Medication info
Pexot Tablet 80 mg (Febuxostat)

Pexot Tablet 80 mg (Febuxostat)

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

MFDS item code 201901360 · Approved 2019.03.06 · Insurance code 648104270

Summary

Main use
Treatment of chronic hyperuricemia in patients with gout
Who uses it
Adults
Adult dosage
1. Adults Administer 40mg or 80mg once daily, regardless of meals. This medicine acts very rapidly; therefore, 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 dose adjustment is required for patients with mild to 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 dose adjustment is required for patients with mild to 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
Kyungdong Pharmaceutical 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 in patients with gout. Hyperuricemia can lead to gout attacks or joint damage due to elevated levels of uric acid in the blood. This drug effectively lowers uric acid levels, alleviating symptoms and helping to reduce the frequency and severity of gout attacks. Continuous treatment improves the quality of life for patients and helps prevent complications.

Dosage and Administration

Adult dosage

1. Adults Administer 40mg or 80mg once daily, regardless of meals. This medicine acts very rapidly; therefore, 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 dose adjustment is required for patients with mild to 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 dose adjustment is required for patients with mild to 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 death in patients with cardiovascular diseases, so it should be administered with caution in patients with a history of cardiovascular disease. Patients who are allergic to this drug's ingredients or excipients, or who are taking specific medications such as mercaptopurine or azathioprine, should not use this drug. Patients with genetic conditions such as lactose intolerance, galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also refrain from using this medication. Patients with liver diseases or a history of liver disease, thyroid dysfunction, ischemic heart disease, or congestive heart failure need regular monitoring and should use this drug cautiously. Patients taking theophylline should exercise caution when using this drug concurrently, although the risk of increased serum theophylline levels is relatively low. Cautious administration is required for long-term transplant recipients, patients with a significant history of cardiovascular diseases, and those with high uric acid production. Side effects such as liver dysfunction, diarrhea, headache, rash, nausea, fatigue, arthralgia, and dizziness may occur during treatment; if any symptoms arise, immediate consultation with healthcare professionals is advised. Do not initiate this drug during an acute gout attack, and it is advisable to concurrently administer preventive treatments such as non-steroidal anti-inflammatory drugs or colchicine, as gout attacks may temporarily increase during the initial dosing period. Caution should be taken as drowsiness, dizziness, and paresthesia may occur, and activities such as driving or operating machinery should be avoided. It is advised that pregnant or breastfeeding women do not use this medication, and there is no experience using it in children under the age of 18. No special reports have been made regarding overdose, but appropriate treatment should be provided based on symptoms. This drug should be kept out of the reach of children, and no special storage conditions are necessary. This medication may interact with various drugs, so it should not be taken with mercaptopurine or azathioprine, and any other medications should be disclosed to the doctor or pharmacist.

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, atrial fibrillation, atrial flutter, heart murmur, ECG abnormalities, palpitations, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal bloating, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, excessive hydrochloric acid, passage of blood in stool, oral ulcers, pancreatitis, gastric ulcer, vomiting, weakness, chest pain, discomfort in the chest, edema, mood disturbances, gait disturbances, influenza-like symptoms, mass, 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, single muscle contraction, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disturbances, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory impairment, heat stroke, drowsiness, mental disorders, migraine, sensory disturbances, sleepiness, transient ischemic attack, tremors, agitation, anxiety, depression, insomnia, excitability, decreased libido, nervousness, panic attacks, personality changes, hematuria, nephrolithiasis, increased urination, proteinuria, renal failure, impaired renal function, urinary urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, dyspnea, epistaxis, nasal dryness, excessive nasal secretion, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin rashes, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peeling, petechiae, photosensitivity, pruritus, purpura, skin discoloration, pigmentation changes, skin lesions, axillary osmidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolongation, increased creatinine, decreased bicarbonate, increased sodium, EEG abnormalities, increased glucose, increased cholesterol, increased triglycerides, increased amylase, increased potassium, increased thyroid-stimulating hormone, decreased platelet count, 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 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, bruising, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity reactions, eosinophilia, drug reactions associated with systemic symptoms, liver failure, jaundice, liver disease, liver dysfunction, angioedema, agranulocytosis, rhabdomyolysis

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

Storage

Store this drug in a tightly sealed container to protect it from air and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Pale yellow to yellow rectangular film-coated tablet

Package unit

30 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.