Febuxostat 40 mg Tablet (Febuxostat)

Adult dosage

1. Adults Administer this medicine at a dose of 40 mg or 80 mg once daily, regardless of meals. As this medicine acts very rapidly, recheck the serum uric acid level after 2 weeks. The treatment goal is to lower and maintain the serum uric acid level below 6 mg/dL (357 μmol/L). 2. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment. The safety and efficacy of this medicine have not been adequately evaluated in patients with severe renal impairment (creatinine clearance less than 30mL/min). 3. Patients with hepatic impairment No special dose adjustment is necessary in patients with mild or moderate hepatic impairment. Only limited information is available for patients with moderate hepatic impairment, and the efficacy and safety of this medicine have not been studied in patients with severe hepatic impairment (Child Pugh Class C).

This drug may increase the risk of cardiovascular death when administered to patients with cardiovascular diseases. Therefore, it is advisable to avoid using this drug in patients with a history of cardiovascular diseases such as myocardial infarction, stroke, or unstable angina, if alternative treatment options are available. Patients allergic to the ingredients or excipients in this drug, and those currently taking Mercaptopurine or Azathioprine should not use this drug. Furthermore, since it contains lactose, patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also refrain from taking it. Patients with liver disease or a history of liver disease should regularly receive liver function tests while using this medication, and those with changes in thyroid function also need to take caution. Patients with heart disease or heart failure, as well as those taking theophylline, should be cautious when using this medication, and it should also be administered carefully to organ transplant recipients or patients with a history of major cardiovascular diseases. This drug may cause various side effects such as liver dysfunction, diarrhea, headache, rash, nausea, fatigue, joint pain, dizziness, etc., and if any abnormal symptoms appear, it should be discussed with healthcare professionals. It is recommended not to start this drug during an acute gout attack and to use nonsteroidal anti-inflammatory drugs or colchicine for at least 6 months to prevent gout flares. During the use of this medication, drowsiness, dizziness, and sensory impairment may occur; thus, it is advisable to avoid driving or operating hazardous machinery. Severe allergic reactions or hypersensitivity reactions have been reported rarely; therefore, if symptoms like rash, difficulty breathing, or swelling occur, administration must be stopped immediately and healthcare professionals should be informed. This drug may interact with other specific medications; particularly patients taking Mercaptopurine, Azathioprine, or theophylline should either not combine these drugs or take caution. It is advisable for pregnant or breastfeeding women not to take this drug, and there is no experience administering it to children under 18 years old.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, dyspnea, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, heart murmur, abnormal ECG, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, melena, oral ulcers, pancreatitis, gastric ulcer, vomiting, weakness, chest pain, chest discomfort, edema, emotional disturbances, gait disorders, influenza-like symptoms, pain, thirst, cholelithiasis, diabetes mellitus, hepatic steatosis, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, loss of appetite, decreased appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramps, muscle single contraction, muscle contracture, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, smell impairment, heat stroke infarction, drowsiness, mental disorders, migraine, sensory disturbances, somnolence, transient ischemic attacks, tremors, agitation, anxiety, depression, insomnia, excitability, decreased libido, nervous hyperreactivity, panic attacks, personality changes, hematuria, nephrolithiasis, polyuria, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, sinus hypersecretion, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin lichen, petechiae, eczema, hair discoloration, hair growth abnormalities, hyperhidrosis, skin peeling, petechiae, photosensitivity, itching, purpura, skin discoloration, pigmentation changes, skin lesions, apocrine dysfunction, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, creatinine increase, bicarbonate decrease, sodium increase, abnormal EEG, glucose increase, cholesterol increase, triglyceride increase, amylase increase, potassium increase, thyroid-stimulating hormone increase, platelet decrease, hematocrit decrease, hemoglobin decrease, MCV increase, red blood cell decrease, creatinine increase, blood urea increase, blood urea creatinine ratio increase, CPK increase, ALP increase, LDH increase, PSA increase, urine output increase, urine output decrease, lymphocyte count decrease, neutrophil count decrease, white blood cell count increase, white blood cell count decrease, abnormal coagulation tests, low-density lipoprotein increase, prothrombin time prolongation, urine casts, positive urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, liver failure, jaundice, liver dysfunction, agranulocytosis, rhabdomyolysis

This medication should be stored in a well-closed container to prevent air or moisture from entering, at room temperature between 1°C and 30°C. Storing it this way helps maintain the effectiveness of the drug for a longer time.

Appearance

White to off-white round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle