Monocard20 mg

Monocard 20 mg is indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral Monocard 20 mg is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Nitrates: Coronary vasodilators

Isosorbide mononitrate relaxes vascular smooth muscles by stimulating cyclic-GMP. It decreases left ventricular pressure (preload) and arterial resistance (afterload).

The usual oral dose is 1 capsule (50 mg) daily or as directed by the registered physician.The recommended regimen of Monocard 20 mg tablets is 20 mg (one tablet) twice daily, with the two doses given 7 hours apart. For most patients, this can be accomplished by taking the first dose on awakening and the second dose 7 hours later. Dosage adjustments are not necessary for elderly patients or patients with altered renal or hepatic function. Multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The dosing regimen for Monocard 20 mg tablets provides a daily nitrate-free interval to avoid the development of this tolerance. Well-controlled studies have shown that tolerance to Monocard 20 mg tablets is avoided when using the twice-daily regimen in which the two doses are given 7 hours apart. This regimen has been shown to have antianginal efficacy beginning 1 hour after the first dose and lasting at least 5 hours after the second dose. The duration (if any) of antianginal activity beyond 12 hours has not been studied; large controlled studies with other nitrates suggest that no dosing regimen should be expected to provide more than about 12 hours of continuous antianginal efficacy per day.In clinical trials, Monocard 20 mg tablets have been administered in a variety of regimens. Single doses less than 20 mg have not been adequately studied, while single doses greater than 20 mg have demonstrated no greater efficacy than doses of 20 mg.

Tablet: The usual oral dose is 1 tablet (20 mg) 2 times daily, first dose in the morning and another 7 hours apart. Although maintenance doses ranging from 20 mg to 120 mg (1-6 tablets), a dose of 10 mg (1/2 tablet) is suitable when lower dosage is used at the starting of treatment or as directed by a registered physician.Sustained Release Capsule: The usual oral dose is 1 capsule (50 mg) daily or as directed by the registered physician.

Concomitant use of Monocard 20 mg with phosphodiesterase inhibitors in any form is contraindicated. Concomitant use of Monocard 20 mg with riociguat, a soluble guanylate cyclase stimulator, is contraindicated. The vasodilating effects of Monocard 20 mg may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety. Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

Isosorbide mononitrate is contraindicated in patients who are allergic to it. Do not use Monocard 20 mg in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use Monocard 20 mg in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Headache, feelings of dizziness, hypotension may occur sometimes.

There are no adequate and controlled studies to date with Isosorbide-5-mononitrate in pregnant women, and the drug should be used during pregnancy only when the potential benefit justified possible risks to the fetus. Execration of Isosorbide-5-mononitrate into human milk is unknown, so precaution should be taken when it is administered to a nursing mother.

Severe hypotension, particularly with upright posture, may occur with even small doses of Monocard 20 mg. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by Monocard 20 mg may be accompanied by paradoxical bradycardia and increased angina pectoris. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence. The importance of these observations to the routine, clinical use of oral Monocard 20 mg is not known.Patients should be told that the antianginal efficacy of Monocard 20 mg tablets can be maintained by carefully following the prescribed schedule of dosing (two doses taken seven hours apart). For most patients, this can be accomplished by taking the first dose on awakening and the second dose 7 hours later.As with other nitrates, daily headaches sometimes accompany treatment with Monocard 20 mg. In patients who get these headaches, the headaches are a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with Monocard 20 mg, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Aspirin and/or acetaminophen, on the other hand, often successfully relieve Monocard 20 mg-induced headaches with no deleterious effect on Monocard 20 mg’s antianginal efficacy.Treatment with Monocard 20 mg may be associated with light-headedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.

Symptoms: Most common symptoms are hypotension, throbbing headache, tachycardia, and flushing. Methemoglobinemia may occur with massive doses.Treatment: Treatment consists of placing patients in recumbent position and administering fluids; alpha-adrenergic vasopressors may be required. Methemoglobinemia should be treated with methyline blue at a dose of 1-2 mg/kg IV slowly.

Store at 20°-30°C.

Nitrates: Coronary vasodilators

Isosorbide mononitrate is the major active metabolite of isosorbide dinitrate (ISDN), and most of the clinical activity of the dinitrate is attributable to the mononitrate. The principal pharmacological action of Monocard 20 mg is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and  pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction and coronary dilatation remains undefined.

Pregnancy Category B: Reproduction studies performed in rats and rabbits at doses of up to 540 and 810 mg/kg/day, respectively, have revealed no evidence of harm to the fetus due to Monocard 20 mg. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Monocard 20 mg should be used during pregnancy only if clearly needed.Nursing Mothers: It is not known whether Monocard 20 mg is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Monocard 20 mg is administered to a nursing woman.