Generic Name: prasugrel (Oral route)
Bleeding Risk: Prasugrel can cause significant, sometimes fatal, bleeding.
Do not use prasugrel in patients with active pathological bleeding or a history of transient ischemic attack or stroke.
In patients 75 years of age and older, prasugrel is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior myocardial infarction) where its effect appears to be greater and its use may be considered. Do not start prasugrel in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue prasugrel at least 7 days prior to any surgery.
Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of prasugrel.
If possible, manage bleeding without discontinuing prasugrel. Discontinuing prasugrel, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events .
Prasugrel can cause significant, sometimes fatal, bleeding in patients with active pathological bleeding or a propensity to bleed, a history of transient ischemic attack or stroke, a body weight of less than 60 kg, or concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytics, chronic use of NSAIDs). Prasugrel is not recommended in patients 75 years of age and older, except for high-risk situations (diabetes, history of prior myocardial infarction). Do not start prasugrel in patients likely to undergo urgent CABG and discontinue at least 7 days prior to any surgery. If possible, manage bleeding without discontinuing prasugrel, as discontinuation in the first few weeks after acute coronary syndrome may increase risk for subsequent cardiovascular events .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Platelet Aggregation Inhibitor
Pharmacologic Class: ADP-Induced Aggregation Inhibitor
Prasugrel is used to lessen the chance of stroke, heart attack, or other serious problems with your heart or blood vessels. It is given in patients who have already had a heart attack or severe chest pain, in patients with other blood circulation problems that could lead to a stroke or heart attack, or in patients who have been treated with a procedure called angioplasty.
A heart attack or stroke may occur when a blood vessel in the heart or brain is blocked by a blood clot. Prasugrel reduces the chance that a harmful blood clot will form by preventing certain cells in the blood from clumping or sticking together. This effect of prasugrel may also increase the chance of serious bleeding in some people.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of prasugrel in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prasugrel in the elderly. Because of prasugrel's toxicity, use in elderly patients 75 years of age and older is not recommended.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Tell all medical doctors, dentists, nurses, and pharmacists you go to that you are taking this medicine. Prasugrel may increase the risk of serious bleeding during an operation or some kinds of dental work. Treatment may have to be stopped about 7 days before the operation or dental work is done.
Check with your doctor right away if you have the following symptoms: change in mental status, dark or bloody urine, difficulty with speaking, fever, pale color of the skin, pinpoint red spots on the skin, seizures, weakness, yellow eyes or skin. These maybe symptoms of a serious condition called thrombotic thrombocytopenic purpura (TTP).
Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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