Medication info

Febuxostat 80 mg (Febuxostat)

Prescription medicationTabletExpired
Ingredient · strength
Febuxostat›80mg / 1 tablet
Manufacturer / importer
Ahn-Guk New Pharm Co., Ltd.
Appearance
Pale yellow to yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201903095 · Approved 2019.05.13

This product's status changed to Expired on 2024.05.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of chronic hyperuricemia in patients with gout
Who uses it
Adults
Adult dosage
1. Adults Administer 40mg or 80mg of this drug once daily, without regard to meals. This drug acts very rapidly; 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). 2. Patients with renal impairment No dose adjustment is necessary 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 below 30mL/min). 3. Patients with hepatic impairment No special dose adjustment is necessary 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
Ahn-Guk New Pharm Co., Ltd.

Efficacy & effects

Treatment of chronic hyperuricemia in patients with gout

  • Chronic hyperuricemia
View approved original text

In patients with gout, chronic hyperuricemia focuses on controlling serum uric acid levels within the normal range to prevent gout attacks and relieve joint damage and pain. To achieve this, uric acid production inhibitors or uric acid excretion promoters are used to lower serum uric acid concentrations, and consistent treatment and lifestyle modifications are necessary. This treatment helps reduce the recurrence of gout and protect joint function. Overall, the treatment of chronic hyperuricemia is used to improve and manage gout symptoms.

Dosage and Administration

Adult dosage

1. Adults Administer 40mg or 80mg of this drug once daily, without regard to meals. This drug acts very rapidly; 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). 2. Patients with renal impairment No dose adjustment is necessary 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 below 30mL/min). 3. Patients with hepatic impairment No special dose adjustment is necessary 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 drug may increase the risk of cardiovascular mortality when used in gout patients with cardiovascular diseases; therefore, patients with a history of major cardiovascular diseases such as myocardial infarction, stroke, or unstable angina should consider alternative treatments. Patients with allergic reactions to this drug's active ingredients or excipients or who are taking mercaptopurine or azathioprine should not use this drug. Additionally, this drug contains lactose and should not be administered to patients with hereditary issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients with a history of liver disease or thyroid dysfunction should use this drug with caution, and regular liver function tests are recommended. During treatment with this drug, symptoms such as dizziness, drowsiness, or numbness may occur, making it safer to avoid driving or operating dangerous machinery. In the initial phase of treatment, gout attacks may temporarily worsen, so this drug should not be initiated until the gout attack settles, and proper management is needed even if gout attacks occur during treatment. As liver function abnormalities may occur, if symptoms such as fatigue, appetite loss, right upper abdominal pain, or jaundice arise, immediate consultation with a physician and liver function testing are necessary. If any symptoms or signs of cardiovascular issues appear, notify medical personnel immediately and receive appropriate care. This drug may interact with specific medications, so caution is needed when used in conjunction with mercaptopurine, azathioprine, theophylline, etc. Pregnant or breastfeeding women are advised not to take this drug, and there is no experience in administering it to children and adolescents under 18 years old.

Side effects

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, respiratory distress, nausea, joint pain, rash, 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, dyspepsia, bloating, increased bowel movement frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, excessive gastric acid, melena, oral ulcers, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, mood disturbances, gait disturbances, influenza-like symptoms, pain, thirst, cholelithiasis, diabetes mellitus, 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 fasciculation, muscle spasm, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disturbances, cerebrovascular accident, Guillain-Barré syndrome, headache, incomplete paralysis, sensory loss, hyposmia, heat ischemia, drowsiness, mental disorder, migraine, sensory disturbances, somnolence, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, nervousness, panic attack, personality changes, hematuria, nephrolithiasis, increased urination, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, sinus hypersecretion, 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, itching, purpura, skin discoloration, pigmentation changes, skin lesions, axillary bromhidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, 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 nitrogen, 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 tests, increased low-density lipoprotein, prolonged prothrombin time, urinary casts, positive leukocytes in urine, positive protein in urine, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, eosinophilia, drug reaction with eosinophilia and systemic symptoms, fever, hematological disorder, kidney disorder, liver disorder, liver failure, jaundice, liver dysfunction, angioedema, agranulocytosis, rhabdomyolysis, increased CPK, toxic hepatitis, itchy rash, hepatic coma, herpes simplex, fecal incontinence, dysuria, frequent bowel movements, tonsillitis, pleural effusion, allergic rhinitis, bone fracture, oliguria, malignant lung neoplasm, peripheral artery occlusive disease

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is safe to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

Pale yellow to yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

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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.