Medication info
Urosoric 40mg (Febuxostat)

Urosoric 40mg (Febuxostat)

Prescription medicationTablet
Ingredient · strength
Febuxostat›40mg / 1 tablet
Manufacturer / importer
Hanlim Pharmaceutical Co., Ltd.
Appearance
White to light yellow round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201506847 · Approved 2015.09.30 · Insurance code 645305220

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
Hanlim 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 in patients with gout. Hyperuricemia is a condition characterized by elevated uric acid levels in the blood, which is important for preventing gout attacks and alleviating symptoms. This drug helps to lower uric acid levels, reduce joint pain and inflammation, and contribute to protecting kidney function in the long term. Thus, it helps to reduce discomfort caused by gout and improve the quality of life.

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 in patients with cardiovascular disease, so it should be used with caution in patients with a history of cardiovascular disease. Patients who are allergic to this drug's active ingredient or excipients, those taking certain medications (Mercaptopurine, Azathioprine), and those with genetic issues such as lactose intolerance should not take this medication. Patients with liver disease, thyroid dysfunction, heart disease, or organ transplant recipients must have regular monitoring such as liver function tests when administering this medication, and be cautious of potential drug interactions. This medication may cause side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, muscle pain, dizziness, etc., so if abnormal symptoms arise, consult a healthcare professional. Do not start this medication during an acute gout attack, and preventive treatment with non-steroidal anti-inflammatory drugs or colchicine is necessary to prevent gout worsening. If symptoms of cardiovascular abnormalities or liver dysfunction occur, immediately discontinue this medication and consult a specialist. This medication may interact with certain other medications, so be sure to inform your healthcare provider if you are taking any other drugs. Women who are pregnant or breastfeeding should avoid this medication, and safety has not been established for children under 18. Caution is advised when driving or operating machinery as drowsiness or dizziness may occur, and keep out of reach of children.

Side effects

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, 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 bloating, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hypersecretion of hydrochloric acid, hematochezia, oral ulcer, pancreatitis, gastric ulcer, vomiting, weakness, chest pain, chest discomfort, edema, mood disorders, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes insipidus, 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 constriction, muscle weakness, musculoskeletal pain, muscle rigidity, taste disturbance, balance disturbance, cerebrovascular accident, Guillain-Barré syndrome, headache, partial hemiplegia, sensory loss, olfactory reduction, heat stroke, drowsiness, mental disorders, migraine, sensory disturbances, somnolence, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, neural hyperexcitability, panic attack, personality changes, hematuria, nephrolithiasis, polyuria, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, excessive sinus secretion, pharyngeal swelling, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin picture, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechial hemorrhage, photosensitivity, itchiness, purpura, skin discoloration, pigment deposition changes, skin lesions, axillary odor, 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 erythrocytes, 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 leukocyte count, decreased leukocyte count, abnormal coagulation test, 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, fever, hematological disorders, renal disorders, liver disorders, hepatic failure, jaundice, liver dysfunction, angioedema, agranulocytosis, rhabdomyolysis

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

Storage

Keep this medication in a tightly sealed container to protect it from air and moisture. It is recommended to store at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White to light yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle

Same-ingredient medicines

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.