Peblin 40 mg (Febuxostat)

Adult dosage

1. Adults Administer 40mg or 80mg once daily, regardless of meals. Because this medication acts very rapidly, recheck the serum uric acid level after 2 weeks. The treatment goal is to lower the serum uric acid level to below 6 mg/dL(357 μmol/L) and maintain it there. 2. Patients with renal impairment No dosage adjustment is necessary in patients with mild to moderate renal impairment. The safety and efficacy of this medication have not been adequately evaluated in patients with severe renal impairment (creatinine clearance less than 30 mL/min). 3. Patients with hepatic impairment No specific dosage adjustment is necessary in patients with mild to 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 drug has been reported to have a higher risk of cardiovascular death compared to allopurinol when administered to patients with cardiovascular diseases; therefore, caution is required for patients with a history of cardiovascular disease. Patients who are allergic to the active ingredient or excipients of this drug, those taking mercaptopurine or azathioprine, and those with lactose intolerance or certain genetic metabolic disorders should not use this medication. Patients with a history of liver disease or changes in thyroid function should regularly receive liver function tests and thyroid function tests while taking this medication. Patients with ischemic heart disease, congestive heart failure, organ transplant recipients, and those with very high uric acid production should also use caution when taking this medication. While taking this drug, side effects such as abnormal liver function, diarrhea, headache, rash, dizziness, and myalgia may occur; if any abnormal symptoms arise, consult healthcare personnel. Acute gout attacks should not start treatment with this drug, and during the initial treatment, gout attacks may temporarily worsen, so it is recommended to use anti-inflammatory drugs or colchicine concurrently. This medication can affect liver function, so it is important to have liver function tests done before and during treatment. This drug may cause drowsiness or dizziness, so care should be taken when driving or operating dangerous machinery. Severe allergic reactions or hypersensitivity reactions have been reported infrequently; if such symptoms appear, stop taking the medication immediately and inform healthcare personnel. This drug may interact with certain medications, so patients taking mercaptopurine, azathioprine, theophylline, etc., must inform their healthcare personnel, and caution is needed when used in combination. Women who are pregnant or breastfeeding are advised not to take this medication, and it has not been used in patients under 18 years of age. In case of overdose, there is no specific antidote, and treatment and supportive care according to symptoms are necessary. Store this medication out of reach of children, and no special storage conditions are required.

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, 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, hematochezia, oral ulcer, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, emotional 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, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramps, muscle single contraction, muscle compression, muscle weakness, musculoskeletal pain, muscle rigidity, taste change, balance disturbance, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory dysfunction, heat stroke, somnolence, psychiatric disorder, migraine, sensory disturbance, drowsiness, transient ischemic attack, tremors, anxiety, depression, insomnia, excitability, decreased libido, neurodermatitis, panic attack, personality changes, hematuria, nephrolithiasis, polyuria, proteinuria, renal failure, renal insufficiency, urgency, incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, sialorrhea, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin rash, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechial hemorrhage, photophobia, pruritus, purpura, skin discoloration, changes in pigmentation, skin lesion, axillary osmidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, 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 nitrogen ratio, increased CPK, increased ALP, increased LDH, increased PSA, increased urinary output, decreased urinary 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 urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, eosinophilia, systemic symptoms, fever, hematological disorders, renal disorders, hepatic disorders, liver failure, jaundice, hepatic impairment, angioedema, agranulocytosis, rhabdomyolysis

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be kept between 1 and 30 degrees Celsius at room temperature.

Appearance

White to pale yellow circular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle