Gen-Nitro

This medicine is also used to relieve an angina attack that is already occurring.

Nitroglycerin belongs to the 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 work load. When used regularly on a long-term basis, or just before exercise or a stressful event, this helps prevent angina attacks from occurring.

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

This product is available in the following dosage forms:

• Spray


• Tablet, Extended Release


• Tablet


• Capsule, Extended Release

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nitroglycerin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitroglycerin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Sildenafil


• Tadalafil


• Vardenafil

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

• Alteplase, Recombinant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs 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 the medicines.

• Acetylcysteine


• Aspirin


• Dihydroergotamine


• Pancuronium

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia, severe or


• Head injury, severe with increased pressure in the head or


• Heart attack, acute (already occurring)a€”Should not be used in patients with these conditions.

• Congestive heart failure or


• Heart attack, recent or


• Hypertrophic cardiomyopathy (a heart disease) or


• Hypotension (low blood pressure) or


• Hypovolemia (low amount of blood)a€”Use with caution. May make these conditions worse.

Proper Use

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.

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 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 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.

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 oral spray and sublingual tablets usually give relief in 1 to 5 minutes. However, if the pain is not relieved, you may use a second spray or tablet . If the pain continues for another 5 minutes, a third spray or tablet may be used. If you still have chest pain after a total of 3 sprays or 3 tablets in a 15-minute period, contact your doctor or go to a hospital emergency room right away.

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.

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.

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.


• 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 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 second spray, use exactly the same steps you used for the first spray.


• Replace the cover after using the medicine.


• 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 angina prevention or treatment:
  
  
  
  • For oral dosage form (extended-release capsules):
    
    
    
    • Adultsa€”2.5 to 6.5 milligrams (mg) three to four times a day. Your doctor may increase your dose as needed.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For sublingual dosage form (spray):
    
    
    
    • Adultsa€”One or two sprays on or under the tongue at the first sign of an angina attack. A spray may be repeated every 5 minutes as needed, for up to 15 minutes. Do not use the medicine more than 3 times in 15 minutes. To prevent angina from exercise or stress, use 1 or 2 sprays 5 to 10 minutes before the activity.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For sublingual dosage form (tablets):
    
    
    
    • Adultsa€”One tablet placed under the tongue or between the cheek and gum at the first sign of an angina attack. One tablet may be used every 5 minutes as needed, for up to 15 minutes. Do not use the medicine more than 3 times in 15 minutes. To prevent angina from exercise or stress, use 1 tablet 5 to 10 minutes before the activity.
    
    
    • Childrena€”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.

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 .

Precautions

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

Do not take sildenafil (ViagraA®), tadalafil (CialisA®), or vardenafil (LevitraA®) while you are using this medicine. Using these medicines together may cause 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. If you have severe pain, talk with your doctor .

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 taking 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 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 this medicine. Check with your doctor if this concerns you.

Serious skin reactions can occur with this medicine. 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 this medicine.

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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

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

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Difficult or labored breathing


• Feeling faint, dizzy, or lightheadedness


• Feeling of warmth or heat


• Flushing or redness of the skin, especially on the face and neck


• Headache


• Rapid weight gain


• Shortness of breath


• Sweating


• Tightness in the chest


• Tingling of the hands or feet


• Unusual weight gain or loss


• Wheezing

Rare

• Bluish-colored lips, fingernails, or palms


• Dark urine


• Fever


• Pale skin


• Rapid heart rate


• Sore throat


• Unusual bleeding or bruising


• Unusual tiredness or weakness

Incidence not known

• Arm, back, or jaw pain


• Blurred vision


• Chest pain or discomfort


• Chest tightness or heaviness


• Confusion


• Cough


• Cracks in the skin


• Difficulty with swallowing


• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• Fainting


• Fast, irregular, pounding, or racing heartbeat or pulse


• Feeling of constant movement of self or surroundings


• Feeling of warmth


• Hives


• Increased sweating


• Itching


• Loss of heat from the body


• Nausea or vomiting


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Rash


• Red, swollen skin


• Redness of the face, neck, arms, and occasionally, upper chest


• Scaly skin


• Sensation of spinning


• Skin rash


• Weakness

Get emergency help immediately 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


• Flushed skin


• Halos around lights


• Headache, severe and throbbing


• Increased sweating


• Loss of appetite


• Loss of consciousness


• Night blindness


• Overbright appearance of lights


• Paralysis


• Slow or irregular heartbeat


• Tunnel vision

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

Less common

• Abdominal or stomach pain


• Body aches or pain


• Congestion


• Hoarseness


• Lack or loss of strength


• Runny nose


• Sneezing


• Stuffy nose


• Tender, swollen glands in the neck


• Voice changes

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.