NITRO-DUR Transdermal patch (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Ingenus Pharmaceuticals, LLC

Λέξεις κλειδιά

50742-513 50742-514 50742-515 50742-516 50742-517 50742-518

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1. Description

Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is: and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and ...

2. Clinical Pharmacology

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

3. Indications and Usage

Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product ...

4. Contraindications

Nitroglycerin is contraindicated in patients who are allergic to it. Allergy to the adhesives used in nitroglycerin patches has also been reported, and it similarly constitutes a contraindication to the ...

5. Warnings

Amplification of the vasodilatory effects of the NITRO-DUR patch by phosphodiesterase inhibitors, eg, sildenafil can result in severe hypotension. The time course and dose dependence of this inter action ...

6.1. General

Severe hypotension, particularly with upright posture, may occur with even small doses of nitroglycerin, particularly in the elderly. The NITRO-DUR Transdermal Infusion System should therefore be used ...

6.2. Information for Patients

Daily headaches sometimes accompany treatment with nitroglycerin. In patients who get these headaches, the headaches may be a marker of the activity of the drug. Patients should resist the temptation to ...

6.4. Drug Interactions

The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety. Concomitant use of NITRO-DUR ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal carcinogenesis studies with topically applied nitroglycerin have not been performed. Rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years developed dose-related fibrotic and neoplastic ...

6.7. Pregnancy

Pregnancy Category C. Animal teratology studies have not been conducted with nitroglycerin transdermal systems. Teratology studies in rats and rabbits, however, were conducted with topically applied nitroglycerin ...

6.9. Nursing Mothers

It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitroglycerin is administered to a nursing woman.

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

Clinical studies of NITRO-DUR Transdermal Infusion System did not include sufficient information to determine whether subjects 65 years and older respond differently from younger subjects. Additional clinical ...

7. Adverse Reactions

Adverse reactions to nitroglycerin are generally dose related, and almost all of these reactions are the result of nitroglycerins activity as a vasodilator. Headache, which may be severe, is the most commonly ...

9. Overdosage

Hemodynamic Effects Nitroglycerin toxicity is generally mild. The estimated adult oral lethal dose of nitroglycerin is 200 mg to 1,200 mg. Infants may be more susceptible to toxicity from nitroglycerin. ...

10. Dosage and Administration

The suggested starting dose is between 0.2 mg/hr* and 0.4 mg/hr*. Doses between 0.4 mg/hr* and 0.8 mg/hr* have shown continued effectiveness for 10 to 12 hours daily for at least 1 month (the longest period ...

11. How Supplied

NITRO-DUR System Rated Release In Vivo* Total nitroglycerin content System size Package Size 0.1 mg/hr 20 mg 5cm2 Unit Dose 30 (NDC 50742-513-01) Package 30 <br ...

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not refrigerate.