Febuxostat 80mg (Febuxostat)

Adult dosage

1. Adults This medicine is administered at a dose of 40 mg or 80 mg once daily, regardless of meals. Because this medicine acts very rapidly, serum uric acid levels should be rechecked after 2 weeks. The treatment goal is to lower and maintain serum uric acid levels 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 medication should not be used in certain patients. For example, individuals allergic to this drug's active ingredient or excipients, those taking certain anticancer medications like mercaptopurine or azathioprine, asymptomatic hyperuricemia patients, organ transplant recipients, patients with very high rates of uric acid production, and those with lactose intolerance or genetic lactose metabolic disorders should not take this medication. Patients with liver disease or a history thereof, those with thyroid function changes, individuals with heart disease, and those concurrently taking the medication theophylline should be particularly cautious when using this medication. Regular liver function tests are necessary to monitor the condition. This medication can cause various side effects including liver dysfunction, nausea, joint pain, and rash. Liver dysfunction can be severe in some patients, so if symptoms like fatigue, loss of appetite, right upper quadrant pain, or jaundice occur, contact a physician immediately. It is advisable not to start taking this medication during an acute gout attack, and joint pain may temporarily worsen at the beginning of treatment; therefore, using anti-inflammatory drugs or colchicine simultaneously is recommended to prevent this. It is important to continue taking the medication even if a gout attack occurs. Since this medication may cause drowsiness or dizziness, caution is advised when driving or operating machinery. Additionally, severe allergic reactions such as Stevens-Johnson syndrome or anaphylaxis have been reported rarely. Symptoms such as skin rash, difficulty breathing, or facial swelling require immediate cessation of the medication and a visit to a medical institution. This medication may interact with certain drugs, therefore it must be avoided if concurrently taking mercaptopurine or azathioprine, and caution is needed when used with theophylline. Furthermore, consultation with a doctor or pharmacist is recommended when taken alongside antacids or non-steroidal anti-inflammatory drugs. It is safest for pregnant or breastfeeding women not to take this medication, and it is not recommended for children or adolescents under 18 due to lack of experience in this age group. In case of overdose, there is no specific antidote, so symptomatic treatment based on symptoms should be administered. This medication should be stored out of reach of children, and no special storage conditions are required.

Liver dysfunction, nausea, joint pain, rash, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, erythrocytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, cardiac murmur, abnormal electrocardiogram, 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, hyperchloremic acidosis, melena, oral ulcer, pancreatitis, gastric ulcer, vomiting, weakness, chest pain, chest discomfort, edema, fatigue, emotional disturbances, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, fatty liver disease, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, decreased appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle spasms, muscle fasciculation, muscle constriction, muscle weakness, musculoskeletal pain, muscle rigidity, myalgia, changes in taste, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, decreased sense of smell, heat stroke, drowsiness, mental disorders, migraine, sensation abnormalities, sleepiness, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, neurogenic irritability, panic attack, personality changes, hematuria, nephrolithiasis, increased frequency of urination, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin rash, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin exfoliation, petechiae, photosensitivity, pruritus, purpura, skin discoloration, changes in pigmentation, skin lesions, axillary osmidrosis, 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 red blood cells, increased creatinine, increased blood urea, increased blood urea 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 leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, liver failure, jaundice, liver damage, liver dysfunction, angioedema, agranulocytosis, rhabdomyolysis, chest pain, hepatic coma, cough, hearing loss, weakness, fever, abdominal pain, diarrhea, malignant lung neoplasm, influenza-like symptoms, gastritis, gout, oliguria, pleural effusion, diarrhea, toxic hepatitis, itchy rash, hepatic coma, herpes simplex, fecal incontinence, dysuria, increased bowel motility, tonsillitis, pleural effusion, allergic rhinitis, foot fracture, oliguria, malignant lung neoplasm, peripheral artery occlusive disease

This medication should be stored in a tightly closed container to avoid contact with air or moisture. It is important to maintain storage temperatures between 1°C and 30°C. This ensures the safety of the medication's effectiveness.

Appearance

Pale yellow to yellow oblong film-coated tablet

Package unit

Domestic use - 30 tablets/bottle, Domestic use - 100 tablets/bottle, Export - 10 tablets/PTP [10T (10T/1PTP)], Export - 30 tablets/PTP [30T (10T/3PTP)], Export - 100 tablets/bottle