Nitro-Dur

Nitro-Dur is a prescription medication used to prevent episodes of angina (sudden chest pain). Nitro-Dur belongs to a group of drugs called nitrates. These work by relaxing (widening) blood vessels, which makes it easier for the heart to pump blood.

Nitro-Dur is available as an extended-release transdermal film. It is applied to the skin once daily and worn for 12 to 14 hours and then removed.

Common side effects of Nitro-Dur include headache, dizziness, decreased blood pressure, and increased chest pain.

Nitro-Dur may cause dizziness. Do not drive or operate heavy machinery until you know how Nitro-Dur affects you.

Nitro-Dur is a prescription medicine used to prevent angina (acute episodes of chest pain) associated with coronary artery disease (CAD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Merck Sharp & Dohme Corp.

Serious side effects have been reported with Nitro-Dur. See the "Nitro-Dur Preacautions" section.

Common side effects of Nitro-Dur include:

• headache
• lightheadedness
• low blood pressure
• fast or irregular heartbeat
• worsening chest pain
• redness or irritation of the skin that was covered by the patch

This is not a complete list of Nitro-Dur side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• beta blockers such as atenolol (Tenormin), carteolol, labetalol (Trandate), metoprolol (Lopressor), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), and timolol (Blocadren)
• calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem), felodipine (Plendil), isradipine (DynaCirc), nifedipine (Procardia), and verapamil (Calan, Isoptin)
• dihydroergotamine (D.H.E. 45, Migranal)
• medications for high blood pressure, heart failure, mental illness or nausea
• phosphodiesterase (PDE-5) inhibitors such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra)
• riociguat (Adempas)

Do not consume alcohol while taking Nitro-Dur, as this can lower your blood pressure.

This is not a complete list of Nitro-Dur drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Nitro-Dur, including:

• slow, fast, or irregular heartbeat
• worsening chest pain
• fainting
• rash
• hives
• itching
• difficulty breathing or swallowing

Nitro-Dur can cause dizziness. Do not drive or operate heavy machinery until you know how Nitro-Dur affects you.

Do not take Nitro-Dur if you:

• are allergic to Nitro-Dur or to any of its ingredients or to the adhesive used in the patch
• are taking a phosphodiesterase (PDE-5) inhibitor such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra)
• are taking riociguat (Adempas)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Nitro-Dur, there are no specific foods that you must exclude from your diet when taking this medication.

Before using Nitro-Dur, tell your doctor about all your medical conditions. Especially tell your doctor if you:

• are allergic to Nitro-Dur or to any of its ingredients
• are dehydrated
• have recently had a heart attack
• have heart failure
• have or have had low blood pressure
• have hypertrophic cardiomyopathy (thickening of the heart muscle)
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take, including prescription nad non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nitro-Dur falls into category C. No animal studies have been conducted with Nitro-Dur transdermal patches. No well-controlled studies have been conducted in pregnant women. Nitro-Dur should only be given to a pregnant woman if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Nitro-Dur crosses into human breast milk. Because many medications can cross into human milk and because of the possiblity for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or to stop the use of this medication. You and your doctor will decide if the benefits outweigh the risks of using Nitro-Dur.

Take Nitro-Dur exactly as prescribed.

Nitro-Dur is available as an extended-release transdermal film. It is applied to the skin once daily and worn for 12 to 14 hours and then removed. Apply Nitro-Dur patches around the same time each day. The patch should be applied to a clean, dry, hairless patch of skin on the upper body or upper arm. Do not apply Nitro-Dur patches to your arms below the elbows, to your legs below the knees, or to skin folds.

If you miss a dose, apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and apply the next dose at the regualr time. Do not apply 2 Nitro-Dur patches at once.

Do not stop using Nitro-Dur without talking to your doctor.

Take this medication exactly as prescribed by yoru doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended dose of Nitro-Dur for the prevention of angina is 0.2 to 0.4 mg/hr for 12 to 14 hours daily.

If you take too much Nitro-Dur, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Nitro-Dur is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Nitro-Dur at room temperature, between 59° and 86°F (15° and 30°C).
• Do not refrigerate.

You must consult your doctor for important information before using this drug.