Febuxostat 40 mg (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 administered to certain patients. For example, individuals with allergies to the active ingredient or excipients, those taking specific immunosuppressive agents such as mercaptopurine or azathioprine, asymptomatic patients with low serum uric acid, organ transplant recipients, and patients with very high rates of uric acid production should not use this medication. Additionally, patients with a genetic issue that prevents the breakdown of lactose should not take this medication. Patients with liver disease or a history of liver disease should use this medication with caution, and regular liver function tests are recommended. Patients with thyroid function changes, heart disease, or heart failure should also exercise caution. Furthermore, caution is advised when taken with the specific medication theophylline, and since there is insufficient information regarding long-term safety, follow a doctor's guidance when used concurrently. This medication may cause various side effects, including liver function abnormalities, nausea, joint pain, rash, anemia, idiopathic thrombocytopenic purpura, leukocytosis/leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation/atrial flutter, heart murmurs, ECG abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, dizziness, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel movements, gastritis, gastroesophageal reflux disease. One should not start taking this medication during an acute gout attack, and it is recommended to treat with other medications for at least 6 months to prevent gout attacks. Gout attacks may occur even while on this medication, but appropriate management should continue without stopping treatment. There might be a slight increase in the risk of cardiovascular issues, particularly myocardial infarction or stroke, so symptoms related to these should be closely monitored. If liver function abnormalities are suspected, discontinue use immediately and undergo liver function testing. If liver function levels rise significantly, the medication should not be re-administered. This medication may cause drowsiness, dizziness, or sensory dulling, so avoid driving or operating hazardous machinery. In case of severe allergic reactions, discontinue use immediately and seek medical assistance, and those with a history of severe allergic reactions should refrain from re-taking this medication. This medication may interact with certain drugs, so if taking other medications, it is essential to inform a healthcare professional. In particular, it should not be used in conjunction with mercaptopurine or azathioprine, and caution is required when used alongside theophylline. It is advisable not to take this medication during pregnancy, and nursing mothers should also avoid it. The safety of this medication has not been confirmed in children or adolescents under 18 years of age, so it is not used in this population. No special dosage adjustment is required for the elderly, but they may be more sensitive, so caution is advised. There are no specific cases of overdose, but appropriate treatment should be provided based on symptoms. This medication should be stored out of reach of children and does not have special storage conditions.

Liver dysfunction, nausea, arthralgia, rash, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, erythrocytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, heart murmur, abnormal electrocardiogram, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, dizziness, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, melena, oral ulcers, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, fatigue, 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 spasm, muscle contraction, muscle stiffness, muscle weakness, musculoskeletal pain, muscle rigidity, myalgia, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory impairment, heat stroke, somnolence, mental disorder, migraine, sensory disturbances, drowsiness, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, nervous hyperactivity, panic attack, personality changes, hematuria, nephrolithiasis, polyuria, proteinuria, renal failure, renal insufficiency, urgency, urinary incontinence, mastalgia, 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 eruption, petechiae, eczema, hair discoloration, hair growth abnormalities, hyperhidrosis, skin peeling, petechial hemorrhage, photosensitivity, pruritus, purpura, skin discoloration, pigmentary changes, skin lesions, axillary osmidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, increased creatinine, bicarbonate decrease, sodium increase, 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/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 urine leukocytes, positive urine protein, contusion, Stevens-Johnson syndrome, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, liver failure, jaundice, hepatic impairment, agranulocytosis, rhabdomyolysis

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

White to light yellow round film-coated tablet

Package unit

<Domestic> 30 tablets/bottle, 100 tablets/bottle <Export> 10T (10T/1PTP)