Transderm Nitro (Nitroglycerin)

There are certain things you and your doctor should be aware of before you use TRANSDERM-NITRO. Follow all the doctor's or pharmacist instructions carefully.

Be sure to tell your doctor if you have ever had any of the following medical problems:

• any unusual or allergic reactions to nitrates, nitrites, or other substances
• poor circulation with very low blood pressure
• increased intracranial pressure (a condition that your doctor can tell you about)
• a recent heart attack, or other serious heart disease, stroke, or head injury
• narrowing of the heart valves
• blood vessel disorder other than angina
• severe anemia
• lung disease

If any of these apply to you, tell your doctor before taking TRANSDERM-NITRO.

To help the doctor decide whether you should use TRANSDERM-NITRO and what extra care should be taken during its use, tell your doctor:

• if you are breast feeding or pregnant or intend to become pregnant while using this medicine.
• what other medicines or remedies, if any, you are using. There are some medicines which may affect how TRANSDERM-NITRO works.
• if you are taking medicines used to treat erectile dysfunction with inhibitors of an enzyme called phosphodiesterase type 5 (PDE5), including VIAGRA (sildenafil), CIALIS (tadalafil) and LEVITRA (vardenafil).

If you are using TRANSDERM-NITRO (nitroglycerin), you must not take any medicines used to treat erectile dysfunction which are part of the group of products called phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA (sildenafil), CIALIS (tadalafil) and LEVITRA (vardenafil). Such a combination can produce severe lowering of blood pressure, loss of consciousness, heart attack or death.

Check with your doctor as soon as possible if any of the following occur:

• angina (chest pain), particularly while patch is off
• greyish-blue coloured lips, fingernails or palms of hands
• dizziness or fainting
• feeling of pressure in the head
• shortness of breath
• unusual tiredness or weakness
• weak or unusually fast heartbeat.

Like all medicines, along with its helpful effects, TRANSDERM-NITRO may cause unwanted side effects. The elderly may be more sensitive to the effects of nitrates. You should know about them so that if they do occur, you can report them to your doctor right away.

When you start using TRANSDERM-NITRO, you may get a headache. This is a common effect. If you need to, you may take a mild pain reliever for this. If it continues or becomes severe, check with your doctor. Flushing of the face may also occur. TRANSDERM-NITRO may also lower the blood pressure and cause dizziness, lightheadedness, or a fainting feeling, especially when you get up quickly from lying or sitting positions. 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 TRANSDERM-NITRO, be careful about the amount of alcohol you drink. Also use extra care when exercising, standing for a long time, driving or doing other things that need your attention; or during hot weather.

In certain cases TRANSDERM-NITRO may cause mild itching under the patch and reddening of the skin after it has been removed. The reddening usually goes away within a few hours. A mild skin cream may be used if needed. It is also important to apply each patch to a different area of skin. If any redness or rash continues, you should consult your doctor.

Other side effects may include palpitations, which is an abnormal feeling of heart beat.

If any of these affects you severely, tell your doctor.

There may be an interaction between TRANSDERM-NITRO and any of the following:

• alcohol
• aldesleukin
• aliskiren
• alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
• alpha agonists (e.g., clonidine, methyldopa)
• alteplase
• angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
• barbiturates (e.g., butalbital, pentobarbital phenobarbital)
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• brimonidine
• bromocriptine
• cabergoline
• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
• clonidine
• dipyridamole
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• duloxetine
• eplerenone
• ergot alkaloids (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• heparin
• hydralazine
• guanfacine
• levodopa
• minoxidil
• other nitrates (e.g., TRANSDERM-NITRO, isosorbide dinitrate, isosorbide mononitrate)
• phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
• quetiapine
• riociguat
• risperidone
• sodium nitrite

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

1. Deciding Where to Apply the Patch: Choose any area of skin which is most comfortable for you, but not past the knees or elbows. Many patients prefer the chest. It is best if the area is hairless. Avoid skin folds. The skin should not be scarred, burned, irritated or broken, since this may alter the amount of medicine you get. You should apply the patch to a different area of skin each day, and wait several days before using the same area again. To help you remember to change the site of patch application regularly, you may wish to use the same area of skin on a particular day of the week.
2. Preparing the Skin: In order for the patch to stick, the skin must be clean and dry without any creams, lotions, oil or powder. If hair is likely to interfere with the patch sticking or removal, it can be clipped but not shaved since this may irritate the skin.
3. Opening the Pouch: Each TRANSDERM-NITRO patch is individually sealed in a protective pouch. Tear open this pouch at the indentation and remove the patch. Do not use scissors, since you may accidentally cut the patch.
4. Recognizing the Patch and Removing the Liner: The patch itself is tan-coloured. A plastic liner covers the adhesive (sticky) side of the patch during storage, and must be removed and discarded before patch use. The plastic liner will be either white on both sides or clear, depending on the size of the patch.
5. Pick up the patch lengthwise with the tab up, and the plastic liner facing you. If you are left-handed it might be easier to start with the tab down and the tan-coloured side facing you. Firmly bend the tab forward with the thumb. With both thumbs, carefully remove the plastic protective liner from the patch starting at the tab. Continue to peel back the plastic liner along the length of the patch, allowing the patch to rest on the outside of your fingers.
6. By removing the plastic liner you have exposed the adhesive side. The adhesive side of the patch appears to have a silver-coloured edge. From this side you should also be able to see the white cream containing nitroglycerin within the patch.
7. Avoid touching the adhesive. If another person applies the patch for you, he/she must be careful not to touch the surface which will be applied to the skin. Apply the tan-coloured patch immediately after opening the pouch and removing the plastic liner. Discard the plastic liner.
8. Applying the Patch: Remember, the skin should be clean and dry without creams, lotions, oil or powder. Place the exposed adhesive side of the patch (i.e. the silver-edged side) on the area you have chosen as explained above. Press it firmly in place with the palm of your hand for 10-20 seconds. Circle the outside edge of the patch with one or two fingers. Once the patch is in place, do not test the adhesion by pulling on it. When applied correctly, the tan-coloured side will be seen when looking at the patch on the skin.
9. When and How to Remove the Patch: The TRANSDERM-NITRO patch should be changed according to the schedule prescribed by your doctor. It is important to respect the patch-off period recommended by your doctor. If you forget to remove it at the scheduled time just remove it as soon as possible and continue to follow your original schedule.
10. Remove the patch by pulling on the tab. Each patch can only be applied once. After use, fold the patch in half with the adhesive side inwards. Throw it away safely out of the reach of children. Any adhesive left on the skin can be removed with rubbing alcohol or light mineral oil.
11. What to Do if TRANSDERM-NITRO Falls Off: Contact with water (as in bathing, swimming, showering) or physical activity will not affect the patch. It is unlikely that the patch will fall off. If the patch does fall off, discard it and put a new patch on a different area of skin. Continue to follow your original schedule.

OVERDOSE:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.