Medication info
Uricoric Tablet 80 mg (Febuxostat)

Uricoric Tablet 80 mg (Febuxostat)

Prescription medicationTablet
Ingredient · strength
Febuxostat›80mg / 1 tablet
Manufacturer / importer
Hankook Pharmaceutical Co., Ltd.
Appearance
Pale yellow to yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201506846 · Approved 2015.09.30 · Insurance code 645305210

Summary

Main use
Treatment of chronic hyperuricemia in patients with gout
Who uses it
Adults
Adult dosage
1. Adults This drug is administered at 40mg or 80mg once daily, regardless of meals. Because this drug acts very rapidly, recheck serum uric acid concentration after 2 weeks. The treatment goal is to lower and maintain 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 drug 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 drug have not been studied in patients with severe hepatic impairment (Child Pugh class C).

Ingredients

Manufacturer
Hankook Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hyperuricemia in patients with gout

  • Chronic hyperuricemia
View approved original text

This medication is used to treat chronic hyperuricemia that occurs in patients with gout. It lowers uric acid levels in the blood, reducing the frequency and intensity of gout attacks, and prevents the accumulation of uric acid crystals to prevent joint damage. Thus, it helps improve discomfort and complications caused by chronic hyperuricemia.

Dosage and Administration

Adult dosage

1. Adults This drug is administered at 40mg or 80mg once daily, regardless of meals. Because this drug acts very rapidly, recheck serum uric acid concentration after 2 weeks. The treatment goal is to lower and maintain 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 drug 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 drug have not been studied in patients with severe hepatic impairment (Child Pugh class C).

Precautions

This medication may increase the risk of cardiovascular death when administered to patients with cardiovascular diseases, so it is advisable to avoid this drug in patients with major cardiovascular conditions such as myocardial infarction or stroke if other treatment modalities are available. Patients allergic to any component of this medication, those taking specific drugs (mercaptopurine, azathioprine), and patients with lactose intolerance or genetic lactose-related disorders should not use this drug. Patients with liver disease or thyroid dysfunction, those with heart disease, patients taking theophylline, organ transplant recipients, and those with a history of cardiovascular diseases or very high uric acid production should use this drug with caution and require regular monitoring. During the course of taking this medication, various side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, and dizziness may occur, and medical consultation is advised if any symptoms arise. This drug should not be initiated during acute gout attacks, and it is recommended to use non-steroidal anti-inflammatory drugs or colchicine to prevent exacerbation of gout symptoms in the early stages of treatment. Liver function tests must be conducted regularly before and during administration of this medication, and if symptoms of liver dysfunction appear, administration should be discontinued immediately, and testing should be performed. Rapid rises in uric acid levels can lead to deposition in the urinary tract, so adequate fluid intake and urinary alkalization should be maintained to prevent this. This drug should not be used in children or adolescents under 18 years of age, and special dose adjustments are not required for the elderly, but caution is necessary. This drug should not be taken together with certain drugs (mercaptopurine, azathioprine), and caution is required if used in combination with theophylline. Pregnant or nursing women are advised not to take this drug, and women of childbearing potential should consult with a physician before use. This medication may cause drowsiness, dizziness, or other symptoms that can impair driving or operating machinery, so caution is advised. If any cardiovascular symptoms or adverse reactions occur while taking this medication, notify medical personnel immediately, and patients with a history of cardiovascular diseases should carefully weigh the benefits and risks of this medication before deciding on its use.

Side effects

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, muscle pain, 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, dizziness, 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, weakness, chest pain, chest discomfort, edema, mood disturbances, gait disturbances, influenza-like symptoms, mass, 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 cramp, muscle myoclonus, muscle constriction, muscle weakness, musculoskeletal pain, muscle rigidity, taste alteration, balance disorder, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory reduction, olfactory impairment, heat stroke, somnolence, mental disorder, migraine, sensory abnormalities, drowsiness, transient ischemic attack, tremors, anxiety, unease, depression, insomnia, excitability, decreased libido, nervousness, panic attack, personality change, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, excessive sinus secretion, pharyngeal edema, pharyngeal congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin ulceration, petechiae, eczema, hair discoloration, hair growth abnormalities, hyperhidrosis, skin desquamation, petechial hemorrhage, photosensitivity, itching, purpura, skin discoloration, changes in pigmentation, skin lesion, axillary hyperhidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, increased creatinine, decreased bicarbonate, increased sodium, EEG abnormalities, 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 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, severe allergic reactions, hypersensitivity reactions, eosinophilia, systemic symptoms accompanying drug reactions, fever, hematological disorders, renal disorders, liver disorders, liver failure, jaundice, hepatic dysfunction, liver dysfunction, angioedema, agranulocytosis, rhabdomyolysis, increased CPK, chest pain, hepatic coma, cough, hearing loss, weakness, fever, abdominal pain, diarrhea, malignant lung neoplasm, influenza-like symptoms, gastritis, gout, oliguria, pleural effusion, itchy rash, hepatic coma, herpes simplex, fecal incontinence, urinary difficulty, frequent bowel movements, tonsillitis, pleural effusion, allergic rhinitis, bone fracture, malignant lung neoplasm, peripheral artery occlusive disease

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Pale yellow to yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle

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Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.