Europe — EMA
Monosordil (Isosorbide 5 Mononitrate)
GNH USA supplies Monosordil (Isosorbide 5 Mononitrate), a nitrate vasodilator for angina pectoris and chronic stable angina.
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What is Isosorbide 5 Mononitrate?
Isosorbide 5-mononitrate, the active ingredient in Monosordil, is a nitrate vasodilator presented as an oral tablet for oral use. It is indicated for the prevention and treatment of angina pectoris in adults. GNH USA supplies Monosordil as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Isosorbide 5 Mononitrate used for?
Monosordil belongs to the nitrate vasodilator class and is used to manage coronary artery disease‑related chest pain. - Angina pectoris: reduces the frequency and severity of chest pain episodes. - Chronic stable angina: improves exercise tolerance and delays onset of symptoms. - Coronary artery disease‑related chest pain: provides prophylactic relief of anginal attacks.
What are the side effects of Isosorbide 5 Mononitrate?
Isosorbide 5‑mononitrate may cause a range of adverse reactions, most of which are dose‑related and transient.
Common Side Effects: - Headache: throbbing pain often occurring shortly after dosing. - Dizziness or light‑headedness: related to blood pressure reduction. - Flushing: warm sensation and reddening of the skin. - Hypotension: mild to moderate drop in blood pressure. - Nausea: occasional gastrointestinal upset. - Palpitations: awareness of heartbeat irregularities.
Serious or Rare Side Effects: - Severe hypotension: marked drop in blood pressure requiring medical attention. - Syncope: fainting episodes due to inadequate cerebral perfusion. - Myocardial infarction: rare but possible in susceptible patients. - Allergic reaction: rash, itching, or swelling indicating hypersensitivity. - Methemoglobinemia: rare blood disorder causing reduced oxygen delivery.
What precautions apply to Isosorbide 5 Mononitrate?
Before initiating therapy with Monosordil, clinicians should consider several safety measures. - Cardiovascular assessment: evaluate baseline blood pressure and heart rate. - Concomitant nitrate use: avoid combining with other nitrates to prevent excessive hypotension. - Phosphodiesterase‑5 inhibitors: do not co‑administer with sildenafil, tadalafil, or similar agents. - Hepatic impairment: use with caution in patients with liver dysfunction. - Pregnancy and lactation: safety not established; weigh potential benefits against risks. - Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.
What does Isosorbide 5 Mononitrate interact with?
Isosorbide 5‑mononitrate can interact with several drug classes, influencing its safety profile.
Major Interactions (Avoid): - Other nitrates (e.g., nitroglycerin, isosorbide dinitrate): risk of profound hypotension. - Phosphodiesterase‑5 inhibitors (sildenafil, tadalafil, vardenafil): may cause severe blood pressure drops.
Moderate Interactions (Monitor Closely): - Antihypertensive agents (beta‑blockers, ACE inhibitors, calcium channel blockers): additive blood pressure‑lowering effect. - Diuretics: may enhance orthostatic hypotension. - Alcohol: can increase vasodilatory effects and dizziness.



