Europe — EMA
Mildronate (Meldonium Dihydrate)
GNH USA supplies Mildronate (Meldonium), a compound for ischemic heart disease, angina pectoris and heart failure.
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What is Meldonium Dihydrate?
Meldonium, the active ingredient in Mildronate, is a compound presented as an oral formulation for oral use. It is used in the management of ischemic heart disease, angina pectoris and heart failure in adult patients. 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 acts on myocardial energy metabolism and is employed in several cardiovascular conditions.
Ischemic heart disease: improves myocardial efficiency and reduces episodes of chest pain. Angina pectoris: enhances cardiac tolerance to exertion and lessens frequency of anginal attacks. Heart failure: supports ventricular function by shifting energy substrate utilization toward glucose.
What are the side effects of Meldonium Dihydrate?
Meldonium may be associated with several adverse reactions that vary in frequency and severity.
Common Side Effects: - Nausea - Headache - Dizziness - Gastrointestinal discomfort - Insomnia - Fatigue
Serious or Rare Side Effects: - Cardiac arrhythmias - Severe hypotension - Allergic skin reactions (rash, pruritus) - Elevated liver enzymes - Myocardial infarction in predisposed patients
What precautions apply to Meldonium Dihydrate?
When prescribing Meldonium, clinicians should consider several safety measures.
Assess cardiac status: evaluate baseline heart function and ischemic burden. Monitor blood pressure: watch for hypotensive episodes, especially during dose initiation. Evaluate renal function: adjust use in patients with significant renal impairment. Review concomitant medications: consider potential additive effects on cardiac metabolism. Avoid use in known hypersensitivity: discontinue if allergic reactions occur. Store at ambient temperature: keep in the original packaging, protect from moisture and direct sunlight.
What does Meldonium Dihydrate interact with?
Meldonium can interact with other medicines that affect cardiac metabolism or hemodynamics.
Major Interactions (Avoid): - MAO inhibitors: risk of severe hypertension. - Strong CYP450 inhibitors (e.g., ketoconazole): may increase Meldonium plasma levels. - Anti‑arrhythmic agents: potential additive effects on cardiac rhythm. - Anticoagulants: heightened bleeding risk. - High‑dose statins: possible muscle toxicity.
Moderate Interactions (Monitor Closely): - Beta‑blockers: monitor heart rate and blood pressure. - Diuretics: watch for electrolyte disturbances. - ACE inhibitors or ARBs: assess renal function and blood pressure. - Other metabolic modulators: observe for altered efficacy. - Herbal supplements (e.g., ginseng): may influence cardiovascular response.



