Pegot Tablet 80 mg (Febuxostat)

Adult dosage

Administer 40mg or 80mg once daily. Recheck the serum uric acid concentration after 2 weeks. The treatment goal is to reduce and maintain the serum uric acid concentration below 6 mg/dL(357 μmol/L). 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). 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 may increase the risk of cardiovascular death when administered to patients with cardiovascular disease, so caution is required. Patients with a history of cardiovascular diseases such as myocardial infarction, stroke, or unstable angina should consider alternative therapies. Patients with allergic reactions to this medication’s components or excipients, those taking mercaptopurine or azathioprine, and individuals with lactose intolerance should not use this medication. Patients with a history of liver disease or thyroid dysfunction, as well as heart failure patients, should use this medication cautiously while regularly monitoring liver and thyroid function. Initial treatment with this medication may temporarily increase gout attacks; therefore, therapy should not begin until gout attacks subside, and concomitant medication should be considered to prevent gout exacerbation during treatment. If symptoms of liver dysfunction (such as fatigue, loss of appetite, jaundice, etc.) occur, therapy should be discontinued immediately, and it must be determined based on liver function test results whether to continue treatment. This medication can cause symptoms such as drowsiness, dizziness, and numbness, so caution is necessary when driving or operating machinery. If symptoms of cardiovascular abnormalities (chest pain, dyspnea, etc.) occur, consult a healthcare provider immediately. Pregnant or breastfeeding women are advised not to take this medication. There is no clinical experience in administering this drug to children under 18 years of age. No special dose adjustment is needed for elderly patients, but caution should be taken considering individual patient conditions. This medication may interact with other drugs, so it is important to inform healthcare providers when taking it alongside mercaptopurine, azathioprine, theophylline, antacids, anticoagulants, etc. Regular checks of liver function and cardiovascular status are important during treatment with this medication.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, shortness of breath, 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 movement frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, passage of bloody stools, oral ulcer, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, emotional disturbance, gait disorder, 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 edema, muscle cramps, muscle fasciculation, muscle spasm, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory dysfunction, heat stroke, drowsiness, mental disorder, migraine, sensory disturbances, sleepiness, transient ischemic attack, tremors, anxiety, depression, insomnia, excitability, decreased libido, neuroticism, panic attack, personality change, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, impaired renal function, urinary urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, shortness of breath, epistaxis, nasal dryness, mucosal hypersecretion, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin necrosis, purpura, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechiae, photosensitivity, pruritus, purpura, skin discoloration, pigmentation changes, skin lesions, bromhidrosis, 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 erythrocytes, increased creatinine, increased blood urea, increased blood urea nitrogen to creatinine ratio, increased CPK, increased ALP, increased LDH, increased PSA, increased urine output, decreased urine output, decreased lymphocytes, decreased neutrophils, increased leukocytes, decreased white blood cells, abnormal coagulation tests, increased low-density lipoprotein, prolonged prothrombin time, urine casts, positive urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, eosinophilia, drug reactions accompanied by systemic symptoms, liver failure, jaundice, liver dysfunction, liver dysfunction, angioedema, agranulocytosis, rhabdomyolysis, increased CPK, chest pain, hepatic coma, cough, hearing loss, asthenia, fever, abdominal pain, diarrhea, malignant lung neoplasm, influenza-like symptoms, gastritis, gout, oliguria, pleural effusion, itchy rash, herpes simplex, fecal incontinence, dysuria, frequent bowel movements, tonsillitis, allergic rhinitis, bone fracture, peripheral artery disease

This medication should be stored in a tightly closed container to prevent air or moisture ingress. Additionally, it should be stored at room temperature between 1°C and 30°C, avoiding excessively hot or cold environments.

Appearance

Pale yellow to yellow oblong film-coated tablet

Package unit

Domestic use: 30 tablets/bottle, 300 tablets/bottle For export: 30 tablets (10 tablets/PTP x 3)