Brand Names:

• Minitran
• Nitrek
• Nitro-Bid
• Nitro-Dur
• 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
• Nitrol
• Nitrong
• Nitrostat

Dosage Forms:

• Patch, Extended Release
• Ointment

Uses of This Medicine:

Nitrates are used to treat the symptoms of angina (chest pain). Depending on the type of dosage form and how it is taken, nitrates are used to treat angina in three ways:

• To relieve an attack that is occurring by using the medicine when the attack begins;
• To prevent attacks from occurring by using the medicine just before an attack is expected to occur; or
• to reduce the number of attacks that occur by using the medicine regularly on a long-term basis.

When applied to the skin, nitrates are used to reduce the number of angina attacks that occur. The only nitrate available for this purpose is topical nitroglycerin

Topical nitroglycerin is absorbed through the skin. It works by relaxing blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. This helps prevent future angina attacks from occurring.

Topical nitroglycerin may also be used for other conditions as determined by your doctor.

These medicines are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, topical nitroglycerin is used in certain patients with the following medical condition:

• Chronic anal fissures

Before Using This Medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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.

Children

Studies on these medicines have been done only in adult patients, and there is no specific information comparing use of nitrates in children with use in other age groups.

Older adults

Dizziness or lightheadedness may be more likely to occur in the elderly, who may be more sensitive to the effects of nitrates.

Pregnancy

Nitrates have not been studied in pregnant women. Before taking these medicines, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding

It is not known whether this medicine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking these medicines and who wish to breast-feed should discuss this with their doctor.

Other medicines

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

• Sildenafil
• Tadalafil
• Vardenafil

Using medicines in this class 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

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. 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia (severe)

• Glaucoma May be worsened by nitroglycerin

• Head injury (recent) or
• Stroke (recent) Nitroglycerin may increase pressure in the brain, which can make problems worse.

• Heart attack (recent) Nitroglycerin may lower blood pressure, which can aggravate problems associated with heart attack.

• Kidney disease or
• Liver disease Effects may be increased because of slower removal of nitroglycerin from the body.

• Overactive thyroid

Proper Use of This Medicine:

Use nitroglycerin exactly as directed by your doctor. It will work only if applied correctly.

The ointment and transdermal forms of nitroglycerin are used to reduce the number of angina attacks. They will not relieve an attack that has already started because they work too slowly. Check with your doctor if you need a fast-acting medicine to relieve the pain of an angina attack.

This medicine usually comes with patient instructions. Read them carefully before using this medicine.

For patients using the ointment form of this medicine:

• 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 dose-measuring papers. 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; just spread in a thin, even layer, covering an area of the same size each time it is applied.
• Apply the ointment to skin that has little or no hair.
• Apply each dose of ointment to a different area of skin to prevent irritation or other skin problems.
• If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since occlusive dressings increase the amount of medicine absorbed through the skin and the possibility of side effects, use them only as directed. If you have any questions about this, check with your health care professional.

For patients using the transdermal (stick-on patch) system:

• 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 and free of scars, cuts, or irritation. Remove the previous patch before applying a new one.
• Apply a new patch if the first one becomes loose or falls off.
• Apply each dose to a different area of skin to prevent skin irritation or other problems.

Dosing

The dose medicines in this class 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 these medicines. 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 (chest pain):
  • For topical dosage form (ointment):
    • Adults 15 to 30 milligrams (mg) (about one to two inches of ointment squeezed from tube) every six to eight hours.
    • Children Use and dose must be determined by your doctor.
  • For transdermal system (skin patch) dosage form):
    • Adults Apply one transdermal dosage system (skin patch) to intact skin once a day. The patch is usually left on for 12 to 14 hours a day and then taken off. Follow your doctor's instructions for when to put on and take off the skin patch.
    • 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

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Do not take sildenafil (e.g., Viagra), tadalafil (e.g., Cialis), or vardenafil (e.g., Levitra) if you are taking this medicine. When sildenafil, tadalafil, or vardenafil are taken with nitrates, the combination can lower blood pressure and cause dizziness, lightheadedness, or fainting. In some cases, sildenafil, tadalafil, or vardenafil taken with nitrates has caused death. If you are taking sildenafil, tadalafil, or vardenafil and you experience an angina attack, you must go to the hospital right away.

If you have been using nitroglycerin regularly for several weeks or more, do not suddenly stop using it. Stopping suddenly may bring on attacks of angina. Check with your doctor for the best way to reduce gradually the amount you are using before stopping completely.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help. If you feel dizzy, sit or lie down.

The 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.

After using a dose of this medicine you may get a headache that lasts for a short time. This is a common side effect, which should become less noticeable after you have used the medicine for a while. If this effect continues, or if the headaches are severe, check with your doctor.

Side Effects of This Medicine:

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 as soon as possible if any of the following side effects occur:

Rare

Blurred vision

dryness of mouth

headache (severe or prolonged)

Signs and symptoms of overdose (in the order in which they may occur)

Bluish-colored lips, fingernails, or palms of hands

dizziness (extreme) or fainting

feeling of extreme pressure in head

shortness of breath

unusual tiredness or weakness

weak and fast heartbeat

fever

convulsions (seizures)

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:

More common

Dizziness or lightheadedness, especially when getting up from a lying or sitting position

fast pulse

flushing of face and neck

headache

nausea or vomiting

restlessness

Less common

Sore, reddened skin

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