Febuxostat 80 mg (Febuxostat)

Adult dosage

1. Adults This medicine is administered at a dose of 40mg or 80mg once daily, without regard to meals. Because this medicine acts very rapidly, recheck the serum uric acid concentration after 2 weeks. The treatment goal is to lower and maintain the serum uric acid concentration at less than 6 mg/dL(357 μmol/L). 2. Patients with renal impairment No dose adjustment is required 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 required in patients with mild or moderate hepatic impairment. 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 when administered to gout patients with cardiovascular disease, so patients with a history of cardiovascular disease are advised to avoid this medication. Patients who are allergic to the active ingredient or excipients, those taking certain immunosuppressants such as mercaptopurine or azathioprine, and those with lactose intolerance or specific metabolic genetic disorders should not use this medication. Patients with a history of liver disease or changes in thyroid function should have their liver and thyroid functions regularly monitored during treatment with this medication; caution is also required for patients with heart disease or heart failure. Patients on theophylline should be cautious when using this medication, as it can significantly increase the metabolites excreted by the kidneys. This medication may cause various side effects including liver dysfunction, diarrhea, headache, rash, fatigue, arthralgia, dizziness, etc., and treatment should be discontinued immediately and evaluated if symptoms of liver dysfunction appear. Do not initiate treatment with this medication during an acute gout attack, as gout attacks may temporarily worsen at the beginning of treatment; appropriate preventive therapy should be accompanied. This medication is not recommended for use in pregnant or breastfeeding women, and there is no experience with administration in children under 18 years of age. In cases of overdose, there is no specific antidote; therefore, appropriate treatment should be provided according to symptoms. This medication may interact with other drugs, so if patients are taking mercaptopurine, azathioprine, theophylline, non-steroidal anti-inflammatory drugs, warfarin, etc., they should consult with their healthcare provider. Caution is advised when driving or operating dangerous machinery, as drowsiness or dizziness may occur.

Abnormal liver function, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, shortness of breath, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, cardiac murmur, electrocardiogram abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, hematochezia, oral ulcers, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, mood disorders, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, fatty liver, hepatitis, hepatomegaly, hypersensitivity, shingles, appetite loss, decreased appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, dyslipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramps, single muscle contraction, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disturbances, cerebrovascular accidents, Guillain-Barré syndrome, headache, partial paralysis, sensory decrease, olfactory impairment, cerebral infarction, somnolence, mental disorders, migraine, sensory disturbances, drowsiness, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, irritability, panic attacks, personality changes, hematuria, nephrolithiasis, pollakiuria, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, shortness of breath, epistaxis, nasal dryness, sinus hypersecretion, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, dermatosis, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechiae, photosensitivity, pruritus, purpura, skin discoloration, pigmentary changes, skin lesions, axillary hyperhidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, creatinine increase, bicarbonate decrease, sodium increase, EEG abnormalities, glucose increase, cholesterol increase, triglyceride increase, amylase increase, potassium increase, thyroid-stimulating hormone increase, platelet decrease, hematocrit decrease, hemoglobin decrease, MCV increase, erythrocyte decrease, creatinine increase, blood urea increase, blood urea/creatinine ratio increase, CPK increase, ALP increase, LDH increase, PSA increase, urinary output increase, urinary output decrease, lymphocyte count decrease, neutrophil count decrease, leukocyte count increase, leukocyte count decrease, abnormal coagulation tests, low-density lipoprotein increase, prothrombin time prolongation, urinary casts, positive urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, eosinophilia, drug reactions associated with systemic symptoms, liver failure, jaundice, liver dysfunction, agranulocytosis, rhabdomyolysis

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance

Pale yellow to yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle