Medication info
Effient 10 mg Tablet (Prasugrel Hydrochloride)

Effient 10 mg Tablet (Prasugrel Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Prasugrel Hydrochloride›10.98mg / 1 tablet
Manufacturer / importer
Daiichi Sankyo Korea Co., Ltd.
Appearance
Pale yellow hexagonal film-coated tablet
Packaging
30 tablets (6 tablets/PTPX5)/box
Approval status
Active

MFDS item code 201004754 · Approved 2010.07.29 · Insurance code 680900220

Summary

Main use
Prevention of thrombotic cardiovascular events in acute coronary syndrome patients undergoing percutaneous coronary intervention
Who takes it
Adults · Children
Adult dose
Adults This medicine is for adults weighing 60 kg or more and aged under 75 years (weight ≥ 60 kg, age < 75 years) only. Administer a single oral loading dose of prasugrel 60 milligrams, followed by a maintenance dose of 10 milligrams once daily. However, in patients at high risk of bleeding, administer a maintenance dose of 5 milligrams once daily. (Refer to bleeding risk factors under 1. Warnings and 3. Patients Requiring Caution in the Precautions for Use.) In patients with unstable angina/non-ST-segment elevation myocardial infarction, if coronary angiography is performed within 48 hours after admission, the loading dose must be administered at the time of percutaneous coronary intervention (PCI). Administer this medicine regardless of meals, and use concomitantly with aspirin (75~325 milligrams daily). Patients with renal impairment No dosage adjustment is required for patients with renal impairment; however, use this medicine with caution because experience with its use is limited. Patients with hepatic impairment No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class A and B); however, use this medicine with caution because experience with its use is limited.
Child dose
The safety and efficacy of this medicine have not been established in pediatric and adolescent patients aged 18 years or younger.

Ingredients

Importer
Daiichi Sankyo Korea Co., Ltd.

Efficacy & effects

Prevention of thrombotic cardiovascular events in acute coronary syndrome patients undergoing percutaneous coronary intervention

  • Acute coronary syndrome
  • stent thrombosis
  • death due to cardiovascular disease
  • non-fatal myocardial infarction
  • non-fatal stroke
  • unstable angina
  • non-ST elevation myocardial infarction
  • ST elevation myocardial infarction
View approved original text

This medication is used for patients with acute coronary syndrome who have undergone or are to undergo coronary intervention. It is particularly suitable for patients with unstable angina or non-ST elevation myocardial infarction, as well as those with ST elevation myocardial infarction undergoing either primary or delayed coronary intervention. This drug reduces the incidence of thrombotic cardiovascular events, including stent thrombosis. Thrombotic cardiovascular events include death due to cardiovascular disease, non-fatal myocardial infarction, or stroke. Therefore, this medication helps prevent and treat acute cardiovascular problems.

How to take

Adult dose

Adults This medicine is for adults weighing 60 kg or more and aged under 75 years (weight ≥ 60 kg, age < 75 years) only. Administer a single oral loading dose of prasugrel 60 milligrams, followed by a maintenance dose of 10 milligrams once daily. However, in patients at high risk of bleeding, administer a maintenance dose of 5 milligrams once daily. (Refer to bleeding risk factors under 1. Warnings and 3. Patients Requiring Caution in the Precautions for Use.) In patients with unstable angina/non-ST-segment elevation myocardial infarction, if coronary angiography is performed within 48 hours after admission, the loading dose must be administered at the time of percutaneous coronary intervention (PCI). Administer this medicine regardless of meals, and use concomitantly with aspirin (75~325 milligrams daily). Patients with renal impairment No dosage adjustment is required for patients with renal impairment; however, use this medicine with caution because experience with its use is limited. Patients with hepatic impairment No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class A and B); however, use this medicine with caution because experience with its use is limited.

Child dose

The safety and efficacy of this medicine have not been established in pediatric and adolescent patients aged 18 years or younger.

Precautions

This medication may cause bleeding; thus, it should not be used in patients with ongoing bleeding or a history of cerebrovascular diseases such as stroke. Elderly patients over 75 years of age or those weighing less than 60 kilograms are at higher risk of bleeding, and use of this medication is not recommended. Patients likely to undergo surgery, such as coronary artery bypass grafting, should discontinue this medication at least 7 days before the surgery. Extra caution should be taken when administered with other medications that may increase the risk of bleeding, and if bleeding symptoms occur, consult a doctor immediately. This medication inhibits platelet aggregation, which can prolong bleeding time. In patients at high risk of bleeding, the decision to administer this medication should be made cautiously, and if bleeding symptoms arise, their condition should be monitored through blood tests. Pregnant or nursing women must consult a healthcare provider before using this medication, and breastfeeding is not recommended during its use. This medication has not been established as safe and effective in children or adolescents under 18 years of age and should not be used in this population. In cases of overdose, the risk of bleeding may increase, so it is essential to adhere to the prescribed dosage and administration. Severe bleeding may require treatment such as platelet transfusion. During the use of this medication, care should be taken when driving or operating machinery, and patients should have regular medical check-ups to reduce the risk of bleeding.

Side effects

  • Bleeding
  • intracranial hemorrhage
  • anemia
  • thrombocytopenia
  • nosebleed
  • gastrointestinal bleeding
  • hemoptysis
  • subcutaneous hematoma
  • post-procedural bleeding
  • retroperitoneal hemorrhage
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  • retinal hemorrhage
  • thrombotic thrombocytopenic purpura
  • allergic reaction
  • angioedema
  • hypertension
  • hypercholesterolemia
  • hyperlipidemia
  • headache
  • low back pain
  • dyspnea
  • nausea
  • dizziness
  • cough
  • hypotension
  • fatigue
  • non-cardiac chest pain
  • atrial fibrillation
  • bradycardia
  • leucopenia
  • rash
  • fever
  • peripheral vascular edema
  • limb pain
  • diarrhea
  • chest pain
  • hemorrhagic ulcer
  • unstable angina
  • acute myocardial infarction
  • angina
  • hematoma
  • atherosclerosis
  • hemorrhagic cerebral infarction
  • vascular stenosis
  • arterial dissection
  • bloody stool
  • gastric ulcer
  • melena
  • esophagitis
  • erosive gastritis
  • lower gastrointestinal bleeding
  • urticaria
  • Henoch-Schönlein purpura
  • congestive heart failure
  • myocardial infarction
  • heart failure
  • coronary artery disease
  • coronary artery occlusion
  • pneumonia
  • pyelonephritis
  • Enterobacter pneumonia
  • soft tissue infection
  • Klebsiella pneumonia
  • sepsis
  • malnutrition
  • hyponatremia
  • vascular stent restenosis
  • vascular stent thrombosis
  • hematuria
  • nephrosclerosis
  • sudden hearing loss
  • contusion
  • petechial hemorrhage
  • easy bruising
  • gum bleeding
  • conjunctival hemorrhage
  • nasopharyngitis
  • upper respiratory tract infection
  • positional vertigo
  • sensory disturbance
  • diabetes
  • decreased appetite
  • dyslipidemia
  • hypokalemia
  • constipation
  • gastroesophageal reflux disease
  • abdominal discomfort
  • upper abdominal pain
  • anal bleeding
  • dyspepsia
  • petechiae
  • purpura
  • pruritus
  • dermatitis
  • exercise-induced dyspnea
  • wet cough
  • pleural effusion
  • pulmonary edema
  • hematuria
  • neurogenic bladder
  • insomnia
  • depression
  • anxiety
  • erectile dysfunction
  • weakness
  • peripheral edema
  • musculoskeletal pain
  • myalgia
  • muscle cramps
  • neck pain
  • limb discomfort
  • flank pain
  • rotator cuff syndrome
  • injection site hematoma
  • tinnitus
  • increased blood sugar
  • decreased serum potassium
  • hepatic steatosis
  • atherosclerosis
  • reflux laryngitis
  • pneumothorax
  • asthma
  • pulmonary congestion
  • hemothorax
  • respiratory failure
  • pleuritic pain
  • aspiration pneumonia
  • fall
  • ligament sprain
  • rib fracture
  • epidural hematoma
  • subdural hemorrhage
  • vehicular accident
  • femoral neck fracture
  • femoral fracture
  • knee fracture
  • meniscus injury
  • clavicle fracture
  • facial bone fracture
  • traumatic intracerebral hemorrhage
  • dental fracture
  • carotid artery occlusion
  • syncope
  • facial paralysis
  • tension headache
  • cerebral edema
  • diabetic neuropathy
  • paralysis
  • gait disturbance
  • vocal cord paralysis
  • decreased level of consciousness
  • sciatica
  • ulnar nerve lesion
  • ischemic stroke
  • ischemic cerebral infarction
  • chronic gastritis
  • peptic ulcer
  • dental pain
  • oral hemorrhage
  • stomatitis
  • abdominal pain
  • dry mouth
  • gum swelling
  • rectal polyp
  • hemorrhoids
  • hematemesis
  • tongue ulcer
  • subcutaneous hemorrhage
  • itchy rash
  • mechanical urticaria
  • hyperhidrosis
  • blisters
  • eczema
  • hair loss
  • skin mass
  • erythema
  • heart failure
  • coronary artery spasm
  • sinus tachycardia
  • Dressler's syndrome
  • arrhythmia
  • myocardial ischemia
  • coronary artery spasm
  • bronchitis
  • shingles
  • rhinitis
  • urinary tract infection
  • periodontitis
  • chronic tonsillitis
  • viral keratitis
  • cystitis
  • sinusitis
  • gastroenteritis
  • boil
  • tinea corporis
  • laryngitis
  • osteoarthritis
  • arthralgia
  • musculoskeletal chest pain
  • musculoskeletal stiffness
  • musculoskeletal discomfort
  • gouty arthritis
  • gout
  • hyperkalemia
  • hyperglycemia
  • chronic renal failure
  • polyuria
  • urolithiasis
  • dysuria
  • urinary disease
  • oliguria
  • renal hematoma
  • ureterolithiasis
  • urethral pain
  • cholelithiasis
  • non-alcoholic fatty liver disease
  • edema
  • systemic edema
  • pain
  • pain at the site of vascular puncture
  • lymphadenitis
  • coagulation disorder
  • disseminated intravascular coagulation
  • increased C-reactive protein
  • weight loss
  • weight gain
  • panic disorder
  • decreased libido
  • sleep disorder
  • sexual dysfunction
  • gynecomastia
  • prostatitis
  • ear bleeding
  • ear pain
  • vestibular disorder
  • conjunctival congestion
  • eye hemorrhage
  • diabetic retinopathy
  • retinal vascular occlusion
  • decreased vision
  • hyperthyroidism
  • ventricular septal defect
  • colon polyp
  • essential thrombocytosis
  • lipoma

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve its efficacy.

Appearance and packaging

Appearance

Pale yellow hexagonal film-coated tablet

Package unit

30 tablets (6 tablets/PTPX5)/box

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.