Medication info

Eliquis 5 mg Tablet (Apixaban)

Prescription medicationTabletOral
Ingredient · strength
Apixaban›5mg / 1 tablet
Manufacturer / importer
Samik Pharmaceutical Co., Ltd.
Appearance
Pink oval biconvex film-coated tablet
Packaging
60 tablets / PTP [(10 tablets / PTP × 6)]
Approval status
Active

MFDS item code 201905370 · Approved 2019.07.29

Summary

Main use
Prevention of stroke and embolism; treatment of venous thrombosis and prevention of recurrence; prevention of thrombosis after joint surgery
Who takes it
Adults
Adult dose
This medicine may be taken with water, with or without food. If a patient forgets to take a dose, they should take this medicine as soon as possible and continue taking it twice daily as before. Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery: The recommended dose is 2.5 mg of this medicine taken orally twice daily. The first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment for patients who have undergone hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment for patients who have undergone knee replacement surgery is 10 ~ 14 days. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose is 5 mg of this medicine taken orally twice daily. However, for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics, the recommended dose is 2.5 mg of this medicine taken orally twice daily: age ≥80 years, body weight ≤60kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L). Treatment should be continued long term. There is limited experience with coadministration of the recommended dose of this medicine with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who have acute coronary syndrome and/or have undergone percutaneous coronary intervention. Treatment of deep vein thrombosis and pulmonary embolism: The recommended dose of this medicine for the treatment of acute deep vein thrombosis and pulmonary embolism is 10mg taken orally twice daily for 7 days, followed by 5mg taken orally twice daily. Reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism: The recommended dose is 2.5mg of this medicine taken orally twice daily, after completion of at least 6 months of treatment with this medicine or another anticoagulant. When switching from a parenteral anticoagulant to this medicine or from this medicine to a parenteral anticoagulant, the switch can be made at the time of the next scheduled dose. When switching from vitamin K antagonist therapy to this medicine, discontinue warfarin or another vitamin K antagonist and start this medicine when the international normalized ratio (INR) is less than 2.0. When switching from this medicine to vitamin K antagonist therapy, continue taking this medicine for 2 days after starting the vitamin K antagonist. After 2 days of concomitant treatment with this medicine and a vitamin K antagonist, measure the INR just before the scheduled dose of this medicine, and continue concomitant treatment with this medicine and the vitamin K antagonist until the INR is 2.0 or higher. As there is no clinical experience in patients receiving dialysis or in patients with creatinine clearance less than 15 mL/min, use of this medicine is not recommended. Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery: No dose adjustment is necessary in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), blood concentrations of this medicine were increased in these patients; therefore, this medicine should be administered with caution in these patients. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: No dose adjustment is necessary in patients with mild or moderate renal impairment. However, patients with serum creatinine ≥1.5 mg/dL (133 micromole/L) who are ≥ 80 years of age or weigh ≤ 60kg should receive 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive 2.5 mg of this medicine twice daily, regardless of age or body weight. Treatment of deep vein thrombosis and pulmonary embolism/Reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism: No dose adjustment is necessary in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), blood concentrations of this medicine were increased in these patients; therefore, this medicine should be administered with caution in these patients. This medicine should not be administered to patients with liver disease associated with coagulopathy and a clinically significant risk of bleeding. No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child Pugh A or B), but this medicine should be administered with caution. Use of this medicine is not recommended in patients with severe hepatic impairment. Patients with hepatic ALT/AST levels exceeding 2 times the upper limit of normal or total bilirubin levels at least 1.5 times the upper limit of normal were excluded from clinical trials; therefore, caution should be exercised when administering this medicine to these patients. Liver function tests should be performed before starting treatment with this medicine. For patients who are unable to swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and administered orally. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

Ingredients

Manufacturer
Samik Pharmaceutical Co., Ltd.

Efficacy & effects

Prevention of stroke and embolism; treatment of venous thrombosis and prevention of recurrence; prevention of thrombosis after joint surgery

  • Venous thromboembolism
  • stroke
  • systemic embolism
  • deep vein thrombosis
  • pulmonary embolism
View approved original text

This medication is used to prevent venous thromboembolism in adult patients who have undergone hip or knee replacement surgery. Additionally, it reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also beneficial in the treatment of already occurring deep vein thrombosis and pulmonary embolism, reducing the recurrence of these conditions. Accordingly, this medication is effectively used in the prevention and treatment of thrombotic-related diseases.

How to take

Adult dose

This medicine may be taken with water, with or without food. If a patient forgets to take a dose, they should take this medicine as soon as possible and continue taking it twice daily as before. Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery: The recommended dose is 2.5 mg of this medicine taken orally twice daily. The first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment for patients who have undergone hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment for patients who have undergone knee replacement surgery is 10 ~ 14 days. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose is 5 mg of this medicine taken orally twice daily. However, for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics, the recommended dose is 2.5 mg of this medicine taken orally twice daily: age ≥80 years, body weight ≤60kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L). Treatment should be continued long term. There is limited experience with coadministration of the recommended dose of this medicine with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who have acute coronary syndrome and/or have undergone percutaneous coronary intervention. Treatment of deep vein thrombosis and pulmonary embolism: The recommended dose of this medicine for the treatment of acute deep vein thrombosis and pulmonary embolism is 10mg taken orally twice daily for 7 days, followed by 5mg taken orally twice daily. Reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism: The recommended dose is 2.5mg of this medicine taken orally twice daily, after completion of at least 6 months of treatment with this medicine or another anticoagulant. When switching from a parenteral anticoagulant to this medicine or from this medicine to a parenteral anticoagulant, the switch can be made at the time of the next scheduled dose. When switching from vitamin K antagonist therapy to this medicine, discontinue warfarin or another vitamin K antagonist and start this medicine when the international normalized ratio (INR) is less than 2.0. When switching from this medicine to vitamin K antagonist therapy, continue taking this medicine for 2 days after starting the vitamin K antagonist. After 2 days of concomitant treatment with this medicine and a vitamin K antagonist, measure the INR just before the scheduled dose of this medicine, and continue concomitant treatment with this medicine and the vitamin K antagonist until the INR is 2.0 or higher. As there is no clinical experience in patients receiving dialysis or in patients with creatinine clearance less than 15 mL/min, use of this medicine is not recommended. Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery: No dose adjustment is necessary in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), blood concentrations of this medicine were increased in these patients; therefore, this medicine should be administered with caution in these patients. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: No dose adjustment is necessary in patients with mild or moderate renal impairment. However, patients with serum creatinine ≥1.5 mg/dL (133 micromole/L) who are ≥ 80 years of age or weigh ≤ 60kg should receive 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive 2.5 mg of this medicine twice daily, regardless of age or body weight. Treatment of deep vein thrombosis and pulmonary embolism/Reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism: No dose adjustment is necessary in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), blood concentrations of this medicine were increased in these patients; therefore, this medicine should be administered with caution in these patients. This medicine should not be administered to patients with liver disease associated with coagulopathy and a clinically significant risk of bleeding. No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child Pugh A or B), but this medicine should be administered with caution. Use of this medicine is not recommended in patients with severe hepatic impairment. Patients with hepatic ALT/AST levels exceeding 2 times the upper limit of normal or total bilirubin levels at least 1.5 times the upper limit of normal were excluded from clinical trials; therefore, caution should be exercised when administering this medicine to these patients. Liver function tests should be performed before starting treatment with this medicine. For patients who are unable to swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and administered orally. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

Precautions

This medication is used to prevent or treat the formation of blood clots by stopping blood from clotting excessively. During the use of this medication, there may be a risk of bleeding, so signs of bleeding should be carefully monitored. If severe bleeding occurs, the use of this medication should be stopped immediately, and a doctor should be consulted. This medication is not administered to patients with a high risk of bleeding or those with coagulation disorders. Special caution is needed when using this medication in patients with severely compromised kidney function or severe liver dysfunction. Combining this medication with certain antidepressants, anti-inflammatory pain medications, or anticoagulants may increase the risk of bleeding, so consultation with a doctor is advised. Elderly individuals or underweight patients may also be at higher risk for bleeding and should therefore be cautious when using this medication. Patients undergoing spinal or epidural anesthesia should consult healthcare professionals about the risk of nerve injury when taking this medication. This medication is not recommended for pregnant or breastfeeding women, and especially for breastfeeding women, it is advised to either stop taking the medication or discontinue breastfeeding. Before undergoing surgery or invasive procedures, this medication should be discontinued for a certain period, and after surgery, the potential risks of bleeding and the need for treatment should be considered before resuming use. This medication may interact with other drugs, so all medications being taken should be disclosed to healthcare providers. In case of overdose, the risk of bleeding may significantly increase, and there is no specific antidote, so appropriate treatment for bleeding control in emergencies is required. This medication does not significantly affect driving or operating machinery, but caution is necessary due to the risk of bleeding and other side effects.

Side effects

  • bleeding
  • bruise
  • nosebleed
  • hematoma
  • anemia
  • thrombocytopenia
  • hypersensitivity
  • allergic edema
  • anaphylactic reaction
  • intracerebral hemorrhage
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  • ocular hemorrhage
  • hypotension
  • intra-abdominal hemorrhage
  • epistaxis
  • hemoptysis
  • airway bleeding
  • nausea
  • gastrointestinal hemorrhage
  • hemorrhoidal bleeding
  • oral bleeding
  • bloody stool
  • rectal bleeding
  • gum bleeding
  • retroperitoneal bleeding
  • transaminase increase
  • aspartate aminotransferase increase
  • gamma-glutamyltransferase increase
  • abnormal liver function tests
  • serum alkaline phosphatase increase
  • serum bilirubin increase
  • skin rash
  • muscle hemorrhage
  • hematuria
  • abnormal vaginal bleeding
  • urogenital bleeding
  • bleeding at the administration site
  • occult blood positive
  • post-procedural bleeding
  • wound secretion
  • incision site bleeding
  • traumatic hemorrhage
  • post-procedural bleeding
  • incision site bleeding
  • hepatitis
  • bile duct obstruction
  • fracture
  • ligament injury
  • coronary artery surgery
  • postoperative bleeding
  • traumatic hematoma
  • hypernatremia
  • metabolic acidosis
  • systemic weakness
  • dehydration
  • septicemia
  • acute renal failure
  • urinary retention
  • neuroinfarction
  • renal dysfunction
  • uterine bleeding
  • vaginal bleeding
  • conjunctivitis
  • visual disturbances
  • unknown primary carcinoma
  • kidney cancer
  • gallbladder carcinoma
  • aortic valve insufficiency
  • aortic stenosis
  • arterial stenosis
  • pericardial effusion
  • angina pectoris
  • cardiac functional impairment syndrome
  • supraventricular tachycardia
  • cardiac arrest
  • colitis
  • gastroesophageal reflux
  • gastritis
  • hematemesis
  • anal fissure
  • heart failure
  • asthenia
  • death
  • worsening condition
  • fever
  • drowsiness
  • seizures
  • polyneuropathy
  • headache
  • hemiplegia
  • dizziness
  • hemiparesis
  • coma
  • soft tissue infection
  • subarachnoid hemorrhage
  • intracranial hemorrhage
  • vitreous hemorrhage
  • emphysema
  • pleural effusion
  • fall
  • surgical intervention
  • eating disorders
  • atrial fibrillation
  • hemorrhagic gastric ulcer
  • melena
  • cerebral infarction
  • cerebral hemorrhage
  • pneumonia
  • respiratory distress
  • vomiting
  • diarrhea
  • esophagitis
  • benign gastrointestinal neoplasm
  • dental disorders
  • anal fissure
  • orthostatic hypotension
  • leg pain
  • peripheral edema
  • fatigue
  • insomnia
  • loss of appetite
  • migraine
  • itchy rash
  • maculopapular skin
  • congestion
  • flushing
  • palpitations
  • constipation
  • abdominal pain
  • dyspepsia
  • pruritus
  • chest pain

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture and should be kept at room temperature between 1 to 30 degrees Celsius. Storing it this way can help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink oval biconvex film-coated tablet

Package unit

60 tablets / PTP [(10 tablets / PTP × 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.