Npxquis Tablets 5 mg (Apixaban)

Adult dose

This medicine should 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. 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 medicine orally twice daily. The initial dose is 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 medicine 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 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 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. (See “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 medicine 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 medicine orally twice daily, and it should be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching medications When switching from parenteral anticoagulant therapy to this medicine or from this medicine 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 medicine When switching from vitamin K antagonist therapy to this medicine, discontinue warfarin or other vitamin K antagonist therapy and start this medicine when the International Normalized Ratio (INR) is less than 2.0. 2) Switching from this medicine to vitamin K antagonist therapy When switching from this medicine to vitamin K antagonist therapy, continue 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 immediately 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. 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 medicine 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 medicine were increased in these patients; therefore, this medicine 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 aged ≥ 80 years or have a body weight ≤ 60kg should receive this medicine at a dose of 2.5 mg twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive this medicine at a dose of 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 medicine were increased in these patients; therefore, this medicine should be administered with caution in these patients. 4. Hepatic impairment No dose adjustment is required 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. 5. Patients unable to swallow tablets For patients unable to swallow tablets, this medicine may be crushed immediately before use, mixed with water or a liquid such as applesauce, and administered orally. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This medication works by thinning the blood to prevent clot formation. Therefore, there is a risk of bleeding, and signs of bleeding must be carefully monitored. If severe bleeding occurs, immediately discontinue this medication. Patients with a history of allergic reactions to this medication, those with current severe bleeding, liver function significantly impaired, or conditions with a high risk of bleeding should not take this medication. Additionally, it should be avoided in conjunction with other anticoagulants. Patients with severely compromised kidney function or mildly impaired liver function, and those taking certain antidepressants or anti-inflammatory pain relievers should use this medication with special caution. Elderly patients or those with low body weight are also at a higher risk for bleeding and need to be monitored carefully. Patients undergoing spinal anesthesia or spinal puncture are at risk of nerve damage when taking this medication, so they should be managed cautiously. This medication may commonly cause side effects like bleeding, bruising, nosebleeds, and hematomas. Severe bleeding, allergic reactions, and liver function abnormalities can also occur, though rarely, so any unusual symptoms should be promptly discussed with a healthcare professional. The risk of bleeding may increase if taken with other medications that elevate bleeding risk, so it is crucial to consult a doctor before combination therapy. For surgical or invasive procedures, this medication should be discontinued at least 24 to 48 hours prior due to bleeding risk, and should be resumed as soon as possible after the procedure when bleeding has stabilized. It is not recommended for use in pregnant or breastfeeding women; breastfeeding should be suspended if this medication is taken during lactation. The safety for pediatric patients has not been established, so it should not be administered to children. In case of overdose, the risk of bleeding significantly increases, so the dosage must be adhered to precisely, and if excessive bleeding occurs, immediate medical attention is required.

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

This medication can be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the medication's efficacy for a longer duration.

Appearance

Pink oval-shaped film-coated tablets with a convex surface on both sides.

Package unit

60 tablets/PTP [10 tablets/PTP × 6]