Europe — EMA
Mildronate (Meldonium Dihydrate)
GNH USA supplies Mildronate (Meldonium), a cardioprotective anti‑ischemic agent for ischemic heart disease, angina and heart failure.
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What is Meldonium Dihydrate?
Meldonium, the active ingredient in Mildronate, is a cardioprotective agent presented as an oral tablet for oral use. It is employed to improve myocardial efficiency in patients with ischemic heart conditions such as angina, heart failure, and cerebral ischemia. The drug works by modulating cardiac energy metabolism, shifting substrate utilization toward glucose, which enhances performance under low‑oxygen conditions. Mildronate is marketed across the European Union and is available only by prescription and is distributed by authorized wholesalers to healthcare facilities.
GNH USA supplies Mildronate as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Meldonium Dihydrate used for?
Mildronate is used in the management of cardiovascular and cerebrovascular ischemic conditions. - Ischemic heart disease: improves myocardial efficiency and reduces symptoms of chest pain. - Angina pectoris: decreases frequency and severity of anginal attacks. - Heart failure: supports cardiac output by enhancing energy metabolism. - Cerebral ischemia: may aid recovery by improving neuronal energy utilization.
What are the side effects of Meldonium Dihydrate?
Meldonium may be associated with several adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Nausea: mild gastrointestinal upset reported in some patients. - Headache: transient headache occurring early in therapy. - Dizziness: occasional light‑headedness, especially on standing. - Insomnia: difficulty sleeping reported by a minority.
Serious or Rare Side Effects: - Severe hypotension: marked drop in blood pressure requiring medical attention. - Cardiac arrhythmia: irregular heart rhythm that may be life‑threatening. - Allergic reaction: rash, itching, or swelling indicating hypersensitivity. - Hepatic enzyme elevation: significant increase in liver function tests.
What precautions apply to Meldonium Dihydrate?
When prescribing Meldonium, clinicians should consider several precautionary measures to ensure safe use. - Cardiac monitoring: assess heart function regularly during treatment. - Renal impairment: adjust dosage or monitor closely in patients with reduced kidney function. - Hypersensitivity: discontinue if signs of allergic reaction appear. - Pregnancy and lactation: use only if potential benefit justifies potential risk, as safety data are limited. - Concomitant anti‑ischemic drugs: evaluate for additive hypotensive effects. - Store at room temperature: keep in the original packaging, protect from moisture and direct sunlight.
What does Meldonium Dihydrate interact with?
Meldonium can interact with other medicines, requiring attention to avoid adverse outcomes.
Major Interactions (Avoid): - MAO inhibitors: combined use may exacerbate hypotensive episodes. - Strong vasodilators: concurrent administration can lead to excessive blood pressure reduction.
Moderate Interactions (Monitor Closely): - Beta‑blockers: may enhance bradycardic effects; monitor heart rate. - Nitrates: additive vasodilatory action may increase risk of dizziness. - Anticoagulants: monitor coagulation parameters as metabolic changes could affect drug levels.



