(pra' soo grel)
|| See TERMINOLOGY & ABBREVIATIONS ||
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, 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 MI) 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.
Additional risk factors for bleeding include: body weight <60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs]). 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.
|Content & Description||
Each 5- or 10-mg tablet contains prasugrel HCl 5.49 or 10.98 mg, equivalent to prasugrel 5 or 10 mg, respectively.
|Indications||In combination with aspirin, for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes [moderate to high risk unstable angina (UA), non ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI)] who are to undergo percutaneous coronary intervention (PCI).|
|Dosage & Administration||Adults (≥18 years) Starting dose: Single 60-mg loading dose (LD) then continued at a 10-mg once daily dose maintenance dose (MD). Patients taking prasugrel should also take aspirin (75-325 mg) daily.
May be taken with or without food (see Pharmacology under Actions).
Elderly (≥75 years): Generally not recommended in patients ≥75 years due to the risk of bleeding (including fatal bleeding) (see Precautions).
Patients Weighing <60 kg: A single 60-mg LD and then continued at a 5-mg once daily MD. The 10-mg MD is not recommended. The evidence for the 5-mg dose is based on pharmacodynamic/pharmacokinetic analyses only and no clinical data currently exist on the safety and efficacy of this dose (see Precautions).
Children and Adolescents: The safety and efficacy of prasugrel has not been established in paediatric patients (see Precautions).
Renal Impairment: No dosage adjustment is necessary for patients with renal impairment; including patients with end-stage renal disease (ESRD). As ESRD significantly impacts both the AUC and Cmax of the active metabolite of prasugrel, the use of prasugrel needs to be closely monitored in this class of patient (see Pharmacokinetics: Special Populations under Actions).
Hepatic Impairment: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh class A and B). The pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic disease (Child-Pugh class C) have not been studied (see Contraindications, Precautions and Pharmacokinetics: Special Populations under Actions).
Asian Populations: No dosage adjustment is necessary based on ethnicity alone. In clinical pharmacology studies, the AUC of the active metabolite of prasugrel was higher in Chinese, Japanese and Korean subjects compared to Caucasian subjects. Therapeutic experience with prasugrel is limited in Asian patients therefore; the use of prasugrel needs to be closely monitored in these patients (see Pharmacokinetics: Special Populations under Actions).
|Overdose||Overdose following prasugrel administration may lead to prolonged bleeding time and subsequent bleeding complications. In rats, lethality was observed only after administration of the very high dose of 2000 mg/kg. Symptoms of acute toxicity in dogs included emesis, increased serum alkaline phosphatase, and hepatocellular atrophy. Symptoms of acute toxicity in rats included mydriasis, irregular respiration, decreased locomotor activity, ptosis, staggering gait and lacrimation. Consistent with known pharmacologic activity, platelet aggregation was inhibited in dogs.
No data are available on the reversal of the pharmacological effect of prasugrel; however, if prompt correction of prolonged bleeding time is required, platelet transfusion and/or other blood products may be considered at the discretion of the treating physician.
|Contraindications||Known hypersensitivity to prasugrel HCl or to any of the excipients of Prasugrel.
Active pathological bleeding; known history of transient ischaemic attack (TIA) or stroke; severe hepatic impairment (Child-Pugh class C).
Lactose: Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Prasugrel.
|Special Precautions||Prior TIA or Stroke: In the phase 3 clinical trial, prasugrel-treated patients with a history of TIA or a history of ischaemic stroke >3 months prior to drug therapy had a higher rate of the primary composite endpoint, including ischaemic or haemorrhagic stroke compared to clopidogrel. The rate of TIMI major or minor bleeding was also increased in these patients compared to patients without a history of TIA or stroke. Patients with a history of ischaemic stroke within 3 months of drug therapy or haemorrhagic stroke were excluded from the phase 3 clinical trial (see Adverse Reactions and Clinical Trials under Actions).
Prasugrel has not been studied without aspirin in patients with prior history of TIA or stroke.
Bleeding Risk: In the phase 3 clinical trial, key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings. Patients with acute coronary syndromes undergoing PCI treated with prasugrel showed an increased risk of major and minor bleeding according to the TIMI classification system. Therefore, use of prasugrel in patients at increased risk of bleeding should only be considered when the benefits in terms of prevention of ischaemic events are deemed to outweigh the risk of serious bleeding. In particular, caution is necessary in patients: ≥75 years [In the phase 3 clinical trial, patients ≥75 years taking prasugrel were at a greater risk of bleeding, including fatal bleeding, compared to patients <75 years. In these patients, prasugrel is generally not recommended; with a propensity to bleed [eg, due to recent trauma or surgery; recent or recurrent gastrointestinal bleeding, active peptic ulcer disease, severe hepatic impairment or moderate to severe renal impairment]; with body weight <60 kg. In these patients, a 5-mg MD is recommended (see Body Weight, Adverse Reactions and Dosage & Administration); with concomitant administration of medications that may increase the risk of bleeding, including oral anticoagulants, nonsteroidal anti-inflammatory drugs (NSAIDs) and fibrinolytics.
Patients should be told that it may take longer than usual for bleeding to stop when they take prasugrel and that they should report any unusual bleeding (site or duration) to their physician.
For patients with active bleeding for whom reversal of the pharmacological effects of prasugrel is required, platelet transfusion may be appropriate.
Body Weight: Of the total number of prasugrel patients in the TRITON study, 4.6% had body weight <60 kg. Individuals with body weight <60 kg had an increased risk of TIMI major or minor bleeding and an increased exposure to the active metabolite of prasugrel. Prasugrel should be used with caution after a careful individual benefit/risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of bleeding. For patients <60 kg, a 5-mg once daily MD should be used, the 10-mg MD is not recommended for these patients (see Bleeding Risk, Dosage & Administration, Adverse Reactions and Pharmacology under Actions).
Surgery: Patients should be advised to inform physicians and dentists that they are taking prasugrel before any surgery is scheduled and before any new medicinal product is taken. If a patient is to undergo elective surgery and an antiplatelet effect is not desired, prasugrel should be discontinued at least 7 days prior to surgery. Increased frequency (3 fold) and severity of bleeding may occur in patients undergoing CABG surgery within 7 days of discontinuation of prasugrel. The benefits and risks of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been defined and urgent CABG is a possibility.
Discontinuation of Prasugrel: In patients with ACS who are managed with PCI, premature discontinuation of any antiplatelet medication, including prasugrel, could result in an increased risk of thrombosis, MI or death. Patients who require premature discontinuation of prasugrel (eg, secondary to active bleeding) should be monitored for cardiac events. Once the patient is stabilised at the discretion of the patient's treating physician, restarting antiplatelet treatment may be considered.
Neoplasms: In TRITON, the incidence of newly diagnosed neoplasms was higher for prasugrel-treated patients compared to clopidogrel-treated patients [1.4% (94/6741) to 1.2% (80/6716) respectively, p=0.3]. The higher incidence appeared to be related to a higher incidence of colorectal neoplasms (19 prasugrel versus 10 clopidogrel). This imbalance may have resulted from the more potent antiplatelet effect of prasugrel bringing more events to medical attention. The nonclinical studies were negative for carcinogenicity and tumour stimulation (see Carcinogenicity in the following text). Bleeding in patients taking antiplatelet therapy warrants diagnostic investigation since it may unmask a previously unsuspected lesion (eg, tumour, ulcer).
Thrombotic Thrombocytopenic Purpura (TTP): TTP has been reported with the use of Prasugrel. TTP is a serious condition and requires prompt treatment.
Hypersensitivity Including Angioedema: Hypersensitivity including angioedema has been reported in patients receiving Prasugrel, including in patients with a history of hypersensitivity reaction to other thienopyridines.
Renal Impairment: No dosage adjustment is necessary for patients with renal impairment; including patients with end-stage renal disease (see Bleeding Risk, Dosage & Administration and Pharmacology under Actions).
Hepatic Impairment: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh class A and B). The pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic disease have not been studied. Prasugrel should not be used in patients with severe hepatic disease due to the potential risk of bleeding in this population (see Precautions and Pharmacology under Actions).
Effects on the Ability to Drive or Operate Machinery: No studies on effects on ability to drive and use machines have been performed. Prasugrel is expected to have no or negligible influence on the ability to drive and use machines.
Carcinogenicity: No compound-related tumours were observed in a 2-year rat study with prasugrel exposures ranging to >75 times the recommended therapeutic exposures in humans (based on plasma exposures to the active and major circulating human metabolites). There was an increased incidence of tumours (hepatocellular adenomas) in mice exposed for 2 years to high doses (>75 times human exposure) but this was considered secondary to prasugrel-induced enzyme-induction. The rodent-specific association of liver tumours and drug-induced enzyme induction is well documented in the literature. Therefore, the increase in liver tumours with prasugrel administration in mice is not considered a relevant human risk.
Genotoxicity: Assays for gene mutations (Ames test) and chromosomal damage (Chinese Hamster Ovary cells in vitro, mouse micronucleus in vivotest) did not provide any evidence of a genotoxic potential for prasugrel.
Effects on Fertility: Animal studies did not indicate direct harmful effects with respect to fertility. Prasugrel had no effect on fertility of male or female rats at oral doses up to 300 mg/kg/day, corresponding to an active metabolite exposure (based on AUC) of approximately 1500 times that anticipated at the recommended human MD.
Use in pregnancy: Pregnancy Category B1: There are no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of a human response, prasugrel should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Embryo foetal developmental toxicology studies in rats and rabbits showed no evidence of malformations at doses corresponding to >100 times the active metabolite exposure anticipated in humans at the MD of 10 mg daily (based on AUC) of prasugrel. Only minor decreases in maternal body weight gain (3%) and offspring body weight (3-5%) were observed relative to controls. In prenatal and postnatal rat studies, a similar dose exposure had no effect on the behavioural or reproductive development of offspring.
Use in lactation: There are no clinical studies in lactating women.
A study in rats has shown that prasugrel metabolites are excreted in the animals' milk. It is not known whether prasugrel is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the nursing woman.
Use in children: Safety and effectiveness in paediatric patients has not been established (see Pharmacology under Actions).
Use in the elderly: Of the total number of prasugrel-treated patients in TRITON, 38.5% were ≥65 years and 13.2% were ≥75 years. The event rate of the primary composite endpoint with prasugrel compared to clopidogrel for patients ≥75 years was 15.98% versus 16.96%; (HR=0.94; 95% CI 0.749, 1.181; p=0.596). Individuals ≥75 years had an increased risk of TIMI major or minor bleeding (including life-threatening and fatal bleeding) due to greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel in patients ≥75 years compared to patients <75 years. There was also an increase in the incidence of stroke in patients ≥75 years compared to those <75 years. The use of prasugrel in patients ≥75 years is generally not recommended due to the risk of bleeding (including fatal bleeding) (see Bleeding Risk, Dosage & Administration, Adverse Reactions and Pharmacology under Actions).
|Adverse Drug Reactions||
Safety in patients with ACS undergoing PCI was evaluated in a clopidogrel-controlled study, TRITON, in which 6741 patients were treated with Prasugrel (60-mg LD and 10 mg once daily MD) for a median of 14.5 months (5802 patients were treated for over 6 months; 4136 patients were treated for >1 year).
|Drug Interactions||Prasugrel can be concomitantly administered with medicinal products metabolised by cytochrome P-450 enzymes (including statins) or medicinal products that are inducers or inhibitors of cytochrome P-450 enzymes. Prasugrel can also be concomitantly administered with ASA, heparin, digoxin and medicinal products that elevate gastric pH, including proton pump inhibitors and H2 blockers. Although not studied in specific interaction studies, prasugrel was co-administered in the phase 3 clinical trial with low molecular weight heparin, bivalirudin and GPIIb/IIIa inhibitors (no information is available regarding the type of GPIIb/IIIa inhibitor used) without evidence of clinically significant adverse interactions.
Potential for Other Drugs to Affect Prasugrel: Inhibitors of CYP3A:Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect prasugrel-mediated IPA or the active metabolite's AUC and Tmax, but decreased the Cmax by 34%-46%. Therefore, CYP3A inhibitors eg, verapamil, diltiazem, indinavir, ciprofloxacin, clarithromycin and grapefruit juice are not anticipated to have a significant effect on the pharmacokinetics of the active metabolite.
Inducers of Cytochrome P-450: Rifampicin (600 mg daily), a potent inducer of CYP3A and CYP2B6 and an inducer of CYP2C9, CYP2C19 and CYP2C8, did not significantly change the pharmacokinetics of prasugrel and its IPA. Therefore, known CYP3A inducers eg, rifampicin, carbamazepine and other inducers of cytochrome P-450 are not anticipated to have significant effect on the pharmacokinetics of the active metabolite.
Drugs that Elevate Gastric pH: Daily co-administration of ranitidine (an H2receptor blocker) or lansoprazole (a proton pump inhibitor) did not change the metabolite's AUC and Tmax, but decreased the Cmax by 14% and 29%, respectively. In the pivotal phase 3 trial, prasugrel was administered without regard to co-administration of a proton pump inhibitor (PPI) or H2 receptor blocker and the reduction in the primary endpoint from 0-3 days was consistent for patients taking prasugrel with and without concomitant use of a PPI or H2 receptor blocker.
Statins: Atorvastatin (80 mg daily) did not alter the pharmacokinetics of prasugrel or its IPA. Therefore, statins that are substrates of CYP3A are not anticipated to have an effect on the pharmacokinetics of prasugrel or its IPA.
Heparin: A single IV dose of unfractionated heparin (100 units/kg) did not significantly alter the prasugrel-mediated IPA. Likewise, prasugrel did not significantly alter the effect of heparin on measures of coagulation. An increased risk of bleeding is possible when prasugrel is co-administered with heparin.
Aspirin: Aspirin (150 mg daily with an additional single 900 mg) did not alter prasugrel-mediated IPA. Although a pharmacodynamic interaction with aspirin leading to an increased risk of bleeding is possible, the demonstration of the efficacy and safety of prasugrel comes from patients concomitantly treated with aspirin.
NSAIDs: Concomitant administration with chronic NSAIDs has not been studied. Because of the potential for increased risk of bleeding, chronic NSAIDs and prasugrel should be co-administered with caution.
Clopidogrel: Following administration of clopidogrel 75 mg daily for 10 days, healthy subjects were switched to prasugrel 10 mg once daily, with or without a 60-mg LD. Throughout the study, all subjects were concurrently taking 81 mg of aspirin once daily. Higher IPA was observed with prasugrel compared to clopidogrel.
Potential for Prasugrel to Affect Other Drugs: Drugs Metabolised by CYP2C9 and 2C19: Prasugrel did not inhibit CYP2C9 or CYP2C19, as it did not affect the pharmacokinetics of S-warfarin or R-warfarin. Because of the potential for increased risk of bleeding, warfarin and prasugrel should be co-administered with caution.
Drugs Metabolised by CYP2B6: Prasugrel is a weak inhibitor of CYP2B6. In healthy subjects, prasugrel decreased exposure to hydroxybupropion, a CYP2B6-mediated metabolite of bupropion, by 23%, which is not considered to be clinically significant. This effect is likely to be of clinical concern only when prasugrel is co-administered with medicinal products for which CYP2B6 is the only metabolic pathway and have a narrow therapeutic window (eg, cyclophosphamide, efavirenz).
Effect on Digoxin: Prasugrel has no clinically significant effect on the pharmacokinetics of digoxin. When prasugrel was co-administered with digoxin, a substrate of P-glycoprotein transporter, the AUC of digoxin was not altered, while Cmax decreased by 17%.
|Pregnancy Category (US FDA)||Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).|
|Caution For Usage||Do not crush or break the tablet.|
|Storage||Store below 30Â°C. Store in the original package.|
Pharmacotherapeutic Group: Platelet aggregation inhibitors excluding heparin. ATC Code: B01AC22.
Pharmacodynamics: Inhibition of platelet aggregation (IPA) induced by 5 or 20 micromol ADP (termed "platelet inhibition" in the remainder of this document) measured by light transmission aggregometry has been assessed in clinical pharmacology studies in healthy subjects and patients with stable atherosclerosis for both prasugrel and clopidogrel with or without aspirin. Following a 60-mg loading dose (LD) of prasugrel, IPA occurs at 15 min for 5 micromol ADP and 30 min for 20 micromol ADP (see Figure 1). This rapid onset of action is a result of the rapid biotransformation of prasugrel to its active metabolite which is responsible for the IPA.
Pharmacokinetics: Prasugrel is a prodrug and is rapidly metabolised to a pharmacologically active metabolite and inactive metabolites. The active metabolite's exposure (AUC) has moderate to low between-subject (27%) and within-subject (19%) variability. Prasugrel's pharmacokinetics are similar in healthy subjects, patients with stable atherosclerosis and patients undergoing percutaneous coronary intervention (PCI).
The Kaplan-Meier curve shows the primary composite endpoint of CV death, nonfatal MI or nonfatal stroke over time in the "All ACS" population (see Figure 2). The "All ACS" event curves separated as early as 3 days and continued to diverge over the 15-month follow-up period. Prasugrel demonstrated a relative risk reduction of 18% and an absolute risk reduction of 0.9% in the primary composite endpoint from 0-3 days (4.7% in the prasugrel group and 5.6% in the clopidogrel group; HR 0.825; 95% CI, 0.711, 0.957; p=0.011). Prasugrel demonstrated a relative risk reduction of 20% and an absolute risk reduction of 1.2% in the primary composite endpoint from 3 days to the end of the study (5.2% in the prasugrel group and 6.4% in the clopidogrel group; HR 0.805; 95% CI, 0.698, 0.927; p=0.003). Primary individual outcome events showed an absolute risk reduction of 2.1% and relative risk reduction of 24.3% in nonfatal MI with prasugrel compared to clopidogrel. A 0.2% absolute risk reduction and 11.4% relative risk reduction in CV death was seen in the prasugrel group compared to clopidogrel while for nonfatal stroke, there was no difference between the prasugrel-treated groups and clopidogrel-treated groups (see Table 1).
For patients who survived an on-study stroke or myocardial infarction, prasugrel-treated patients demonstrated a relative risk reduction of 33% and an absolute risk reduction of 4.1% in the incidence of subsequent primary endpoint events compared to clopidogrel-treated patients (7.8% for prasugrel and 11.9% for clopidogrel, HR 0.67; 95% CI, 0.45, 0.98, p=0.037).
The secondary endpoint data for the UA/NSTEMI and STEMI populations are similar to those for the "All ACS" population.
|ATC Classification||B01AC22 - prasugrel, in the class of platelet aggregation inhibitors (excluding heparin), used in the treatment of thrombosis.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|APAGREL 10||Healthcare Pharmacuticals Ltd.||Prasugrel Hydrochloride INN which is equivalent to Prasugrel 10mg||Tablet||30's MRP 600 Tk|
|APAGREL 5||Healthcare Pharmacuticals Ltd.||Prasugrel Hydrochloride INN which is equivalent to Prasugrel 5mg||Tablet||30's MRP 360 Tk|
|EFIGREL 10||Square Pharmaceuticals Ltd.||Prasugrel Hydrochloride 10mg||Tablet||2x10's: 401.20 MRP|
|EFIREL||Opsonin Pharma Limited||Prasugrel hydrochloride INN 5mg & 10mg||Tablet||5mg x20's, 10mg x10's: 240.00 & 200.00 MRP|
|HEMAGREL||ACI Ltd.||Prasugrel hydrochloride INN 5mg & 10mg||Tablet||5mg x30's, 10mg x20's: 360.00 & 400.00 MRP|
|PRASULET||Beacon Pharmaceuticals Limited||Prasugrel hydrochloride INN 5mg & 10mg||Tablet||5mg x30's, 10mg x30's: 359.00 & 599.00 MRP|
|Prasurel 10||Incepta Pharmaceuticals Limited||Prasugrel Hydrochloride INN which is eq. to prasugrel 10mg||Tablet||10x2's:MRP 400 Tk|
|Prasurel 5||Incepta Pharmaceuticals Limited||Prasugrel Hydrochloride INN which is eq. to prasugrel 5 mg||Tablet||10x3's:MRP 360 Tk|
|PRASUVA 10||Beximco Pharmaceuticals Ltd||Prasugrel Hydrochloride INN which is eq. to Prasugrel 10mg||Tablet||20's: 400.00 MRP|
|PRASUVA 5||Beximco Pharmaceuticals Ltd||Prasugrel Hydrochloride INN which is eq. to Prasugrel 5mg||Tablet||30's: 360.00 MRP|
Prasugrel may cause serious or life-threatening bleeding. inform your doctor if you currently have or have had a condition that causes you to bleed more easily than normal, if you have recently had surgery or been injured in any way, or if you have or have ever had a stomach ulcer; bleeding in your stomach, intestines, or head; a stroke or mini-stroke; a condition that may cause bleeding in your intestines such as polyps (abnormal growths in the lining of the large intestine) or diverticulitis (inflamed bulges in the lining of the large intestine); or liver disease. inform your doctor if you are taking medications that may cause bleeding including anticoagulants (blood thinners) such as warfarin (Coumadin); heparin; other medications to treat or prevent blood clots; or regular use of a non-steroidal anti-inflammatory medications such as ibuprofen (Advil, Motrin) and naproxen (Aleve). Your doctor may not prescribe prasugrel for you if you have any of these conditions, you are taking any of these medications, you weigh less than 132 lb (60 kg), or you are older than 75 years of age. Your doctor also will probably not prescribe prasugrel if you are likely to need heart bypass surgery (a certain type of open heart surgery) right away. While you are taking prasugrel, you will probably bruise and bleed more easily than usual, bleed for longer than usual, and have nosebleeds. However, if you experience any of the following symptoms, call your doctor immediately: bleeding that is unexplained, severe, long-lasting, or uncontrollable; pink or brown urine; red or black, tarry stools; vomit that is bloody or that looks like coffee grounds; coughing up blood or blood clots; or bruises that are unexplained or that get larger.
If you are having surgery, including dental surgery, or any type of medical procedure, inform your doctor or dentist that you are taking prasugrel. Your doctor will probably inform you to stop taking prasugrel at least 7 days before your surgery is scheduled.
Your doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with prasugrel and each time you refill your prescription. Read the information carefully and ask your doctor if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.
Talk to your doctor about the risk of taking prasugrel.
Why is Prasugrel prescribed?
Prasugrel is used along with aspirin to prevent serious or life-threatening problems with the heart and blood vessels in people who have had a heart attack or severe chest pain and have been treated with angioplasty (procedure to open the blood vessels that supply blood to the heart). Prasugrel is in a class of medications called anti-platelet medications. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke.
How should Prasugrel be used?
Prasugrel comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take prasugrel at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take prasugrel exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablet whole; do not split, chew, or crush it.
Prasugrel will help prevent serious problems with your heart and blood vessels only as long as you take the medication. Do not stop taking prasugrel without talking to your doctor. If you stop taking prasugrel, there is a higher risk that you may have a heart attack, develop a blood clot, or die.
Other uses for Prasugrel
Prasugrel may be prescribed for other uses; ask your doctor for more information.
Before taking prasugrel,
- inform your doctor if you are allergic to prasugrel, any other medications, or any of the ingredients in prasugrel tablets. Ask your pharmacist for a list of the ingredients.
- inform your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section.
- inform your doctor if you have or have ever had kidney disease.
- inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking prasugrel, call your doctor.
What special dietary instructions to follow?
Unless your doctor informs you otherwise, continue your normal diet.
What to do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can Prasugrel cause?
Prasugrel may cause side effects. inform your doctor if any of these symptoms are severe or do not go away:
pain in the back, arms, or legs
purple patches on the skin
yellowing of the skin or eyes
shortness of breath
slow, fast, or irregular heartbeat
slow or difficult speech
sudden weakness of an arm or leg
swelling of the eyes, face, mouth, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
Prasugrel may cause other side effects. Call your doctor if you have any unusual problems while taking Prasugrel.
What to know about storage and disposal of Prasugrel?
Keep Prasugrel 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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
What other information to know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Prasugrel.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
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.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
|| See FDA approved Prescribing Information from Brand Manufacturer |||Manufacturer's|
|| Back to top ||
*Trademark name & prescribing information are the property of their respective Manufacturers.