Pezotat Tablets 40 mg (Febuxostat)

Adult dosage

1. Adults Administer 40mg or 80mg once daily, regardless of meals. This medicine acts very rapidly, so 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 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 less than 30mL/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 medication may increase the risk of cardiovascular mortality when administered to patients with cardiovascular disease; therefore, patients with a history of cardiovascular disease should consider alternative treatment methods. Patients with allergies to the main ingredient or excipients, those taking mercaptopurine or azathioprine, and specific genetic lactose intolerant patients should not use this medication. Patients with a history of liver disease should undergo regular liver function tests while taking this medication, and patients with thyroid dysfunction should also be cautious. Patients with heart disease or heart failure, as well as those on theophylline, should be carefully administered with this medication due to potential interactions. This medication should not be initiated during acute gout attacks, and to prevent worsening of attacks in the initial treatment period, it is recommended to co-administer with anti-inflammatory drugs or colchicine. Liver function abnormalities may occur, so liver function tests should be performed before and during treatment, and if symptoms of liver dysfunction appear, immediate consultation with healthcare professionals is advised. During the use of this medication, symptoms such as drowsiness or dizziness may occur, so it is advisable to avoid dangerous activities like driving or operating machinery. Serious allergic reactions have been reported rarely; thus, if symptoms like skin rashes, breathing difficulties, or swelling occur, administration should be stopped immediately and healthcare providers should be notified. This medication should not be used during pregnancy, and it is also advisable to avoid use while breastfeeding. Safety in pediatric patients under 18 years has not been established, so it should not be used in this population; while no special dosage adjustment is required for the elderly, caution is warranted. In cases of overdose, there is no specific antidote, and appropriate management should be provided according to symptoms. This medication should be kept out of the reach of children, and special storage conditions are not required. Finally, this medication may interact with other drugs; therefore, especially when taken with mercaptopurine, azathioprine, theophylline, etc., consultation with a healthcare provider is essential.

Liver function abnormalities, 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, ECG abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, passage of blood in stool, oral ulcer, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, mood disorders, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, glucosuria, fatty liver, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, loss of appetite, reduced appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramps, muscle single contraction, muscular tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory dysfunction, infarction of the heat, drowsiness, mental disorders, migraine, sensory abnormalities, somnolence, transient ischemic attacks, tremors, restlessness, anxiety, depression, insomnia, excitability, decreased libido, neural hypersensitivity, panic attacks, personality changes, hematuria, nephrolithiasis, frequent urination, proteinuria, kidney failure, renal insufficiency, urgency of urination, urinary incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, increased sinus secretion, pharyngeal swelling, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin eruptions, petechial hemorrhage, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin exfoliation, petechiae, photosensitivity, pruritus, purpura, skin discoloration, changes in pigmentation, 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 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, urinary casts, positive urinary white blood cells, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reactions, eosinophilia, drug reactions with systemic symptoms, fever, hematological disorders, renal disorders, liver disorders, liver function abnormalities, liver failure, jaundice, agranulocytosis, rhabdomyolysis

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. This will help maintain the medication's efficacy and safety for a prolonged time.

Appearance

White to off-yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle