Nitro-Dur transdermal

Name: Nitro-Dur transdermal

What is the most important information I should know about Nitro-Dur (nitroglycerin transdermal)?

You should not use this medicine if you are allergic to any type of adhesive on a bandage or other transdermal skin patch, or if you are using medicine to treat pulmonary arterial hypertension (PAH), such as riociguat, (Adempas), sildenafil (Revatio), or tadalafil (Adcirca).

Do not take erectile dysfunction medicine (Viagra, Cialis, and others) while you are using nitroglycerin transdermal, or you could have a sudden and serious decrease in blood pressure.

What happens if I miss a dose?

Apply a patch as soon as you remember, and keep it on for the rest of your wearing time without changing your patch removal schedule. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra patches to make up the missed dose.

What should I avoid while using Nitro-Dur (nitroglycerin transdermal)?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of nitroglycerin.

Side Effects

Headache, dizziness, lightheadedness, nausea, and flushing may occur as your body adjusts to this medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Headache is often a sign that this medication is working. Your doctor may recommend treating headaches with an over-the-counter pain reliever (such as acetaminophen, aspirin). If the headaches continue or become severe, tell your doctor promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Nitro-Dur Patch, Transdermal 24 Hours side effects by likelihood and severity.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: drugs used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), certain drugs to treat migraine headaches (ergot alkaloids such as ergotamine), riociguat.

This medication may interfere with certain laboratory tests (including blood cholesterol levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

For Healthcare Professionals

Applies to nitroglycerin: buccal tablet extended release, intravenous solution, oral capsule extended release, rectal ointment, sublingual powder, sublingual spray, sublingual tablet, transdermal film extended release, transdermal ointment

General

The most common side effect is headache.[Ref]

Nervous system

Very common (10% or more): Headache (up to 64%)
Common (1% to 10%): Dizziness, lightheadedness, syncope, vertigo, drowsiness
Rare (0.1% to 0.01%): Severe and prolonged headache
Very rare (less than 0.01%): Cerebral ischemia
Frequency not reported: Faintness, somnolence[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, angina increased, paradoxical bradycardia, tachycardia, orthostatic hypotension, blood pressure decreased, facial flushing
Uncommon (0.1 to 1%): Circulatory collapse
Rare (less than 0.1%): Bradycardia, cyanosis, flushing, heart rate increase
Frequency not reported: Crescendo angina, rebound hypertension, palpitations, hypertension, decreased arterial oxygen tension, severe arterial hypotension with bradycardia, transient flushing[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting
Rare (0.01% to 0.1%): Dry mouth
Very rare (less than 0.01%): Heartburn, halitosis
Frequency not reported: Abdominal pain, retching, lip and tongue swelling[Ref]

Dermatologic

Uncommon (0.1% to 1%): Dermatitis contact, erythema, pruritus, burning, irritation, eczema, urticaria
Rare (0.01 to 0.1%): Allergic skin reactions, rash
Very rare (less than 0.01%): Exfoliative dermatitis, drug rash
Frequency not reported: Cutaneous flushing, diaphoresis, angioedema
Postmarketing reports: Rash generalized[Ref]

Other

Common (1% to 10%): Asthenia, weakness
Frequency not reported: Retrosternal discomfort[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity reactions, anaphylaxis
Frequency not reported: Allergic reaction, anaphylactoid reaction[Ref]

Psychiatric

Common (1% to 10%): Restlessness
Frequency not reported: Apprehension[Ref]

Respiratory

Very rare (less than 0.01%): Impairment of respiration
Frequency not reported: Hypoxemia, dyspnea[Ref]

Hematologic

Very rare (less than 0.01%): Methemoglobinemia[Ref]

Ocular

Rare (less than 0.1%): Blurred vision
Frequency not reported: Increased ocular pressure[Ref]

Musculoskeletal

Frequency not reported: Muscle twitching[Ref]

Some side effects of Nitro-Dur may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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