Transderm-Nitro

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 to be useful in aborting an acute attack.

Nitroglycerin Transdermal System 0.1 mg/hr-tan, round (imprinted Transderm-Nitro 0.1 mg/hr), supplied in a foil-lined pouch

30 Systems.........................................NDC 0078-0332-85

Nitroglycerin Transdermal System 0.2 mg/hr-tan, oblong (imprinted Transderm-Nitro 0.2 mg/hr), supplied in a foil-lined pouch

30 Systems.........................................NDC 0078-0333-85

Nitroglycerin Transdermal System 0.4 mg/hr-tan, oblong (imprinted Transderm-Nitro 0.4 mg/hr), supplied in a foil-lined pouch

30 Systems.........................................NDC 0078-0334-85

Nitroglycerin Transdermal System 0.6 mg/hr-tan, oblong (imprinted Transderm-Nitro 0.6 mg/hr), supplied in a foil-lined pouch

30 Systems.........................................NDC 0078-0335-85

*Rated release in vivo. Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied Transderm-Nitro systems would be rated at 2.5 mg/24 hr (0.1 mg/hr), 5 mg/24 hr (0.2 mg/hr), 10 mg/24 hr (0.4 mg/hr), 15 mg/24 hr (0.6 mg/hr), and 20 mg/24 hr (0.8 mg/hr).

Do not store above 30°C (86°F).

Do not store unpouched. Apply immediately upon removal from the pouch.

REV: June 2000. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936.

Nitroglycerin is in a group of drugs called nitrates. Nitroglycerin dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

Nitroglycerin transdermal is used to prevent attacks of chest pain (angina).

Nitroglycerin transdermal may also be used for purposes not listed in this medication guide.

You should not use this medication if you are allergic to nitroglycerin, isosorbide mononitrate (Imdur), or isosorbide dinitrate (BiDil, Isordil). Do not use nitroglycerin transdermal if you are allergic to any type of adhesive on a bandage or other transdermal skin patch.

To make sure you can safely use nitroglycerin, tell your doctor if you have any of these other conditions:

• congestive heart failure;
• a history of heart attack, stroke, or head injury;
• low blood pressure;
• glaucoma; or
• anemia (lack of red blood cells).

FDA pregnancy category C. It is not known whether nitroglycerin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether nitroglycerin transdermal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Nitroglycerin is a prescription medication used to treat or prevent episodes of angina (sudden chest pain). Nitroglycerin belongs to a group of drugs called nitrates which work by relaxing (widening) blood vessels making it easier for the heart to pump blood.

This medication comes in tablet form to be dissolved under the tongue or between the cheek and gum at the first sign of chest pain. The dose may be repeated every 5 minutes until chest pain is relieved. Seek emergency medical attention if the pain persists after 3 doses.

Common side effects of nitroglycerin include headache, dizziness, and weakness.

Nitroglycerin may cause the following side effects:

• headache
• vertigo (a major symptom of balance disorder)
• dizziness
• weakness
• heart palpitations (unusual awareness of the heartbeat)
• low blood pressure upon rising from a seated position
• nausea and vomiting
• sweating
• paleness
• fainting
• flushing (warm or red condition of your skin)
• other skin reactions that may be severe

Nitroglycerin may cause a false test result of decreased serum cholesterol.

Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of nitroglycerin. For a complete list, ask your doctor or pharmacist.

Nitroglycerin should be kept in the original glass container and tightly capped after each use to prevent loss of tablet potency.

Store nitroglycerin tablets at room temperature (between 68° and 77°F).

Adverse reactions to nitroglycerin are generally dose-related, and almost all of these reactions are the result of nitroglycerin’s activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.

   Allergic reactions to nitroglycerin are also uncommon, and the great majority of those reported have been cases of contact dermatitis or fixed drug eruptions in patients receiving nitroglycerin in ointments or patches. There have been a few reports of genuine anaphylactoid reactions, and these reactions can probably occur in patients receiving nitroglycerin by any route.

   Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred (see OVERDOSAGE).

   Application-site irritation may occur but is rarely severe.

   In two placebo-controlled trials of intermittent therapy with nitroglycerin patches at 0.2 to 0.8 mg/hr, the most frequent adverse reactions among 307 subjects were as follows:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nitroglycerin transdermal in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitroglycerin transdermal in the elderly. However, elderly patients are more likely to have low blood pressure and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin transdermal.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Avanafil
• Riociguat
• Sildenafil
• Tadalafil
• Vardenafil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alteplase, Recombinant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetylcysteine
• Aspirin
• Dihydroergotamine
• Pancuronium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cardioversion (medical heart procedure) or
• Defibrillation (medical heart procedure)—Use with caution. The patch should be removed before having these procedures.

• Congestive heart failure or
• Heart attack, recent or
• Hypertrophic cardiomyopathy (a heart disease) or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse.

If you will be using this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you take riociguat (Adempas®), sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®). Using one of these medicines while treated with nitroglycerin may cause severe drops in blood pressure, blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.

This medicine may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. Ask you doctor if you can take aspirin or acetaminophen to treat the headache.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are using this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

Do not stop using this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Tell the doctor in charge that you are using this medicine before having a magnetic resonance imaging (MRI) scan. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.