Medication info
Seoul Febuxostat 40 Milligrams

Seoul Febuxostat 40 Milligrams

Prescription medicationTablet
Ingredient · strength
Febuxostat›40mg / 1 tablet
Manufacturer / importer
Seoul Pharmaceutical Co., Ltd.
Appearance
White to yellowish round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201902896 · Approved 2019.05.07 · Insurance code 652904370

Summary

Main use
Treatment of chronic hyperuricemia in patients with gout
Who uses it
Adults
Adult dosage
Administer 40 mg or 80 mg once daily. 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). 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). No special dose adjustment is necessary in patients with mild or moderate hepatic impairment. 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).

Ingredients

Manufacturer
Seoul 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 high levels of uric acid in the blood, which can lead to gout attacks. The drug helps lower the blood uric acid levels, preventing gout attacks and alleviating symptoms. Patients can reduce pain and complications associated with gout by regularly taking this medication. Therefore, it is used for the treatment of chronic hyperuricemia in gout patients.

Dosage and Administration

Adult dosage

Administer 40 mg or 80 mg once daily. 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). 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). No special dose adjustment is necessary in patients with mild or moderate hepatic impairment. 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).

Precautions

This drug may increase the risk of cardiovascular mortality when administered to patients with cardiovascular diseases, so it should be used cautiously in patients with a history of cardiovascular disease. Patients with allergies to the main ingredient or excipients of this drug, those taking the specific medications mercaptopurine or azathioprine, and patients with hereditary diseases such as lactose intolerance should not use this medication. Patients with liver disease or changes in thyroid function, heart disease or heart failure patients, and those on specific drug combinations should use this medication with caution. Various side effects such as liver function abnormalities, diarrhea, headache, rash, fatigue, myalgia, dizziness, etc., may occur during treatment; therefore, any unusual symptoms should be reported to a healthcare provider immediately. In cases of acute gout attacks, the initiation of this medication should be avoided, and it is recommended to continue with other medications for a certain period to prevent gout attacks. Drowsiness or dizziness may occur during treatment, so it is advisable to avoid hazardous activities such as driving or machine operation. It is preferable for pregnant or nursing women not to take this medication, and there is no experience in administering this drug to children under 18 years of age, so it should not be given. This medication can interact with other drugs, so if you are taking any other medications, be sure to inform your healthcare provider, especially that it should not be combined with mercaptopurine or azathioprine. Before and during treatment, liver function tests should be performed regularly, and if symptoms of liver function decline appear, the medication should be discontinued immediately and medical attention should be sought. This drug should be kept out of reach of children and does not require special storage conditions.

Side effects

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, respiratory difficulty, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, heart 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, emotional disturbance, gait disturbance, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, hepatic steatosis, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, anorexia, appetite decrease, appetite increase, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramp, muscle fasciculation, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance abnormalities, cerebrovascular accident, Guillain-Barré syndrome, headache, hemiparesis, sensory loss, olfactory decline, cerebral infarction, drowsiness, mental disorder, migraine, sensory abnormalities, sleepiness, transient ischemic attack, tremors, agitation, anxiety, depression, insomnia, excitability, decreased libido, neurological irritability, panic attack, personality change, hematuria, nephrolithiasis, pollakiuria, proteinuria, renal failure, kidney dysfunction, urinary urgency, urinary incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, excessive nasal secretions, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin rash, petechiae, eczema, hair discoloration, hair growth abnormalities, hyperhidrosis, skin peeling, petechial hemorrhage, photosensitivity, pruritus, purpura, skin discoloration, pigmentary changes, skin lesions, axillary hyperhidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, creatinine increase, bicarbonate decrease, sodium increase, EEG abnormalities, glucose increase, cholesterol increase, triglyceride increase, amylase increase, potassium increase, thyroid-stimulating hormone increase, platelet decrease, hematocrit decrease, hemoglobin decrease, MCV increase, erythrocyte decrease, creatinine increase, blood urea increase, blood urea nitrogen to creatinine ratio increase, CPK increase, ALP increase, LDH increase, PSA increase, urinary output increase, urinary output decrease, lymphocyte count decrease, neutrophil count decrease, leukocyte count increase, leukocyte count decrease, coagulation test abnormalities, LDL increase, prothrombin time prolongation, urinary casts, positive urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, liver failure, jaundice, liver dysfunction, agranulocytosis, rhabdomyolysis

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. The best storage temperature is at room temperature, ideally between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White to yellowish round film-coated tablet

Package unit

30 tablets/bottle, 100 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.

Questions about this medicine

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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.