isosorbide mononitrate


Micro Labs


Zizawa Healthcare
Full Prescribing Info
Isosorbide mononitrate.
Each film-coated also contains the following excipients: Lactose, hypromellose K4M, isopropyl alcohol, povidone, magnesium stearate, tablet coat (TC5035) and dichloromethane.
Isosorbide mononitrate is 1,4:3,6-dianhydro-D-glucitol, 5-nitrate.
Pharmacotherapeutic Group: Antiangina pectoris. ATC Code: C01DA14, vasodilator used in cardiac diseases.
Pharmacology: Isosorbide mononitrate is an organic nitrate, a vasodilator which is common with other cardioactive nitrates. It produces decreased left and right ventricular end-diastolic pressures to a greater extent than the decrease in systemic arterial pressure; thereby, reducing afterload and especially, the preload of the heart.
Isosorbide mononitrate influences the oxygen supply to ischaemic myocardium by causing the redistribution of blood flow along collateral channels and from epicardial to endocardial regions by selective dilation of large epicardial vessels. It reduces the requirement of the myocardium for oxygen by increasing venous capacity causing a pooling of blood in peripheral veins; thereby, reducing ventricular volume and heart wall distension.
Pharmacokinetics: Isosorbide mononitrate is readily absorbed from the gastrointestinal tract. Following oral administration of conventional tablets, peak plasma levels are reached in 30 min to 1 hr; onset of actions occur within 20 min and lasts for about 8-10 hrs. Isosorbide mononitrate does not undergo first-pass hepatic metabolism and bioavailability is nearly 100%. Isosorbide mononitrate is widely distributed with a large apparent volume of distribution. It is taken up by smooth muscle cells of blood vessels, and the nitrate group is cleaved to inorganic nitrate and then to nitric oxide. Isosorbide mononitrate is metabolized to inactive metabolites. Only about 2% of isosorbide mononitrate is excreted unchanged in urine. An elimination half-life of about 4-5 hrs has been reported.
Prophylaxis of angina pectoris. Adjunctive therapy in congestive heart failure not responding to cardiac glycosides or diuretics.
Dosage/Direction for Use
Adults: Initially, 30-60 mg given orally in the morning as a single dose; titrate upward as needed giving at least 3 days interval. Maximum Daily Single Dose: 240 mg.
Symptoms: Headache, hypotension, nausea, vomiting, sweating, tachycardia, vertigo, restlessness, warm flushed skin, blurred vision and syncope. A rise in intracranial pressure with confusion and neurological deficits can sometimes occur. Methaemoglobinemia.
Treatment: Consider oral activated charcoal if ingestion of a potentially toxic amount has occurred within 1 hr. Observe for at least 12 hrs after the overdose. Monitor blood pressure and pulse. Correct hypotension by raising the foot of the bed and/or by expanding the intravascular volume. Other measures as indicated by the patient's clinical condition. If severe hypotension persist despite the above measures, consider the use of inotropes.
Known hypersensitivity to isosorbide mononitrate, to any of the excipients of Nitrofix-SR or to other nitrates.
Acute myocardial infarction with low filling pressure, acute circulatory failure (shock, vascular collapse), very low blood pressure, hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intracranial pressure eg, following a head trauma and including cerebral hemorrhage.
Special Precautions
Isosorbide mononitrate should be used with caution in patients who have a recent history of myocardial infarction or who are suffering from hypothyroidism, hypothermia, malnutrition, and severe liver or renal disease.
Isosorbide mononitrate tablets contain lactose and therefore, it should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Use in pregnancy: No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide mononitrate in pregnancy.
Use in children: The safety and efficacy in children has not been established.
Use In Pregnancy & Lactation
Use in pregnancy: No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide mononitrate in pregnancy.
Adverse Reactions
A very common (>10% of patients) adverse reactions to isosorbide mononitrate is throbbing headache. The incidence of headache diminishes gradually with time and continued use. At the start of therapy or when the dosage is increased, hypotension and/or lightheadedness in the upright position are commonly observed (ie in 1-10% of patients). These symptoms may be associated with dizziness, drowsiness, reflex tachycardia and a feeling of weakness.
Drug Interactions
Concurrent administration of drugs with blood pressure-lowering properties eg, β-blockers, calcium-channel blockers, vasodilators, alprostadil, aldesleukin, angiotensin II receptor antagonist and/or alcohol may potentiate the hypotensive effect of isosorbide mononitrate. This may also occur with neuroleptics and tricyclic antidepressants.
Store below 30°C.
MIMS Class
Anti-Anginal Drugs
ATC Classification
C01DA14 - isosorbide mononitrate ; Belongs to the class of organic nitrate vasodilators. Used in the treatment of cardiac disease.
FC tab 30 mg x 3 x 10's. 60 mg x 3 x 10's.
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