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Indications & Uses
Prasugrel Hydrochloride is used to lower the rate of thrombotic cardiovascular (CV) events, including stent thrombosis, in patients with acute coronary syndrome (ACS) who are going to be managed with percutaneous coronary intervention (PCI). This applies in two groups of patients. The first is patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). The second is patients with ST-elevation myocardial infarction (STEMI) who are managed with primary or delayed PCI.
Pharmacology
Prasugrel is a thienopyridine and a prodrug. It blocks ADP receptors by acting irreversibly on the P2Y12 receptor on platelets. Its active metabolite stops adenosine diphosphate (ADP) from binding to the platelet receptor, and this impairs the ADP-mediated activation of the glycoprotein GPIIb/IIIa complex. Prasugrel is proposed to work in a similar way to clopidogrel.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For adults, Prasugrel is started with a single 60 mg loading dose and then continued at 10 mg once a day. People taking it should also take ASA every day (75 mg to 325 mg). In patients with acute coronary syndrome (ACS) who are managed with PCI, stopping any antiplatelet agent too early, Prasugrel included, could increase the risk of thrombosis, myocardial infarction or death because of the patient's underlying disease. Treatment for up to 12 months is recommended, unless stopping Prasugrel is clinically indicated.
Patients ≥75 years old: use in this age group is generally not recommended. If the prescribing physician weighs the benefit and risk carefully for the individual patient and decides treatment is necessary in patients ≥75 years of age, a 60 mg loading dose should be followed by a reduced maintenance dose of 5 mg. Patients ≥75 years of age are more sensitive to bleeding and have higher exposure to the active metabolite of prasugrel.
Patients weighing <60 kg: give a single 60 mg loading dose and then continue at 5 mg once daily. The 10 mg maintenance dose is not recommended. This is because exposure to the active metabolite of prasugrel increases, and so does the risk of bleeding, in patients with body weight <60 kg when they are given 10 mg once daily, compared with patients <60 kg.
Renal impairment: no dose adjustment is needed for patients with renal impairment, including those with end-stage renal disease.
Hepatic impairment: no dose adjustment is needed in subjects with mild to moderate hepatic impairment (Child-Pugh class A and B). Therapeutic experience in patients with mild and moderate hepatic dysfunction is limited.
Children and adolescents: Prasugrel is not recommended for children below 18 years of age, because there is a lack of data on safety and efficacy.
Side Effects
Common side effects of Prasugrel Hydrochloride are anaemia, haematoma, epistaxis, gastrointestinal haemorrhage, rash, ecchymosis, haematuria, vessel puncture site haematoma, puncture site haemorrhage and contusion. Uncommon ones are hypersensitivity including angioedema, eye haemorrhage, haemoptysis, retroperitoneal haemorrhage, rectal haemorrhage, haematochezia, gingival bleeding and post-procedural haemorrhage. Rare ones are thrombocytopaenia and subcutaneous haematoma.
Cautions & Contraindications
Warnings & Precautions
Bleeding risk In the phase 3 clinical trial, people were excluded if they had an increased risk of bleeding, anaemia, thrombocytopaenia or a history of pathological intracranial findings. Patients with acute coronary syndromes who had PCI and were treated with Prasugrel Hydrochloride and ASA showed a higher risk of major and minor bleeding on the TIMI classification system. So Prasugrel Hydrochloride should be considered for patients at increased risk of bleeding only when the benefit of preventing ischaemic events is judged to outweigh the risk of serious bleeding. This concern applies especially to patients aged 75 years or older. It also applies to those with a tendency to bleed (for example after recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, or active peptic ulcer disease). Patients with a body weight below 60 kg are also included, and in them the 10 mg maintenance dose is not recommended. A 5 mg maintenance dose should be used instead. The same concern applies to patients taking other medicines that may increase the risk of bleeding, including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs) and fibrinolytics. Surgery Patients should be advised to tell their doctors and dentists that they are taking prasugrel before any surgery is scheduled, and before any new medicine is started. If a patient is going to have elective surgery and an antiplatelet effect is not wanted, Prasugrel Hydrochloride should be stopped at least 7 days before the surgery. Bleeding may be more frequent (3-fold) and more severe in patients who have CABG surgery within 7 days of stopping prasugrel. The benefits and risks of prasugrel should be weighed carefully in patients whose coronary anatomy has not been defined and in whom urgent CABG is a possibility.
Contraindications
Prasugrel must not be given to patients who have any of the following: hypersensitivity to the active substance or to any of the excipients, active pathological bleeding, a history of stroke or transient ischaemic attack (TIA), or severe hepatic impairment (Child-Pugh class C).
Pregnancy & Breastfeeding
There are no adequate and well-controlled studies of Prasugrel in pregnant women. Studies in rats and rabbits, at doses up to 30 times the recommended therapeutic exposures in humans, showed no evidence of harm to the fetus. Animal studies don't always predict how humans will respond, though.
It is not known whether Prasugrel passes into human milk. Many drugs do, so Prasugrel should be used during nursing only if the possible benefit to the mother justifies the possible risk to the nursing infant.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
Taking too much Prasugrel Hydrochloride can make the bleeding time longer, and that can lead to bleeding problems. There's no data on how to reverse the effect of prasugrel. But if the prolonged bleeding time needs to be corrected quickly, a platelet transfusion and/or other blood products may be considered.
Pharmaceutical precautions
Store in a cool and dry place, protected from light.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Prasugrel Hydrochloride in a dry place, away from light and heat. Keep it out of the reach of children.
Drug Interactions
Common questions about Prasurel 10 mg
What is Prasurel 10 mg Tablet?
Prasurel 10 mg Tablet is a medicine that contains Prasugrel Hydrochloride. It is made by Incepta Pharmaceuticals Ltd. It belongs to the Anti-platelet drugs group of medicines.
What is Prasurel used for?
Prasugrel Hydrochloride is used to lower the rate of thrombotic cardiovascular (CV) events, including stent thrombosis, in patients with acute coronary syndrome (ACS) who are going to be managed with percutaneous coronary intervention (PCI). This applies in two groups of patients.
What are the side effects of Prasurel?
Common side effects of Prasugrel Hydrochloride are anaemia, haematoma, epistaxis, gastrointestinal haemorrhage, rash, ecchymosis, haematuria, vessel puncture site haematoma, puncture site haemorrhage and contusion. Uncommon ones are hypersensitivity including angioedema, eye haemorrhage, haemoptysis, retroperitoneal haemorrhage, rectal haemorrhage, haematochezia, gingival bleeding and post-procedural haemorrhage.
Can I take Prasurel during pregnancy or while breastfeeding?
There are no adequate and well-controlled studies of Prasugrel in pregnant women. Studies in rats and rabbits, at doses up to 30 times the recommended therapeutic exposures in humans, showed no evidence of harm to the fetus. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Prasurel?
Taking too much Prasugrel Hydrochloride can make the bleeding time longer, and that can lead to bleeding problems. There's no data on how to reverse the effect of prasugrel. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Prasurel?
Store Prasugrel Hydrochloride in a dry place, away from light and heat. Keep it out of the reach of children.
Can I take other medicines with Prasurel?
Some medicines can interact with Prasugrel Hydrochloride, for example: Warfarin Sodium, Heparin Sodium, Aspirin, Digoxin. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Prasurel is already among the lowest-priced brands of Prasugrel Hydrochloride at this strength.
Do I need a prescription for Prasurel?
Prasurel is a prescription (Rx) medicine. Take it as your doctor advises.