uloric说明书

Instructions

Generic name: Febuxostat

Product name: uloric

Full names: uloric, febuxostat, febuxostat, feburic, febuxostat, zurig

[Main Ingredients] The active ingredient of this product is febuxostat.

[Characteristics] This product is a film-coated tablet, which appears off-white after the coating is removed.

[Indications] It is used for the treatment of chronic hyperuricemia (gout).

【Usage and Dosage】

The starting dose of uloric is 40 mg once daily. If the blood uric acid level is still not less than 6 mg/dl (approximately 360 μmol/L) after 2 weeks, it is recommended that the dose be increased to 80 mg once a day.

Food and antacid effects do not need to be considered when administering the drug.

【Special groups】

1. Patients with hepatic insufficiency: Patients with mild or moderate hepatic insufficiency (Child-Pugh Class A.B) do not need to adjust the dose. The efficacy and safety of febuxostat have not been studied in patients with severe hepatic insufficiency (Child-Pugh class C), so uloric should be used with caution in these patients.

2. Patients with renal insufficiency: Patients with mild or moderate renal insufficiency (Clcr30-89ml/min) do not need to adjust the dose. There are insufficient study data in patients with severe renal insufficiency (Clcr<30ml/min), so uloric should be used with caution in these patients.

【Adverse reactions】

Common adverse reactions of uloric include headache, diarrhea, back pain, joint pain, rash, elevated transaminases, etc. There are also serious adverse reactions that may cause rash with eosinophilia and systemic symptoms.

[Contraindications] This product is contraindicated in patients receiving azathioprine and mercaptopurine treatment.

[Pediatric Use] The safety and effectiveness of this product in treating patients under 18 years of age have not been determined.

[Dose for Elderly Patients] There is no need to adjust the dosage for elderly patients. According to foreign literature reports, in uloric clinical studies, people aged 65 and over accounted for 16% of the total number of subjects, and people aged 75 and over accounted for 4%. Comparing subjects of different age groups, there is no clinically significant difference in effectiveness and safety, but it cannot be ruled out that some elderly patients are more sensitive to this product. After multiple oral administrations of uloric in elderly subjects (65 years and above), Cmax and AUC24 were similar to those in young subjects (18-40 years old).

[Drugs for Pregnant and Lactating Women] Pregnant women The FDA pregnancy safety classification is Category C: insufficient controlled studies have been conducted in pregnant women. Therefore, uloric should only be used during pregnancy if it is confirmed that the potential benefits outweigh the risks to the fetus. Oral administration of uloric to rats and rabbits at 48 mg/kg (equivalent to 40 and 51 times the plasma exposure at the human dose of 80 mg/d, respectively, based on body surface area conversion) showed no teratogenicity during organogenesis. However, during the organogenesis and lactation periods, oral doses of up to 48 mg/kg in rats (equivalent to 40 times the plasma exposure at the human dose of 80 mg/d based on body surface area conversion) can lead to increased mortality and reduced weight gain in neonatal rats. A study of lactating women in rats found that uloric is excreted in breast milk. However, it is not known whether it is excreted in human milk. Since many drugs can be secreted into breast milk, lactating women should use this product with caution.