Medication info

Nexotab 80mg (Febuxostat)

Prescription medicationTabletExpired
Ingredient · strength
Febuxostat›Strength being verified
Manufacturer / importer
NexPhaem Korea Co., Ltd.
Appearance
Pale yellow to yellow oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201902401 · Approved 2019.04.18

This product's status changed to Expired on 2024.04.18. 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
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 dose 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 less than 30mL/min). No specific dose adjustment is required in patients with mild or moderate hepatic impairment. 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
NexPhaem Korea Co., Ltd.

Efficacy & effects

Treatment of chronic hyperuricemia in patients with gout

  • Chronic hyperuricemia
View approved original text

In patients with gout, chronic hyperuricemia focuses on controlling uric acid levels within the normal range to prevent gout attacks and prevent joint damage. This is achieved by using medication to inhibit uric acid production or promote uric acid excretion. By this treatment, pain and inflammation caused by gout can be reduced, and the quality of life can be improved. Therefore, the treatment of chronic hyperuricemia is very important for effectively managing gout.

Dosage and Administration

Adult dosage

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 dose 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 less than 30mL/min). No specific dose adjustment is required in patients with mild or moderate hepatic impairment. 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 medication may increase the risk of cardiovascular death when administered to patients with cardiovascular disease; therefore, patients with a history of cardiovascular disease should use it with caution. Patients allergic to the active ingredient or excipients of this medication, patients taking certain other drugs (mercaptopurine, azathioprine), and patients with lactose intolerance or related genetic diseases should not use this medication. Patients with a history of liver disease or thyroid dysfunction should have regular liver function tests and thyroid function tests before taking this medication, and patients with heart disease or heart failure should also be careful. Various side effects such as impaired liver function, diarrhea, headache, rash, fatigue, and myalgia may occur with this medication, so if abnormal symptoms arise, consult healthcare professionals. Do not start this medication during acute gout attacks, and it is recommended to use preventive medications along with it, as gout symptoms may worsen during the initial treatment period. If symptoms of cardiovascular abnormalities (chest pain, difficulty breathing, etc.) occur, inform healthcare professionals immediately and receive appropriate measures. If symptoms of liver function impairment (weakness, loss of appetite, jaundice, etc.) occur, immediately discontinue taking the medication and undergo liver function tests. This medication may cause drowsiness or dizziness, requiring caution during driving or operating dangerous machinery. Women who are pregnant or breastfeeding are advised not to use this medication, and it is not recommended for use in children under 18 years of age. There is no specific antidote for overdose of this medication, so treatment should be symptomatic. This medication may interact with several other drugs, so if you are taking other medications, make sure to inform your healthcare professionals, especially caution is required when combined with certain medications. This medication should be kept out of the 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, dyspnea, anemia, idiopathic thrombocytopenic purpura, leukocytosis, leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia, angina, atrial fibrillation, atrial flutter, cardiac murmurs, ECG abnormalities, palpitations, bradycardia, tachycardia, hearing loss, tinnitus, vertigo, blurred vision, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, increased bowel frequency, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gum pain, hematemesis, hyperchlorhydria, hematochezia, oral ulcers, pancreatitis, gastric ulcer, vomiting, asthenia, chest pain, chest discomfort, edema, emotional disturbance, gait disturbance, influenza-like symptoms, mass, pain, thirst, cholelithiasis, diabetes insipidus, hepatic steatosis, hepatitis, hepatomegaly, hypersensitivity, herpes zoster, anorexia, appetite decrease, appetite increase, dehydration, diabetes, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight loss, weight gain, arthritis, arthric rigidity, joint swelling, muscle cramps, muscle single contraction, muscle tightness, muscle weakness, musculoskeletal pain, muscle rigidity, taste changes, balance disturbance, cerebrovascular accident, Guillain-Barré syndrome, headache, partial paralysis, sensory decrease, olfactory reduction, heat stroke, drowsiness, mental disorder, migraine, sensory disturbance, somnolence, transient ischemic attack, tremor, agitation, anxiety, depression, insomnia, excitability, decreased libido, nervousness, panic attack, personality change, hematuria, nephrolithiasis, frequency of 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 discoloration, petechiae, eczema, hair discoloration, abnormal hair growth, hyperhidrosis, skin exfoliation, petechial hemorrhage, photosensitivity, pruritus, purpura, skin discoloration, pigmentation changes, skin lesions, bromhidrosis, urticaria, flushing, facial flushing, hypertension, hypotension, activated partial thromboplastin time prolonged, creatinine increase, bicarbonate decrease, sodium increase, EEG abnormalities, glucose increase, cholesterol increase, triglyceride increase, amylase increase, potassium increase, thyroid-stimulating hormone increase, platelet decrease, hematocrit decrease, hemoglobin decrease, MCV increase, erythrocyte decrease, creatinine increase, blood urea increase, blood urea/creatinine ratio increase, CPK increase, ALP increase, LDH increase, PSA increase, urine output increase, urine output decrease, lymphocyte count decrease, neutrophil count decrease, leukocyte count increase, leukocyte count decrease, coagulation test abnormalities, low-density lipoprotein increase, prothrombin time prolonged, urine casts, urine leukocyte positive, urine protein positive, bruise, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute anaphylactic reaction, shock, eosinophilia, systemic symptoms, drug reaction (DRESS), liver failure, jaundice, liver impairment, agranulocytosis, rhabdomyolysis

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. Moreover, it is best to store the medication at room temperature, which is not too cold or too hot, specifically between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow to yellow oval 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.

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.