Medication info

Entikare Tablet 60 mg (Ticagrelor)

Prescription medicationTabletOralExpired
Ingredient · strength
Ticagrelor›Strength being verified
Manufacturer / importer
Daehan New Pharm Co., Ltd.
Appearance
Pink, round, biconvex, film-coated tablet
Packaging
56 tablets/box [(14 tablets/PPT*4)]
Approval status
Expired

MFDS item code 201906687 · Approved 2019.09.24

This product's status changed to Expired on 2024.09.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of thrombotic cardiovascular events (such as myocardial infarction) and stroke
Who takes it
Adults · Children
Adult dose
Do not use this medicine concomitantly with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). ㆍAcute coronary syndrome: Administer an initial dose of 180mg, followed by 90mg twice daily. Treatment for 12 months is recommended unless discontinuation is clinically necessary. Patients taking this medicine should also take a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. ㆍPatients with a history of myocardial infarction (occurring at least 1 year previously) and at high risk of thrombotic cardiovascular events: Administer 60mg twice daily. Patients taking this medicine should also take a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - Patients taking 90mg of this medicine or another ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel) during the first year after myocardial infarction may continue treatment with 60mg of this medicine. - Treatment with this medicine may also be initiated in patients within 2 years after myocardial infarction or within 1 year after discontinuing a previous ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel). - The safety and efficacy of this medicine were evaluated at 3 years of follow-up. ㆍPatients with type 2 diabetes who have undergone percutaneous coronary intervention (PCI) for coronary artery disease: Administer 60mg twice daily. Patients taking this medicine should also take a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - Refer to the relevant dosage and administration instructions for patients with acute coronary syndrome. - Data on the safety and efficacy of treatment for more than 3 years are limited. ㆍPatients with acute ischemic stroke or high-risk transient ischemic attack: Administer an initial dose of 180mg, followed by 90mg twice daily for 30 days. Patients taking this medicine should also take a maintenance dose of aspirin (75 - 100mg), unless specifically contraindicated. In patients with acute ischemic stroke or high-risk transient ischemic attack, an initial loading dose of aspirin (300-325mg) is recommended. Method of administration This medicine is administered orally and may be taken with or without food. ㆍPatients who have difficulty swallowing tablets may crush this medicine into a fine powder, disperse it in half a glass of water, drink the mixture immediately, then rinse the glass with another half glass of water and drink it. This mixture may also be administered through a nasogastric tube (CH8 or larger); it is important to flush the tube with water after administration. ㆍWhen switching from another antiplatelet medicine to this medicine, start this medicine 24 hours after the last dose of the previous medicine. ㆍIf a dose is missed, take only 1 tablet (the next scheduled dose) at the next scheduled dosing time. Patients with renal impairment No dose adjustment is necessary in patients with renal impairment. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment. This medicine has not been studied in patients with severe hepatic impairment, and experience in patients with moderate hepatic impairment is limited.
Child dose
The safety and efficacy of this medicine have not been established in pediatric patients under 18 years of age (see 'Other' section).

Ingredients

Manufacturer
Daehan New Pharm Co., Ltd.

Efficacy & effects

Prevention of thrombotic cardiovascular events (such as myocardial infarction) and stroke

  • Thrombotic cardiovascular events
  • cardiovascular abnormalities
  • myocardial infarction
  • stroke
  • acute coronary syndrome
  • risk of thrombotic cardiovascular events
  • type 2 diabetes
  • coronary artery disease
  • acute ischemic stroke
  • transient ischemic attack
View approved original text

This medicine helps reduce the incidence of thrombotic cardiovascular events, such as cardiovascular-related death, myocardial infarction, and stroke, when used in combination with aspirin. It is particularly effective in patients with acute coronary syndrome or high-risk patients with a history of myocardial infarction more than 1 year ago. Additionally, it is used to reduce the risk of myocardial infarction and stroke in patients with type 2 diabetes who have coronary artery disease and have undergone PCI. Adult patients with acute ischemic stroke or high-risk transient ischemic attack can also lower their risk of stroke through this medication. Thus, it plays a crucial role in the prevention of thrombotic cardiovascular events and reduction of strokes, contributing to the management of patients' health.

How to take

Adult dose

Do not use this medicine concomitantly with other ADP receptor inhibitors (ticlopidine, clopidogrel, prasugrel). ㆍAcute coronary syndrome: Administer an initial dose of 180mg, followed by 90mg twice daily. Treatment for 12 months is recommended unless discontinuation is clinically necessary. Patients taking this medicine should also take a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. ㆍPatients with a history of myocardial infarction (occurring at least 1 year previously) and at high risk of thrombotic cardiovascular events: Administer 60mg twice daily. Patients taking this medicine should also take a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - Patients taking 90mg of this medicine or another ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel) during the first year after myocardial infarction may continue treatment with 60mg of this medicine. - Treatment with this medicine may also be initiated in patients within 2 years after myocardial infarction or within 1 year after discontinuing a previous ADP receptor inhibitor (ticlopidine, clopidogrel, prasugrel). - The safety and efficacy of this medicine were evaluated at 3 years of follow-up. ㆍPatients with type 2 diabetes who have undergone percutaneous coronary intervention (PCI) for coronary artery disease: Administer 60mg twice daily. Patients taking this medicine should also take a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. - Refer to the relevant dosage and administration instructions for patients with acute coronary syndrome. - Data on the safety and efficacy of treatment for more than 3 years are limited. ㆍPatients with acute ischemic stroke or high-risk transient ischemic attack: Administer an initial dose of 180mg, followed by 90mg twice daily for 30 days. Patients taking this medicine should also take a maintenance dose of aspirin (75 - 100mg), unless specifically contraindicated. In patients with acute ischemic stroke or high-risk transient ischemic attack, an initial loading dose of aspirin (300-325mg) is recommended. Method of administration This medicine is administered orally and may be taken with or without food. ㆍPatients who have difficulty swallowing tablets may crush this medicine into a fine powder, disperse it in half a glass of water, drink the mixture immediately, then rinse the glass with another half glass of water and drink it. This mixture may also be administered through a nasogastric tube (CH8 or larger); it is important to flush the tube with water after administration. ㆍWhen switching from another antiplatelet medicine to this medicine, start this medicine 24 hours after the last dose of the previous medicine. ㆍIf a dose is missed, take only 1 tablet (the next scheduled dose) at the next scheduled dosing time. Patients with renal impairment No dose adjustment is necessary in patients with renal impairment. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment. This medicine has not been studied in patients with severe hepatic impairment, and experience in patients with moderate hepatic impairment is limited.

Child dose

The safety and efficacy of this medicine have not been established in pediatric patients under 18 years of age (see 'Other' section).

Precautions

This drug inhibits the aggregation of platelets in the blood to prevent the formation of clots, thus reducing the risk of cardiovascular events such as myocardial infarction or stroke. This medication poses a risk of bleeding; hence, it should not be used in patients with existing pathological active bleeding or a history of intracranial bleeding. Patients scheduled for surgery are recommended to stop taking this medication at least 5 days prior to surgery. If symptoms of hypotension arise during the use of this medication, the possibility of bleeding should be suspected, and it is preferable to treat the bleeding without discontinuing the medication. Patients allergic to this medication, those with pathological bleeding, severe liver dysfunction, or those taking strong CYP3A4 inhibitors should not use this medication. Patients at increased risk of bleeding, those who have recently undergone surgery, patients with bradycardia, those experiencing shortness of breath, the elderly, and those with reduced kidney function should use this medication cautiously. Patients with asthma or chronic obstructive pulmonary disease may experience shortness of breath when taking this medication, so caution is advised. This medication may interact with other drugs, particularly CYP3A4 inhibitors or inducers, and medications that affect blood coagulation should be used with caution. Women who are pregnant or breastfeeding may face risks while taking this medication, so consultation with a physician is necessary. The safety and effectiveness of this medication in children under 18 years have not been established, and it is not recommended for this age group. Overdosage may increase bleeding risk, and as there is no specific antidote, immediate medical treatment should be sought. If dizziness or confusion symptoms appear during the use of this medication, patients should avoid driving or operating machinery. This medication should be kept out of reach of children and stored in its original packaging.

Side effects

Hemorrhage, intracranial hemorrhage, ocular hemorrhage, ear hemorrhage, hypotension, dyspnea, respiratory tract hemorrhage, gastrointestinal hemorrhage, diarrhea, nausea, dyspepsia, constipation, retroperitoneal hemorrhage, skin hemorrhage, rash, pruritus, muscle hemorrhage, urinary tract hemorrhage, genital hemorrhage, elevated serum creatinine, post-procedural hemorrhage, traumatic hemorrhage, thrombotic thrombocytopenic purpura, bradyarrhythmia, heart block, angioedema, Cheyne-Stokes respiration, central sleep apnea, confusion, dizziness, syncope, headache, vertigo, ear hemorrhage, chest pain, pulmonary hemorrhage, pharyngitis, upper respiratory infection, asthma, pleural effusion, bronchitis, pneumothorax, pneumonia, pulmonary edema, weakness, anaphylactic shock, epistaxis, hemoptysis, hematoma, cerebral hemorrhage, spinal stenosis, dementia, migraine, paralysis, gait abnormalities, rectal bleeding, anal bleeding, appendicitis, tendon disease, bursitis, rhabdomyolysis, diabetes mellitus, hyperkalemia, hyperglycemia, thirst, hepatitis, snoring, aneurysm, heart failure, palpitations, ventricular tachycardia, arrhythmia, ventricular fibrillation, cardiac arrest, ventricular fibrillation, cardiac arrest, atrial fibrillation, ventricular tachycardia, asystole, atrial fibrillation, ventricular tachycardia, asystole, ventricular fibrillation, cardiac arrest, complete heart block, urinary tract infection, kidney stones, cerebral ischemia, venous stenosis, cerebral infarction, arterial stenosis, angina pectoris, coronary artery thrombosis, myocardial ischemia, anemia, vestibular disorder, malignant neoplasm of the male reproductive system, chemical poisoning, post-procedural hematoma, laceration, road traffic accident, trauma, oral edema, influenza-like illness, tuberculosis infection, hyperthermia, unspecified hernia, shortness of breath, generalized edema, thrombosis, deep vein thrombosis, deep vein thrombosis, intracardiac thrombus, coagulopathy, thrombocytosis, speech impairment, brain hypoxia, scalp tenderness, peripheral neuropathy, neck stiffness, vocal disturbances, seizures, neuropathy, neuralgia, movement disorders, tremors, lower limb paralysis, coma, sensory loss, oral pain, gastritis, belching, irritable bowel syndrome, stomatitis, ulcerative stomatitis, benign gastrointestinal neoplasm, dental disease, tongue disease, tendinitis, arthropathy, chondrocalcinosis, spondyloarthritis, arthritis, contact dermatitis, fungal dermatitis, skin diseases, erythematous rash, hyperkeratosis, acute urticaria, onychomycosis, hair loss, scleroderma, dermatofibroma, increased sweating, hyperlipidemia, hypertriglyceridemia, hypercholesterolemia, lipodystrophy, dehydration, increased AST, increased ALT, drowsiness, neurosis, depression, memory disturbances, erectile dysfunction, anxiety, orthostatic hypotension, exacerbation of hypertension, cyanosis, palpitations, bradycardia, atrial fibrillation, increased urination, dysuria, urinary tract infection, ocular congestion, ocular pain, visual disturbances, benign prostatic hyperplasia, ovarian cyst, amenorrhea, vaginitis, loss of taste, olfactory abnormalities, increased TSH, hypothyroidism, injection site reaction, injection site pain, concussion, intervertebral disc disease, non-drug allergy, nasal septum deviation, surgical site reaction

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

Storage

This medication should be stored in a tightly closed container, protected from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to preserve its efficacy and safety.

Appearance and packaging

Appearance

Pink, round, biconvex, film-coated tablet

Package unit

56 tablets/box [(14 tablets/PPT*4)]

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.

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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.