Febric Tablet 80 mg (Febuxostat)

Adult dose

1. Adults This medicine is administered at a dose of 40mg or 80mg once daily, regardless of meals. As this medicine acts very rapidly, 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 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). 3. Patients with hepatic impairment 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 can increase the risk of cardiovascular death in patients with pre-existing cardiovascular diseases; thus, cardiovascular status should be carefully evaluated before administration. Individuals with allergic reactions to any of the active ingredients or excipients, those taking mercaptopurine or azathioprine, and individuals with certain genetic lactose degradation disorders should not take this medication. Patients with a history of liver disease, thyroid dysfunction, heart disease, and organ transplant recipients should be closely monitored with regular liver function tests and thyroid function tests while on this medication. This medication may temporarily worsen gout attacks at the outset of treatment; therefore, it is advisable not to start taking it until the gout attack subsides, and if a gout attack occurs during treatment, appropriate management should continue without discontinuation of the medication. If any symptoms such as liver dysfunction, weakness, loss of appetite, or jaundice appear during treatment, consult a doctor immediately and undergo liver function tests. If liver function tests show a significant increase, the medication should be discontinued. This medication may cause drowsiness, dizziness, or sensory impairment, so caution should be exercised when driving or operating hazardous machinery. Severe allergic reactions, skin rashes, and drug reactions accompanied by eosinophilia and systemic symptoms may occur; therefore, if these symptoms appear, discontinue use immediately and notify healthcare personnel. This medication may interact with certain other drugs; if you are currently taking other medications, be sure to inform your healthcare provider, especially if taking mercaptopurine, azathioprine, or theophylline. It is recommended that women who are pregnant or breastfeeding do not take this medication, and it has not been studied for use in individuals under 18 years of age. In cases of overdose, since there is no specific antidote, treatment and supportive care should be tailored to symptoms. This medication should be kept out of reach of children and does not require any special storage conditions.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, arthritis pain, limb pain, gout, myalgia, pruritus, shortness of breath, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, cardiac murmur, electrocardiogram abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, increased bowel frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, melena, oral ulcer, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, mood changes, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, liver 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 hypsarrhythmia, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, hyposmia, heat stroke, drowsiness, mental disorders, migraine, sensory abnormalities, sleepiness, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, reduced libido, nervousness, panic attack, personality change, hematuria, nephrolithiasis, frequency of urination, proteinuria, renal failure, renal impairment, urgency of urination, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, shortness of breath, nosebleeds, nasal dryness, excessive sinus secretion, 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, petechiae, photosensitivity, itching, 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 platelets, decreased hematocrit, decreased hemoglobin, increased MCV, decreased red blood cells, increased creatinine, increased blood urea, increased blood urea to creatinine 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, bruise, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, eosinophilia, systemic symptoms, liver failure, jaundice, liver impairment, agranulocytosis, rhabdomyolysis

This medication should be stored in a tightly closed container to prevent air and moisture from entering, preferably at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy over time.

Appearance

Light yellow to yellow oblong film-coated tablet with a score line on one side and '80' embossed on the other side.

Package unit

30 tablets/bottle, 100 tablets/bottle