Europe — EMA
Isosorbide Mononitrate Milpharm
GNH USA supplies Isosorbide Mononitrate Milpharm (Isosorbide Mononitrate), an organic nitrate for chronic stable angina pectoris.
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What is Isosorbide Mononitrate, Diluted Ph. Eur.?
Isosorbide Mononitrate, the active ingredient in Isosorbide Mononitrate Milpharm, is an organic nitrate presented as an oral tablet for oral use. It is employed to relieve chronic stable angina pectoris in adult patients who require long‑term anti‑anginal therapy.
GNH USA supplies Isosorbide Mononitrate Milpharm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Isosorbide Mononitrate, Diluted Ph. Eur. used for?
Isosorbide Mononitrate belongs to the organic nitrate class and is used to manage coronary artery disease‑related angina.
- Chronic stable angina pectoris: improves myocardial oxygen supply by reducing cardiac preload and afterload, thereby decreasing the frequency of angina attacks. - Variant (Prinzmetal) angina: provides prophylactic relief through sustained vasodilation of coronary vessels. - Post‑myocardial infarction angina prophylaxis: helps prevent recurrent chest pain during the recovery phase.
What are the side effects of Isosorbide Mononitrate, Diluted Ph. Eur.?
Isosorbide Mononitrate may cause a range of adverse reactions, from mild to severe.
Common Side Effects: - Headache: throbbing or pressure‑type pain, often transient. - Dizziness or light‑headedness: related to blood pressure reduction. - Flushing: warm sensation with reddening of the skin. - Nausea or abdominal discomfort. - Hypotension: mild drop in blood pressure, especially after the first dose.
Serious or Rare Side Effects: - Severe hypotension: marked blood pressure fall requiring medical attention. - Syncope: fainting episodes due to sudden circulatory changes. - Tachycardia: rapid heart rate as a compensatory response. - Allergic reactions: rash, pruritus, or angioedema. - Worsening angina or myocardial ischemia despite therapy.
What precautions apply to Isosorbide Mononitrate, Diluted Ph. Eur.?
Before initiating therapy, clinicians should evaluate cardiovascular status and consider patient‑specific factors. - Assess blood pressure: ensure baseline values are adequate to tolerate vasodilation. - Monitor for hypotension: especially after dose escalation or when combined with other vasodilators. - Avoid abrupt discontinuation: taper to prevent rebound angina. - Caution in hepatic impairment: dose adjustment may be required. - Use with care in elderly patients: increased sensitivity to blood pressure changes. - Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.
What does Isosorbide Mononitrate, Diluted Ph. Eur. interact with?
Isosorbide mononitrate can interact with several drug classes, altering its safety profile.
Major Interactions (Avoid): - Other nitrates (e.g., nitroglycerin, isosorbide dinitrate): additive vasodilatory effect leading to severe hypotension. - Phosphodiesterase‑5 inhibitors (e.g., sildenafil, tadalafil): risk of profound blood pressure fall. - Alcohol: potentiates hypotensive response.
Moderate Interactions (Monitor Closely): - Antihypertensive agents (ACE inhibitors, beta‑blockers): may enhance blood pressure lowering. - Diuretics: can increase risk of dehydration and hypotension. - CYP3A4 inhibitors (e.g., erythromycin, ketoconazole): may raise plasma levels of isosorbide mononitrate. - Antiplatelet drugs: monitor for increased bleeding tendency.
Frequently asked questions
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Product details
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