Unipharm Tablet (Febuxostat)

Adult dosage

Adults: Administer 40mg or 80mg once daily, with or without food. This medicine 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). Patients with renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment. The safety and efficacy of this medicine have not been adequately evaluated in patients with severe renal impairment (creatinine clearance below 30mL/min). Patients with hepatic impairment: No special dose 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 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 should be exercised in patients with a history of cardiovascular disease. Patients with allergic reactions to the active ingredient or excipients of this medication, those taking specific drugs (mercaptopurine, azathioprine), and those with genetic metabolic disorders such as lactose intolerance should not use this medication. Patients with liver disease or thyroid dysfunction should have regular liver function tests and thyroid function tests performed before initiating treatment, and patients with heart disease or heart failure should also use this medication cautiously. This medication may temporarily worsen gout attacks at the start of treatment, so it should not be initiated during a gout attack. If a gout attack occurs while on treatment, the medication should not be discontinued but should be properly managed. Liver function abnormalities may occur, so liver function tests should be performed before and during treatment. If symptoms of liver impairment (fatigue, loss of appetite, jaundice, etc.) occur, consult a physician immediately. This medication may cause neurological side effects such as drowsiness, dizziness, and paresthesia, so caution is advised when driving or operating machinery. Severe allergic reactions or hypersensitivity (Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, etc.) have been reported rarely, and if such symptoms arise, discontinue use immediately and inform healthcare personnel. This medication may interact with various drugs, so caution is needed when used in combination with especially mercaptopurine, azathioprine, and theophylline, and dose adjustment or monitoring may be necessary depending on concomitant medications. It is recommended not to use this medication during pregnancy, and it should also be avoided while breastfeeding as it may be excreted in breast milk. The safety and efficacy of this medication have not been established in children and adolescents under 18 years, and it is not used in the elderly unless necessary, although no special dose adjustments are required, they may be more sensitive. In case of overdose, there is no specific antidote, so symptomatic treatment and supportive therapy should be implemented, and it should be kept out of the reach of children.

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, muscle pain, itching, shortness of breath, 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, bloating, increased bowel movement 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 disturbance, influenza-like symptoms, pain, thirst, cholelithiasis, diabetes insipidus, 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, single muscle contraction, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory impairment, heat stroke, drowsiness, mental disorders, migraine, sensory abnormalities, somnolence, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, neuroirritability, panic attacks, personality changes, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, renal insufficiency, urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, shortness of breath, nosebleed, nasal dryness, excessive sinus secretion, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, vascular edema, dermatitis, skin rash, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechiae, photosensitivity, pruritus, 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, urine casts, positive urinary leukocytes, positive urinary protein, contusion, 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 protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C. Storing it this way helps preserve the medication's efficacy and safety over time.

Appearance

Pale yellow to yellow film-coated tablets with a bisecting line on one side.

Package unit

28 tablets/bottle