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JAMP PRASUGREL is a brand name for Prasugrel, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS....................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
JAMP
Prasugrel (prasugrel hydrochloride) is contraindicated in: patients with a known history of transient ischemic attack (TIA) or stroke (see ADVERSE REACTIONS and CLINICAL TRIALS) patients with active pathological bleeding, such as gastrointestinal bleeding or intracranial hemorrhage patients with severe hepatic impairment (Child-Pugh Class C) (see DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY) patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container (see DOSAGE FORMS, COMPOSITION AND PACKAGING) WARNINGS AND PRECAUTIONS Risk of Bleeding JAMP Prasugrel increases the risk of bleeding.
In patients ≥75 years of age, JAMP Prasugrel is not recommended because of the increased risk of fatal and intracranial bleeding (see WARNINGS AND PRECAUTIONS - Special Populations, ADVERSE REACTIONS and ACTION AND CLINICAL PHARMACOLOGY).
In patients with a body weight <60 kg, JAMP Prasugrel is not recommended because of increased risk of major bleeding. This is due to an increase in exposure to the active metabolite of prasugrel (see WARNINGS AND PRECAUTIONS - Special Populations, ADVERSE REACTIONS and ACTION AND CLINICAL PHARMACOLOGY).
Bleeding Risk Timing of Loading Dose in UA/NSTEMI In a clinical trial of NSTEMI patients (the ACCOAST study), Prasugrel Tablets loading dose (30 mg) given 2 to 48 hours prior to diagnostic coronary angiography followed by 30 mg at the time of PCI increased the risk of major and minor peri-procedural bleeding compared with prasugrel loading dose (60 mg) at the time of PCI (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).
In the clinical trial that established the efficacy and safety of Prasugrel Tablets (TRITON-TIMI 38), Prasugrel Tablets and the control drug were not administered to UA/NSTEMI patients until coronary anatomy was established. g. due to recent trauma, recent surgery, recent or recurrent gastrointestinal (GI) bleeding, active peptic ulcer disease, moderate hepatic impairment, or renal impairment) (see ADVERSE REACTIONS and ACTION AND CLINICAL PHARMACOLOGY) with concomitant administration of medications that may increase the risk of bleeding, including oral anticoagulants, non steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics (see ACTION AND CLINICAL PHARMACOLOGY).
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Elective Surgery If a patient is to undergo elective surgery and an antiplatelet effect is not desired, JAMP Prasugrel should be discontinued at least 7 days prior to surgery (see ACTION AND CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
Reversal of Effect For patients with active bleeding for whom reversal of the pharmacological effects of JAMP Prasugrel is required, platelet transfusion may be appropriate. Discontinuation of JAMP Prasugrel In patients with ACS who are managed with PCI, premature discontinuation of any antiplatelet medication, including JAMP Prasugrel, could result in an increased risk of thrombosis, myocardial infarction, or death due to the patient’s underlying disease.
g. secondary to active bleeding) should be monitored for atherothrombotic events. Once the patient is stabilized, at the discretion of the patient’s treating physician, JAMP Prasugrel should be restarted as soon as possible. Gastrointestinal JAMP Prasugrel should be used with caution in patients with recent or recurrent gastrointestinal bleeding.
Hematologic Thrombotic Thrombocytopenic Purpura (TTP) has been reported with the use of Prasugrel Tablets. TTP is a serious condition and requires prompt treatment. Hepatic No dosage adjustment is necessary in subjects with mild to moderate hepatic impairment (Child-Pugh Class A and B).
The pharmacokinetics and pharmacodynamics of Prasugrel Tablets in patients with severe hepatic disease (Child-Pugh Class C) have not been studied. JAMP Prasugrel should not be used in this population due to the potential risk of bleeding (see CONTRAINDICATIONS and ACTION AND CLINICAL PHARMACOLOGY).
Hypersensitivity Including Angioedema Hypersensitivity including angioedema has been reported in patients receiving Prasugrel Tablets, including patients with a history of hypersensitivity reaction to other thienopyridines (see ADVERSE REACTIONS – Post-Market Adverse Drug Reactions).
2% of patients treated with Prasugrel Tablets and clopidogrel, respectively. The sites contributing to the differences were primarily colon and lung. In a Phase 3 clinical study of acute coronary syndrome patients with unstable angina/non-ST segment elevation not undergoing percutaneous coronary intervention, data for malignancies were prospectively collected, and independently adjudicated.
7% of patients treated with Prasugrel Tablets and clopidogrel, respectively. The site of malignancies was balanced between treatment groups except for colorectal malignancies. 1% clopidogrel and most were detected during investigation of GI bleeding or anemia.
It is unclear if these observations are causally-related, are the result of increased detection due to bleeding, or random occurrences. The non-clinical studies were negative for carcinogenicity and tumour stimulation (see TOXICOLOGY, Carcinogenicity).
g. tumour, ulcer). Peri-operative Considerations If a patient is to undergo elective surgery and an antiplatelet effect is not desired, JAMP Prasugrel should be discontinued at least 7 days prior to surgery (see ACTION AND CLINICAL PHARMACOLOGY and CLINICAL […]