Liquisium Tablet 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 then 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 taken orally twice daily. The first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment in patients who have undergone hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment in 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, the recommended dose for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics 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 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. (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, and treatment should be started after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between 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 To switch from vitamin K antagonist therapy to this medicine, discontinue warfarin or the other vitamin K antagonist 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 To switch 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, perform an INR test 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 There is no clinical experience in patients receiving dialysis or in patients with creatinine clearance less than 15 mL/min; therefore, 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 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 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 blood concentrations of this medicine were increased in these patients; 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 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 medicine to these patients. Liver function tests should be performed before starting treatment with this medicine. 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 beverage 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 is used to prevent or treat blood clots by stopping excessive blood coagulation. While taking this medication, one should carefully monitor for signs of bleeding as bleeding may occur. If severe bleeding occurs, the medication should be stopped immediately. It should not be administered to patients with certain conditions. For example, patients who are allergic to the medication, have active bleeding, severe liver dysfunction, or have had recent gastrointestinal ulcers, intracranial hemorrhage, or surgeries on the brain or spinal cord are at risk if they use this medication. Moreover, using it in conjunction with other anticoagulants significantly increases the risk of bleeding, so concomitant use is not recommended. Patients with specific genetic issues such as lactose intolerance should also avoid taking this medication. Patients with compromised kidney or liver function may have increased blood concentrations of the medication and should use it with caution. Taking this medication alongside certain antidepressants or anti-inflammatory painkillers may also increase bleeding risks, so caution is advised. Particularly, elderly or underweight patients may have a higher risk of bleeding. Patients receiving spinal or epidural anesthesia may experience severe nerve damage due to this medication, so the timing of taking the medication around anesthesia should be adjusted, and neurological symptoms should be frequently checked. This medication is not recommended for patients at high risk of bleeding or for those with pulmonary embolism. When administering to cancer patients, careful evaluation of bleeding and thromboembolic risks is necessary. Common side effects of this medication include bleeding, bruising, nosebleeds, and hematomas, and if severe bleeding occurs, immediate consultation with a healthcare professional is required. In the case of surgery or invasive procedures, it is advisable to discontinue this medication for a certain period to reduce the risk of bleeding, and it is recommended to resume it as soon as possible once the condition stabilizes post-procedure. This medication is not recommended for pregnant or breastfeeding women, and its safety in children has not been established. Interactions with other medications may occur during treatment, so it is essential to consult with a doctor or pharmacist, especially if taking antifungal agents, antiviral agents, anticoagulants, antidepressants, or anti-inflammatory painkillers. In case of overdose, there may be an increased risk of bleeding, and an immediate visit to a medical institution is necessary, as there is no specific antidote for this medication. Treatment to stop the bleeding may be required if necessary. This medication does not significantly affect driving or operating machinery, but caution is required if symptoms such as bleeding or dizziness occur.

Hemorrhage, bruise, nosebleed, hematoma, anemia, thrombocytopenia, hypersensitivity, allergic edema, anaphylactic reaction, cerebral hemorrhage, ocular hemorrhage, hypotension, intra-abdominal hemorrhage, nasal hemorrhage, hemoptysis, tracheal hemorrhage, nausea, gastrointestinal hemorrhage, rectal bleeding, oral bleeding, blood in stools, rectal hemorrhage, gum bleeding, retroperitoneal hemorrhage, increased transaminases, increased aspartate aminotransferase, increased gamma-glutamyltranspeptidase, abnormal liver function tests, increased serum alkaline phosphatase, increased serum bilirubin, skin rash, muscle hemorrhage, hematuria, abnormal vaginal bleeding, genitourinary bleeding, bleeding at the site of administration, positive occult blood, post-procedural bleeding, wound site discharge, incision site bleeding, traumatic bleeding, post-operative bleeding, incision site bleeding, hepatitis, biliary disorder, fracture, ligament disorder, coronary artery surgery, post-operative hemorrhage, traumatic hematoma, hypernatremia, metabolic acidosis, systemic weakness, dehydration, septicemia, acute renal failure, urinary retention, cerebral infarct, abnormal kidney function, uterine bleeding, vaginal bleeding, conjunctivitis, visual disturbance, unspecified adenocarcinoma, renal cancer, gallbladder carcinoma, aortic valve insufficiency, aortic stenosis, arterial stenosis, pericardial effusion, angina, syndrome of inappropriate antidiuretic hormone secretion, supraventricular tachycardia, cardiac arrest, colitis, gastroesophageal reflux, gastritis, hematemesis, anal fissure, heart failure, weakness, death, deterioration of condition, fever, drowsiness, seizures, polyneuropathy, headache, hemiparesis, dizziness, hemiplegia, coma, soft tissue infection, subarachnoid hemorrhage, intracranial hemorrhage, vitreous hemorrhage, emphysema, pleural effusion, pneumonia, shortness of breath, vomiting, diarrhea, esophagitis, benign gastrointestinal neoplasm, dental disease, anal fissure, orthostatic hypotension, leg pain, peripheral edema, fatigue, insomnia, loss of appetite, migraine, itchy rash, maculopapular rash, congestion, flushing, palpitations, constipation, abdominal pain, dyspepsia, pruritus, chest pain

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. Additionally, it is recommended to store the medication at room temperature, between 1 to 30 degrees Celsius, and not in excessively hot or cold places.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets/PTP [(10 tablets/PTP x 6)], 30 tablets/bottle, 60 tablets/bottle