Medication info

Peroxy Tablet 80mg (Febuxostat)

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

MFDS item code 201902320 · Approved 2019.04.16

This product's status changed to Expired on 2024.04.16. 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 this medicine at a dose of 40mg or 80mg once daily, with or without food. 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 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 below 30mL/min). 3. Patients with hepatic impairment No specific 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 medicine have not been studied in patients with severe hepatic impairment (Child Pugh class C).

Ingredients

Manufacturer
Seongwon Adcock Pharmaceuticals 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 occurring in patients with gout. Hyperuricemia can lead to gout attacks and joint damage due to elevated levels of uric acid in the blood; this drug effectively lowers uric acid levels, alleviating symptoms and preventing complications. Ongoing treatment helps reduce the frequency of recurrent gout attacks and improves the quality of life for patients. Therefore, it is used to improve symptoms associated with chronic hyperuricemia related to gout.

Dosage and Administration

Adult dosage

1. Adults Administer this medicine at a dose of 40mg or 80mg once daily, with or without food. 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 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 below 30mL/min). 3. Patients with hepatic impairment No specific 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 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 gout patients with cardiovascular disease; hence it should be used cautiously in patients with a history of cardiovascular disease. Patients allergic to any ingredients or excipients in this drug, those taking certain medications (mercaptopurine, azathioprine), and those with genetic lactose intolerance should not use this drug. Patients with liver disease or changes in thyroid function should have regular liver function tests and thyroid function tests during treatment with this drug. Patients with heart disease, heart failure, or those taking theophylline should be cautious when combining this drug. This drug should not be initiated during an acute gout attack, as a temporary worsening of gout attacks may occur; therefore, appropriate preventive treatment is necessary. This drug can cause side effects such as liver dysfunction, diarrhea, headache, rash, fatigue, myalgia, dizziness; consult a healthcare professional if symptoms occur. If cardiovascular symptoms or abnormal signs appear, notify a healthcare professional immediately, and patients at high cardiovascular risk should carefully consider whether to use this drug. Women who are pregnant or breastfeeding should avoid this drug, and it is not recommended for use in children under 18 years of age. No special dose adjustment is needed for the elderly, but caution should be exercised considering individual sensitivity. This drug may interact with certain medications, so inform healthcare professionals about any concurrent medications, especially avoid combining with mercaptopurine and azathioprine. In case of overdose, there is no specific antidote, so treatment and supportive care according to symptoms are needed. This drug should be stored out of reach of children, and no special storage conditions are 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 pectoris, atrial fibrillation, atrial flutter, heart murmur, abnormal ECG, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, dizziness, blurred vision, abdominal distention, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, hematochezia, oral ulcers, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, mood changes, gait disturbance, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, hepatic steatosis, 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 fasciculation, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory dysfunction, cerebral infarction, somnolence, psychiatric disorders, migraine, sensory abnormalities, drowsiness, transient ischemic attack, tremor, restlessness, anxiety, depression, insomnia, excitability, decreased libido, irritability, panic attacks, personality changes, hematuria, nephrolithiasis, polyuria, proteinuria, renal failure, renal insufficiency, urgency, incontinence, mastalgia, 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, petechiae, photosensitivity, pruritus, purpura, skin pigmentation changes, skin lesions, 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 platelets, decreased hematocrit, decreased hemoglobin, increased MCV, decreased red blood cells, increased creatinine, increased blood urea, increased blood urea 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, 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 eosinophilia and systemic symptoms, fever, hematological disorders, kidney disorders, liver disorders, liver failure, jaundice, agranulocytosis, rhabdomyolysis

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 store at room temperature between 1 degree and 30 degrees Celsius. Maintaining proper temperature and container conditions can help preserve the drug's efficacy for a long time.

Appearance and packaging

Appearance

Pale yellow to yellow rectangular 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.