Prasugrel is used in people who've had a balloon angioplasty to open blocked arteries after having a heart attack or severe chest pain. Prasugrel may help lower your risk of having another heart attack or stroke.

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

Prasugrel increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop, if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds.

You may need to stop using the medicine for a short time before any surgery or dental treatment. Do not stop taking prasugrel unless your doctor tells you to.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. If you also take aspirin, follow your doctor's instructions about how much to take and for how long.

Prasugrel can be taken with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Because prasugrel keeps your blood from clotting, prasugrel can also make it easier for you to bleed, even from a minor injury. Seek emergency medical attention if you have any bleeding that will not stop.

Tell your doctor if you have a planned surgery or dental work.

Do not stop using prasugrel without your doctor's advice, even if you feel fine. Stopping this medicine too soon may increase your risk of a blood clot, heart attack, or death.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for Acute Coronary Syndrome:

Initial dose: 60 mg orally once
Maintenance dose: 10 mg orally once a day

Comments:
-No clear benefit was observed when the loading dose of this drug was administered prior to diagnostic coronary angiography compared to at the time of percutaneous coronary intervention (PCI); however, risk of bleeding was increased with early administration in patients undergoing PCI or early coronary artery bypass graft surgery (CABG).
-Aspirin 75 to 325 mg daily should be taken with this drug.

Use: To reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with PCI for unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), or ST segment elevation myocardial infarction (STEMI).

Usual Geriatric Dose for Acute Coronary Syndrome:

65 to less than 75 years:
-Initial dose: 60 mg orally once
-Maintenance dose: 10 mg orally once a day

75 years or older: Use is generally not recommended in such patients, except in high-risk situations (e.g., diabetes or prior myocardial infarction) when benefit outweighs risk.

Comments:
-No clear benefit was observed when the loading dose of this drug was administered prior to diagnostic coronary angiography compared to at the time of percutaneous coronary intervention (PCI); however, risk of bleeding was increased with early administration in patients undergoing PCI or early coronary artery bypass graft surgery (CABG).
-Aspirin 75 to 325 mg daily should be taken with this drug.

Use: To reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with PCI for unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), or ST segment elevation myocardial infarction (STEMI).

You should not use prasugrel if you are allergic to it, or if you have:

• active bleeding such as a stomach ulcer or bleeding in the brain (such as from a head injury);

• a history of stroke, including TIA ("mini-stroke"); or

• if you are scheduled to have surgery, especially heart bypass surgery (coronary artery bypass graft, or CABG).

Tell your doctor if you have ever had:

• a stomach ulcer, colon polyps, or diverticulosis;

• bleeding problems;

• surgery, an injury, or a medical emergency;

• liver or kidney disease;

• if you are allergic to clopidogrel or ticlopidine;

• if you weigh less than 132 pounds (60 kilograms); or

• if you also use other medicines to treat or prevent blood clots.

Tell your doctor if you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. The medication will come with a gray cylinder that helps keep the tablets dry; leave this cylinder in the container with the medication. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with prasugrel may cause you to bruise or bleed easily.

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

Prasugrel increases your risk of bleeding, which can be severe or life-threatening.

Prasugrel may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• any bleeding that will not stop;

• pink or brown urine;

• signs of a serious blood-clotting problem--pale skin, purple spots under your skin or on your mouth, fever, fast heart rate, weakness, stomach pain, trouble breathing, jaundice (yellowing of the skin or eyes);

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

The risk of bleeding is higher in older adults.

Common side effects of prasugrel may include:

• nosebleeds; or

• easy bruising or bleeding.

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.

Tell your doctor about all your other medicines, especially:

• opioid medication; or

• any other medicines to treat or prevent blood clots, including heparin or warfarin (Coumadin, Jantoven).

This list is not complete. Other drugs may affect prasugrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.