Medication info

Pecatorin Tablet 40 mg (Febuxostat)

Prescription medicationTabletExpired
Ingredient · strength
Febuxostat›40mg / 1 tablet
Manufacturer / importer
Eden Pharma Co., Ltd.
Appearance
White to off-white round film-coated tablet
Packaging
Domestic use - 30 tablets/bottle, Domestic use - 100 tablets/bottle
Approval status
Expired

MFDS item code 201906283 · Approved 2019.09.04

This product's status changed to Expired on 2024.09.04. 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 This drug is administered once daily at a dose of 40mg or 80mg, regardless of meals. This drug acts very rapidly; recheck serum uric acid levels after 2 weeks. The treatment goal is to lower and maintain serum uric acid levels 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 drug 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. 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
Eden Pharma 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 cause excessive accumulation of uric acid in the body, leading to pain and inflammation in the joints. This medication lowers uric acid levels to alleviate symptoms and prevent recurrence. Therefore, it is effective in managing chronic excess uric acid and reducing gout attacks.

Dosage and Administration

Adult dosage

1. Adults This drug is administered once daily at a dose of 40mg or 80mg, regardless of meals. This drug acts very rapidly; recheck serum uric acid levels after 2 weeks. The treatment goal is to lower and maintain serum uric acid levels 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 drug 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. 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 medication may increase the risk of cardiovascular death in patients with cardiovascular disease; therefore, it should be used with caution in individuals with a history of cardiovascular disease. It should not be used in patients who are allergic to this drug's active ingredient or excipients, or in patients who are taking the specific medications mercaptopurine or azathioprine, or those with lactose intolerance. Patients with liver disease or thyroid dysfunction should have their liver and thyroid function tested regularly while using this drug, and caution is also necessary for patients with heart disease or heart failure. When co-administered with theophylline, caution is advised due to an increased elimination of metabolites, with insufficient long-term safety information available. During an acute gout attack, it is recommended not to initiate this medication and to use non-steroidal anti-inflammatory drugs or colchicine to prevent worsening of the gout attack. This medication can cause a variety of side effects, including liver dysfunction, diarrhea, headache, rash, fatigue, and dizziness; if any abnormal symptoms occur, consult a physician. Women who are pregnant or breastfeeding are advised not to take this medication, and it is not to be used in children under 18 years of age as safety has not been established. In the case of overdose, there is no specific antidote, so it is important to receive treatment based on symptoms. This medication should be stored out of reach of children, and no specific storage conditions are required. Additionally, this medication may interact with various drugs, so if you are taking other medications, be sure to inform medical personnel.

Side effects

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, extremity pain, gout, myalgia, pruritus, dyspnea, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, heart murmur, abnormal ECG, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, passage of blood in stool, oral ulcers, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, emotional disturbances, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, hepatic steatosis, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, loss of appetite, appetite reduction, appetite increase, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramps, muscle fasciculation, muscle constriction, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disorders, cerebrovascular accident, Guillain–Barré syndrome, headache, partial incomplete paralysis, sensory loss, olfactory reduction, heat injury, drowsiness, mental disorders, migraine, sensory disturbances, sleepiness, transient ischemic attack, tremors, restlessness, anxiety, depression, insomnia, excitability, decreased libido, nervousness, panic attacks, personality changes, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, renal insufficiency, urgency in urination, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, excessive sinus secretion, pharyngomegaly, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, dermographism, petechiae, eczema, hair discoloration, hair growth abnormalities, hyperhidrosis, skin peeling, petechiae, photosensitivity, pruritus, purpura, skin discoloration, pigmentation changes, skin lesions, axillary hyperhidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, prolonged activated partial thromboplastin time, increased creatinine, reduced 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 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, serious allergic reaction, hypersensitivity, eosinophilia, systemic symptoms, drug reaction with eosinophilia and systemic symptoms, fever, hematological disorders, renal impairment, liver impairment, hepatic failure, jaundice, liver injury, agranulocytosis, rhabdomyolysis

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will ensure the medication's effectiveness is safely maintained for a long time.

Appearance and packaging

Appearance

White to off-white round film-coated tablet

Package unit

Domestic use - 30 tablets/bottle, Domestic use - 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.