Nitro-Dur 0.4: Uses, Side Effects and Dosage

What is NITRO-DUR used for?

NITRO-DUR is used in adults to prevent angina (chest pain).

NITRO-DUR is NOT intended to be used for acute angina attacks. Sublingual nitroglycerin medications should be used if you are having an acute angina attack.

How does NITRO-DUR work?

NITRO-DUR is a patch applied directly to the skin. The nitroglycerin passes from the adhesive surface through the skin - allowing medication to be absorbed directly into the bloodstream. Nitroglycerin causes the blood vessels to relax and increases the supply of blood and oxygen to the heart reducing the likeliness of having an angina attack.

The amount of NITRO-DUR you need will depend upon your body's needs. Observe the dosing instructions given to you by your prescribing physician and report to him/her if your condition changes.

What are the ingredients in NITRO-DUR?

Medicinal ingredients: Nitroglycerin

Non-medicinal ingredients: Polymers used mainly in the adhesive of the patch.

NITRO-DUR comes in the following dosage forms:

Transdermal patch: 40 mg (0.2 mg/hour), 80 mg (0.4 mg/hour), 120 mg (0.6 mg/hour), 160 mg

(0.8 mg/hour)

Do not use NITRO-DUR if you:

• are allergic to nitroglycerin, nitrates, or to any non-medicinal ingredient in the formulation.
• are taking medication for erectile dysfunction such as VIAGRA* (sildenafil citrate), CIALIS* (tadalafil), LEVITRA* or STAXYN* (vardenafil).

• are taking medications used to treat high blood pressure in your lungs such as

  ADEMPAS* (riociguat), REVATIO* (sildenafil citrate) or ADCIRCA* (tadalafil).

• have had a recent heart attack, or other serious heart problems, stroke, or head injury.
• experience lightheadedness, dizziness or fainting when going from lying or sitting to standing up (postural hypotension).
• have severe anemia (low iron levels in your blood or low red blood cell count).
• have narrowing of the heart valves.
• have an eye disease called closed angle glaucoma or any other condition that increases the pressure in your eyes.

To help avoid side effects and ensure proper use, talk to your prescribing physician before you take NITRO-DUR. Talk about any health conditions or problems you may have, including if you:

• have heart failure
• have low blood pressure or take diuretics (“water pills”)
• have lung disease

• Are breast feeding, pregnant or intend to become pregnant. Your healthcare professional will decide whether you should use NITRO-DUR and what extra care should be taken during its use

• are less than 18 years old

Other warnings you should know about:

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to NITRO-DUR. Dizziness, lightheadedness, or fainting can occur, especially after the first dose and when the dose is increased.

Tolerance to NITRO-DUR and similar drugs can occur after long periods of use. Chronic use can lead to angina attacks being brought on more easily. Do not suddenly stop using NITRO-DUR. Talk to your prescribing physician if you wish to discontinue using NITRO-DUR.

Tell your prescribing physician about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with NITRO-DUR:

• Do not take any drugs used to treat erectile dysfunction such as VIAGRA* (sildenafil citrate), CIALIS* (tadalafil), LEVITRA* or STAXYN* (vardenafil) if you are using

  NITRO-DUR.

• Do not use NITRO-DUR if you are taking drugs used to treat high blood pressure in your lungs such as ADEMPAS^* (riociguat), REVATIO^* (sildenafil citrate) or ADCIRCA^* (tadalafil).
• Drugs used to treat high blood pressure.
• Diuretics (“water pills”)
• Drugs used to treat depression called “tricyclic antidepressants”.
• Tranquillizers.
• Other drugs that may have the same effect as NITRO-DUR.

• Alcohol.

• Drugs used to treat migraine headaches (such as dihydroergotamine).
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling (such as ibuprofen, naproxen, and celecoxib).
• Acetylsalicylic acid (Aspirin)

How to use NITRO-DUR:

1. 1. Patches should be applied for 12 to 14 hrs, and taken off for 10 to 12 hrs.
2. 2. Do not cut NITRO-DUR, use part patches or apply more than one patch at a time.
3. 3. Do not reuse patch. Discard after first use in a safe manner.
4. 4. Allow NITRO-DUR to stay in place as directed by your prescribing physician.
5. 5. Showering is permitted with NITRO-DUR in place.
6. 6. NITRO-DUR is packaged 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 prescribing physician to renew your NITRO-DUR prescription.
7. 7. It is important that you do not miss a day of your NITRO-DUR therapy. If your schedule needs to be changed, your prescribing physician will give you specific instructions.
8. 8. NITRO-DUR has been prescribed for you. Do not give your medication to anyone else.
9. 9. Notify your prescribing physician if your condition changes.

Placement area

• Apply to clean, dry, hairless areas of the skin, each successive application to a different site. Select a reasonably hair-free application site. An appropriate application area can be shaved ifrequired
• 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 the unit away from you, then toward you until you hear a "SNAP".

• Twist the patch gently to lift the plastic backing. 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 patch away from the skin.

• Wash skin area with soap and water. Towel dry. Wash hands.
• After removal, the patch should be discarded in a manner that prevents accidental application or ingestion by children or pets.
• You should use a different application site every day.

Skin care

1. 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 after washing.
2. 2. Any redness or rash that does not disappear within a few hours should be called to your prescribing physician's attention.

Usual adult dose:

The starting dose is one NITRO-DUR 0.2 patch (10 cm²), usually applied in the morning. If well tolerated and depending on response, dose may be increased to 0.4 mg/hr, maximum 0.8 mg/hr.

Patches should be applied for 12 to 14 hrs, and taken off for 10 to 12 hrs. Apply to clean, dry, hairless areas of the skin, each successive application to a different site.

Overdose:

The patch should be removed immediately and the underlying skin washed thoroughly.

If you think you have taken too much NITRO-DUR, contact your prescribing physician, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you have forgotten to apply NITRO-DUR at the scheduled time apply it as soon as you remember.

What are possible side effects from using NITRO-DUR ?

These are not all the possible side effects you may feel when taking NITRO-DUR. If you experience any side effects not listed here, contact your prescribing physician. Please also see Warnings and Precautions.

Side effects may include:

• Headache
• Flushing of the face
• Nausea, vomiting

• Rash, redness, itching and/or burning in the area where the patch was applied

  NITRO-DUR may also lower the blood pressure and cause dizziness, lightheadedness, or a fainting feeling, especially when you get up quickly from lying or sitting. Getting up slowly may help. If you feel dizzy, sit or lie down. You may be more likely to experience headaches, dizziness, or lightheadedness if you drink alcohol, stand for a long time, or if the weather is hot. While using NITRO-DUR, be careful about the amount of alcohol you drink. Also use extra care when exercising, standing for a long time, driving, or during hot weather.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your prescribing physician.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store between 15 to 30˚C. Do not refrigerate.

Keep out of reach and sight of children.

If you want more information about NITRO-DUR:

• Talk to your prescribing physician.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website https://www.canada.ca/en/health-canada.html https://health-products.canada.ca/dpd-bdpp/index-eng.jsp; Questions/Concerns: 1-833-300-5309.