Febuxostat 40 mg (Febuxostat)

Adult dosage

1. Adults Administer 40 mg or 80 mg of this medicine once daily, with or without food. This medicine acts very rapidly; therefore, recheck the serum uric acid level after 2 weeks. The treatment goal is to lower and maintain the serum uric acid level below 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 below 30 mL/min). 3. Patients with hepatic impairment No special dose adjustment is required 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 mortality in patients with cardiovascular disease; therefore, patients with major cardiovascular conditions such as myocardial infarction, stroke, or unstable angina should consider alternative treatments first. Patients with allergies to the ingredients or excipients in this drug, those taking mercaptopurine or azathioprine, and patients with certain genetic lactose intolerance should not use this drug. Patients with liver disease or changes in thyroid function, as well as those with ischemic heart disease or congestive heart failure, should undergo regular liver function tests and thyroid function tests when using this drug, and caution is required. Patients taking theophylline should also exercise caution when used in combination, and it should be administered carefully to transplant recipients or patients with rapidly increasing uric acid production. This drug may cause side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, arthralgia, dizziness, limb pain, gout, myalgia, pruritus, dyspnea, anemia, thrombocytopenia, leukocytosis, leukopenia, neutropenia, splenomegaly, thrombocytopenia, angina pectoris, atrial fibrillation, atrial flutter, cardiac murmurs, electrocardiogram abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, and visual disturbances. If symptoms of liver dysfunction occur, the treatment should be stopped immediately, and examinations should be conducted. This drug should not be initiated during an acute gout attack, and during the initial administration, gout attacks may temporarily worsen; thus, it is recommended to use anti-inflammatory medications or colchicine to prevent this. Caution should be exercised when engaging in dangerous activities such as driving or operating machinery, as drowsiness or dizziness may occur. If any cardiovascular symptoms or allergic reactions occur, immediate notification to a medical institution is required, and if a severe allergic reaction occurs, this medication should not be taken again. Women who are pregnant or breastfeeding are advised not to take this drug, and it is not used in children under the age of 18 as there is no experience in this population. This drug may interact with other medications; therefore, it is essential to inform healthcare professionals of any currently taken medications, especially vigilance is required against simultaneous use with mercaptopurine, azathioprine, and theophylline. In case of overdose, since there are no specific antidotes, treatment and supportive therapy according to symptoms will be necessary. This drug should be stored out of reach of children and does not require special storage conditions.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, arthralgia, limb pain, gout, myalgia, pruritus, dyspnea, vomiting, arthralgia, rash, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina pectoris, atrial fibrillation, atrial flutter, heart murmur, ECG abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, excessive hydrochloric acid secretion, melena, oral ulcers, pancreatitis, gastric ulcer, vomiting, weakness, chest pain, chest discomfort, edema, mood disturbances, gait disturbances, 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, dyslipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramps, muscle single contractions, muscle constrictions, muscle weakness, musculoskeletal pain, muscle rigidity, altered taste, balance disturbances, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory impairment, thermal occlusion, drowsiness, mental disorders, migraine, sensory abnormalities, sleepiness, transient ischemic attack, tremors, restlessness, anxiety, depression, insomnia, excitability, decreased libido, neural irritability, panic attacks, personality changes, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, excessive sinus secretion, pharyngeal swelling, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, vascular edema, dermatitis, skin rash, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechiae, photosensitivity, itching, purpura, skin discoloration, pigmentation changes, skin lesions, axillary sweat anomalies, urticaria, flushing, facial flushing, hypertension, hypotension, prolonged activated partial thromoplastin 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 nitrogen 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, urine casts, positive urinary leukocyte, positive urinary protein, contusions, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reactions, hypersensitivity reactions, eosinophilia, systemic symptoms, liver failure, jaundice, liver dysfunction, agranulocytosis, rhabdomyolysis

This drug must be stored in a tightly sealed container to avoid exposure to air or moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy for a long time.

Appearance

White to light yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle