Medication info
Febric 40 mg (Febuxostat)

Febric 40 mg (Febuxostat)

Prescription medicationTabletOral
Ingredient · strength
Febuxostat›40mg / 1 tablet
Manufacturer / importer
SK Chemicals Co., Ltd.
Appearance
White to light yellow, round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201307583 · Approved 2013.05.31 · Insurance code 644704010

Summary

Main use
Treatment of chronic hyperuricemia in patients with gout
Who takes it
Adults
Adult dose
1. Adults This medication is administered once daily at a dose of 40mg or 80mg, regardless of meals. As this medication acts very rapidly, serum uric acid levels should be rechecked 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 necessary in patients with mild to moderate renal impairment. The safety and efficacy of this medication 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 medication have not been studied in patients with severe hepatic impairment (Child Pugh class C).

Ingredients

Manufacturer
SK Chemicals Co., Ltd.

Efficacy & effects

Treatment of chronic hyperuricemia in patients with gout

  • Chronic hyperuricemia
View approved original text

This medication effectively treats chronic hyperuricemia occurring in patients with gout. Hyperuricemia can lead to gout attacks and joint damage due to excessive accumulation of uric acid in the body; this drug lowers uric acid levels to alleviate symptoms and prevent complications. Continued use helps manage chronic gout and contributes to improving the patient's quality of life.

How to take

Adult dose

1. Adults This medication is administered once daily at a dose of 40mg or 80mg, regardless of meals. As this medication acts very rapidly, serum uric acid levels should be rechecked 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 necessary in patients with mild to moderate renal impairment. The safety and efficacy of this medication 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 medication 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; therefore, risks and benefits should be carefully considered before administration. Patients with an allergy to this drug's active ingredients or excipients, or those taking certain medications such as Mercaptopurine and Azathioprine should not use this drug. This drug contains lactose and should not be given to patients with lactose intolerance or specific genetic lactose metabolism disorders. Patients with a history of liver disease should undergo regular liver function tests while taking this drug, and caution is necessary due to potential changes in thyroid function. Patients with heart disease or heart failure, as well as those taking the specific medication Theophylline, should use this drug cautiously. Transplant recipients or patients with a history of significant cardiovascular diseases should also use this drug with caution. This medication may temporarily worsen gout attacks during the initial treatment phase, so administration should not begin until gout attacks stabilize, and gout symptoms should be managed appropriately during treatment. While taking this drug, symptoms such as dizziness or drowsiness may occur, so caution should be taken with activities like driving or operating machinery. Liver function abnormalities may occur, requiring liver function tests before and during treatment; if symptoms of liver dysfunction appear, usage should be stopped immediately and a physician consulted. This drug can cause various adverse reactions, especially skin rashes, headaches, diarrhea, fatigue, and respiratory difficulties, so patients should inform healthcare professionals if any symptoms arise. Combination with certain medications (such as Mercaptopurine and Azathioprine) should be avoided; caution is needed when used together with Theophylline. Use during pregnancy is not recommended, and breastfeeding mothers should also avoid taking this medication. Experience using this drug in children under 18 is lacking, so it should not be administered; it can be used in the elderly without special dosage adjustments, but caution is advised. While no specific overdose reports are available, appropriate medical treatment should be provided based on symptoms. This medication should be kept out of reach of children and does not require special storage conditions.

Side effects

Liver dysfunction, dizziness, diarrhea, headache, rash, nausea, fatigue, joint pain, limb pain, gout, myalgia, pruritus, shortness of breath, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina pectoris, atrial fibrillation, atrial flutter, heart murmurs, electrocardiogram abnormality, 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, hyperacidity, melena, oral ulcers, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, mood disorder, gait disturbance, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes insipidus, fatty liver, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, appetite loss, decreased appetite, increased appetite, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, joint stiffness, joint swelling, muscle cramps, muscle twitching, muscle contracture, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paresis, sensory impairment, olfactory impairment, heat ischemic stroke, drowsiness, mental disorders, migraine, sensory abnormalities, sleepiness, 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, 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, angioedema, dermatitis, skin eruption, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin exfoliation, petechiae, photosensitivity, pruritus, purpura, skin discoloration, pigmentation changes, skin lesions, apocrine dysfunction, urticaria, flushing, facial flushing, hypertension, hypotension, prolonged activated partial thromboplastin time, 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 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 urinary white blood cells, positive urinary protein, contusion, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, eosinophilia, systemic symptoms, drug reactions, liver failure, jaundice, liver damage, angioedema, agranulocytosis, rhabdomyolysis

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

Storage

This drug can be sensitive to air and moisture, so it should be stored in a sealed container. The storage temperature should be maintained at room temperature between 1°C and 30°C. By storing it this way, the drug's effectiveness can be safely maintained.

Appearance and packaging

Appearance

White to light yellow, round 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.

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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.