Prasugrel

Prasugrel is used for people who have had a balloon angioplasty to open blocked arteries after a heart attack or severe chest pain. Prasugrel may help reduce your chances of having another heart attack or stroke.

Prasugrel may also be used for other reasons not mentioned in this medication guide.

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.

Prasugrel increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical help if you have bleeding that won't 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.

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.

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.

Usual Adult Dose for Acute Coronary Syndrome:

Initial dose: 60 mg orally onceMaintenance dose: 10 mg orally once a dayComments:-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 day75 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).

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

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

• 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.

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.