Nitronal

In the U.S.

• Nitro-Bid
• NITRONAL

Available Dosage Forms:

• Solution
• Kit
• Injectable

Therapeutic Class: Coronary Vasodilator

Chemical Class: Nitrate

Nitroglycerin injection is used to treat hypertension (high blood pressure) during surgery or to control congestive heart failure in patients who have had a heart attack. It may also be used to produce hypotension (low blood pressure) during surgery. Nitroglycerin injection is sometimes used to treat angina (chest pain) in patients who have been treated with other medicines that did not work well.

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.

This medicine is to be given only by or under the direct supervision of your doctor.

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 injection 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 injection 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 injection.

Breast Feeding

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.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Avanafil
• Riociguat
• 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
• Heparin

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

Interactions with Food/Tobacco/Alcohol

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Allergy to corn or corn products or
• Constrictive pericarditis (a heart disease) or
• Pericardial tamponade (a heart disease) or
• Restrictive cardiomyopathy (a heart disease)—Should not be used in patients with these conditions.

• Diabetes or
• Hypertrophic cardiomyopathy (a heart disease) or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse.

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure it is working properly.

Do not take riociguat (Adempas®), sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) 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.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

This medicine may cause headaches. These headaches are a sign that the medicine is working. If you have severe pain, talk with your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

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 or nurse immediately if any of the following side effects occur:

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

• 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 a lying or sitting position
• fainting
• fast or irregular heartbeat
• sweating

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

• 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
• convulsions
• disturbed color perception
• double vision
• feeling of constant movement of self or surroundings
• flushed skin
• halos around lights
• headache, severe and throbbing
• increased sweating
• loss of appetite
• loss of consciousness
• nausea or vomiting
• night blindness
• overbright appearance of lights
• paralysis
• sensation of spinning
• slow or irregular heartbeat
• tunnel vision

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.

Nitronal
Glyceryl trinitrate
1 mg/ml

For intravenous administration

10 ampoules of 25 ml
for single dose use only

Each ampoule contains 25 mg glyceryl trinitrate
in isotonic aqueous solution (1 mg/ml).

For directions for use, see package leaflet
or data sheet

POHL BOSKAMP