Dinitra 10 mg 60 tablets

Dinitra 10 mg 60 tablets

Active Ingredients:

Each tablet contains:

Isosorbide dinitrate 10 mg

Inactive ingredients:

Lactose D.C., croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.

Clinical Pharmacology:

The principal pharmacological action of Isosorbide dinitrate is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation 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 lesistance, 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.

Indications and usage:

Dinitra tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. 

Contraindications:

The Isosorbide dinitrate tablet is contraindicated in patients who are allergic to Isosorbide dinitrate or any of its other ingredients.

Warning:

Amplification of the vasodilatory effects of lisosorbide dinitrate by sildenafil can result in severe hypotension.

Precautions:

General: Severe hypotension, particularly with upright posture, may occur with even small doses of Isosorbide dinitratete. 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 Isosorbide dinitrate may be accompanied by paradoxical bradycardia and increased angina pectoris.

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

Drug Interactions:

The vasodilating effects of Isosorbide dinitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Pregnancy and Nursing Mothers:

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.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Dosage and administration:

With immediate-release Isosorbide dinitratete, it appears that one daily dose-free interval must be at least 14 hours long.

The usual starting dose of isosorbide dinitrate oral tablets is 5 mg to 20 mg, two or three times daily. 

For maintenance therapy, 10 mg to 40 mg, two or three times daily is recommended. Some patients may require higher doses. 

A patient anticipating activity likely to cause angina should take one isosorbide dinitrate sublingual tablet (2.5 to 5 mg) about 15 minutes before the activity is expected to begin.

Isosorbide dinitrate sublingual tablets may be used to abort an acute anginal episode, but its use is recommended only in patients who fail to respond to sublingual nitroglycerin.

Storage:

Store at a temperature not exceeding 30 C.

Package:

A Carton Box contains blisters with 60 tablets.