Please sign in so that we can notify you about a reply
Indications/Uses
Long-term treatment of circulatory disorders affecting the coronary arteries (ischaemic heart disease). Prevention of attacks of angina (heart pain). Follow-up treatment of heart attacks when symptoms of angina persist. High blood pressure in the lung circulation (pulmonary hypertension). Treatment of severe weakness of heart muscle (chronic cardiac failure), in combination with cardiac glycosides and/or diuretics.
Dosage/Direction for Use
Unless otherwise prescribed, 40 mg once daily or 20 mg twice daily.
In exceptional cases, the dose may be increased to 40 mg twice daily. In order to obtain the full effect of the drug, when a daily dose of 40 mg twice daily is taken, the second tablet should not be taken not more than 8 hours after the first tablet.
Route and Duration of Use: Tablets should be swallowed whole with a little fluid after meals.
Treatment with ISMN should not be abruptly discontinued, but tailed off gradually, since withdrawal phenomena (a "rebound effect") cannot be ruled out.
In exceptional cases, the dose may be increased to 40 mg twice daily. In order to obtain the full effect of the drug, when a daily dose of 40 mg twice daily is taken, the second tablet should not be taken not more than 8 hours after the first tablet.
Route and Duration of Use: Tablets should be swallowed whole with a little fluid after meals.
Treatment with ISMN should not be abruptly discontinued, but tailed off gradually, since withdrawal phenomena (a "rebound effect") cannot be ruled out.
Overdosage
Symptoms and Treatment for Overdosage and Antidote: Depending on the degree of intoxication, the clinical picture includes the following principal symptoms: Hypotension with reflex tachycardia, weakness, dizziness, confusion, headache, asthmatic symptoms, flushing, nausea, vomiting, diarrhea. With severe intoxication, cyanosis, dyspnea, confusion, slowing of breathing and heart rate, and paralysis may develop.
Very high doses may lead to a rise in intracranial pressure with cerebral symptoms. With chronic overdosage, methemoglobinemia may occur.
Treatment of Overdosage: In addition to general measures eg, gastric lavage and supine posture with elevation of the legs, patients must be given intensive care with monitoring and if necessary correction of vital parameters. In the presence of severe hypotension and/or shock, volume replacement should be given. In addition, noradrenaline and/or dopamine may be infused to assist the circulation.
Administration of adrenaline and related substances is contraindicated.
In methemoglobinemia, exchange transfusion is given. In milder cases, 10-20 mL of methylene blue solution (1%) is given intravenously.
Very high doses may lead to a rise in intracranial pressure with cerebral symptoms. With chronic overdosage, methemoglobinemia may occur.
Treatment of Overdosage: In addition to general measures eg, gastric lavage and supine posture with elevation of the legs, patients must be given intensive care with monitoring and if necessary correction of vital parameters. In the presence of severe hypotension and/or shock, volume replacement should be given. In addition, noradrenaline and/or dopamine may be infused to assist the circulation.
Administration of adrenaline and related substances is contraindicated.
In methemoglobinemia, exchange transfusion is given. In milder cases, 10-20 mL of methylene blue solution (1%) is given intravenously.
Administration
SR cap: May be taken with or without food: Swallow whole, do not chew/crush., Tab: Should be taken with food.
Contraindications
ISMN must not be used in patients with: Hypersensitivity to nitrate compounds, acute myocardial infarction with low filling pressures, impaired function of the left ventricle (left heart failure) with low filling pressures), shock, very low blood pressure, disease of the heart muscle with narrowing of the cavity of the heart (hypertrophic obstructive cardiomyopathy), constrictive pericarditis, pericardial tamponade, aortic stenosis, mitral stenosis, marked anaemias, head trauma, cerebral hemorrhage, closed-angle glaucoma, hyperthyroidism, concomitant therapy with sildenafil citrate.
Note: Administration of ISMN, particularly to patients with high blood pressure of unknown cause in the lung circulation (primary pulmonary hypertension) may give rise to transient reduction in the oxygen content of the arterial blood (hypoxaemia), due to the passage of a relative excess of blood to under-ventilated segments of the lung (hyperperfusion of hypoventilated alveolar territory).
This applies particularly to patients with circulatory disorders of the coronary arteries (ischaemic heart disease).
Particularly careful medical supervision is required in: Aortic and/or mitral stenosis, tendency to circulatory disorders associated with low blood pressure (orthostatic circulatory disorders), diseases associated with increased pressure inside the skull (intracranial hypertension) (further increases in pressure have so far only been observed in association with intravenous administration of glyceryl trinitrate), patients with severe disorders of kidney function.
ISMN is not suitable for the treatment of acute attacks of angina.
Note: Administration of ISMN, particularly to patients with high blood pressure of unknown cause in the lung circulation (primary pulmonary hypertension) may give rise to transient reduction in the oxygen content of the arterial blood (hypoxaemia), due to the passage of a relative excess of blood to under-ventilated segments of the lung (hyperperfusion of hypoventilated alveolar territory).
This applies particularly to patients with circulatory disorders of the coronary arteries (ischaemic heart disease).
Particularly careful medical supervision is required in: Aortic and/or mitral stenosis, tendency to circulatory disorders associated with low blood pressure (orthostatic circulatory disorders), diseases associated with increased pressure inside the skull (intracranial hypertension) (further increases in pressure have so far only been observed in association with intravenous administration of glyceryl trinitrate), patients with severe disorders of kidney function.
ISMN is not suitable for the treatment of acute attacks of angina.
Special Precautions
Precautionary Statement: Development of tolerance may occur with all forms of nitrate therapy particularly with the long-acting preparations that maintain continuously high plasma nitrate concentration.
Special Note: Even when appropriately used, the use of this drug may alter the patient's reaction times to such an extent as to impair the capacity to drive or operate machinery. This applies particularly in combination with alcohol.
Special Note: Even when appropriately used, the use of this drug may alter the patient's reaction times to such an extent as to impair the capacity to drive or operate machinery. This applies particularly in combination with alcohol.
Adverse Reactions
Nitrate headache. Fall in BP. Nausea, vomiting, transient skin disorders & allergic skin reactions.
Drug Interactions
Simultaneous ingestion of blood pressure lowering agents (antihypertensive agents), beta blockers, calcium antagonists, other blood vessel dilating agents (vasodilators), neuroleptics or tricyclic antidepressants and alcohol may potentiate the blood pressure lowering effect of ISMN.
The blood pressure raising effect of dihydroergotamine may be increased by simultaneous ingestion of ISMN. Weakening of the effect of ISMN by the ingestion of non-steroidal antirheumatic drugs cannot be ruled out. Concomitant therapy with NO-donators eg, the active substance of ISMN and sildenafil citrate a marked increase of blood lowering effect may occur.
The blood pressure raising effect of dihydroergotamine may be increased by simultaneous ingestion of ISMN. Weakening of the effect of ISMN by the ingestion of non-steroidal antirheumatic drugs cannot be ruled out. Concomitant therapy with NO-donators eg, the active substance of ISMN and sildenafil citrate a marked increase of blood lowering effect may occur.
Storage
Store at temperatures not exceeding 30°C. Keep dry and protect from light.
Action
Mode of Action: Isosorbide-5-mononitrate has a direct relaxant effect on vascular smooth muscle and leads to vasodilation. Isosorbide-5-mononitrate causes dilatation particularly of venous vessels. The blood supply to the heart is reduced and the preload causes a fall in the raised filling pressures of both ventricles with a consequent reduction in ventricular size and wall tension. This results in reduced myocardial oxygen consumption. Arterial dilatation also occurs, leading to a reduction in afterload and a fall in blood pressure.
Finally, there is also a coronary vasodilator effect.
Pharmacokinetics Data: Isosorbide is rapidly and completely absorbed following oral administration. The systemic availability is 90-100%. Isosorbide-5-mononitrate is almost completely metabolised in the liver. The metabolites formed are inactive. The plasma half-life is 4-5 hours. Isosorbide-5-mononitrate is almost entirely excreted by the kidneys in the form of its metabolites. Only approximately 2% is eliminated by the kidneys in unchanged form. In the presence of impaired renal function, the plasma half-life may be prolonged.
Finally, there is also a coronary vasodilator effect.
Pharmacokinetics Data: Isosorbide is rapidly and completely absorbed following oral administration. The systemic availability is 90-100%. Isosorbide-5-mononitrate is almost completely metabolised in the liver. The metabolites formed are inactive. The plasma half-life is 4-5 hours. Isosorbide-5-mononitrate is almost entirely excreted by the kidneys in the form of its metabolites. Only approximately 2% is eliminated by the kidneys in unchanged form. In the presence of impaired renal function, the plasma half-life may be prolonged.
MedsGo Class
Anti-Anginal Drugs
Features
Brand
Angistad
Full Details
Dosage Strength
20 mg
Drug Ingredients
- Isosorbide
Drug Packaging
Tablet 1's
Generic Name
Isosorbide Mononitrate
Dosage Form
Tablet
Registration Number
DRP-528
Drug Classification
Prescription Drug (RX)