Nitrostat

It is always important to share with your doctor and pharmacist all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking.

You should not take nitroglycerin if you are taking the following drugs:

• Stendra (avanafil)
• Adempas (riociguat)
• Viagra (sildenafil)
• Cialis (tadalafil)
• Levitra (vardenafil)

If you are taking any of the following medications talk to your doctor about alternatives to nitroglycerin:

• Arginine
• Acetadote (acetylcysteine)
• Selzentry (maraviroc)
• Medications for Parkinon's disease, like Caberlin (carbegoline), Azilect (rasagiline), and Emsam, Elderpryl or Zelapar (selegiline)
• Ergot-containing medications for migrainesm like Cafergot (ergotamine), Migranal (dihydroergotamine), and Methergine (methylergonovine)

Nitroglycerin and Alcohol

Severe reactions have been reported in cases where patients taking high doses of nitroglycerin were also drinking alcohol. It's best to avoid drinking while taking this drug.

Nitroglycerin and Grapefruit Juice

To date, it remains unclear as to whether nitroglycerin is processed by the liver the same way as grapefruit juice.

To be on the safe side, it might be a good idea to avoid drinking grapefruit while taking this drug.

Do not use nitroglycerin if you are taking sildenafil (Viagra, Revatio), tadalafil (Cialis), or vardenafil (Levitra). Serious, life-threatening side effects can occur if you take nitroglycerin while you are using sildenafil.

Nitroglycerin can cause severe headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use nitroglycerin. Do not stop taking the medication. Ask your doctor before using any headache pain medication.

NitroStat is a prescription medicine used to treat and prevent angina associated with coronary artery disease (CAD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before using NitroStat, tell your doctor if you are taking:

• any medicines that are used to treat angina, heart failure, or an irregular heartbeat.
• any medicines that reduce blood pressure.
• any diuretics (water pills).
• medications to treat depression or psychiatric illness.
• ergotamine or similar drugs for migraine headaches.
• aspirin.
• the blood thinner medicine heparin.
• any medicines for erectile dysfunction.

Tell your doctor if you are pregnant or plan to become pregnant or if you are breastfeeding.

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

Take this medicine 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.

This medicine 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 this medicine. 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. This medicine 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 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 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 this medicine, 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 this medicine 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.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Store in original container.
• Keep lid tightly closed.
• Do not use if this medicine is out of date.
• 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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Nitrostat (nitroglycerin sublingual tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Nitrostat. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Nitrostat.

Review Date: October 4, 2017

Nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Nitrostat is supplied as white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each, with color-coded labels, and in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each.

Store at Controlled Room Temperature 20° - 25°C (68° - 77°F) [see USP].

Rx only

Distributed by

Parke-Davis

Division of Pfizer Inc, NY, NY 10017

LAB-0180-4.0

Revised March 2014

13056200

Read this information carefully before you start Nitrostat® (NYE-troe-stat) and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about Nitrostat, ask your doctor. Your doctor will know if Nitrostat is right for you.

What is Nitrostat?

Nitrostat is a type of medicine known as an organic nitrate and is a vasodilating agent. It is used to treat a type of chest pain called angina.

What is Angina?

Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Nitrostat can relieve this pain.

Who should not use Nitrostat?

Do not use Nitrostat if you are allergic to organic nitrates (like the active ingredient in Nitrostat).

You should not take Nitrostat if you have the following conditions:

• very recent heart attack
• severe anemia
• increased pressure in the head

Do not take Nitrostat with drugs for erectile dysfunction, like VIAGRA® (sildenafil citrate), CIALIS® (tadalafil), or LEVITRA® (vardenafil hydrochloride), as this may lead to extreme lowering of your blood pressure.

What should I tell my doctor before taking Nitrostat?

Before using Nitrostat, tell your doctor if:

• You are taking any medicines that are used to treat angina, heart failure, or an irregular heartbeat.
• You are taking any medicines that reduce blood pressure.
• You are taking any diuretics (water pills).
• You are taking medications to treat depression or psychiatric illness.
• You are taking ergotamine or similar drugs for migraine headaches.
• You are taking aspirin.
• You are taking the blood thinner medicine heparin.
• You are taking any medicines for erectile dysfunction.
• You are pregnant or plan to become pregnant.
• You are breastfeeding.

How should I take Nitrostat?

• Do not chew, crush, or swallow Nitrostat tablets.
• You should sit down when taking Nitrostat tablets and use caution when you stand up. This eliminates the possibility of falling due to lightheadedness or dizziness.
• One tablet should be dissolved under the tongue or in the oral cavity at the first sign of chest pain.
• The dose may be repeated approximately every 5 minutes, until the chest pain is relieved.
• If the pain persists after a total of 3 tablets in a 15-minute period, or is different than you typically experience, call your doctor or seek emergency help.
• Nitrostat may be used 5 to 10 minutes prior to activities that might cause chest pain.
• You feel a burning or tingling sensation in your mouth when you take Nitrostat.

What should I avoid while taking Nitrostat?

• Do not breastfeed. It is not known if Nitrostat will pass through your milk.
• Do not consume alcohol while taking Nitrostat, as this can lower your blood pressure.
• Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.

What are the possible side effects of Nitrostat?

Nitrostat may cause the following side effects:

• headache
• vertigo (a major symptom of balance disorder)
• dizziness
• weakness
• heart palpitations (unusual awareness of the heartbeat)
• low blood pressure upon rising from a seated position
• nausea and vomiting
• sweating
• paleness
• fainting
• flushing (warm or red condition of your skin)
• other skin reactions that may be severe

Nitrostat may cause a false test result of decreased serum cholesterol.

Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of Nitrostat. For a complete list, ask your doctor or pharmacist.

How do I store Nitrostat?

Nitrostat should be kept in the original glass container and tightly capped after each use to prevent loss of tablet potency.

Store Nitrostat tablets at room temperature (between 68° and 77°F).

General advice about Nitrostat

Sometimes doctors will prescribe a medicine for a condition that is not included in the patient information leaflets. Only use Nitrostat the way your doctor told you to. Do not give Nitrostat to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about Nitrostat, or you can visit the Pfizer website at www.pfizer.com or call 1-800-438-1985.

Distributed by

Parke-Davis

Dvision of Pfizer Inc, NY, NY 10017

LAB-0422-1.0

Revised May 2011

13056200

Since Nitrostat is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 2 hours away. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction to Nitrostat: 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.

Nitrostat can cause severe headaches. These headaches may gradually become less severe as you continue to use this medicine. 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 Nitrostat;

• 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 Nitrostat 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.