Jungheon Febuxostat 80 mg Tablets

Adult dosage

1. Adults Administer 40mg or 80mg of this medication once daily, regardless of meals. This medication acts very rapidly, so recheck serum uric acid levels 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 dosage adjustment is required in patients with mild or moderate renal impairment. The safety and efficacy of this medication have not been adequately evaluated in patients with severe renal impairment (creatinine clearance below 30mL/min). 3. Patients with hepatic impairment No special dosage 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 medication have not been studied in patients with severe hepatic impairment (Child Pugh class C).

This medication may increase the risk of cardiovascular death in gout patients with cardiovascular disease, so patients with a history of cardiovascular disease should carefully consider whether to use it. Patients who are allergic to the active ingredient or excipients of this medication, those taking mercaptopurine or azathioprine, and patients with certain genetic lactase deficiency disorders should not take this medication. For patients with a history of liver disease or those with thyroid dysfunction, ischemic heart disease, or congestive heart failure, and organ transplant recipients, careful use with regular liver function and thyroid function tests is required. This medication may cause a temporary increase in gout attacks during the initial phase of treatment, so it is advisable not to initiate treatment until gout attacks are resolved, and to manage appropriately without discontinuing even if gout attacks occur during treatment. Liver function abnormalities may occur; therefore, liver function tests should be performed before and during use, and if symptoms of liver dysfunction (such as fatigue, loss of appetite, discomfort in the right upper abdomen, jaundice, etc.) occur, treatment should be ceased immediately and tests conducted. This medication may cause drowsiness, dizziness, and numbness, necessitating caution during risky activities such as driving or operating machinery. If symptoms of cardiovascular abnormalities (such as chest pain or shortness of breath) occur, consult with a healthcare professional immediately, and consideration should be given to the risk of cardiovascular death when determining treatment. This medication may be risky when combined with mercaptopurine or azathioprine; therefore, they should not be taken together, and caution is also advised when combined with theophylline. Pregnant or breastfeeding women should not take this medication, and there is no experience in administering it to children under 18. In case of overdose, since there is no specific antidote, symptomatic treatment is required; it should be kept out of reach of children.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, arthralgia, limb pain, gout, myalgia, pruritus, dyspnea, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina pectoris, atrial fibrillation, atrial flutter, heart murmur, abnormal electrocardiogram, 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, melena, oral ulcers, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, emotional disturbances, walking difficulties, flu-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, hepatic steatosis, 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 cramps, muscle fasciculations, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, changes in taste, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory reduction, heat stroke, drowsiness, mental disorders, migraine, sensory disturbances, somnolence, transient ischemic attack, tremors, agitation, anxiety, depression, insomnia, excitability, decreased libido, irritability, panic attacks, personality changes, hematuria, nephrolithiasis, frequent urination, proteinuria, kidney failure, renal insufficiency, urinary 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, vascular edema, dermatitis, skin pruritus, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin desquamation, petechiae, photosensitivity, itching, purpura, skin discoloration, pigmentary 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 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 leukocyte count, decreased leukocyte count, abnormal coagulation tests, increased low-density lipoprotein, prolonged prothrombin time, urine casts, positive urine leukocytes, positive urine protein, contusion, Stevens-Johnson syndrome, acute anaphylaxis reaction, shock, severe allergic reaction, hypersensitivity reaction, liver failure, jaundice, liver dysfunction, agranulocytosis, rhabdomyolysis

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance

Light yellow to yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle