Medication info
Febuxostat Tablet 80 milligrams (Febuxostat)

Febuxostat Tablet 80 milligrams (Febuxostat)

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

MFDS item code 202001230 · Approved 2020.02.20 · Insurance code 622805180

Summary

Main use
Treatment of chronic hyperuricemia in patients with gout
Who uses it
Adults
Adult dosage
1. Adults This medicine is administered at a dose of 40mg or 80mg once daily, regardless of meals. As this medicine 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 dosage 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). 3. Patients with hepatic impairment No special dosage 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
Mothers Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hyperuricemia in patients with gout

  • Chronic hyperuricemia
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Chronic hyperuricemia occurring in gout patients is a condition in which uric acid accumulates excessively in the body, leading to gout attacks and joint damage. This medication effectively lowers uric acid levels in the body, helping to alleviate the frequency and symptoms of gout attacks and prevent joint damage. With consistent treatment, it contributes to the management of chronic gout and improves the patient's quality of life.

Dosage and Administration

Adult dosage

1. Adults This medicine is administered at a dose of 40mg or 80mg once daily, regardless of meals. As this medicine 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 dosage 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). 3. Patients with hepatic impairment No special dosage 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 death when administered to patients with cardiovascular diseases, so patients with cardiovascular diseases should avoid this medication. Patients allergic to the active ingredient or excipients of this medication, those taking the specific drugs mercaptopurine or azathioprine, and patients with genetic issues such as lactose intolerance should not use this medication. Patients with liver diseases, thyroid dysfunctions, ischemic heart diseases, or congestive heart failure should undergo regular tests such as liver function tests when using this medication and must use it with caution. This medication may cause side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, muscle pain, and dizziness, and consultations with medical professionals should be made if these symptoms occur. Do not initiate this medication during an acute gout attack, and preventive treatments with anti-inflammatory medications or colchicine may be necessary as gout attacks may temporarily increase during the initial dosing period. This medication may cause drowsiness or dizziness, so caution is needed when driving or operating machinery. If symptoms of liver dysfunction or abnormalities are discovered, immediately discontinue the medication and seek medical attention. It is advisable not to take this medication during pregnancy or while breastfeeding, and it should not be administered to children under the age of 18. This medication may interact with other drugs, so it is essential to inform healthcare professionals, especially if taking mercaptopurine, azathioprine, theophylline, or others. In case of overdose, there is no specific antidote, and treatment should be based on symptoms, and it should be stored out of reach of children.

Side effects

Abnormal liver function, 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 pectoris, atrial fibrillation, atrial flutter, heart murmur, electrocardiogram abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, indigestion, bloating, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, 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, zoster, decreased appetite, appetite loss, 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 disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory decline, heat stroke, drowsiness, mental disorders, migraine, sensory disturbances, sleepiness, transient ischemic attack, tremors, agitation, anxiety, depression, insomnia, excitability, decreased libido, neuroticism, panic attacks, personality changes, hematuria, nephrolithiasis, increased urinary frequency, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence, mastalgia, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, sinus hypersecretion, pharyngeal swelling, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin pigmentation disorders, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechial hemorrhage, photosensitivity, pruritus, purpura, skin discoloration, pigmentation changes, skin lesions, fox odor changes, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolonged, 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, increased blood urea 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, urine casts, positive urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reaction, eosinophilia, drug reaction with systemic symptoms, fever, hematological disorders, renal disorders, hepatic disorders, liver failure, jaundice, liver dysfunction, abnormal liver function, 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 or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help preserve the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

Pale yellow to yellow oblong 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.