Nitrek (Transdermal)

Nitroglycerin ointment or skin patch is used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.

Nitroglycerin belongs to a group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload. When used regularly over a long period, this helps prevent angina attacks from happening.

This medicine is available only with your doctor's prescription.

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 your 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.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against its benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the effects of nitroglycerin transdermal in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the usefulness of nitroglycerin transdermal. However, older patients are more likely to have low blood pressure and age-related liver, kidney, or heart issues, which may require caution and a dose adjustment for those receiving nitroglycerin transdermal.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In such cases, your doctor may need to adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the following medicines while using this medicine. The following interactions are based on their potential significance and may not cover all possibilities.

Using this medicine with any of the following medicines is not recommended. Your doctor might decide not to prescribe this medication or change some of the other medicines you are taking.

• Avanafil
• Riociguat
• Sildenafil
• Tadalafil
• Vardenafil

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

• Alteplase, Recombinant

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both 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 them.

• Acetylcysteine
• Apomorphine
• Aspirin
• Dihydroergotamine
• Pancuronium

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used when eating food or specific types of food, as interactions may occur. Using alcohol or tobacco with certain medicines can also lead to interactions. The following interactions are based on their potential significance and may not cover all possibilities.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

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

• Congestive heart failure or
• Recent heart attack or
• Hypertrophic cardiomyopathy (a heart disease) or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood)—Use with caution. This may worsen these conditions.

Along with its necessary effects, this medicine can cause some unwanted effects. Not all side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Lightheadedness

Less common

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting
• fainting
• fast or irregular heartbeat
• nausea
• sweating
• unusual tiredness or weakness

Rare

• Bluish-colored lips, fingernails, or palms
• dark urine
• difficulty breathing
• fever
• headache
• pale skin
• rapid heart rate
• sore throat
• unusual bleeding or bruising

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• cough
• difficulty swallowing
• hives or rash
• itching, scaling, severe redness, soreness, or swelling of the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Get emergency help right away if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred or loss of vision
• bulging soft spot on the head of an infant
• change in consciousness
• change in the ability to see colors, especially blue or yellow
• cold, clammy skin
• disturbed color perception
• double vision
• feeling of constant movement of self or surroundings
• halos around lights
• severe and throbbing headache
• loss of consciousness
• night blindness
• overbright appearance of lights
• paralysis
• sensation of spinning
• tunnel vision

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your health care professional may be able to provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Rare

• Burning, itching, redness, skin rash, swelling, or soreness at the application site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Minitran
• Nitrek
• Nitro-Bid
• Nitro-Dur

In Canada

• Nitrodur 0.2
• Nitro-Dur 0.2
• Nitro-Dur 0.3
• Nitrodur 0.4
• Nitro-Dur 0.4
• Nitrodur 0.6
• Nitro-Dur 0.6
• Nitro-Dur 0.8
• Transderm-Nitro
• Trinipatch 0.2
• Trinipatch 0.4
• Trinipatch 0.6

Available Dosage Forms:

• Patch, Extended Release
• Ointment

Therapeutic Class: Antianginal

Chemical Class: Nitrate

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.

• How do you take GoNitro to treat an angina attack (chest pain)?
• What is the shelf life of nitroglycerin tablets?