- ISCHEMIC HEART DISEASE DRUGS
- CARDIOVASCULAR DRUGS
- Pharmaceutical Form : Film Coated Tablets
- Composition : Isosorbide Dinitrate 10 mg/ Ctd. Tab
- Active Substance : Isosorbide Dinitrate
Isosorbide dinitrate acts as a peripheral and coronary vasodilator which causes relaxation of smooth muscle (producing a vasodilatory effect on both peripheral arteries and veins), lowering of peripheral arterial blood pressure, decreased venous return to the heart and decreased left ventricular filling pressure (preload).
Isosorbide dinitrate is readily absorbed from the oral mucosa and also following oral administration. It undergoes extensive first pass metabolism, mainly in the liver.
The major metabolites are isosorbide 2-mononitrate and isosorbide 5-mononitrate which both possess vasodilatory activity and may contribute to the activity of the parent compound.
Prophylaxis and treatment of angina; left ventricular failure.
hypersensitivity to nitrates; hypotensive conditions and hypovolaemia; hypertrophic cardiomyopathy, aortic stenosis, cardiac tamponade, constrictive pericarditis, mitral stenosis; toxic pulmonary oedema; head trauma, cerebral haemorrhage; cerebrovascular disease; marked anaemia.
The benefits of isosorbide dinitrate in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use isosorbide dinitrate in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
Hepatic Impairment: caution in severe impairment.
Renal Impairment: manufacturers advise use with caution in severe impairment.
Use in pregnancy and lactation:
Pregnancy Category C: There are no adequate, well-controlled studies in pregnant women. Isosorbide dinitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether isosorbide dinitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isosorbide dinitrate is administered to a nursing woman
-ACE inhibitors: enhanced hypotensive effect when ACE inhibitors given with nitrates.
-Adrenergic neuron blockers: enhanced hypotensive effect when adrenergic neuron blockers given with nitrates.
-Alcohol: enhanced hypotensive effect when alcohol given with nitrates.
-Aldesleukin: enhanced hypotensive effect when aldesleukin given with nitrates.
-Alpha-blockers: enhanced hypotensive effect when alpha-blockers given with nitrates.
-General anesthetics: enhanced hypotensive effect when general anesthetics given with nitrates.
-Analgesics: hypotensive effect of nitrates antagonized by NSAIDs.
-Angiotensin-II Receptor Antagonists: enhanced hypotensive effect when nitrates given with angiotensin-II receptor antagonists.
-Antidepressants: enhanced hypotensive effect when nitrates given with MAOIs
-Antipsychotics: enhanced hypotensive effect when nitrates given with phenothiazines, Anxiolytics and Hypnotics.
-Beta-blockers: enhanced hypotensive effect when nitrates given with beta-blockers.
-Calcium-channel Blockers: enhanced hypotensive effect when nitrates given with calcium-channel blockers.
-Clonidine: enhanced hypotensive effect when nitrates given with clonidine.
-Corticosteroids: hypotensive effect of nitrates antagonized by corticosteroids.
-Diazoxide: enhanced hypotensive effect when nitrates given with diazoxide.
-Diuretics: enhanced hypotensive effect when nitrates given with diuretics.
-Dopaminergics: enhanced hypotensive effect when nitrates given with levodopa.
-Methyldopa: enhanced hypotensive effect when nitrates given with methyldopa.
-Moxisylyte (thymoxamine): enhanced hypotensive effect when nitrates given with moxisylyte.
-Moxonidine: enhanced hypotensive effect when nitrates given with moxonidine.
-Muscle Relaxants: enhanced hypotensive effect when nitrates given with baclofen or tizanidine.
-Estrogens: hypotensive effect of nitrates antagonized by estrogens.
-Prostaglandins: enhanced hypotensive effect when nitrates given with alprostadil.
-Sildenafil: hypotensive effect of nitrates significantly enhanced by .sildenafil (avoid concomitant use).
-Tadalafil: hypotensive effect of nitrates significantly enhanced by tadalafil (avoid concomitant use).
-Vardenafil: possible increased hypotensive effect when nitrates given with vardenafil (avoid concomitant use).
-Vasodilator Antihypertensive: enhanced hypotensive effect when nitrates given with hydralazine, minoxidil or sodium nitroprusside
hypothyroidism, malnutrition, hypothermia; recent history of myocardial infarction; heart failure due to
obstruction; hypoxaemia or other ventilation and perfusion abnormalities; susceptibility to angle-closure
glaucoma; metal-containing transdermal systems should be removed before magnetic resonance imaging procedure; cardioversion or diathermy; avoid abrupt withdrawal; monitor blood pressure and heart rate during intravenous infusion.
postural hypotension, tachycardia (but paradoxical bradycardia also reported); throbbing headache, dizziness; less commonly nausea, vomiting, heartburn; flushing; syncope; temporary hypoxaemia; rash.
DOSAGE & ADMINISTRATION:
By mouth, daily in divided doses, angina 30–120 mg, left ventricular failure 40–160 mg, up to 240 mg if required.
Symptoms: The ill effects of isosorbide dinitrate overdose are generally the results of isosorbide dinitrate’s
capacity to induce vasodilation, venous pooling, reduced cardiac output, and hypotension. These haemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion and moderate fever; vertigo; palpitations; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhoea); syncope (especially in the upright posture); air hunger and
dyspnoea, later followed by reduced ventilatory effort; diaphoresis; with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.
Treatment: In general, treatment should be symptomatic and supportive.
STORAGE CONDITIONS: store up to 30ºC.
Box of Isordin 5: (20 – 50) Tab.
Box of Isordin 10: (20 – 50) Tab.
Box of Isordin 20: (20 – 50) Tab.