Ismo

DRUG DESCRIPTION

Isosorbide mononitrate is 1,4:3,6-dianhydro-D-glucitol, 5-nitrate, an organic nitrate whose structural formula is:

and whose molecular weight is 191.14. The organic nitrates are vasodilators, active on both arteries and veins. Each Ismo tablet contains 20 mg of isosorbide mononitrate. The inactive ingredients in each tablet are colloidal silicon dioxide, D&C Yellow 10 Aluminum Lake, FD&C Yellow 6 Aluminum Lake, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 20, povidone, sodium starch glycolate, titanium dioxide and hydroxypropyl cellulose.

What are the possible side effects of isosorbide mononitrate (Imdur, ISMO, Monoket)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fast, slow, pounding, or uneven heart rate;


• feeling like you might pass out;


• trouble breathing, blue-colored skin, tired feeling; or


• worsening angina pain.

Less serious side effects may include:

• headache, mild...

Read All Potential Side Effects and See Pictures of Ismo »

What are the precautions when taking isosorbide mononitrate (Ismo)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as nitroglycerin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: recent head injury.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, low blood pressure, loss of too much body water (dehydration), other heart problems (such as recent heart attack).

This drug may make you dizzy. Do not drive, use machinery, or do any...

Read All Potential Precautions of Ismo »

Ismo Consumer (continued)

SIDE EFFECTS: Headache, dizziness, lightheadedness, nausea, and flushing may occur as your body adjusts to this medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Headache is often a sign that this medication is working. Your doctor may recommend treating headaches with an over-the-counter pain reliever (such as acetaminophen, aspirin). If the headaches continue or become severe, tell your doctor promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as nitroglycerin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: recent head injury.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, low blood pressure, loss of too much body water (dehydration), other heart problems (such as recent heart attack).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Older adults may be more sensitive to the side effects of this medication, especially dizziness and lightheadedness, which could increase the risk of falls.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk or if it may harm a nursing infant. Consult your doctor before breast-feeding.

Ismo Patient Information Including Side Effects

Brand Names: Imdur, ISMO, Monoket

Generic Name: isosorbide mononitrate (Pronunciation: EYE soe SOR bide MON oh NYE trate)

• What is isosorbide mononitrate (Ismo)?


• What are the possible side effects of isosorbide mononitrate (Ismo)?


• What is the most important information I should know about isosorbide mononitrate (Ismo)?


• What should I discuss with my healthcare provider before taking isosorbide mononitrate (Ismo)?


• How should I take isosorbide mononitrate (Ismo)?


• What happens if I miss a dose (Ismo)?


• What happens if I overdose (Ismo)?


• What should I avoid while taking isosorbide mononitrate (Ismo)?


• What other drugs will affect isosorbide mononitrate (Ismo)?


• Where can I get more information?

What is isosorbide mononitrate (Ismo)?

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

Isosorbide mononitrate is used to prevent angina attacks (chest pain).

Isosorbide mononitrate will not treat an angina attack that has already begun.

Isosorbide mononitrate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of isosorbide mononitrate (Ismo)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fast, slow, pounding, or uneven heart rate;


• feeling like you might pass out;


• trouble breathing, blue-colored skin, tired feeling; or


• worsening angina pain.

Less serious side effects may include:

• headache, mild dizziness;


• warmth, redness, or tingling under your skin;


• nausea, vomiting, constipation, diarrhea;


• pain or stiffness in joints or muscles;


• hot flashes; or


• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about isosorbide mononitrate (Ismo)?

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

You should not use this medication if you are allergic to isosorbide mononitrate, isosorbide dinitrate, (Isordil, Dilatrate, Isochron), 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 mononitrate, tell your doctor if you have congestive heart failure, low blood pressure, or kidney disease.

Isosorbide mononitrate 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 mononitrate. Ask your doctor before using any headache pain medication.

Isosorbide mononitrate will not treat an angina attack that has already begun.

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 mononitrate suddenly. Stopping suddenly could cause a severe angina attack.

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