Febuxostat Tablets
Feibusita Pian
Fei Bu Si Ta Tablets
Fei Bu Si Ta Pian
FUNCTION and INDICATIONS
For gout patients with hyperuricemia long-term treatment.
Not recommended for the no clinical symptoms of hyperuricemia.
INGREDIENTS
Febuxostat.
DESCPRIPTION
This product is film-coated tablets, remove the coating was white.
SPECIFICATION AND PACKAGE
40mg*10 tablets/box.
USAGE AND DOSAGE
The oral recommended dose of febuxostat is 40 mg or 80 mg once daily.
The recommended initial dose of febuxostat is 40 mg once daily. If after 2 weeks, serum uric acid levels are still not lower than 6mg / dl (about 360μmol / L), the proposed dose increased to 80mg, once daily.
When administered, there is no need to consider the effects of food and antacids influence.
Special crowd
Hepatic insufficiency: No dose adjustment is needed in patients with mild to moderate hepatic insufficiency (Child-PughA, grade B). No severe hepatic dysfunction (Child-Pugh C-Class) patients have been studied for efficacy and safety with febuxostat, so they should be used with caution.
Renal insufficiency: No dose adjustment is needed in patients with mild to moderate renal insufficiency (Clcr 30-89 ml / min). The recommended initial dose of febuxostat is 40 mg once daily. If after 2 weeks, serum uric acid level is still not less than 6mg / dl, the proposed dose increased to 80mg, once daily. There is not enough data on patients with severe renal insufficiency (Clcr <30 ml / min), so these patients should be used with caution.
Uric acid levels
After 2 weeks of starting febuxostat treatment, it is possible to assess whether the blood uric acid level has reached the target value (less than 6 mg / dl).
Gout attack
In the early stages of taking this product may induce gout attacks, this is because the changes in serum uric acid levels lead to tissue deposition of urate was mobilized. To prevent the onset of gout in the initial phase of febuxostat administration, it is recommended to take both NSAIDs and colchicine at the same time. Prophylactic treatment can benefit up to 6 months.
During nFebuxostat treatment,if gout attacks,does not need stop medication. Should be based on the patient's individual circumstances,treat gout accordingly.
REFERENCES
QAQ about febuxostat,please visit here.
ADVERSE REACTION
Common Adverse Reactions: Non-febuxostat treatment group with at least 1% incidence and at least 0.5% higher adverse reactions than placebo.
According to the situation of renal insufficiency were given different doses of allopurinol, including 100mg10 cases, 200mg145 cases, 300mg1122 cases.
The most common adverse reactions that led to discontinuation of treatment were liver dysfunction with discontinuation of treatment rates of 1.8% in the 40 mg febuxostat group, 1.2% in the 80 mg fentanyl group and 0.9% in the allopurinol group.
In addition to the adverse reactions in Table 1, although dizziness was more than 1% in the febuxostat group, it was lower than 0.5% in the placebo group.
Occasionally adverse reactions
In Phase II and Phase III clinical studies, the following adverse effects occurred in subjects less than 1% at doses ranging from 40 to 240 mg:
Blood and lymphatic system: anemia, idiopathic thrombocytopenic purpura, leukocytosis / diminution, neutropenia, pancytopenia, splenomegaly, thrombocytopenia.
Heart: angina, atrial fibrillation / atrial flutter, heart murmur, abnormal ECG, palpitations, sinus bradycardia, tachycardia.
Ear and lost: deafness, tinnitus, dizziness.
Eye: blurred vision.
Gastrointestinal: bloating, abdominal pain, constipation, dry mouth, indigestion, flatulence, frequent stools, gastrointestinal upset, gastritis, gastroesophageal reflux disease, gum pain, hemoptysis, hyperacidity, blood in the stool, mouth ulcers, pancreatitis , Peptic ulcer, vomiting.
Systemic and Administration Site: Weakness, chest / chest discomfort, edema, fatigue, abnormal sensations, abnormal gait, flu-like symptoms, mass, pain, thirst.
Hepatobiliary system: gallstones / cholecystitis, hepatic steatosis, hepatitis, hepatomegaly.
Immune System: Allergic reactions.
Infection: Shingles.
Complication: contusion.
Metabolism and nutrition: anorexia, loss of appetite / increase, dehydration, diabetes, hypercholesterolemia, hyperglycemia, hyperlipemia, hypertriglyceridemia, hypokalemia, weight loss / increase.
Musculoskeletal and connective tissue: arthritis, joint stiffness, swollen joints, muscle spasms / convulsions / tension / weakness, skeletalgia / stiffness, myalgia.
Nervous system: dysgeusia, balance disorders, cerebrovascular accident, Guillain-Barré syndrome, headache, hemiparesis, dysesthesia, hyposmia, lacunar infarction, drowsiness, mental disorders, migraine, sensory abnormalities, drowsiness, shortness of breath Cerebral ischemia attack, tremor.
Mental illness: irritability, anxiety, depression, insomnia, irritability, loss of libido, neuroticism, acute anxiety, personality change.
Urinary system: hematuria, kidney stones, urinary frequency, proteinuria, renal failure, renal insufficiency, urinary urgency, urinary incontinence.
Reproductive system and breast: breast pain, erectile dysfunction, male breast development.
Respiratory, chest, mediastinum: bronchitis, cough, dyspnea, epistaxis, nasal dryness, excessive sinusoidal secretion, pharyngeal edema, respiratory congestion, sneezing, throat inflammation, upper respiratory tract infection.
Skin and Subcutaneous Tissues: Hair loss, angioedema, dermatitis, skin scarring, ecchymosis, eczema, hair color change, hair growth abnormalities, hyperhidrosis, peeling, petechia, photodamage, pruritus, purpura, / Pigmentation, skin lesions, abnormal skin odor, urticaria.
Blood vessels: red, hot flashes, high blood pressure, low blood pressure.
Laboratory indicators: activated partial thromboplastin time, creatine, bicarbonate reduction, increased sodium, abnormal EEG, elevated blood glucose, elevated cholesterol, elevated triglycerides, elevated amylase, potassium Increased thyrotropin, decreased platelet count, decreased hematocrit, decreased hemoglobin, increased average volume of erythrocytes, decreased erythrocyte, creatinine, elevated blood urea nitrogen, elevated blood urea nitrogen / creatinine ratio, creatine phosphokinase Increase, increase in alkaline phosphatase, increase in lactate dehydrogenase, increase in prostate-specific antigen, increase / decrease in urine output, decrease in lymphocyte count, decrease in neutrophil count, increase / decrease in white blood cells, coagulation test abnormalities , Low-density lipoprotein increased prothrombin time, tubular urine, urine leukocytes positive, urine protein positive.
Cardiovascular risk
Cardiovascular events and death are among the pre-established endpoints of APTC (Anti-Plateletrialists' Volumes), including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, both in randomized studies and in long-term sclerotic studies. In a randomized phase III trial, the incidence of APTC events per 100 patient-years was, respectively, placebo 0 (95% CI 0.00 to 6.16), febuxostat 40 mg 0 (95% CI 0.00 to 1.08 ), Febuxostat 80mg group 1.09 (95% CI 0.44-2.24) and allopurinol group 0.60 (95% CI 0.16-1.53).
In long-term scalability studies, the incidence of APTC events were 0.97 (95% CI 0.57 to 1.56) in the febuxostat 80 mg group and 0.58 (95% CI 0.02 to 3.24) in the allopurinol group.
In conclusion, the patients in the febuxostat group had a higher incidence of APTC events compared to the allopurinol group, but the causality with febuxostat was uncertain. Medication should be monitored myocardial infarction and stroke symptoms and signs.
2, foreign products after the market experience
Adverse reactions to the use of febuxostat after its listing were screened. Since these adverse reactions are reported spontaneously from an unknown number of patients, it is impossible to accurately assess their frequency of occurrence or to determine their causal relationship with the drug.
Abnormal hepatobiliary: liver failure (some are fatal), jaundice, severe abnormal liver function test results, liver disease.
Immune System: Allergic reactions.
Musculoskeletal and connective tissue: rhabdomyolysis.
Mental disorders: Psychiatric behaviors that include offensive tendencies.
Urinary system: tubulointerstitial nephritis.
Skin and Subcutaneous Tissues: Systemic rashes, Stevens Johnson syndrome, skin allergies.
CONTRAINDICATIONS
Contraindicated in patients receiving the treatment of azathioprine, mercaptopurine..
Warning
1.Gout attack
In the early days of taking febuxostat, the frequency of attacks of gout frequently increased. This is due to the reduced serum uric acid concentration, resulting in the mobilization of uric acid deposited in the tissue. To prevent the onset of gout attacks, it is recommended to take non-steroidal anti-inflammatory drugs or colchicine at the same time.
During febuxostat treatment, gout without discontinuation of febuxostat treatment. Should be based on the specific circumstances of patients, gout for the appropriate treatment.
2.Cardiovascular events
In randomized controlled trials, patients with febuxostat had a higher probability of developing cardiovascular thromboembolic events (including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) compared to allopurinol Fefebuterol was 0.74 per 100 patients for one year (95% CI: 0.36 to 1.37) and allopurinol was 0.60 per 100 patients-years (95% CI: 0.16 to 1.53). The causal relationship between febuxostat and cardiovascular thrombosis has not yet been determined. Pay attention to monitoring the symptoms and signs of myocardial infarction and stroke when medication.
3.Effects on the liver
Post-marketing reports of fatal and non-fatal liver failure have been reported in patients taking febuxostat, although there is insufficient information in these reports to establish the causal link between them. In a randomized controlled trial, aminotransferases were observed to be elevated to more than 3 times the upper limit of normal (ULN) (2%, 2%, and 2% respectively for febuxostat and allopurinol; ALT: 3%, 2%). Elevated transaminases have no dose-effect relationship.
Patients should undergo a liver function test (serum alanine aminotransferase (ALT), AST before first use of febuxostat, Alkaline phosphatase and total bilirubin) as baseline levels.
Patients with fatigue, loss of appetite, right upper quadrant discomfort, soy sauce, urine, or jaundice, which may indicate symptoms of liver damage, should be promptly tested for liver function. Clinically, if the patient is found to have liver dysfunction (ALT over 3 times the upper limit of the reference range), discontinue the medication and investigate to determine possible causes. Febuxostat should not be reused in patients with abnormal liver function tests and no other reasonable explanation.
If the patient's serum ALT exceeds 3 times the reference range and its serum total bilirubin exceeds 2 times the reference range, while excluding other causes, the patient is now at risk of severe drug-induced liver damage Among these patients, these patients should not be re-used febuxostat. For those patients with low serum ALT or elevated bilirubin and other reasonable explanations, the use of febuxostat treatment should be cautious.
5.Secondary hyperuricemia
This product is not yet used in patients with secondary hyperuricemia (including organ transplant recipients) research, it is not recommended to apply this product in patients with a large increase in urate (such as malignant disease, Lesch-Nyhan syndrome ). A few cases showed that urinary xanthine concentrations increased significantly after the urinary tract deposition.
DRUG INTERACTION
If use with the other drugs at the same time may occur drug interactions,details please consult your physician or pharmacist.
PHARMACOLOGIC ACTION
STORAGE
Hermetically sealed,keep in cool and dry places.
PERIOD OF VALIDITY
24 months.
CERTIFICATE NO
Stage Food and Drug Administration Approval number:H20130081.
Manufactured
JIANGSU HENGRUI PHARMACEUTICAL CO.,LTD
Tips: Please read the directions for use in retail or directed by physician.
Part of the goods frequent replacement of packaging, such as goods and pictures are not exactly the same, please refer to the goods you receive.
General Cautions
Keep away from animals and children.This product has not been evaluated by the FDA. It is not intended to diagnose, treat, cure, or prevent any disease.We highly recommend that you consult with a Traditional Chinese Medical practitioner or physician before taking any products or if you have any questions regarding your health.
