prasugrel (Rx)

Brand and Other Names:Effient
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 5mg
  • 10mg

Acute Coronary Syndrome

Reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) managed by means of percutaneous coronary intervention (PCI) who have either (a) unstable angina or non-ST-elevation MI (NSTEMI) or (b) ST-elevation MI (STEMI) when managed with primary or delayed PCI

60 mg PO once as loading dose, then 10 mg/day PO in combination with aspirin 81-325 mg/day; if patient <60 kg, consider 5 mg/day PO because of potentially increased bleeding risk (efficacy and safety not established)

Dosing Modifications

Renal impairment

  • No dosage adjustment necessary
  • End-stage renal disease: Limited experience; these patients are generally at higher risk of bleeding

Hepatic impairment

  • Mild-to-moderate (Child-Pugh Class A or B): No dosage adjustment necessary
  • Severe (Child-Pugh Class C): Not studied

Dosing in low weight patients

  • Patients (<60 kg) had an increased exposure to active metabolite of prasugrel and an increased risk of bleeding on a 10-mg daily maintenance dose
  • Consider lowering the maintenance dose to 5-mg in patients <60 kg

Sickle Cell Disease (Orphan)

Orphan designation for treatment of sickle cell disease

Sponsor

  • Eli Lilly; Lilly Corporate Center; Indianapolis, IN 46285

Not recommended

Acute Coronary Syndrome

<75 years

  • 60 mg PO once as loading dose, then 10 mg/day PO in combination with aspirin 81-325 mg/day
  • Weight <60 kg: consider 5 mg/day because of potentially increased bleeding risk (efficacy and safety not established)

≥75 years

  • Generally not recommended, because of increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk patients (diabetes or prior MI), for whom effect appears to be greater and use may be considered
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Interactions

Interaction Checker

and prasugrel

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              Serious - Use Alternative (10)

              • apixaban

                prasugrel and apixaban both increase anticoagulation. Avoid or Use Alternate Drug.

              • cangrelor

                cangrelor decreases effects of prasugrel by receptor binding competition. Avoid or Use Alternate Drug. The expected antiplatelet effect of a 60 mg loading dose of prasugrel was blocked when prasugrel was administered during a cangrelor infusion. Therefore, prasugrel should not be administered until cangrelor infusion is discontinued.

              • codeine

                codeine will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Co-administration of opioid agonists delay and reduce absorption of prasugrel and its active metabolite presumably by slowing gastric emptying; consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of opioid agonists

              • heparin

                heparin, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

              • hydromorphone

                hydromorphone will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Co-administration of opioid agonists delay and reduce absorption of prasugrel and its active metabolite presumably by slowing gastric emptying; consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of opioid agonists

              • morphine

                morphine will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Coadministration of opioid agonists delay and reduce the absorption of prasugrel?s active metabolite presumably because of slowed gastric emptying. Consider using a parenteral antiplatelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists. Risks associated with other opioids are unknown.

              • oxycodone

                oxycodone will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Co-administration of opioid agonists delay and reduce absorption of prasugrel and its active metabolite presumably by slowing gastric emptying; consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of opioid agonists

              • oxymorphone

                oxymorphone will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Co-administration of opioid agonists delay and reduce absorption of prasugrel and its active metabolite presumably by slowing gastric emptying; consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of opioid agonists

              • protamine

                protamine, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

              • warfarin

                warfarin, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

              Monitor Closely (61)

              • acalabrutinib

                acalabrutinib increases effects of prasugrel by anticoagulation. Modify Therapy/Monitor Closely. Coadministration of acalabrutinib with antiplatelets or anticoagulants may further increase risk of hemorrhage. Monitor for signs of bleeding and consider the benefit-risk of withholding acalabrutinib for 3-7 days presurgery and postsurgery depending upon the type of surgery and the risk of bleeding.

              • antithrombin alfa

                antithrombin alfa, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.

              • antithrombin III

                antithrombin III, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.

              • argatroban

                argatroban, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.

              • aspirin

                aspirin, prasugrel. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.

              • aspirin rectal

                aspirin rectal, prasugrel. pharmacodynamic synergism. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.

              • aspirin/citric acid/sodium bicarbonate

                aspirin/citric acid/sodium bicarbonate, prasugrel. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.

              • azficel-T

                azficel-T, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.

              • betrixaban

                prasugrel, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.

              • bivalirudin

                bivalirudin, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.

              • caplacizumab

                caplacizumab, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor.

              • celecoxib

                celecoxib, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • choline magnesium trisalicylate

                choline magnesium trisalicylate, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • citalopram

                citalopram increases effects of prasugrel by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of bleeding.

              • dabigatran

                dabigatran, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

              • dalteparin

                dalteparin, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.

              • deferasirox

                deferasirox, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.

              • defibrotide

                defibrotide increases effects of prasugrel by Other (see comment). Use Caution/Monitor. Comment: Defibrotide may enhance effects of platelet inhibitors.

              • diclofenac

                diclofenac, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • diflunisal

                diflunisal, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • edoxaban

                edoxaban, prasugrel. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.

              • enoxaparin

                enoxaparin, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.

              • etodolac

                etodolac, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • fenoprofen

                fenoprofen, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • fentanyl

                fentanyl will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Coadministration of opioid agonists delay and reduce the absorption of prasugrel?s active metabolite presumably because of slowed gastric emptying. Consider using a parenteral antiplatelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists. Risks associated with other opioids are unknown.

              • fish oil

                fish oil, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Patients taking fish oil and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .

              • fish oil triglycerides

                fish oil triglycerides will increase the level or effect of prasugrel by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.

              • flurbiprofen

                flurbiprofen, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • fondaparinux

                fondaparinux, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.

              • green tea

                green tea increases effects of prasugrel by pharmacodynamic synergism. Use Caution/Monitor. (Theoretical interaction). Combination may increase risk of bleeding.

              • ibrutinib

                ibrutinib will increase the level or effect of prasugrel by anticoagulation. Use Caution/Monitor. Ibrutinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and monitor for signs of bleeding.

              • ibuprofen

                ibuprofen, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • ibuprofen IV

                ibuprofen IV, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • ibuprofen/famotidine

                ibuprofen/famotidine, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • icosapent

                icosapent, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.

              • imatinib

                imatinib, prasugrel. Either increases toxicity of the other by Other (see comment). Modify Therapy/Monitor Closely. Comment: Imatinib may cause thrombocytopenia; bleeding risk increased when imatinib is coadministered with anticoagulants, NSAIDs, platelet inhibitors, and thrombolytic agents.

              • indomethacin

                indomethacin, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • ketoprofen

                ketoprofen, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • ketorolac

                ketorolac, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • ketorolac intranasal

                ketorolac intranasal, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • meclofenamate

                meclofenamate, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • mefenamic acid

                mefenamic acid, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • melatonin

                melatonin increases effects of prasugrel by anticoagulation. Use Caution/Monitor. Melatonin may decrease prothrombin time.

              • meloxicam

                meloxicam, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • nabumetone

                nabumetone, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • naproxen

                naproxen, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • omega 3 carboxylic acids

                omega 3 carboxylic acids, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

              • omega 3 fatty acids

                omega 3 fatty acids, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3-fatty acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .

              • oxaprozin

                oxaprozin, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • piracetam

                piracetam increases effects of prasugrel by pharmacodynamic synergism. Use Caution/Monitor.

              • piroxicam

                piroxicam, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • porfimer

                prasugrel decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.

              • rivaroxaban

                rivaroxaban, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

              • salsalate

                salsalate, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • selumetinib

                prasugrel and selumetinib both increase anticoagulation. Modify Therapy/Monitor Closely. An increased risk of bleeding may occur in patients taking a vitamin-K antagonist or an antiplatelet agent with selumetinib. Monitor for bleeding and INR or PT in patients coadministered a vitamin-K antagonist or an antiplatelet agent with selumetinib.

              • sodium zirconium cyclosilicate

                sodium zirconium cyclosilicate will decrease the level or effect of prasugrel by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

              • sulindac

                sulindac, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • ticagrelor

                ticagrelor, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Increased risk of bleeding during concomitant use of medications that increase potential for bleeding.

              • tolmetin

                tolmetin, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • vorapaxar

                prasugrel, vorapaxar. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Coadministration of anticoagulants, antiplatelets, or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

              • vortioxetine

                prasugrel increases effects of vortioxetine by anticoagulation. Use Caution/Monitor.

              Minor (5)

              • devil's claw

                devil's claw, prasugrel. pharmacodynamic synergism. Minor/Significance Unknown. May prolong bleeding time. Conflicting evidence. Use with caution.

              • ginger

                ginger, prasugrel. pharmacodynamic synergism. Minor/Significance Unknown. May prolong bleeding time. Conflicting evidence. Use with caution.

              • ginkgo biloba

                ginkgo biloba, prasugrel. pharmacodynamic synergism. Minor/Significance Unknown. May prolong bleeding time. Conflicting evidence.ÿ Use with caution.

              • horse chestnut seed

                horse chestnut seed, prasugrel. pharmacodynamic synergism. Minor/Significance Unknown. May prolong bleeding time. Theoretical. Use with caution.

              • verteporfin

                prasugrel decreases effects of verteporfin by pharmacodynamic antagonism. Minor/Significance Unknown.

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              Adverse Effects

              1-10%

              Hypertension (7.5%)

              Hypercholesterolemia/hyperlipidemia (7%)

              Headache (5.5%)

              Back pain (5%)

              Dyspnea (4.9%)

              Nausea (4.6%)

              Dizziness (4.1%)

              Cough (3.9%)

              Hypotension (3.9%)

              Fatigue (3.7%)

              Noncardiac chest pain (3.1%)

              Atrial fibrillation (2.9%)

              Bradycardia (2.9%)

              Leukopenia (<4 x 10^9 WBC/L) (2.8%)

              Rash (2.8%)

              Pyrexia (2.7%)

              Peripheral edema (2.7%)

              Pain in extremity (2.6%)

              Diarrhea (2.3%)

              <1%

              Thrombotic thrombocytopenic purpura

              Abnormal hepatic function

              Angioedema

              Hematoma

              Hemolysis

              Hemorrhage

              Abnormal liver function

              Postmarketing Reports

              Blood and lymphatic system disorders: Thrombocytopenia, thrombotic thrombocytopenic purpura (TTP)

              Immune system disorders: Hypersensitivity reactions (eg, anaphylaxis)

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              Warnings

              Black Box Warnings

              Potential for significant, sometimes fatal, bleeding

              • Prasugrel can cause significant, sometimes fatal, bleeding
              • Do not use in patients with active pathological bleeding or a history of transient ischemic attack or stroke
              • In patients ≥75 years of age, use is generally not recommended, owing to increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (eg, diabetes or prior MI)
              • Do not start in patients likely to undergo urgent coronary artery bypass graft surgery (CABG); when possible, discontinue prasugrel at least 7 days prior to any surgery
              • If possible, manage bleeding without discontinuing (risk of subsequent cardiovascular events is increased if prasugrel stopped, particularly in first few weeks after ACS)
              • Suspect bleeding in any patient who is hypotensive and has recently undergone invasive or surgical procedures

              Additional risk factors for bleeding

              • Weight <60 kg increases risk of bleeding
              • Propensity to bleed (eg, recent trauma, recent surgery, recent or recurrent GI bleeding, active peptic ulcer disease, severe hepatic impairment, or moderate-to-severe renal impairment)
              • Concomitant use of other drugs that increase bleeding risk

              Contraindications

              Hypersensitivity

              Active pathologic bleeding (eg, peptic ulcer, intracranial hemorrhage)

              Prior TIA or stroke

              Cautions

              Hypersensitivity with angioedema reported

              Bleeding diathesis

              Thrombocytopenic purpura occurring within 2 weeks of initiation of therapy reported

              Discontinue treatment for active bleeding, elective surgery, stroke, or TIA; premature discontinuation of any antiplatelet medication conveys an increased risk of stent thrombosis, myocardial infarction, and death; patients who require premature discontinuation of a thienopyridine will be at increased risk for cardiac events; avoid lapses in therapy, and if thienopyridines must be temporarily discontinued because of an adverse event(s), restart as soon as possible

              Risk increases in patients receiving drug who undergo CABG

              Premature discontinuation increases risk of stent thrombosis, MI, and death

              See Black Box Warnings

              Drug interactions overview

              • Coadministration with warfarin or nonsteroidal anti-inflammatory drugs (NSAIDs) (used chronically) increases the risk of bleeding
              • Coadministration of opioid agonists delay and reduce the absorption of prasugrel’s active metabolite presumably because of slowed gastric emptying
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              Pregnancy & Lactation

              Pregnancy

              There are no data with prasugrel use in pregnant women to inform a drug-associated risk

              Due to the mechanism of action, and the associated identified risk of bleeding, consider the benefits and possible risks to the fetus when prescribing prasugrel to a pregnant woman

              Lactation

              There is no information regarding the presence of prasugrel in human milk, the effects on the breastfed infant, or the effects on milk production

              Metabolites of prasugrel were found in rat milk

              Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for prasugrel and any potential adverse effects on the breastfed child from prasugrel or from the underlying maternal condition

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              A prodrug, a thienopyridine that inhibits platelet activation and aggregation through irreversible binding of active metabolite to adenosine phosphate (ADP) platelet receptors (specifically, P2Y12 receptor)

              Absorption

              Bioavailability: >78%

              Peak plasma time: 30 min

              Absorption: >79%

              With high fat, high calorie meal, peak plasma concentration decreased by 49% and peak plasma time increased from 0.5-1.5 hr

              Distribution

              Protein bound: 98% (active metabolite)

              Vd: 44-68 L (active metabolite)

              Metabolism

              Rapidly hydrolyzed in intestine to active metabolite via CYP3A4 and CYP2B6

              Elimination

              Half-life: 7 hr (range, 2-15 hr)

              Clearance: 112-166 L/hr

              Excretion: Urine (68%), feces (27%)

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              Administration

              Oral Administration

              Take with or without food

              Storage

              Tablets: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F); dispense and keep product in original container; keep container closed and do not remove desiccant from bottle

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              prasugrel oral
              -
              10 mg tablet
              prasugrel oral
              -
              10 mg tablet
              prasugrel oral
              -
              5 mg tablet
              prasugrel oral
              -
              10 mg tablet
              prasugrel oral
              -
              10 mg tablet
              prasugrel oral
              -
              10 mg tablet
              prasugrel oral
              -
              5 mg tablet
              Effient oral
              -
              10 mg tablet
              Effient oral
              -
              5 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              prasugrel oral

              PRASUGREL - ORAL

              (PRA-soo-grel)

              COMMON BRAND NAME(S): Effient

              WARNING: Prasugrel can rarely cause very serious (possibly fatal) bleeding. Tell your doctor right away if you notice any signs of serious bleeding. See also Side Effects and Precautions sections.

              USES: Prasugrel is used with aspirin by patients with heart disease (recent heart attack, unstable angina) who undergo a certain heart procedure (angioplasty). This medication helps to prevent other serious heart/blood vessel problems (such as heart attacks, strokes, blood clots in stents). It works by blocking platelets from sticking together and prevents them from forming harmful blood clots. This "anti-platelet" effect helps to keep blood flowing smoothly in your body.

              HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking prasugrel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once a day. Your doctor may direct you to take this medication with low-dose aspirin (usually 81-162 milligrams a day). Follow your doctor's instructions carefully.The manufacturer directs not to split the tablet before taking it. However, many similar drugs (immediate-release tablets) can be split. Follow your doctor's directions on how to take this medication.It is very important to take prasugrel exactly as directed. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Also, do not stop using this medication unless directed by your doctor.The dosage is based on your medical condition, weight, and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

              SIDE EFFECTS: Headache, nausea, nosebleed, and stomach upset may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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.This medication can cause serious bleeding. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, coughing up blood, bloody/black/tarry stools, bloody urine, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, shortness of breath, chest pain, difficulty swallowing.Prasugrel has rarely caused a certain blood disorder (thrombotic thrombocytopenic purpura). Get medical help right away if you develop symptoms of this blood disorder, including: vision changes, trouble speaking, confusion, yellowing eyes/skin, dark urine, signs of kidney problems (such as change in the amount of urine), unusual weakness/tiredness, unexplained fever.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 or at www.fda.gov/medwatch.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 prasugrel, tell your doctor or pharmacist if you are allergic to it; or to similar antiplatelet drugs (thienopyridines such as clopidogrel); 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: blood disorders (such as hemophilia), bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood clots in the brain (stroke, transient ischemic attack-TIA), recent major injury/surgery, liver disease, stomach/intestinal ulcers.Before having surgery or any medical/dental procedures (including heart bypass surgery-CABG), tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine will increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.Older adults (75 years or older) may be more sensitive to the side effects of this drug, especially bleeding. Discuss the risks and benefits with your doctor.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. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: tipranavir.This medication is sometimes used together with other drugs that have "blood thinning" or anti-platelet effects, such as aspirin or heparin. When these combinations are prescribed by your doctor, you will require closer monitoring to minimize your risk of bleeding. Keep all medical and laboratory appointments.Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen, naproxen) that may increase your risk for bleeding if taken together with this medication. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Store the medication in the original bottle with the desiccant to protect against moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.