Febuxostat 80 mg (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 medication may increase the risk of cardiovascular death in patients with gout who have cardiovascular disease; hence, patients with a history of significant cardiovascular diseases such as myocardial infarction, stroke, or unstable angina should consider alternative treatments. Patients with allergies to any ingredients or excipients contained in this medication, those taking mercaptopurine or azathioprine, and patients with lactose intolerance or specific genetic metabolic disorders should not use this medication. Patients with a history of liver disease, thyroid dysfunction, ischemic heart disease, or congestive heart failure should regularly monitor liver and thyroid function and be closely observed while using this medication. This medication is not initiated at the beginning of a gout attack, and gout attacks may temporarily worsen after initiation, so it is recommended to use it for at least 6 months in conjunction with non-steroidal anti-inflammatory drugs or colchicine. Side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, dizziness may occur; if any of these symptoms arise, consult a healthcare professional immediately. This medication may cause drowsiness, dizziness, or numbness, so caution should be exercised when engaging in hazardous activities such as driving or operating machinery. If cardiovascular symptoms or abnormal signs appear, promptly inform a healthcare professional and seek appropriate action; in case of a severe allergic reaction, discontinue the medication immediately. This medication may interact with certain drugs; if taking mercaptopurine, azathioprine, theophylline, etc., inform your healthcare provider, and if necessary, carefully decide on dosage adjustments or concomitant use. Pregnant or breastfeeding women are advised not to take this medication, and it has not been tested in children under the age of 18, so it is not to be administered to them. In cases of overdose, since there is no specific antidote, it is crucial to receive appropriate treatment and supportive care according to symptoms. Store this medication out of reach of children, and no special storage conditions are required.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, arthralgia, limb pain, gout, myalgia, pruritus, shortness of breath, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, heart murmur, abnormal electrocardiogram, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, hematochezia, oral ulcers, pancreatitis, gastric ulcer, vomiting, weakness, chest pain, chest discomfort, edema, mood disorders, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, fatty liver, hepatitis, liver enlargement, 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 spasms, muscle twitching, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory impairment, olfactory dysfunction, lacunar infarction, somnolence, psychiatric disorders, migraine, sensory disturbances, drowsiness, transient ischemic attack, tremors, restlessness, anxiety, depression, insomnia, excitability, decreased libido, neurogenic irritability, panic attacks, personality changes, hematuria, nephrolithiasis, increased urinary frequency, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, shortness of breath, epistaxis, nasal dryness, sinus hypersecretion, pharyngeal swelling, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, vascular edema, dermatitis, skin necrosis, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin desquamation, petechial hemorrhage, photosensitivity, pruritus, purpuric rash, skin discoloration, pigmentary changes, skin lesions, apocrine dysfunction, urticaria, flushing, facial flushing, hypertension, hypotension, prolonged activated partial thromboplastin time, increased creatinine, decreased bicarbonate, increased sodium, abnormal EEG, increased glucose, increased cholesterol, increased triglycerides, increased amylase, increased potassium, increased thyroid-stimulating hormone, decreased platelet count, decreased hematocrit, decreased hemoglobin, increased MCV, decreased red blood cells, increased creatinine, increased blood urea nitrogen, increased blood urea nitrogen to creatinine ratio, increased CPK, increased ALP, increased LDH, increased PSA, increased urine output, decreased urine output, decreased lymphocyte count, decreased neutrophil count, increased leukocyte count, decreased leukocyte count, abnormal coagulation tests, increased low-density lipoprotein, prolonged prothrombin time, urinary casts, positive urinary leukocytes, positive urinary proteins, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, eosinophilia, systemic symptoms, fever, hematological disorders, renal disorders, hepatic disorders, liver dysfunction, liver failure, jaundice, vascular edema, agranulocytosis, rhabdomyolysis

This medication should be stored in a tightly closed container to protect it from air and moisture, at room temperature between 1 and 30 degrees Celsius. This is a method to maintain the efficacy of the medication and prevent degradation.

Appearance

Pale yellow to yellow oblong film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle