Febuxostat Tablet 80 mg (Febuxostat)

Adult dosage

1. Adults Administer 40mg or 80mg once daily, with or without food. This medicine acts very rapidly; therefore, 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 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 below 30mL/min). 3. Patients with hepatic impairment No specific dose adjustment is necessary 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 medicine may increase the risk of cardiovascular mortality when administered to patients with cardiovascular diseases, so caution is advised for patients with a history of cardiovascular conditions. It should not be administered to patients with allergic reactions to the components or excipients of this medication, those taking mercaptopurine or azathioprine, and certain genetically lactose intolerant patients. Patients with liver disease or thyroid function changes should have their liver and thyroid functions regularly monitored when using this medication. Patients with ischemic heart disease, congestive heart failure, organ transplant recipients, patients with a history of major cardiovascular diseases, and those with high uric acid production rates should also use this medication with caution. Various side effects such as liver dysfunction, diarrhea, headache, rash, dizziness, fatigue, muscle pain, etc., may occur while taking this medication, so it is advisable to consult a healthcare professional immediately if unusual symptoms appear. Do not start this medication during an acute gout attack, and since the initial dose may temporarily increase gout attacks, it is recommended to use a nonsteroidal anti-inflammatory drug or colchicine together. Careful observation for cardiovascular symptoms is necessary, and patients with a history of cardiovascular disease should carefully consider the risks and benefits of this medication. If symptoms of liver dysfunction appear (weakness, loss of appetite, discomfort in the right upper abdomen, jaundice, etc.), discontinue use and conduct liver function tests immediately. This medication may cause drowsiness, dizziness, and numbness, so caution is advised during hazardous activities such as driving or operating machinery. Pregnant or breastfeeding women are advised not to take this medication, and there is no experience of use in children or adolescents under 18 years old.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, arthralgia, limb pain, gout, myalgia, pruritus, dyspnea, anemia, 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 movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, excessive hydrochloric acid, hematochezia, oral ulcer, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, mood changes, gait disturbance, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, 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 cramp, muscle fasciculation, muscle constriction, muscle weakness, musculoskeletal pain, muscle rigidity, change in taste, balance disorder, cerebrovascular accident, Guillain-Barré syndrome, headache, incomplete paralysis, sensory loss, olfactory impairment, heat stroke, somnolence, mental disorder, migraine, sensory disturbance, drowsiness, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, reduced libido, nervous hypersensitivity, panic attack, personality change, hematuria, nephrolithiasis, increased urination, proteinuria, renal failure, impaired renal function, urinary urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, excessive sinus secretion, 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, pigmentation changes, skin lesions, axillary hyperhidrosis, 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 red blood cells, increased creatinine, increased blood urea nitrogen, increased blood urea creatinine ratio, increased CPK, increased ALP, increased LDH, increased PSA, increased urine output, decreased urine 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 leukocytes, positive urinary protein, bruise, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, liver failure, jaundice, liver dysfunction, angioedema, agranulocytosis, rhabdomyolysis

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The recommended storage temperature is between 1 degree and 30 degrees Celsius at room temperature to maintain the efficacy and safety of the medication.

Appearance

Pale yellow to yellow oblong film-coated tablet with a dividing line on one side

Package unit

28 tablets/bottle