Medication info

PesoTat 80 mg (Febuxostat)

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

MFDS item code 201903574 · Approved 2019.05.30

This product's status changed to Expired on 2024.05.30. 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
Administer 40mg or 80mg once daily. 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). No dosage adjustment is required 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). No special dosage adjustment is required 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
KMS 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 worsen gout symptoms and cause joint pain due to elevated uric acid levels in the blood. It helps mitigate these issues, prevents gout attacks, and improves quality of life. Therefore, it is effectively used in the treatment of chronic hyperuricemia.

Dosage and Administration

Adult dosage

Administer 40mg or 80mg once daily. 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). No dosage adjustment is required 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). No special dosage adjustment is required 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 death when administered to patients with cardiovascular disease, so use with caution if there is a history of cardiovascular disease. This drug should not be used in patients who are allergic to its active ingredients or excipients or are taking certain medications such as mercaptopurine or azathioprine. Patients with lactose intolerance or certain genetic metabolic disorders should also not take this medication. Patients with liver disease or thyroid dysfunction, those with heart disease, or organ transplant recipients should have regular monitoring, including liver function tests, when taking this medication. When taken with theophylline, the metabolite of theophylline may be extensively excreted in urine, leading to concerns about long-term safety. This medication may temporarily exacerbate gout attacks at the beginning of treatment, so it is advisable to delay starting treatment until gout attacks subside, although treatment should continue even if a gout attack occurs during use. Liver function abnormalities may occur, so liver function tests should be performed before and during treatment, and if symptoms of liver dysfunction appear, consult a healthcare professional immediately. Drowsiness and dizziness may occur, so be cautious when driving or operating machinery. It is recommended that pregnant or breastfeeding women do not take this medication. Due to insufficient clinical experience, administration is not advised for children and adolescents under 18 years of age. In cases of overdose, there are no specific antidotes, so treatment should be symptomatic. Keep out of reach of children, and special storage conditions are not required. This medication may interact with various drugs, so inform your healthcare provider of any other medications you are taking.

Side effects

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, respiratory distress, 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, flatulence, 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 changes, gait disturbances, flu-like symptoms, mass, pain, thirst, cholelithiasis, diabetes insipidus, fatty liver disease, 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, muscle spasms, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disturbances, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, anosmia, heat stroke, drowsiness, mental disorders, migraine, sensory abnormalities, sleepiness, transient ischemic attack, tremors, restlessness, anxiety, depression, insomnia, excitability, decreased libido, irritability, panic attacks, personality changes, hematuria, nephrolithiasis, increased frequency of urination, proteinuria, renal failure, renal insufficiency, urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, shortness of breath, epistaxis, nasal dryness, hypersecretion of sinuses, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, angioedema, dermatitis, skin rash, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin peels, petechial hemorrhages, photosensitivity, pruritus, purpura, skin discoloration, pigment changes, skin lesions, axillary smell, 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 nitrogen, 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 leukocytes in urine, positive protein in urine, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, severe allergic reaction, hypersensitivity, eosinophilia, systemic symptoms, fever, hematologic disorders, renal disorders, liver disorders, liver failure, jaundice, liver dysfunction, agranulocytosis, rhabdomyolysis

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This storage will help preserve the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Light yellow to yellow rectangular film-coated tablets

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.

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.