Nitroglycerin transdermal

FDA label, Mylan Pharmaceuticals Inc., transdermal, effective 2014-11-03. Full label on DailyMed

Other products: Nitroglycerin, Nitroglycerin intravenous

Package labels

Loading package label images…

Patient handout

Looking up MedlinePlus…

From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Nitrate Vasodilator

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Drug interactions

Check interactions

Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.

  • Nitroglycerin transdermal
Label text (1 paragraph)

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 Nitroglycerin Transdermal Systems with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS ). Concomitant use of Nitroglycerin Transdermal Systems with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see CONTRAINDICATIONS ). 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.

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 use of this product. Do not use Nitroglycerin Transdermal Systems in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary arterial hypertension. Concomitant use can cause severe drops in blood pressure. Do not use Nitroglycerin Transdermal Systems in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Safety data

Reported adverse events (FAERS)

Loading
Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for nitroglycerin transdermal. Check the label's hepatic warnings.

Pregnancy and lactation

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 ointment at doses up to 80 mg/kg/day and 240 mg/kg/day, respectively. No toxic effects on dams or fetuses were seen at any dose tested. There are no adequate and well controlled studies in pregnant women. Nitroglycerin should be given to a pregnant woman only if clearly needed.

Lactation

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.

Breastfeeding (LactMed)

Topical use of nitroglycerin for anal fissures by nursing mothers appears to have no adverse effects on their breastfed infants. Topical use on the nipples has been used for alleviation of Raynaud phenomenon of the nipples, but only after cessation of breastfeeding. Nitroglycerin should not be used topically on the nipples during breastfeeding. Sublingual and intravenous nitroglycerin have not been studied during breastfeeding. Observe infants for flushing and discomfort after breastfeeding.

Source: LactMed: Nitroglycerin (NICHD, public domain)Revised Oct 15, 2024

Supply and cost

Drug shortage status

Loading

Recalls (last 24 months)

Loading

Therapeutic equivalence (Orange Book)

Loading

Price ladder

Not the price at the counter
Loading

These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

Products and NDCs

Loading

Recruiting clinical trials

Loading