Medication info
Hyrolin Tablet 90 mg (Ticagrelor)

Hyrolin Tablet 90 mg (Ticagrelor)

Prescription medicationTabletOral
Ingredient · strength
Ticagrelor›90mg / 1 tablet
Manufacturer / importer
Hanmi Pharm Co., Ltd.
Appearance
Yellow, biconvex, round film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201800743 · Approved 2018.02.07

Summary

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

Ingredients

Manufacturer
Hanmi Pharm Co., Ltd.

Efficacy & effects

Prevention of thrombotic cardiovascular events (e.g., myocardial infarction and stroke) 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 attacks
View approved original text

This medication is used to reduce the incidence of thrombotic cardiovascular events, including death due to cardiovascular causes, myocardial infarction, and stroke in adult patients when taken in conjunction with aspirin. It is especially effective in patients with acute coronary syndrome or those at high risk who have a history of myocardial infarction more than one year ago. Additionally, it helps prevent myocardial infarction and stroke in patients with coronary artery disease who have type 2 diabetes and have undergone percutaneous coronary intervention (PCI) but have no history of myocardial infarction or stroke. In patients who have had acute ischemic stroke or high-risk transient ischemic attacks, taking this medication with aspirin can lower the incidence of stroke. In summary, this medication improves cardiovascular health by reducing the incidence of various high-risk thrombotic cardiovascular events and stroke when used with aspirin.

How to take

Adult dose

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

Child dose

Safety and efficacy have not been established in pediatric patients under 18 years of age (see “Other”).

Precautions

This medication inhibits platelet aggregation in the blood and prevents thrombus formation. The risk of bleeding may increase, so it should not be used in patients with current bleeding or a history of intracranial hemorrhage. It is advisable to discontinue this medication at least 5 days prior to any scheduled surgery. During treatment, symptoms of bleeding such as nosebleeds, gum bleeding, hematuria, and easy bruising should be monitored closely. If bleeding is suspected, inform healthcare personnel immediately. Additionally, this medication can affect heart rhythm, therefore it should be administered cautiously in patients with bradycardia (slow heart rate) symptoms, and patients with asthma or chronic obstructive pulmonary disease should be particularly careful as breathing difficulties may occur. This medication should not be given to patients with severely impaired liver and kidney function, and caution should be exercised during co-administration with certain antibiotics or antivirals, as drug concentration may increase, raising the risk of side effects. Women who are pregnant or breastfeeding should consult healthcare professionals before taking this medication due to associated risks. Elderly patients or those with reduced kidney function should have regular kidney function tests while on this medication, as there may be an increase in uric acid levels or symptoms of gout. In cases of overdose, the risk of bleeding increases significantly, and as there is currently no antidote for this medication, appropriate treatment must be sought immediately. Patients should also be cautious when driving or operating machinery, as dizziness or confusion may occur during treatment. Finally, this medication should only be taken as prescribed by a physician, and patients should not change or stop the dose on their own.

Side effects

  • Hemorrhage
  • intracranial hemorrhage
  • ocular hemorrhage
  • ear hemorrhage
  • hypotension
  • respiratory distress
  • respiratory tract hemorrhage
  • gastrointestinal hemorrhage
  • diarrhea
  • nausea
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  • dyspepsia
  • constipation
  • retroperitoneal hemorrhage
  • skin hemorrhage
  • rash
  • itching
  • muscle hemorrhage
  • urinary tract hemorrhage
  • genitourinary hemorrhage
  • elevated serum creatinine
  • post-procedural hemorrhage
  • traumatic hemorrhage
  • thrombotic thrombocytopenic purpura
  • bradycardia arrhythmia
  • atrioventricular block
  • angioedema
  • confusion
  • dizziness
  • syncope
  • headache
  • vertigo
  • ear hemorrhage
  • thrombosis
  • deep vein thrombosis
  • cardiac thrombosis
  • thrombocytosis
  • chest pain
  • pulmonary hemorrhage
  • pneumonia
  • pulmonary edema
  • pharyngitis
  • upper respiratory infection
  • asthma
  • pleural effusion
  • bronchitis
  • pneumothorax
  • weakness
  • anaphylactic shock
  • hematoma
  • cerebral hemorrhage
  • spinal canal stenosis
  • dementia
  • migraine
  • paralysis
  • gait disturbance
  • rectal hemorrhage
  • anal hemorrhage
  • appendicitis
  • tendonitis
  • bursitis
  • rhabdomyolysis
  • hepatitis
  • snoring
  • aneurysm
  • heart failure
  • cardiac rhythm disorders
  • palpitations
  • ventricular tachycardia
  • arrhythmia
  • ventricular fibrillation
  • cardiac arrest
  • ventricular fibrillation
  • atrial fibrillation
  • atrial arrhythmia
  • complete heart block
  • urinary tract infection
  • kidney stones
  • cerebral ischemia
  • venous stenosis
  • cerebral infarction
  • arterial stenosis
  • angina
  • coronary thrombosis
  • myocardial ischemia
  • myocardial infarction
  • anemia
  • vestibular disorders
  • malignant male genital neoplasm
  • chemical poisoning
  • post-procedural hematoma
  • laceration
  • road traffic accident
  • trauma
  • nausea
  • vomiting
  • acute renal failure
  • hyperuricemia
  • gout
  • coma
  • speech disorders
  • cerebral hypoxia
  • scalp tenderness
  • peripheral neuropathy
  • cervical rigidity
  • voice disorders
  • seizures
  • neuropathy
  • neuralgia
  • movement disorders
  • tremor
  • lower limb paralysis
  • oral pain
  • gastroenteritis
  • belching
  • irritable bowel syndrome
  • stomatitis
  • ulcerative stomatitis
  • benign gastrointestinal neoplasm
  • dental disease
  • tongue disease
  • tendinitis
  • osteoarthritis
  • chondrocalcinosis
  • spinal osteoarthritis
  • arthritis
  • contact dermatitis
  • fungal dermatosis
  • skin disease
  • erythematous rash
  • hyperkeratosis
  • acute urticaria
  • onychomycosis
  • hair loss
  • scleroderma
  • dermatofibroma
  • increased sweating
  • hyperlipidemia
  • hypertriglyceridemia
  • hypercholesterolemia
  • lipodystrophy
  • dehydration
  • hepatitis
  • cholelithiasis
  • gallbladder disease
  • increased alkaline phosphatase
  • fatty liver
  • drowsiness
  • neurosis
  • depression
  • hallucinations
  • memory disturbances
  • erectile dysfunction
  • anxiety
  • orthostatic hypotension
  • hypertension exacerbation
  • cyanosis
  • palpitations
  • bradycardia
  • atrial fibrillation
  • polyuria
  • dysuria
  • urinary tract infection
  • conjunctival injection
  • eye pain
  • visual disturbances
  • tinnitus
  • ear pain
  • lymphadenopathy
  • eosinophilia
  • leukocytosis
  • sexual dysfunction
  • benign prostatic hyperplasia
  • ovarian cyst
  • amenorrhea
  • vaginitis
  • loss of taste
  • altered smell
  • increased TSH
  • hypothyroidism
  • injection site reactions
  • injection site pain

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

Storage

Store this medication in a tightly sealed container to protect it from air or moisture and keep it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, biconvex, round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)

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.