Litesaban Tablets 2.5 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) 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. 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 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 concomitant administration of the recommended dose of this medicine with an antiplatelet agent after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who also have acute coronary syndrome and/or have undergone percutaneous coronary intervention. (Refer to ‘5. General Precautions, 1) Interactions with other drugs that affect hemostasis’ and ‘12. Clinical Trial Information, 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, AUGUSTUS trial’ under Precautions for Use.) 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 taken orally twice daily for 7 days, followed by 5mg taken 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 taken orally twice daily, to be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching medication When switching from parenteral anticoagulant treatment 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 treatment to this medicine When switching from vitamin K antagonist treatment to this medicine, discontinue warfarin or other vitamin K antagonist treatment and start this medicine when the International Normalized Ratio (INR) is less than 2.0. 2) Switching from this medicine to vitamin K antagonist treatment When switching from this medicine to vitamin K antagonist treatment, 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. 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. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the blood concentration of this medicine increased in these patient groups; 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 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. 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. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the blood concentration of this medicine increased in these patient groups; therefore, this medicine should be administered with caution in these patients. 4. Hepatic impairment 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. 5. Patients who cannot swallow tablets For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with a liquid such as water or applesauce, and administered orally. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This medication is used to prevent or treat thrombus formation by inhibiting blood coagulation. However, bleeding may occur during treatment, so signs of bleeding should be monitored closely. If severe bleeding occurs, discontinue the medication immediately and seek appropriate treatment if necessary. This drug should not be administered to patients with certain conditions. For example, it can be hazardous for patients with hypersensitivity to this drug, clinically significant bleeding, liver disease with coagulation disorders, recent history of gastrointestinal ulcers or intracranial hemorrhage, etc. Additionally, caution is needed when used in combination with other anticoagulants, and it should not be administered to patients with lactose intolerance. Patients with severely impaired kidney or liver function, those taking certain antidepressants or anti-inflammatory drugs concurrently, elderly patients, and underweight individuals should use this medication with caution. Special attention is needed for patients undergoing spinal or epidural anesthesia due to the risk of hematoma formation. This drug commonly causes adverse reactions such as bleeding, bruising, nosebleeds, and hematomas, while serious bleeding or allergic reactions may occur in rare cases. If any adverse reactions are suspected, consult a healthcare professional immediately. This drug may interact with other medications, so inform your healthcare provider if you are taking any other drugs. Caution is especially required when used in conjunction with certain antifungals, antivirals, anticoagulants, antiplatelets, and serotonin reuptake inhibitors, as the risk of bleeding may increase. Pregnant or breastfeeding women are advised not to take this medication, as it may pass into breast milk, and breastfeeding should be suspended if this drug is used. The safety and effectiveness of this drug in children have not been established, so it should not be administered to pediatric patients. Before undergoing surgery or invasive procedures, this drug should be discontinued for a certain period, as the risk of bleeding may increase; follow the healthcare provider's instructions. In case of overdose, the risk of bleeding may significantly increase, so adhere to the prescribed dosage and consult a healthcare professional immediately if any abnormal symptoms arise.

Hemorrhage, contusion, nosebleed, hematoma, anemia, thrombocytopenia, hypersensitivity, allergic edema, anaphylactic reaction, cerebral hemorrhage, ocular hemorrhage, hypotension, intra-abdominal hemorrhage, epistaxis, hemoptysis, airway hemorrhage, nausea, gastrointestinal hemorrhage, hemorrhoidal bleeding, oral hemorrhage, rectal bleeding, gum bleeding, retroperitoneal hemorrhage, increased transaminases, increased aspartate aminotransferase, increased gamma-glutamyltransferase, abnormal liver function tests, increased serum alkaline phosphatase, increased serum bilirubin, skin rash, muscle hemorrhage, hematuria, abnormal vaginal bleeding, urogenital bleeding, bleeding at the site of administration, positive occult blood, post-procedural bleeding, wound site discharge, incision site bleeding, traumatic hemorrhage, post-procedural bleeding, incision site bleeding, hepatitis, biliary dysfunction, fracture, ligament injury, coronary artery surgery, postoperative hemorrhage, traumatic hematoma, hypernatremia, metabolic acidosis, systemic weakness, dehydration, sepsis, acute renal failure, urinary retention, neurological infarction, renal dysfunction, uterine bleeding, vaginal bleeding, conjunctivitis, visual disturbances, carcinoma of unknown primary origin, kidney cancer, cholangiocarcinoma, aortic valve insufficiency, aortic stenosis, arterial stenosis, pericardial effusion, angina, syndrome of inappropriate anti-diuretic hormone secretion, supraventricular tachycardia, cardiac arrest, colitis, gastroesophageal reflux, gastroenteritis, hematemesis, anal fissure, heart failure, myasthenia, death, worsening condition, fever, drowsiness, convulsions, polyneuropathy, headache, hemiparesis, dizziness, hemiplegia, coma, soft tissue infection, subarachnoid hemorrhage, intracranial hemorrhage, vitreous hemorrhage, emphysema, pleural effusion, vomiting, diarrhea, esophagitis, benign gastrointestinal neoplasm, dental disease, anal fissure, orthostatic hypotension, leg pain, peripheral edema, fatigue, insomnia, loss of appetite, migraine, pruritic rash, maculopapular rash, congestion, flushing, pneumonia, dyspnea, palpitations, constipation, abdominal pain, dyspepsia, pruritus, chest pain

Store this medication in a tightly closed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance

Pale yellow, round film-coated tablet

Package unit

60 tablets/box [10 tablets/PTPX6]