effects. - Strong CYP450 inducers (e.g., rifampicin): may markedly reduce Meldonium plasma levels, diminishing therapeutic benefit.
Moderate Interactions (Monitor Closely): - Beta‑blockers: additive anti‑ischemic action may require blood pressure monitoring. - Calcium channel blockers: potential for enhanced vasodilatory effect, observe for hypotension. - Nitrates: combined use may increase risk of severe headache or hypotension.



