Medication info
Seoul Febuxostat Tablets 80 mg

Seoul Febuxostat Tablets 80 mg

Prescription medicationTablet
Ingredient · strength
Febuxostat›80mg / 1 tablet
Manufacturer / importer
Seoul Pharmaceutical Co., Ltd.
Appearance
Pale yellow to yellow oblong film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201902894 · Approved 2019.05.07 · Insurance code 652904380

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 commonly seen in patients with gout. It controls blood uric acid levels to prevent gout attacks and reduces the risk of kidney-related complications. Additionally, it helps alleviate joint pain and inflammation caused by chronic hyperuricemia. This drug can effectively improve symptoms related to gout.

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 medication may increase the risk of cardiovascular mortality in patients with cardiovascular disease; thus, patients with a history of cardiovascular disease should consider alternative treatments. Patients allergic to the active ingredient or excipients, or those currently taking certain medications (mercaptopurine, azathioprine), should not use this medication. Patients with genetic issues such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also avoid this medication. Patients with liver disease, thyroid dysfunction, heart disease, heart failure, organ transplant recipients, a history of cardiovascular disease, or patients with elevated uric acid production should use this medication with caution and should have regular liver function tests and thyroid function tests. This medication may cause side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, myalgia, dizziness, and others. If serious allergic reactions or symptoms of liver dysfunction occur, discontinue use immediately and seek medical attention. Do not start taking this medication during an acute gout attack, and it is recommended to take anti-inflammatory medications or colchicine for gout attack prevention. This medication may cause drowsiness, dizziness, or numbness, so caution is advised when driving or operating dangerous machinery. It may interact with certain medications, so inform your doctor or pharmacist if you are taking other medications. It is advisable for pregnant or breastfeeding women to avoid this medication, and there is no experience with its use in children under 18 years of age, so it should not be administered to them. There is no specific antidote in case of overdose, so appropriate treatment based on symptoms is important. Store this medication out of the reach of children, and special storage conditions are not required.

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 distension, abdominal pain, constipation, dry mouth, indigestion, bloating, increased bowel frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, passage of blood-stained stool, oral ulcers, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, emotional disturbances, gait disorders, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, fatty liver, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, anorexia, decreased appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramps, muscle fasciculations, muscular tightness, muscle weakness, musculoskeletal pain, muscle rigidity, altered taste, balance disorders, cerebrovascular accidents, Guillain-Barré syndrome, headache, incomplete paralysis, sensory reduction, olfactory decline, heat stroke, drowsiness, mental disorders, migraine, sensory disturbances, somnolence, transient ischemic attacks, tremors, agitation, anxiety, depression, insomnia, excitability, decreased libido, nervousness, panic attacks, personality changes, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, renal insufficiency, urinary urgency, incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, epistaxis, nasal dryness, excess nasal secretion, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory tract infection, alopecia, vascular edema, dermatitis, skin rash, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechial hemorrhage, photosensitivity, pruritus, purpura, skin discoloration, changes in pigmentation, 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 platelet count, 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, urinary casts, positive urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reactions, eosinophilia, drug responses accompanied by systemic symptoms, liver failure, jaundice, liver dysfunction, agranulocytosis, rhabdomyolysis

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. Additionally, it should be stored at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's efficacy safely.

Appearance and packaging

Appearance

Pale yellow to yellow oblong film-coated tablets

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.