Febuxostat 40 mg (Febuxostat)

Adult dosage

1. Adults This medicine is administered once daily at a dose of 40mg or 80mg, regardless of meals. 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 below 6 mg/dL(357 μmol/L). 2. Patients with renal impairment No dosage 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 specific dosage adjustment is required 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 cardiovascular disease, so it should be used with caution in those with a history of cardiovascular disease. Patients with hypersensitivity to this drug's active ingredient or excipients, those taking the specific drugs mercaptopurine and azathioprine, and those with lactose intolerance or certain genetic metabolic disorders should not take this medication. Patients with a history of liver disease must have regular liver function tests while taking this medication, and those with thyroid function changes should also exercise caution. Patients with heart disease or heart failure, as well as those taking the specific drug theophylline, should be cautious when using this medication in combination. While taking this medication, side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, and dizziness may occur; consult a healthcare professional if these symptoms arise. Do not start this medication during an acute gout attack, and preventive treatment may be necessary as gout attacks may temporarily worsen at the beginning of treatment. This medication may cause drowsiness or dizziness when driving or operating machinery, so caution is advised; if a severe allergic reaction occurs, discontinue use immediately and inform a healthcare professional. Pregnant or breastfeeding women are advised not to take this medication, and it is considered safe for those under 18 years old to avoid use due to insufficient experience.

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 pectoris, atrial fibrillation, atrial flutter, heart murmur, abnormal electrocardiogram, palpitations, tachycardia, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, increased bowel frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, excessive hydrochloric acid, passing blood in stool, oral ulcer, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, emotional disturbances, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes insipidus, hepatic steatosis, hepatitis, hepatomegaly, hypersensitivity, shingles, loss of appetite, appetite decrease, appetite increase, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramping, muscle fasciculation, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disturbances, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, smell reduction, cortical infarction, drowsiness, mental disorders, migraine, sensory disturbances, sleepiness, transient ischemic attack, tremors, agitation, anxiety, depression, insomnia, excitability, decreased libido, neuromuscular irritability, panic attacks, personality changes, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, sinonasal hypersecretion, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin necrosis, petechial hemorrhage, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin exfoliation, petechiae, photosensitivity, itching, purpura, skin discoloration, pigmentation changes, skin lesions, apocrine gland dysfunction, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, increased creatinine, decreased bicarbonate, increased sodium, abnormal EEG, increased glucose, increased cholesterol, increased triglycerides, increased amylase, increased potassium, increased thyroid-stimulating hormone, decreased platelets, decreased hematocrit, decreased hemoglobin, increased MCV, decreased erythrocytes, increased creatinine, increased blood urea, increased blood urea to creatinine ratio, increased CPK, increased ALP, increased LDH, increased PSA, decreased urine output, decreased lymphocytes, decreased neutrophils, increased or decreased leukocytes, abnormal coagulation tests, increased low-density lipoprotein, prolonged prothrombin time, urine casts, positive leukocytes and proteins in urine, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, eosinophilia, systemic symptoms, fever, hematological disorders, renal disorders, liver disorders, liver failure, jaundice, hepatic impairment, liver function abnormalities, angioedema, agranulocytosis, rhabdomyolysis

Store this medication in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is best to keep the medication at room temperature between 1°C and 30°C, away from extremes of heat or cold.

Appearance

White to pale yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle