Aggrenox Drug Description

AGGRENOX (aspirin, extended-release dipyridamole) is a combination antiplatelet agent intended for oral administration. Each hard gelatin capsule contains 200 mg dipyridamole in an extended-release form and 25 mg aspirin, as an immediate-release sugar-coated tablet. In addition, each capsule contains the following inactive ingredients: acacia, aluminum stearate, colloidal silicon dioxide, corn starch, dimethicone, hypromellose, hypromellose phthalate, EndureRX lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, povidone, stearic acid, sucrose, talc, tartaric acid, titanium dioxide and triacetin.

Each capsule shell contains gelatin, red iron oxide and yellow iron oxide, titanium dioxide and water.

Dipyridamole

Dipyridamole is an antiplatelet agent chemically described as 2,2',2'',2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula:

C₂₄H₄₀N₈O₄.............................Mol. Wt. 504.63

Dipyridamole is an odorless yellow crystalline substance, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and is practically insoluble in water.

Aspirin

The antiplatelet agent aspirin (acetylsalicylic acid) is chemically known as benzoic acid, 2- (acetyloxy)-, and has the following structural formula:

C₉H₈O₄.......................Mol. Wt. 180.16

Aspirin is an odorless white needle-like crystalline or powdery substance. When exposed to moisture, aspirin hydrolyzes into salicylic and acetic acids, and gives off a vinegary odor. It is highly lipid soluble and slightly soluble in water.

SIDE EFFECTS:Headache, nausea, and heartburn may occur. Talk with your doctor if you have a severe headache when you first start taking this medication. Your doctor may change your dose for the first week to lessen headache. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

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: easy bleeding/bruising, uncontrolled bleeding from gums or nose, fast/slow/irregular heartbeat, dark urine, yellowing eyes/skin.

This drug may infrequently cause serious bleeding (especially from the stomach or intestines). If you notice any of the following rare but serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: bloody/black/tarry stools, fainting, pale/bluish skin color, unusual weakness, vomit with blood or that looks like coffee grounds, persistent stomach/abdominal pain.

Get medical help right away if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of bleeding in the brain or stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: severe 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 if you are allergic to dipyridamole; or to aspirin; or to other salicylates (such as choline salicylate); or to NSAIDs (such as ibuprofen, naproxen); 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), bleeding problems (such as hemophilia, vitamin K deficiency, low platelets), low blood pressure (hypotension), heart problems (such as angina, heart attack), stomach problems (such as ulcers, heartburn), kidney disease, liver disease, a certain muscle problem (myasthenia gravis), growths in the nose (nasal polyps), bleeding in the brain.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may instruct you to stop aspirin/dipyridamole 7-10 days before surgery. Do not stop taking this medication without first talking with the doctor who prescribed it.

The amount of aspirin in this medication may not be enough to prevent heart attack. If you need aspirin to prevent heart attack, consult your doctor or pharmacist for more information.

This drug contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.

Older adults may be more sensitive to the side effects of this drug such as bleeding.

Aspirin is not recommended for use during pregnancy. This medication should be used only when clearly needed during the first 6 months of pregnancy. Do not use this medication during the last 3 months of pregnancy because of possible harm to the unborn baby or problems during delivery. Discuss the risks and benefits with your doctor.

Aspirin and dipyridamole passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Important Safety Information

AGGRENOX is a prescription medication used to lower the risk of stroke in people who have had a “mini-stroke” (transient ischemia attack or TIA) or stroke due to a blood clot.

AGGRENOX should be avoided in patients allergic to any ingredient in AGGRENOX, allergic to non-steroidal anti-inflammatory drugs (NSAIDS), or who have the combination of asthma, runny nose and nasal polyps. AGGRENOX should not be given to a child Viagra Super Active Plus or teenager due to the risk of Reye’s syndrome.

AGGRENOX may cause an increased bleeding risk, including into the brain, stomach or intestines and any bleeding may take longer to stop. AGGRENOX should be avoided in patients with a history of stomach ulcers or those who drink three or more alcoholic drinks a day due to the risk of bleeding. Patients should inform their doctor of all medications they are currently taking including NSAIDS or blood thinners.

AGGRENOX should be avoided during pregnancy, especially in the third trimester, or in patients with severe liver or kidney problems. The most common side effects of AGGRENOX are headache, upset stomach and diarrhea.

AGGRENOX is an FDA-approved prescription medication to lower the risk of stroke in people who have had either a TIA (transient ischemic attack or “mini-stroke”) or stroke due to a blood clot. AGGRENOX is proven to be effective: In a clinical study, AGGRENOX helped reduce the risk of stroke in patients who had a TIA or stroke due to a blood clot. Patients taking AGGRENOX twice daily were 22% less likely to have stroke than patients taking low-dose aspirin (25 mg twice daily) alone. Over 90% of patients on AGGRENOX remained free of recurrent stroke. Learn about the study. ESPS2 (European Stroke Prevention Study) was a 24-month study in which 6602 patients over the age of 18 had an ischemic stroke or TIA (“mini-stroke” or transient ischemic attack) within 3 months prior to entry. Patients received treatment with either AGGRENOX (aspirin/extended-release dipyridamole); extended-release dipyridamole (200 mg alone); aspirin (25 mg alone); or a sugar pill (placebo) twice daily (morning and evening).


Before starting treatment.

It’s important to share certain information with your doctor before you begin treatment with AGGRENOX. Your doctor should know:

Any medication you are taking, or plan to take in the future. This includes prescription and over-the-counter medication as well as vitamins and herbal supplements.
Any allergies or illnesses you may have. Your doctor can help you decide if AGGRENOX is right for you.
If you have a history of stomach ulcers or drink more than 3 alcoholic drinks a day.
If you are or think you might be pregnant. AGGRENOX may not be right for you.
Who should not take AGGRENOX.

AGGRENOX contains aspirin. So some people should not take AGGRENOX or should be aware of the risks associated with aspirin. AGGRENOX should be avoided by:

Patients who are hypersensitive to any of the components of AGGRENOX or who are allergic to non-steroidal anti-inflammatory drugs (NSAIDs).
Patients with asthma in combination with runny nose and nasal polyps.
Women in the third trimester of pregnancy.
Children or teenagers with viral infections because of the risk of Reye's syndrome.
Patients with a history of stomach ulcers. These patients should avoid using aspirin.
In addition, patients who consume 3 or more alcoholic drinks every day should be aware of the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. AGGRENOX and other medicines may affect each other, causing side effects.

AGGRENOX is not right for everyone. Talk to your doctor to find out if AGGRENOX is right for you. Our guide to working with your doctor—which includes questions to ask about AGGRENOX—may help.

During treatment.

Always take AGGRENOX exactly how your doctor prescribed. When you do, be sure to follow these instructions:

Swallow AGGRENOX whole. Do not crush or chew the capsules.
You can take your AGGRENOX with or without food.
If you miss a dose, take your next dose at the usual time. Do not take 2 doses at one time.
If you take more AGGRENOX (overdose) than prescribed, call your healthcare provider or the Poison Control Center to get emergency help right away.

Headaches during treatment.

Headaches are not uncommon when you first start taking AGGRENOX, but often lessen as treatment continues. Tell your healthcare provider if you have a severe headache. Your healthcare provider may change the instructions for taking AGGRENOX.