Nitro-Dur

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.

Nitro-Dur®
(nitroglycerin) Transdermal Infusion System

Summary

NITRO-DUR® is a unique method of administering nitroglycerin to the bloodstream. NITRO-DUR eliminates the swallowing of pills or the application of a messy ointment. Nitroglycerin is a medication your doctor has prescribed for you to help reduce the frequency and severity of angina attacks (chest pain).

How your NITRO-DUR Transdermal Infusion System works

Nitroglycerin causes the veins (vessels that return blood to the heart) to relax so that the work load of the heart is reduced. This lowers the heart's oxygen needs.

As a result, the heart muscle is well nourished and the frequency of angina attacks is reduced. NITRO-DUR is applied directly to the skin. The nitroglycerin passes from the adhesive surface through the skin—allowing medication to be absorbed directly into the bloodstream. This manner of delivering medicine to your bloodstream provides you with nitroglycerin with one daily application of a NITRO-DUR unit.

Instructions for use

Placement area

Select a reasonably hair-free application site. Avoid extremities below the knee or elbow, skin folds, scar tissue, burned or irritated areas.

Application

Wash hands before applying.

Hold the unit with brown lines facing you, in an up and down position.

Bend the sides of unit away from you, then toward you until you hear the “SNAP”.

Peel off one side of the plastic backing.

Using the other half of the backing as a handle, apply the sticky side of the patch to the skin.

Press the sticky side on the skin, and smooth down.

Fold back the remaining side of the patch. Grasp the edge of the plastic applicator by the stripe, and pull it across the skin.

Wash hands to remove any drug.

Removal

Press down on the center of the system to raise its outer edge away from the skin.

Grasp the edge gently, and slowly peel the unit away from skin.

Wash skin area with soap and water. Towel dry. Wash hands. You may use a different application site every day.

Skin care

1. After you remove NITRO-DUR, your skin may feel warm and appear red. This is normal. The redness will disappear in a short time. If the area feels dry, you may apply a soothing lotion.
2. Any redness or rash that does not disappear should be called to your doctor's attention.

Cautions

If your doctor has prescribed “under-the-tongue” nitroglycerin tablets in addition to NITRO-DUR, you should sit down before taking the “under-the-tongue” tablet. If dizziness should occur, notify your doctor. This may be an indication that the “under-the-tongue” tablet dosage needs to be reduced.

Possible side effects

The most common side effect experienced by people taking nitroglycerin is headache. Your doctor may tell you to take a mild analgesic to relieve the headache.

Some people may experience dizziness. This is due to a slight decrease in blood pressure, which is usually experienced when a person changes position, from lying flat to sitting upright or from sitting to standing. If this occurs, sit down until the dizziness stops, then notify your doctor.

He or she may wish to reduce your NITRO-DUR dosage. In some people, nitroglycerin preparations may cause the skin to feel flushed or the heart to beat faster. If this should occur, notify your doctor; again, he or she may wish to change your NITRO-DUR dosage.

NITRO-DUR is a unique drug that depends on direct contact with the skin to work. For this reason, the skin should be reasonably hair-free, clean, and dry.

Other information

1. Allow NITRO-DUR to stay in place as directed by your doctor.
2. Showering is permitted with NITRO-DUR in place.
3. NITRO-DUR should be kept out of reach of children and pets.
4. Store at room temperature 77°F (25°C).
5. NITRO-DUR is boxed so that you have a 30-day supply. Be sure to check your supply periodically. Before it runs low, you should visit your pharmacist for a refill or ask your doctor to renew your NITRO-DUR prescription.
6. It is important that you do not miss a day of your NITRO-DUR therapy. If your schedule needs to be changed, your doctor will give you special instructions.
7. NITRO-DUR has been prescribed for you. Do not give your medication to anyone else.
8. NITRO-DUR is for prevention of angina; not for treatment of an acute angina attack.
9. Notify your doctor if angina attacks change for the worse.

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

Your pharmacist can provide more information about nitroglycerin transdermal.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 10.01. Revision date: 2/17/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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.

This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to Nitro-Dur. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. It will only work if applied correctly.

This form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The ointment and patch forms release medicine gradually to provide an effect for 7 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.

You should use this medicine first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not use it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

For patients using the ointment:

• Before applying a new dose of ointment, remove any ointment remaining on the skin from a previous dose. This will allow the fresh ointment to release the nitroglycerin properly.
• This medicine comes with papers to help measure the dose. Use them to measure the length of ointment squeezed from the tube and to apply the ointment to the skin. Do not rub or massage the ointment into the skin. Spread it in a thin, even layer, and cover an area of skin that is the same size each time it is applied.
• Apply the ointment to skin with little or no hair that is free of scars, cuts, or irritation.
• Apply each dose of ointment to a different area of skin to prevent irritation.
• If your doctor has ordered an airtight covering or dressing (such as plastic kitchen wrap) be placed over this medicine, make sure you know how to apply it. Airtight dressings will increase the amount of medicine absorbed through the skin and may cause more side effects. Use them only as directed and check with your doctor if you have any questions about this.

For patients using the patch system:

• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.
• Do not try to trim or cut the adhesive patch to adjust the dosage. Check with your doctor if you think the medicine is not working as it should.
• Apply the patch to a clean, dry skin area with little or no hair that is free of scars, cuts, or irritation.
• Always remove a previous patch before applying a new one.
• Apply a new patch if the first one becomes loose or falls off.
• Apply each patch to a different area to prevent skin irritation.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For prevention of angina:
  • For transdermal dosage form (ointment):
    • Adults—At first, 7.5 milligrams (mg), one-half inch of ointment, two times a day. Apply the first dose in the morning right after you wake up, and the second dose 6 hours later. Your doctor may increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For transdermal dosage form (skin patch):
    • Adults—Apply one patch once a day in the morning. Leave the patch in place for a total of 12 to 14 hours.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold it in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Nitro-Dur affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have your blood pressure checked often. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Talk with your doctor before you drink alcohol.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Nitro-Dur while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• Do not use this medicine to treat chest pain that becomes worse. Talk with your doctor.
• If you have been taking Nitro-Dur for a long time without a break, it may not work as well. This is known as tolerance. Be sure to have a "nitrate-free" period of time each day. Talk with your doctor if this medicine stops working well. Do not take more than ordered.
• Do not stop taking Nitro-Dur all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
• If you are 65 or older, use Nitro-Dur with care. You could have more side effects.
• The patch may have metal. Take off the patch before an MRI or cardioversion.
• Your skin may be red or feel warm after you take the patch off. This is normal. If these effects do not go away, call your doctor.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Throw away all patches in a sealed container away from children and pets.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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

Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO.,INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 1987, 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 10/2014

uspi-mk9025-pch-1410r002

Rx only

Please read this instruction sheet carefully before using Nitro-Dur

Information for the Patient About
Nitro-Dur®
(nitroglycerin)
Transdermal Infusion System

Summary

Nitro-Dur® is a unique method of administering nitroglycerin to the bloodstream. Nitro-Dur eliminates the swallowing of pills or the application of a messy ointment. Nitroglycerin is a medication your doctor has prescribed for you to help reduce the frequency and severity of angina attacks (chest pain).

How your Nitro-Dur Transdermal Infusion System works

Nitroglycerin causes the veins (vessels that return blood to the heart) to relax so that the work load of the heart is reduced. This lowers the heart's oxygen needs.

As a result, the heart muscle is well nourished and the frequency of angina attacks is reduced. Nitro-Dur is applied directly to the skin. The nitroglycerin passes from the adhesive surface through the skinallowing medication to be absorbed directly into the bloodstream. This manner of delivering medicine to your bloodstream provides you with nitroglycerin with one daily application of a Nitro-Dur unit.

Instructions for use

Placement area

Select a reasonably hair-free application site. Avoid extremities below the knee or elbow, skin folds, scar tissue, burned or irritated areas.

Application

Wash hands before applying.

Hold the unit with brown lines facing you, in an up and down position.

Bend the sides of unit away from you, then toward you until you hear the "SNAP".

Peel off one side of the plastic backing.

Using the other half of the backing as a handle, apply the sticky side of the patch to the skin.

Press the sticky side on the skin, and smooth down.

Fold back the remaining side of the patch. Grasp the edge of the plastic applicator by the stripe, and pull it across the skin.

Wash hands to remove any drug.

Removal

Press down on the center of the system to raise its outer edge away from the skin.

Grasp the edge gently, and slowly peel the unit away from skin.

Wash skin area with soap and water. Towel dry. Wash hands. You may use a different application site every day.

Skin care

Cautions

If your doctor has prescribed "under-the-tongue" nitroglycerin tablets in addition to Nitro-Dur, you should sit down before taking the "under-the-tongue" tablet. If dizziness should occur, notify your doctor. This may be an indication that the "under-the-tongue" tablet dosage needs to be reduced.

Possible side effects

The most common side effect experienced by people taking nitroglycerin is headache. Your doctor may tell you to take a mild analgesic to relieve the headache.

Some people may experience dizziness. This is due to a slight decrease in blood pressure, which is usually experienced when a person changes position, from lying flat to sitting upright or from sitting to standing. If this occurs, sit down until the dizziness stops, then notify your doctor.

He or she may wish to reduce your Nitro-Dur dosage. In some people, nitroglycerin preparations may cause the skin to feel flushed or the heart to beat faster. If this should occur, notify your doctor; again, he or she may wish to change your Nitro-Dur dosage.

Nitro-Dur is a unique drug that depends on direct contact with the skin to work. For this reason, the skin should be reasonably hair-free, clean, and dry.

Other information

1. Allow Nitro-Dur to stay in place as directed by your doctor.
2. Showering is permitted with Nitro-Dur in place.
3. Nitro-Dur should be kept out of reach of children and pets.
4. Store at room temperature 77°F (25°C).
5. Nitro-Dur is boxed so that you have a 30-day supply. Be sure to check your supply periodically. Before it runs low, you should visit your pharmacist for a refill or ask your doctor to renew your Nitro-Dur prescription.
6. It is important that you do not miss a day of your Nitro-Dur therapy. If your schedule needs to be changed, your doctor will give you special instructions.
7. Nitro-Dur has been prescribed for you. Do not give your medication to anyone else.
8. Nitro-Dur is for prevention of angina; not for treatment of an acute angina attack.
9. Notify your doctor if angina attacks change for the worse.

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

Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO.,INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 1987, 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 10/2014

usppi-mk9025-pch-1410r002

NDC 0085-3310-30
Contents: 30 units

Nitro-Dur®
(nitroglycerin)
Transdermal Infusion System

0.2
mg/hr
(10 cm2)

Each unit contains 40 mg of
nitroglycerin in acrylic-based
polymer adhesives with a
resinous cross-linking agent.

Rated release in vivo 0.2 mg/hr.

Rx only

NDC 0085-0819-30
Contents: 30 units

Nitro-Dur®
(nitroglycerin)
Transdermal Infusion System

0.8
mg/hr
(40 cm2)

Each unit contains 160 mg of
nitroglycerin in acrylic-based
polymer adhesives with a
resinous cross-linking agent.

Rated release in vivo 0.8 mg/hr.

Rx only