Dilatrate-SR (Oral, Sublingual)

Isosorbide dinitrate is used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.

Isosorbide dinitrate belongs to a group of medicines called nitrates. It works by relaxing the blood vessels, which increases the supply of blood and oxygen to the heart while reducing its workload. When used regularly over a long period, this helps prevent angina attacks from happening.

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

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 ensure that this medicine 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 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 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.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits of the medicine. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of isosorbide dinitrate in children. Safety and effectiveness have not been established.

Geriatric

Studies to date have not shown any specific problems in elderly patients that would limit the usefulness of isosorbide dinitrate. However, older patients are more likely to have liver, kidney, or heart issues related to aging, which may require caution and possible dose adjustments for those taking isosorbide dinitrate.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been chosen based on their potential significance and are not a complete list.

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

• Avanafil
• Riociguat
• Sildenafil
• Tadalafil
• Vardenafil

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Make sure to inform your doctor if you have any other medical conditions, especially:

• Congestive heart failure
• Recent heart attack
• Hypertrophic cardiomyopathy (a type of heart disease)
• Hypotension (low blood pressure)
• Hypovolemia (low blood volume)—Use with caution. May worsen these conditions.

Along with its required effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

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

Rare

• 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

Incidence not known

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

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.

In the U.S.

• Dilatrate-SR
• Isochron
• IsoDitrate
• Isordil Titradose

In Canada

• Apo-Isdn
• Isordil

Available Dosage Forms:

• Tablet
• Capsule, Extended Release
• Tablet, Extended Release

Therapeutic Class: Antianginal

Chemical Class: Nitrate

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 form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The extended-release form releases medicine gradually to provide its effect for 8 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.

You should take this medicine 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.

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 and let it dissolve there. Do not eat, drink, smoke, or use chewing tobacco while a tablet is dissolving.

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

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: For oral dosage forms (extended-release tablets or sustained-release capsules): Adults—At first, 40 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 160 mg per day. Children—Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults—At first, 5 to 20 milligrams (mg) two or three 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 (tablets): Adults—2.5 to 5 milligrams (mg) about 15 minutes before expected physical or emotional stress. 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

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

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.