Febuxostat 40 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 mortality when administered to patients with cardiovascular disease, so alternative treatments should be considered for such patients. Individuals with allergies to the active ingredient or excipients of this medication, those taking certain immunosuppressants (mercaptopurine, azathioprine), and patients with lactose intolerance or related 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 function checked regularly while taking this medication, and caution is also needed in patients with heart disease or those taking specific medications (theophylline). Various side effects such as liver function abnormalities, diarrhea, headache, rash, dizziness, etc., can occur while taking this medication, so any symptoms should be discussed with a healthcare professional immediately. This medication should not be initiated during an acute gout attack, and it is recommended to use nonsteroidal anti-inflammatory drugs or colchicine for the prevention of gout attacks instead. If symptoms of liver function decline (fatigue, loss of appetite, jaundice, etc.) occur while taking this medication, it should be discontinued immediately, and testing should be conducted, and in cases of severe liver dysfunction, it should not be reinstituted. Dizziness or drowsiness may occur while taking this medication, so caution is advised when driving or operating dangerous machinery. Women who are pregnant or breastfeeding should avoid taking this medication, and it should not be administered to children or adolescents under 18 years of age. This medication may interact with other drugs, especially when used in conjunction with mercaptopurine, azathioprine, and theophylline; it is essential to consult a healthcare professional in such situations. There have been no reported special cases of overdose, but if symptoms occur, immediate assistance from a healthcare professional is needed. This medication should be kept out of reach of children, and no special storage conditions are required.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, dyspnea, vomiting, joint pain, rash, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, heart murmur, ECG abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, dizziness, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, passage of blood in stool, oral ulcer, pancreatitis, gastric ulcer, vomiting, weakness, chest pain, chest discomfort, edema, emotional disturbance, walking impairment, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes insipidus, fatty liver, hepatitis, hepatomegaly, hypersensitivity, shingles, anorexia, decreased appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, dyslipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramps, muscle single contraction, muscle contraction, muscle weakness, musculoskeletal pain, muscle rigidity, altered taste, balance disturbance, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, hyposmia, cortical infarction, drowsiness, mental disorder, migraine, sensory disturbance, sleepiness, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, nervous irritability, panic attack, personality change, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, excess mucus secretion, 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, itching, purpura, skin discoloration, pigmentary changes, skin lesions, abnormal sweating, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, increased creatinine, bicarbonate reduction, sodium increase, EEG abnormalities, 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 nitrogen to 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 lipoprotein, prolonged prothrombin time, urinary casts, positive urinary white blood cells, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, serious allergic reaction, hypersensitivity reactions with eosinophilia and systemic symptoms, fever, hematological disorders, kidney disorders, liver disorders, liver failure, jaundice, hepatic impairment, liver dysfunction, angioedema, agranulocytosis, rhabdomyolysis, increased CPK, elevated ALT, elevated AST, hepatic coma, cough, hearing loss, weakness, fever, abdominal pain, diarrhea, malignant pulmonary neoplasm, influenza-like symptoms, gastritis, gout, oliguria, pleural effusion, itchy rash, herpes simplex, fecal incontinence, dysuria, frequent bowel movements, tonsillitis, allergic rhinitis, bone fracture, malignant pulmonary neoplasm, peripheral artery occlusive disease

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to store it at room temperature between 1 to 30 degrees Celsius.

Appearance

White to off-white round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle