Medication info

Febute 40 mg (Febuxostat)

Prescription medicationTabletExpired
Ingredient · strength
Febuxostat›40mg / 1 tablet
Manufacturer / importer
AhnGuk NewPharm Co., Ltd.
Appearance
White to slightly yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201903096 · 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
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). 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). 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
AhnGuk NewPharm 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. Chronic hyperuricemia can lead to complications such as gout attacks or kidney stones due to elevated uric acid levels in the blood, thus this drug helps effectively control uric acid levels to relieve symptoms and prevent complications.

Dosage and Administration

Adult dosage

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). 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). 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 death in patients with cardiovascular disease, so caution should be exercised when administering to those with a history of heart disease. It should not be used in patients who are allergic to this drug's active ingredients or excipients, or are taking certain drugs such as mercaptopurine and azathioprine. Patients with a genetic disorder that prevents lactose digestion should not take this medication. Patients with liver disease or a history of liver problems should undergo regular liver function tests while taking this drug, and caution is advised for patients with thyroid dysfunction. Patients with heart failure or ischemic heart disease, and those taking the drug theophylline should also be cautious when using this drug. This drug should not be initiated during an acute gout attack, and non-steroidal anti-inflammatory drugs or colchicine should be used together to prevent exacerbation of gout symptoms during the initial treatment phase. This drug may cause side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, joint pain, dizziness, etc., and consultation with a physician is necessary if abnormal symptoms occur. Any symptoms of cardiovascular abnormalities or liver dysfunction should be reported to medical staff immediately, especially if liver function test values significantly rise, which may require discontinuation of this medication. Caution is necessary when driving or operating machinery as drowsiness or dizziness may occur. It is advisable not to take this medication during pregnancy or lactation, and its use is not recommended in children or adolescents under 18 years of age. In case of overdose, there is no specific antidote, and treatment should be supportive according to symptoms. It should be stored out of reach of children. This drug may interact with several other medications, so it is essential to inform medical staff of any other medications being taken.

Side effects

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, dyspnea, vomiting, joint pain, rash, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, heart murmur, ECG abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, excessive hydrochloric acid, bleeding per rectum, oral ulcers, pancreatitis, gastric ulcer, vomiting, weakness, chest pain, chest discomfort, edema, mood changes, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, fatty liver, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, poor 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 changes, balance disturbances, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory disturbance, olfactory dysfunction, heat stroke, drowsiness, mental disorders, migraine, sensory abnormalities, sleepiness, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, neuroinhibition, panic attack, personality changes, hematuria, nephrolithiasis, frequent 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, vascular edema, dermatitis, skin rash, petechial hemorrhage, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechiae, photophobia, pruritus, purpura, skin discoloration, changes in pigmentation, skin lesions, axillary osmidrosis, 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, red blood cell decrease, creatinine increase, blood urea increase, blood urea nitrogen ratio increase, CPK increase, ALP increase, LDH increase, PSA increase, urine output increase, urine output decrease, lymphocyte decrease, neutrophil decrease, leukocyte increase, leukocyte decrease, blood coagulation tests abnormalities, low-density lipoprotein increase, prothrombin time prolongation, 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 reactions accompanied by systemic symptoms, fever, hematologic disorders, kidney disorders, liver disorders, liver failure, jaundice, hepatic dysfunction, vascular edema, agranulocytosis, rhabdomyolysis, CPK increase, ALT elevation, AST elevation, hearing loss, weakness, fever, abdominal pain, diarrhea, malignant lung neoplasm, influenza-like symptoms, gastritis, gout, oliguria, pleural effusion, itchy rash, hepatic encephalopathy, herpes simplex, fecal incontinence, dysuria, frequent bowel movements, tonsillitis, allergic rhinitis, bone fracture, peripheral artery occlusive disease

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White to slightly yellow 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.

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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.