Febuxostat 80 mg (Febuxostat)

Adult dosage

1. Adults Administer this medicine 40mg or 80mg once daily, regardless of 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 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 special 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 drug may increase the risk of cardiovascular death when administered to patients with cardiovascular diseases; therefore, patients with a history of cardiovascular diseases should consider other treatment options first. Patients allergic to the active ingredient or excipients of this drug, those taking certain medications (mercaptopurine, azathioprine), and those with lactose intolerance or specific genetic metabolic disorders should not use this medication. Patients with liver disease, thyroid dysfunction, or heart disease should regularly undergo liver function tests and thyroid function tests while using this medication, and caution is needed if they are taking theophylline. Various side effects can occur during the use of this drug, including liver function abnormalities, diarrhea, headache, rash, dizziness, and muscle pain; thus, if any unusual symptoms appear, consult a doctor. It is essential not to start this medication during an acute gout attack, as gout attacks may temporarily worsen. Continued use along with appropriate preventive measures is important. This medication may affect liver function; therefore, liver function tests should be conducted before and during treatment, and if symptoms of liver dysfunction occur, discontinue use immediately. If cardiovascular symptoms or abnormalities appear, promptly notify medical personnel and receive appropriate measures, particularly if there is a history of cardiovascular disease. This medication may cause drowsiness and dizziness, so it is advisable to avoid driving or operating hazardous machinery. Women who are pregnant or breastfeeding should not take this drug, and its use is not recommended in children under 18 years due to a lack of clinical experience. Be cautious as this drug may interact with certain medications (such as mercaptopurine, azathioprine), and consultation with a specialist is necessary when used in combination with other drugs. There is no specific antidote for overdose; therefore, symptomatic treatment and supportive therapy are required. Store this medication out of the reach of children, and although there are no specific storage conditions, it is recommended to avoid direct sunlight.

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, cardiac murmur, abnormal electrocardiogram, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel movement frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, passage of blood in stool, oral ulcers, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, emotional disturbances, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, fatty liver, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, anorexia, decreased appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle spasms, muscle single contraction, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, imbalance, cerebrovascular accident, Guillain-Barré syndrome, headache, incomplete paralysis, sensory loss, olfactory decrease, heat stroke, somnolence, mental disorders, migraine, sensory disturbances, drowsiness, transient ischemic attack, tremors, restlessness, anxiety, depression, insomnia, excitability, decreased libido, irritability, panic attacks, personality changes, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, renal insufficiency, urgency, urinary incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, sinus hypersecretion, pharyngeal swelling, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin eruptions, petechial hemorrhage, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechiae, photosensitivity, pruritus, purpura, skin pigmentation changes, skin lesions, 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, increased blood urea to creatinine ratio, increased CPK, increased ALP, increased LDH, increased PSA, increased or decreased urinary output, decreased lymphocytes, decreased neutrophils, increased or decreased white blood cells, abnormal blood coagulation tests, increased low-density lipoprotein, prolonged prothrombin time, urine casts, positive urine leukocytes and proteins, bruises, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reactions, eosinophilia, drug reactions accompanied by systemic symptoms, liver failure, jaundice, liver dysfunction, agranulocytosis, rhabdomyolysis

Store this medication in a tightly closed container to prevent exposure to air and moisture, and keep it at temperatures between 1 and 30 degrees Celsius. Following these storage conditions will help maintain the drug's efficacy and ensure safety in use.

Appearance

Pale yellow to yellow oval film-coated tablets with a dividing line on one side.

Package unit

28 tablets/bottle, 30 tablets/bottle