Febuxostat 40 mg (Febuxostat)

Adult dosage

1. Adults Administer 40 mg or 80 mg of this medicine once daily, regardless of meals. 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 needed 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 30 mL/min). 3. Patients with hepatic impairment No special dose adjustment is needed 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 may increase the risk of cardiovascular mortality in gout patients with cardiovascular disease. Therefore, it is advisable for patients with major cardiovascular diseases such as myocardial infarction, stroke, or unstable angina to consider alternative treatments whenever possible. Patients with allergies to this medication's active ingredient or excipients, those currently taking mercaptopurine or azathioprine, as well as patients with lactose intolerance or certain genetic metabolic disorders should not take this medication. Patients with a history of liver disease or changes in thyroid function, ischemic heart disease, or congestive heart failure should use this medication with caution and undergo regular liver function tests. While this medication treats gout by controlling uric acid levels, a gout attack may temporarily worsen on initial administration. Thus, it is recommended to use it for at least 6 months along with non-steroidal anti-inflammatory drugs or colchicine. During treatment, side effects such as liver function abnormalities, skin rashes, diarrhea, headaches, dizziness, and fatigue may occur; any unusual symptoms should be discussed with a doctor. This medication can interact with other drugs, so it is essential to inform healthcare providers, especially if taking mercaptopurine, azathioprine, theophylline, naproxen, or warfarin. It is safer for women who are pregnant or breastfeeding to avoid this medication, and safety has not been established for children under 18 years of age. Elderly patients do not require special dosage adjustments, but attention should be paid to their body’s reactions during treatment. This medication may cause drowsiness, dizziness, or a reduced sense of sensation, so caution is needed while driving or operating machinery. There is no specific antidote for overdose; supportive therapy must be administered according to the symptoms. This medication should be kept out of reach of children, and no special storage conditions are required.

Abnormal liver function, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, muscle pain, pruritus, respiratory distress, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, heart murmur, abnormal ECG, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, passage of blood in stools, oral ulcer, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, mood disturbances, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, hepatic steatosis, hepatitis, liver enlargement, hypersensitivity, herpes zoster, anorexia, decreased appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, articular stiffness, articular swelling, muscle cramp, isolated muscle contraction, muscle spasm, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disturbances, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory impairment, heat stroke, drowsiness, mental disorders, migraine, sensory disturbances, somnolence, transient ischemic attack, tremors, agitation, anxiety, depression, insomnia, excitability, decreased libido, neurosensitization, panic attacks, personality changes, hematuria, nephrolithiasis, frequency of urination, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, respiratory distress, epistaxis, nasal dryness, excessive secretion from the sinuses, oropharyngeal swelling, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, vascular edema, dermatitis, skin necrolysis, 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, 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 platelet count, 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 urinary output, decreased urinary output, decreased lymphocyte count, decreased neutrophil count, increased leukocyte count, decreased leukocyte count, abnormal coagulation tests, increased low-density lipoprotein, prolonged prothrombin time, urinary casts, positive urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, serious allergic reaction, hypersensitivity reaction, eosinophilia, drug reaction with systemic symptoms, liver failure, jaundice, liver dysfunction, agranulocytosis, rhabdomyolysis

This medication should be stored in a sealed container to protect it from air and moisture. It is also important to maintain a temperature between 1°C and 30°C while storing the medication. This helps to preserve the effectiveness and safety of the drug.

Appearance

White to light yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle