Medication info

Jungheon Febuxostat Tablet 40 mg

Prescription medicationTabletExpired
Ingredient · strength
Febuxostat›40mg / 1 tablet
Manufacturer / importer
Jungheon Pharmaceutical Co., Ltd.
Appearance
White to slightly yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201906086 · Approved 2019.08.27

This product's status changed to Expired on 2024.08.27. 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 40mg or 80mg of this medication once daily, regardless of meals. This medication acts very rapidly, so 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 required in patients with mild or moderate renal impairment. The safety and efficacy of this medication have not been adequately evaluated in patients with severe renal impairment (creatinine clearance below 30mL/min). 3. Patients with hepatic impairment 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 medication have not been studied in patients with severe hepatic impairment (Child Pugh class C).

Ingredients

Manufacturer
Jungheon 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 cause gout attacks due to excessive accumulation of uric acid in the body, so it helps control this and alleviate symptoms while preventing complications. It helps keep uric acid levels within the normal range for patients, reducing the risk of recurrent gout. This drug plays an important role in effectively managing gout symptoms and improving the quality of life. Therefore, it is used for the treatment of chronic hyperuricemia.

Dosage and Administration

Adult dosage

1. Adults Administer 40mg or 80mg of this medication once daily, regardless of meals. This medication acts very rapidly, so 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 required in patients with mild or moderate renal impairment. The safety and efficacy of this medication have not been adequately evaluated in patients with severe renal impairment (creatinine clearance below 30mL/min). 3. Patients with hepatic impairment 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 medication have not been studied in patients with severe hepatic impairment (Child Pugh class C).

Precautions

This medication may increase the risk of cardiovascular mortality in gout patients with cardiovascular diseases; therefore, patients with a history of cardiovascular disease such as myocardial infarction, stroke, or unstable angina should consider alternative treatment options. Patients with allergies to this medication's active ingredients or excipients, those taking mercaptopurine or azathioprine, and patients with lactose intolerance or specific hereditary metabolic disorders should not be administered this medication. Patients with a history of liver disease should undergo regular liver function tests while using this medication, and patients with changes in thyroid function should also exercise caution. Caution should be exercised when administering this medication to patients with ischemic heart disease, congestive heart failure, and organ transplant recipients. This medication may temporarily increase gout attacks at the beginning of treatment; therefore, it is advisable to use anti-inflammatory drugs or colchicine for at least 6 months to prevent exacerbation of gout. If a gout attack occurs during treatment, the medication should not be discontinued but appropriately managed, and the frequency and intensity of gout attacks decrease with long-term use. Liver function abnormalities have been reported, so liver function tests are recommended before and during administration, and if symptoms such as malaise, loss of appetite, upper abdominal pain, or jaundice occur, treatment should be stopped immediately, and medical advice should be sought. This medication can cause drowsiness, dizziness, and numbness, so caution is needed when driving or operating dangerous machinery. Severe allergic reactions or hypersensitivity have been rarely reported; if symptoms such as rash, difficulty breathing, or swelling occur, discontinue the medication immediately and consult healthcare personnel. This medication may be dangerous when taken with mercaptopurine or azathioprine, so co-administration should be avoided, and caution is also needed when used with theophylline. Pregnant or breastfeeding women should preferably not take this medication, and it has not been used in patients under 18 years of age due to lack of experience. In the case of overdose, special antidotes are not available, and treatment and supportive care according to symptoms are needed. This medication should be stored out of the reach of children, and no special storage conditions are required.

Side effects

Cardiovascular death, liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, arthralgia, limb pain, gout, myalgia, pruritus, dyspnea, vomiting, arthralgia, rash, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina pectoris, atrial fibrillation, atrial flutter, heart murmur, ECG abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, 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, emotional disturbance, gait disturbance, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, hepatic steatosis, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, decreased appetite, appetite loss, increased appetite, dehydration, diabetes, hypercholesterolemia, dyslipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramping, muscle single contraction, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disturbances, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, olfactory loss, hypopigmented infarction, drowsiness, mental disorder, migraine, sensory disturbances, somnolence, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, nervousness, panic attack, personality changes, hematuria, nephrolithiasis, increased urination, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary 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 blistering, petechial hemorrhage, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin exfoliation, petechiae, photosensitivity, pruritus, purpura, skin discoloration, pigmentary changes, skin lesions, axillary bromhidrosis, 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 platelets, decreased hematocrit, decreased hemoglobin, increased MCV, decreased red blood cells, increased creatinine, increased blood urea, increased blood urea nitrogen/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 urinary leukocytes, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, liver failure, jaundice, hepatic impairment, agranulocytosis, rhabdomyolysis

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White to slightly yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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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.