Medication info

Tiglia Tablet 60 mg (Ticagrelor)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Ticagrelor›60mg / 1 tablet
Manufacturer / importer
Korea Biochem Pharmaceutical Co., Ltd.
Appearance
Pink, double convex, round film-coated tablet
Packaging
60 tablets/PTP (10 tablets/PTP x 6)
Approval status
Approval withdrawn

MFDS item code 201901121 · Approved 2019.02.22

This product's status changed to Approval withdrawn on 2024.01.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of thrombotic cardiovascular events (e.g., myocardial infarction) and stroke
Who takes it
Adults · Children
Adult dose
This medicine 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 medicine is clinically necessary. Patients taking this medicine should also take a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. 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 medicine should also take a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. Patients who took 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. Patients 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. For patients with acute coronary syndrome, refer to the corresponding dosage and administration. Data on the safety and efficacy of this medicine when administered 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 medicine should also take 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. This medicine is administered orally and may be taken with or without food. For patients who have difficulty swallowing tablets, crush this medicine into a fine powder, disperse it in half a glass of water, and drink immediately; 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 nasogastric tube with water after administration. When switching from another antiplatelet agent to this medicine, start this medicine 24 hours after the last dose of the previous medicine. If a dose is missed, take only 1 tablet (the next scheduled dose) at the next scheduled dosing time. No dose adjustment is necessary in patients with renal 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 with its use in patients with moderate hepatic impairment is limited.
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established (see the 'Other' section).

Ingredients

Manufacturer
Korea Biochem Pharmaceutical Co., Ltd.

Efficacy & effects

Prevention of thrombotic cardiovascular events (e.g., myocardial infarction) and stroke

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

This medication helps to reduce the risk of death from thrombotic cardiovascular events, namely myocardial infarction or stroke, in adult patients when used in conjunction with aspirin. It is particularly effective for patients with acute coronary syndrome or those with a history of myocardial infarction at least 1 year prior who are at high risk of thrombotic cardiovascular events. Additionally, it reduces the incidence of myocardial infarction or stroke in patients with type 2 diabetes who have experienced percutaneous coronary intervention (PCI) due to coronary artery disease, when used with aspirin. Patients with acute ischemic stroke or high-risk transient ischemic attack (TIA) can also reduce the risk of stroke recurrence by using this medication with aspirin. Thus, this medication is used to reduce the incidence of thrombotic cardiovascular events and strokes.

How to take

Adult dose

This medicine 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 medicine is clinically necessary. Patients taking this medicine should also take a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. 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 medicine should also take a maintenance dose of aspirin (75 - 150mg), unless specifically contraindicated. Patients who took 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. Patients 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. For patients with acute coronary syndrome, refer to the corresponding dosage and administration. Data on the safety and efficacy of this medicine when administered 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 medicine should also take 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. This medicine is administered orally and may be taken with or without food. For patients who have difficulty swallowing tablets, crush this medicine into a fine powder, disperse it in half a glass of water, and drink immediately; 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 nasogastric tube with water after administration. When switching from another antiplatelet agent to this medicine, start this medicine 24 hours after the last dose of the previous medicine. If a dose is missed, take only 1 tablet (the next scheduled dose) at the next scheduled dosing time. No dose adjustment is necessary in patients with renal 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 with its use in patients with moderate hepatic impairment is limited.

Child dose

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

Precautions

This medication prevents the formation of blood clots by inhibiting the aggregation of platelets in the blood. Use of this medication may increase the risk of bleeding; therefore, it should not be used in patients with active pathological bleeding or a history of intracranial bleeding. If surgery is planned, the medication should be discontinued at least 5 days before the procedure to minimize the risk of bleeding. During the course of using this medication, bleeding symptoms may occur, so if low blood pressure or sudden signs of bleeding are observed, medical personnel should be informed immediately. Patients who are taking this medication and have a tendency to bleed or are taking other medications that increase the risk of bleeding should use it with caution, as the risk of bleeding may increase when combined with anticoagulants like warfarin. This medication should not be used in patients with severely impaired liver function or in combination with strong CYP3A4 inhibitors such as certain antifungals and antibiotics. Side effects such as shortness of breath, bradycardia, and thrombocytopenia have been reported, so patients should consult a doctor if these symptoms occur. This medication is not recommended during pregnancy, and women of childbearing age should take appropriate contraceptive measures to avoid pregnancy while using it. Breastfeeding women should consider discontinuing breastfeeding or stopping the medication, as this medication may be excreted in breast milk. In the case of overdose, there is an increased risk of bleeding, and immediate medical attention is required; this medication is not removed by dialysis. Patients using this medication may experience dizziness or confusion, so caution is advised when driving or operating machinery. This medication should not be used in patients under 18 years of age as its safety and effectiveness have not been established. Elderly patients or those with impaired renal function can use it without special dose adjustments, but regular renal function tests are recommended. Interactions may occur with other medications, so patients must inform medical personnel about any medications they are currently taking.

Side effects

  • Hemorrhage
  • intracranial hemorrhage
  • ocular hemorrhage
  • ear hemorrhage
  • hypotension
  • dyspnea
  • respiratory tract hemorrhage
  • gastrointestinal hemorrhage
  • diarrhea
  • nausea
Show 107 more
  • indigestion
  • constipation
  • retroperitoneal hemorrhage
  • skin hemorrhage
  • rash
  • pruritus
  • muscle hemorrhage
  • urinary tract hemorrhage
  • reproductive tract hemorrhage
  • post-procedure hemorrhage
  • traumatic hemorrhage
  • thrombocytopenic purpura
  • bradyarrhythmia
  • atrioventricular 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
  • nasal hemorrhage
  • hemoptysis
  • hematoma
  • cerebral hemorrhage
  • gait abnormality
  • rectal hemorrhage
  • anal hemorrhage
  • appendicitis
  • hepatitis
  • snoring
  • aneurysm
  • heart failure
  • palpitations
  • ventricular tachycardia
  • arrhythmia
  • ventricular fibrillation
  • cardiac arrest
  • ventricular fibrillation
  • urinary tract infection
  • kidney stones
  • cerebral ischemia
  • cerebral infarction
  • arterial stenosis
  • angina
  • coronary thrombosis
  • myocardial ischemia
  • anemia
  • vestibular dysfunction
  • malignant male reproductive neoplasm
  • chemical poisoning
  • post-procedural hematoma
  • laceration
  • road traffic accident
  • trauma
  • nausea
  • vomiting
  • acute renal failure
  • insomnia
  • anxiety
  • memory disturbance
  • erectile dysfunction
  • restlessness
  • orthostatic hypotension
  • exacerbation of hypertension
  • atrial fibrillation
  • conjunctival congestion
  • visual disturbance
  • frequent urination
  • dysuria
  • urinary tract infection
  • renal cyst
  • urinary retention
  • cyanosis
  • tinnitus
  • ear pain
  • lymphadenopathy
  • eosinophilia
  • sexual dysfunction
  • ovarian cyst
  • loss of taste
  • olfactory disturbance
  • increased TSH
  • hypothyroidism
  • injection site reaction
  • injection site pain
  • urticaria
  • increased sweating
  • back pain
  • myalgia
  • skeletal pain
  • arthralgia
  • urticaria

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

Storage

This medication may be sensitive to air and moisture, so it should be kept in a tightly sealed container. It should also be stored in a place that is not too hot or too cold, ideally at room temperature between 1 and 30 degrees.

Appearance and packaging

Appearance

Pink, double convex, round film-coated tablet

Package unit

60 tablets/PTP (10 tablets/PTP x 6)

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.