Isordil

Isordil® (isosorbide dinitrate) Oral Titradose® Tablets are available as follows:

5 mg, round, pink tablets imprinted "BPI 152" on one side and deeply scored on reverse side:

NDC 0187-0152-01, bottles of 100.

40 mg, round, light green tablets imprinted "BPI 192" on one side and deeply scored on reverse side:

NDC 0187-0192-01, bottles of 100.

Store at controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30° (59° to 86°F) [see USP Controlled Room Temperature].

Protect from light.

Keep bottles tightly closed.

Dispense in a light-resistant, tight container.

Keep out of reach of children.

Manufactured By: MEDA Manufacturing GmbH Cologne, Germany D-51063. Revised: Oct 2016

Isordil is part of the drug class:

• Antihemmorhoidal Muscle Relaxants

Isosorbide dinitrate is in a group of drugs called nitrates. Isosorbide dinitrate dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

Isosorbide dinitrate is used to treat or prevent attacks of chest pain (angina).

Only the sublingual tablet should be used to treat an angina attack that has already begun.

Isosorbide dinitrate regular and extended-release tablets are used to prevent angina attacks but will not treat an angina attack.

Isosorbide dinitrate may also be used for purposes other than those listed in this medication guide.

Do not use isosorbide dinitrate if you are taking sildenafil (Viagra). Serious, life-threatening side effects can occur if you take isosorbide dinitrate while you are using sildenafil.

You should not use this medication if you are allergic to isosorbide dinitrate, isosorbide mononitrate (Imdur, ISMO, Monoket), or nitroglycerin, or if you have early signs of a heart attack (chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling).

Before taking isosorbide dinitrate, tell your doctor if you have congestive heart failure, low blood pressure, or kidney disease.

Isosorbide dinitrate can cause severe headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use the medication. Do not stop taking isosorbide dinitrate. Ask your doctor before using any headache pain medication.

Only the sublingual tablet should be used to treat an angina attack that has already begun.

Isosorbide dinitrate regular and extended-release tablets are used to prevent angina attacks but will not treat an angina attack.

It is important to keep taking this medicine as directed to prevent an angina attack. Get your prescription refilled before you run out of medicine completely.

Do not stop taking isosorbide dinitrate suddenly. Stopping suddenly could cause a severe angina attack.

Do not use isosorbide dinitrate if you are taking sildenafil (Viagra). Serious, life-threatening side effects can occur if you take isosorbide dinitrate while you are using sildenafil.

You should not use this medication if you are allergic to isosorbide dinitrate, isosorbide mononitrate (Imdur, ISMO, Monoket), or nitroglycerin, or if you have early signs of a heart attack (chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take isosorbide dinitrate:

• congestive heart failure;
• low blood pressure; or
• kidney disease.

FDA pregnancy category C. It is not known whether isosorbide dinitrate is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether isosorbide dinitrate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Isosorbide dinitrate can cause severe headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use isosorbide dinitrate. Do not stop taking the medication. Ask your doctor before using any headache pain medication.

Taking isosorbide dinitrate with certain other medicines can cause severely low blood pressure. This includes medicine to treat erectile dysfunction or pulmonary arterial hypertension. Serious, life-threatening side effects may occur.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• avanafil (Stendra);

• a diuretic or "water pill";

• nitroglycerin;

• riociguat (Adempas);

• sildenafil (Viagra, Revatio);

• tadalafil (Cialis, Adcirca); or

• vardenafil (Levitra, Staxyn).

This list is not complete. Other drugs may interact with isosorbide dinitrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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 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 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.

Isordil (isosorbide dinitrate) Sublingual tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. However, because the onset of action of sublingual ISDN is significantly slower than that of sublingual nitroglycerin, sublingual ISDN is not the drug of first choice for abortion of an acute anginal episode.

Allergic reactions to organic nitrates are extremely rare, but they do occur. Isordil is contraindicated in patients who are allergic to isosorbide dinitrate or any of its other ingredients.

Isordil® (isosorbide dinitrate) Sublingual Tablets are available as follows:

2.5 mg, round, yellow tablets imprinted "2.5" on one side and "W" on reverse side:
NDC 0008-4139-01, bottles of 100.

5 mg, round, pink tablets imprinted "5" on one side and "W" on reverse side:
NDC 0008-4126-01, bottles of 100.

Store at room temperature, approximately 25° C (77° F)
Protect from light
Keep bottles tightly closed
Dispense in a light-resistant, tight container
Use carton to protect blisters from light

10 mg, round, white tablets imprinted "10" on one side and "Wyeth" on reverse side:
NDC 0008-4161-01, bottles of 100.

Store at room temperature, approximately 25° C (77° F)
Keep tightly closed
Dispense in a tight container

ALSO AVAILABLE
Oral Titradose® Tablets in the following dosage strengths:

5 mg, NDC 0008-4152, in bottles of 100 or 1,000.

10 mg, NDC 0008-4153, in bottles of 100 or 1,000.

20 mg, NDC 0008-4154, in bottles of 100 or 500.

30 mg, NDC 0008-4159, in bottles of 100.

40 mg, NDC 0008-4192, in bottles of 100.

Wyeth Laboratories
A Wyeth-Ayerst Company
Philadelphia, PA 19101

CI 4370-3