IsoDitrate (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 and increasing the supply of blood and oxygen to the heart while reducing its workload. When used regularly over a long time, 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. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on the effects of isosorbide dinitrate in children. Its safety and effectiveness have not been established for the pediatric population.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of isosorbide dinitrate. However, older adults are more likely to have age-related liver, kidney, or heart issues, which may require caution and a dose adjustment for those taking isosorbide dinitrate.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with precautions. Your doctor may need to adjust your dose or take other precautions if you are taking this medicine along with any of the following:

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may change some of the other medicines you are taking.

• Avanafil
• Riociguat
• Sildenafil
• Tadalafil
• Vardenafil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may impact the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

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

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:

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 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
• 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.