Febuxostat 40 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 cardiovascular mortality in patients with cardiovascular diseases; therefore, patients with a history of major cardiovascular diseases, such as myocardial infarction or stroke, are advised to choose alternative treatments if possible. Patients who are allergic to the ingredients or excipients of this medication, those taking mercaptopurine or azathioprine, and patients with lactose intolerance or specific genetic metabolic disorders should not take this medication. Patients with liver disease or thyroid dysfunction should have liver and thyroid function monitored regularly while taking this medication, and those with heart failure or ischemic heart disease should also exercise caution. This medication may significantly increase the excretion of metabolites in urine when taken in conjunction with another drug called theophylline, so caution is advised if taken together. Side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, muscle pain, and dizziness may occur during the course of treatment; if symptoms of liver dysfunction appear, discontinue use immediately and consult a physician. When an acute gout attack occurs, this medication should not be initiated, and it is recommended to take gout attack prevention medication together for at least 6 months, as gout attacks may worsen in the early stages of treatment. This medication may cause drowsiness or dizziness; caution should be exercised while driving or operating dangerous machinery. It is advised that pregnant or breastfeeding women not take this medication, and it is not recommended for use in children under 18 years of age due to a lack of experience. In case of overdose, special antidotes are not available, so appropriate treatment should be administered based on symptoms. 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, bloating, increased bowel frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, blood in stool, oral ulcer, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, mood disturbances, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes insipidus, fatty liver, 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 constriction, muscle weakness, musculoskeletal pain, rigidity, taste changes, balance disorder, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory loss, heat stroke, drowsiness, mental disorders, migraine, sensory disturbances, somnolence, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, neuroirritability, panic attack, personality changes, hematuria, nephrolithiasis, increased urination, 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 rash, purpura, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechiae, photosensitivity, pruritus, purpura, skin discoloration, pigment changes, skin lesions, axillary hyperhidrosis, 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 platelets, decreased hematocrit, decreased hemoglobin, increased MCV, decreased erythrocytes, 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 protein, bruising, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, liver failure, jaundice, liver dysfunction, angioedema, agranulocytosis, rhabdomyolysis

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly closed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. Proper storage will ensure the safety and effectiveness of the medication.

Appearance

White to off-white round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle