Eriquin Tablet 5mg (Apixaban)

Adult dose

This medication should be taken with water, with or without food. If a patient forgets to take a dose, they should take this medication as soon as they remember and continue taking it twice daily as before. 1. Adults 1) Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery The recommended dose is 2.5 mg of this medication taken orally twice daily. The initial 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. 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose is 5 mg of this medication taken orally twice daily. However, the recommended dose for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics is 2.5 mg of this medication 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 concomitant administration of the recommended dose of this medication with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation accompanied by acute coronary syndrome and/or percutaneous coronary intervention. (Refer to ‘5. General precautions, 1) Interactions with other drugs that affect hemostasis’ under Precautions for Use and ‘12. Clinical Trial Information, 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, AUGUSTUS trial’.) 3) Treatment of deep vein thrombosis and pulmonary embolism The recommended dose of this medication for the treatment of acute deep vein thrombosis and pulmonary embolism is 10mg orally twice daily for 7 days, followed by 5mg orally twice daily. 4) Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg of this medication taken orally twice daily, and it should be administered after completing at least 6 months of treatment with this medication or another anticoagulant. 2. Switching medications When switching from parenteral anticoagulant therapy to this medication or from this medication to a parenteral anticoagulant, the switch can be made at the time of the next scheduled dose. 1) Switching from vitamin K antagonist therapy to this medication To switch from vitamin K antagonist therapy to this medication, discontinue warfarin or another vitamin K antagonist and start this medication when the International Normalized Ratio (INR) is less than 2.0. 2) Switching from this medication to vitamin K antagonist therapy To switch from this medication to vitamin K antagonist therapy, continue taking this medication for 2 days after starting the vitamin K antagonist. After 2 days of concomitant treatment with this medication and the vitamin K antagonist, measure the INR immediately before the scheduled dose of this medication, and continue concomitant treatment with this medication and the vitamin K antagonist until the INR is 2.0 or higher. 3. Renal impairment As there is no clinical experience in patients on dialysis or in patients with creatinine clearance less than 15 mL/min, use of this medication is not recommended. 1) 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 medication were increased in these patients; therefore, this medication should be administered with caution in these patients. 2) 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 age ≥ 80 years or have a body weight ≤ 60kg should receive this medication at 2.5 mg twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive this medication at 2.5 mg twice daily, regardless of age or body weight. 3) Treatment of deep vein thrombosis and pulmonary embolism/ Reduction of the risk of recurrence of 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 medication were increased in these patients; therefore, this medication should be administered with caution in these patients. 4. Hepatic impairment This medication 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 medication should be administered with caution. Use of this medication is not recommended in patients with severe hepatic impairment. Patients with hepatic ALT/AST greater than 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 medication to these patients. Liver function tests should be performed before starting this medication. 5. Patients unable to swallow tablets For patients unable to swallow tablets, this medication may be crushed immediately before use, mixed with water or a beverage such as applesauce, and administered orally. This medication may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This medication is used to prevent or treat the formation of blood clots by inhibiting blood coagulation. During treatment, bleeding may occur, so signs of bleeding should be carefully monitored. If serious bleeding occurs, the medication should be discontinued immediately. It should not be administered to patients with allergies to this medication, those with active severe bleeding, coagulation disorders, or severely impaired liver function. Additionally, it may be risky for patients who have recently had gastrointestinal ulcers, intracranial bleeding, spinal or brain surgery, or in cancer patients at high risk of bleeding. Patients with severe kidney or liver disease should exercise particular caution when using this medication. Taking this medication alongside certain antidepressants, nonsteroidal anti-inflammatory drugs, or acetylsalicylic acid may increase bleeding risk, so precautions are necessary. Patients receiving epidural or spinal anesthesia should consult with healthcare professionals, as this medication carries a rare risk of serious nerve damage. It is also not recommended for patients undergoing thrombolysis or pulmonary embolectomy. Common side effects while taking this medicine include bleeding, bruising, nosebleeds, hematomas, thrombocytopenia, epistaxis, hemoptysis, nausea, gastrointestinal bleeding, hemorrhoidal bleeding, oral bleeding, blood in stools, rectal bleeding, gum bleeding, abnormal liver function tests, skin rash, muscle bleeding, hematuria, abnormal vaginal bleeding, urogenital bleeding, site of administration bleeding, occult blood, post-procedural bleeding, wound exudate, incision site bleeding, traumatic bleeding, falls, surgical interventions, and vomiting. If any abnormal symptoms occur, notify healthcare professionals immediately. Before undergoing surgery or invasive procedures, this medication should be discontinued at least 24 to 48 hours prior. After procedures, consider bleeding risks and hemostatic status before resuming administration. If discontinued, it is crucial to resume dosing as soon as possible due to the risk of thrombosis. Pregnant or breastfeeding women are advised against using this medication. In cases of breastfeeding, they should either discontinue breastfeeding or stop taking this medication. This medication has not established safety and efficacy in children and should not be used in that population. For the elderly, special dose adjustments are not typically necessary; however, caution is needed in those with low body weight or impaired kidney function. This medication may interact with other drugs; caution is especially warranted when combined with strong CYP3A4 and P-gp inhibitors or inducers. Additionally, using this medication with anticoagulants or antiplatelet agents may increase bleeding risks, so discussions with healthcare professionals are essential. In case of overdose, the risk of bleeding increases, so administration should be stopped immediately and medical treatment sought, as there is no antidote available and management should focus on controlling the bleeding.

• Hemorrhage
• contusion
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• cerebral hemorrhage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to maintain storage temperatures between 1 and 30 degrees Celsius, which helps preserve the medication's effectiveness.

Appearance

Pink, egg-shaped, biconvex film-coated tablet

Package unit

10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6]