Nitroglycerin oral / sublingual

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. Alcohol may increase certain side effects of nitroglycerin (dizziness, drowsiness, feeling light-headed, or fainting).

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek emergency medical attention if you have symptoms of a heart attack, such as:

• chest pain or pressure;

• pain spreading to your jaw or shoulder; or

• nausea, sweating, general ill feeling.

Nitroglycerin can cause severe headaches. These headaches may gradually become less severe as you continue to use nitroglycerin. Do not stop taking this medicine. Ask your doctor before using any headache pain medication.

Call your doctor at once if you have:

• severe or throbbing headaches that do not become less severe with continued use of nitroglycerin;

• pounding heartbeats or fluttering in your chest;

• slow heart rate;

• blurred vision or dry mouth; or

• a light-headed feeling, like you might pass out.

Common side effects may include:

• mild burning or tingling with the tablet in your mouth;

• headache;

• dizziness, spinning sensation;

• nausea, vomiting;

• flushing (warmth, redness, or tingly feeling);

• pale skin, increased sweating; or

• feeling weak or dizzy.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with nitroglycerin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with nitroglycerin, especially:

• aspirin or heparin;

• a diuretic or "water pill";

• medicine to treat depression or mental illness; or

• ergot medicine to treat migraine headache, such as dihydroergotamine, ergotamine, ergonovine, or methylergonovine.

This list is not complete and many other drugs can interact with nitroglycerin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

In the U.S.

• Gonitro
• Nitrocot
• Nitrolingual
• NitroMist
• Nitroquick
• Nitrostat
• Nitrotab
• Nitro-Time

In Canada

• Gen-Nitro
• Nitrolingual Pumpspray

Available Dosage Forms:

• Spray
• Tablet, Extended Release
• Tablet
• Capsule, Extended Release
• Packet

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Take nitroglycerin exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

Nitroglycerin is available as two types of products that are used for different reasons. The extended-release capsules are used every day on a specific schedule to prevent angina attacks. The oral spray, sublingual powder, and sublingual tablets work quickly to stop an angina attack that has already started or they can be used to prevent angina if you plan to exercise or expect a stressful event.

When you begin to feel an attack of angina starting (chest pains, tightness or squeezing in the chest), sit down. Then place a sublingual powder or tablet in your mouth or under your tongue. If you use the oral spray, you should spray it on or under the tongue. You may become dizzy, lightheaded, or faint soon after using a tablet or spray, so it is safer to sit rather than stand while the medicine is working. If you become dizzy or faint while sitting, take several deep breaths and bend forward with your head between your knees. Remain calm and you should feel better in a few minutes.

If you are taking the nitroglycerin sublingual powder: Empty the contents of a packet under your tongue. Close your mouth and breathe normally. Allow powder to dissolve without swallowing. Do not rinse or spit for 5 minutes after taking nitroglycerin. Do not take more than 3 packets in 15 minutes. If you still have pain after you take a total of 3 packets, this is an emergency. Call 911. Do not drive yourself to the hospital.

Nitroglycerin sublingual tablets should not be chewed, crushed, or swallowed. They work much faster when absorbed through the lining of the mouth. Place the tablet under the tongue or between the cheek and gum, and let it dissolve. Do not eat, drink, smoke, or use chewing tobacco while a tablet is dissolving.

Nitroglycerin sublingual tablets usually give relief in 1 to 5 minutes. However, if the pain is not relieved, you may use a second tablet 5 minutes after you take the first tablet. If the pain continues for another 5 minutes, a third tablet may be used. If you still have chest pain after a total of 3 tablets, contact your doctor or go to a hospital emergency room right away. Do not drive yourself and call 911, if necessary.

You may administer 1 or 2 sprays of Nitroglycerin oral spray at the onset of chest pain. If the pain continues after 5 minutes, a third spray may be used. You must wait 5 minutes after the first 1 or 2 sprays before using a third spray. If you still have chest pain after a total of 3 sprays, contact your doctor or go to a hospital emergency room right away. Do not drive yourself and call 911 if necessary. Do not use more than 3 sprays in a 15-minute period.

Swallow the extended-release capsule whole. Do not split, crush, or chew it.

You should take the extended-release capsule first thing in the morning and follow the same schedule each day. nitroglycerin works best if you have a "drug-free" period of time every day when you do not take 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.

To use the oral spray:

• Remove the plastic cap.
• Do not shake the container.
• If this is a new bottle or container, prime the pump before use by releasing a test spray. This must be done 5 or 10 times into the air away from your face and other people.
• If this is an old bottle and you have not used it for more than 6 weeks, you must prime it again with 1 or 2 test sprays. If it is not been used within 3 months, prime it up to 5 sprays.
• Hold the container upright with your forefinger on top of the grooved button. Open your mouth and bring the container as close to it as possible.
• Press the button firmly with the forefinger to release the spray 1 or 2 times onto or under the tongue. Do not inhale or breathe in the spray.
• Release the button and close your mouth, but do not swallow right away. Do not spit out the spray or rinse your mouth for at least 5 to 10 minutes.
• If you need a third spray, you must wait 5 minutes after the second spray. Use exactly the same steps you used for the first spray. No more than 3 sprays should be given within 15 minutes.
• Replace the cover after using the medicine.
• Always place the spray bottle in an upright position if not in use. Also, check the fluid level of Nitromist® container regularly. If the fluid reaches the top or middle of the hole on the side of container, this is an indicator that you must get a refill.
• Do not use the spray near heat, an open flame, or while smoking.

Dosing

The dose of nitroglycerin 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 nitroglycerin. 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 or treatment of angina:
  • For oral dosage form (extended-release capsules):
    • Adults—2.5 to 6.5 milligrams (mg) 3 to 4 times a day. Your doctor may increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For sublingual dosage form (powder):
    • Adults—1 or 2 packets placed under the tongue at the first sign of an angina attack. 1 packet may be used every 5 minutes as needed, for up to 15 minutes. Do not take more than 3 packets in 15 minutes.
    • Children—Use and dose must be determined by your doctor.
  • For sublingual dosage form (spray):
    • Adults—1 or 2 sprays on or under the tongue at the first sign of an chest pain. Sprays may be repeated every 5 minutes as needed. You must wait 5 minutes before administering a third spray if 2 sprays are used initially. Do not use more than 3 sprays in 15 minutes. To prevent angina from exercise or stress, use 1 or 2 sprays 5 to 10 minutes before the activity.
    • Children—Use and dose must be determined by your doctor.
  • For sublingual dosage form (tablets):
    • Adults—1 tablet placed under the tongue or between the cheek and gum at the first sign of an angina attack. 1 tablet may be used every 5 minutes as needed, for up to 15 minutes. Do not take more than 3 tablets in 15 minutes. To prevent angina from exercise or stress, use 1 tablet 5 to 10 minutes before the activity.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of nitroglycerin, take 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. Do not double doses.

Storage

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.

Store the extended-release capsules in a closed container at room temperature, away from heat, moisture, and direct light.

Store the sublingual powder at room temperature, away from heat, moisture, and direct light.

Sublingual tablets should be kept in the original glass bottle. Screw the cap on tightly after each use and store the bottle at room temperature, away from heat, moisture, and direct light.

Store the oral spray at room temperature, away from heat and direct light. Do not freeze. Do not keep nitroglycerin inside a car where it could be exposed to extreme heat or cold. Do not forcefully open the container or throw it into a fire, even if it is empty.

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

Do not take avanafil (Stendra®), riociguat (Adempas®), sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using nitroglycerin. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you have an angina attack, you must go to the hospital right away.

nitroglycerin 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. If you have severe pain, talk with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.

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 taking nitroglycerin, 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 nitroglycerin without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Blurred vision or dryness of the mouth may occur while using nitroglycerin. Check with your doctor if this concerns you.

Serious skin reactions can occur with nitroglycerin. Check with your doctor right away if you have cracks in the skin, feeling of warmth, loss of heat from the body, rash, red, swollen skin, redness of the face, neck, arms, and occasionally, upper chest, or scaly skin while you are using nitroglycerin.

Make sure any doctor or dentist who treats you knows that you are using nitroglycerin. You may need to stop using nitroglycerin several days before you have medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.