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Dilatrate-SR 40mg Caps 1X100 each Mfg.by: Auxilum Pharmaceuticals

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Dilatrate-SR 40mg Caps 1X100 each Mfg.by: Auxilum Pharmaceuticals

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Dilatrate-SR 40mg Caps 1X100 each Mfg.by: Auxilum Pharmaceuticals. This item requires a valid order from a physician licensed in the USA. Item No.:RXD1169580/RXB10032013. NDC: 00091-0920-01
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Supplier Material : 092001Generic Code : 000505 ISOSORBIDE DINITRATE ORAL CAPSULE ER 40
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Description
The organic nitrates are vasodilators, active on both arteries and veins. Each dilatrate?-SR sustained release capsule contains 40 mg of isosorbide dinitrate, in a micro-dialysis delivery system that causes the active drug to be released over an extended period. Each capsule also contains ethylcellulose, lactose, pharmaceutical glaze, starch, sucrose and talc. The capsule shells contain D&C Red 33, D&C Yellow 10, gelatin and titanium dioxide.

Indications and Usage

dilatrate?-SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Contraindications

Allergic reactions to organic nitrates are extremely rare, but they do occur. Isosorbide dinitrate is contraindicated in patients who are allergic to it.

Warnings

Amplification of the vasodilatory effects of dilatrate? SR by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.

The benefits of extended-release oral 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. Because the effects of extended-release oral isosorbide dinitrate are so difficult to terminate rapidly, this formulation is not recommended in these settings.

Precautions

General

Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide dinitrate. 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.

As tolerance to isosorbide dinitrate develops, the effects of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted.

Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the interdosing intervals in some of these trials, anginal attacks have been more easily provoked than before treatment and patients have demonstrated hemodynamic rebound and decreased exercise tolerance. The importance of these observations to the routine, clinical use of controlled-release oral isosorbide dinitrate is not known.

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.

Information for patients

Patients should be told that the antianginal efficacy of isosorbide dinitrate is strongly related to its dosing regimen, so the prescribed schedule of dosing should be followed carefully. In particular, daily headaches sometimes accompany treatment with isosorbide dinitrate. 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 isosorbide dinitrate, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Aspirin and/or acetaminophen, on the other hand, often successfully relieve isosorbide dinitrate-induced headaches with no deleterious effect on isosorbide dinitrate?s antianginal efficacy.

Treatment with isosorbide dinitrate may be associated with lightheadedness 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.

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.