Febuxostat 80 mg (Febuxostat)

Adult dosage

1. Adults Administer 40mg or 80mg of this medicine once daily, with or without food. This medicine acts very rapidly; therefore, recheck the serum uric acid level after 2 weeks. The treatment goal is to reduce 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 specific 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 gout patients with cardiovascular diseases, so it should be administered cautiously in patients with a history of cardiovascular diseases. Patients with hypersensitivity to the active ingredient or excipients, those taking mercaptopurine or azathioprine, and certain genetically predisposed lactose intolerant patients should not be administered this medication. Patients with liver disease or thyroid dysfunction, ischemic heart disease or congestive heart failure should undergo regular liver function tests and thyroid function tests while using this medication. Caution is necessary regarding long-term safety due to increased metabolites when co-administered with theophylline. Do not initiate this medication during an acute gout attack, and consider co-administration with anti-inflammatory agents or colchicine as gout attacks may temporarily increase at the beginning of treatment. If gout attacks occur during the course of this medication, do not discontinue use but manage appropriately. Regular liver function tests should be conducted before and during treatment as liver dysfunction may occur, and administration should be stopped immediately if symptoms of liver function impairment are observed. As there is a risk of uric acid rapidly increasing and precipitating in the urinary tract, adequate hydration and urinary alkalization are necessary. This medication is not recommended for asymptomatic hyperuricemia patients or organ transplant recipients. Drowsiness, dizziness, or numbness may occur, so avoid driving or operating dangerous machinery. Severe allergic reactions may occur infrequently, so if symptoms such as rash or difficulty breathing appear, discontinue use immediately and consult a physician. This medication may interact with several other drugs, particularly mercaptopurine, azathioprine, and theophylline, so caution or avoidance is advised. It should not be taken during pregnancy, and it is also advisable not to use it while breastfeeding. There is no experience in administering to children and adolescents under 18 years of age. No specific cases have been reported in overdose, but symptomatic treatment is required as needed. Keep 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, dyspnea, 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, flatulence, increased bowel movement frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hypersecretion of gastric acid, passage of blood in stools, oral ulcer, pancreatitis, gastric ulcer, vomiting, weakness, chest pain, chest discomfort, edema, emotional disturbance, gait disorder, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, hepatic steatosis, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, anorexia, decreased appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramps, fasciculations, muscle spasm, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disturbance, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, smell impairment, heat stroke, drowsiness, mental disorder, migraine, sensory disturbances, somnolence, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, irritability, panic attack, personality changes, hematuria, nephrolithiasis, frequency of urination, proteinuria, renal failure, renal insufficiency, urgency, urinary incontinence, mastalgia, 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 rash, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechiae, photosensitivity, pruritus, purpura, skin discoloration, changes in pigmentation, skin lesions, axillary osmidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, extended 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 platelets, reduced hematocrit, reduced hemoglobin, increased MCV, decreased red blood cells, increased creatinine, increased blood urea, increased blood urea and creatinine ratio, increased CPK, increased ALP, increased LDH, increased PSA, increased urinary output, decreased urinary output, decreased lymphocyte count, decreased neutrophil count, increased white blood cell count, decreased white blood cell count, abnormal coagulation tests, increased low-density lipoproteins, prolonged prothrombin time, urinary casts, positive urine leukocytes, positive urine protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, hepatic failure, jaundice, liver dysfunction, agranulocytosis, rhabdomyolysis

This medication is susceptible to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness and safety of the medication for a long time.

Appearance

Pale yellow to yellow oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle