Medication info

Megafebukjeong 40mg (Febuxostat)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Febuxostat›40mg / 1 tablet
Manufacturer / importer
LNC Bio Co., Ltd.
Appearance
White to pale yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001263 · Approved 2020.02.21

This product's status changed to Approval withdrawn on 2024.07.02. 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 medicine once daily, with or without food. This medicine acts very rapidly, so recheck serum uric acid concentration after 2 weeks. The treatment goal is to lower and maintain serum uric acid concentration below 6 mg/dL(357 μmol/L). 2. Patients with renal impairment Dose adjustment is not necessary in 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 necessary in 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
LNC Bio 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 increased uric acid levels in the blood, causing pain and inflammation in the joints, thereby improving conditions and preventing gout attacks. Additionally, it effectively lowers uric acid levels, reducing chronic complications. Therefore, this drug is very helpful in treating hyperuricemia associated with gout.

Dosage and Administration

Adult dosage

1. Adults Administer 40mg or 80mg of this medicine once daily, with or without food. This medicine acts very rapidly, so recheck serum uric acid concentration after 2 weeks. The treatment goal is to lower and maintain serum uric acid concentration below 6 mg/dL(357 μmol/L). 2. Patients with renal impairment Dose adjustment is not necessary in 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 necessary in 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 should not be used in patients who have allergic reactions to certain components or are taking certain medications. In particular, it should not be administered to patients with normal uric acid levels who have no symptoms, patients who have received organ transplants, or patients with very rapid uric acid production. This drug contains lactose and is not suitable for people with lactose intolerance or related genetic conditions. It is important for patients with liver disease or thyroid dysfunction to undergo regular liver function tests when using this medication. Caution is required for those with heart disease or taking certain medications simultaneously. This drug may cause various side effects such as liver function abnormalities, skin rashes, digestive disorders, and neurological issues, so symptoms should be closely monitored. It should not be initiated during an acute gout attack, and appropriate treatment should proceed simultaneously as gout symptoms may worsen. If symptoms of liver dysfunction appear, stop taking the drug immediately and undergo tests, verifying the condition through liver tests. Dizziness or drowsiness may occur while driving or operating machinery, so caution is advised. If severe allergic reactions occur, stop using this medication immediately and consult healthcare professionals. Since interactions with other medications may occur, it is essential to inform about any medications being taken. It is safest for pregnant or breastfeeding women not to take this medication. There is no experience with administering this drug to children and adolescents under 18 years of age, so it should not be given to them. There is no specific treatment for overdose, and treatment will be based on symptoms. This drug should be kept out of reach of children, and special storage conditions are not required.

Side effects

Liver dysfunction, nausea, joint pain, rash, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina pectoris, atrial fibrillation, atrial flutter, heart murmur, abnormal electrocardiogram, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, dizziness, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, bloating, increased bowel movements, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, hematochezia, oral ulcer, pancreatitis, gastric ulcer, vomiting, weakness, chest pain, chest discomfort, edema, fatigue, emotional disturbances, gait disturbances, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes mellitus, fatty liver, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, loss of appetite, appetite decrease, appetite increase, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle spasms, muscle single contraction, muscle contracture, muscle weakness, musculoskeletal pain, muscle rigidity, myalgia, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory loss, decreased sense of smell, heat stroke, drowsiness, mental disorders, migraine, sensory abnormalities, sleepiness, transient ischemic attack, tremors, agitation, anxiety, depression, insomnia, excitability, decreased libido, nervosity, panic attack, personality changes, hematuria, nephrolithiasis, frequent urination, proteinuria, renal failure, kidney insufficiency, urgency, urinary incontinence, breast pain, erectile dysfunction, gynecomastia, bronchitis, cough, shortness of breath, epistaxis, nasal dryness, sinus hypersecretion, pharyngeal edema, airway congestion, sneezing, throat irritation, upper respiratory infection, alopecia, vascular edema, dermatitis, skin necrosis, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin desquamation, purpura, photosensitivity, pruritus, livido, skin discoloration, 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 test, increased low-density lipoprotein, prolonged prothrombin time, urine casts, positive urine white blood cells, positive urine protein, contusion, Stevens-Johnson syndrome, acute anaphylactic reaction, shock, severe allergic reaction, liver failure, jaundice, liver dysfunction, liver dysfunction, vascular edema, agranulocytosis, rhabdomyolysis, chest pain, hepatic coma, cough, hearing loss, weakness, fever, abdominal pain, diarrhea, malignant pulmonary neoplasm, influenza-like symptoms, gastritis, gout, oliguria, pleural effusion, pruritic rash, hepatic coma, herpes simplex, fecal incontinence, dysuria, frequent bowel movements, tonsillitis, pleural effusion, allergic rhinitis, bone fracture, oliguria, malignant pulmonary neoplasm, peripheral artery occlusive disease

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. In addition, it is advisable to store it at room temperature between 1 degree Celsius and 30 degrees Celsius.

Appearance and packaging

Appearance

White to pale yellow round 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.