Febuxostat Tablets

Pharmacological action: Febuxostat is a 2-arylthiazole derivative and a xanthine oxidase inhibitor that reduces serum uric acid concentration by inhibiting uric acid synthesis. At conventional therapeutic concentrations, Febuxostat does not inhibit other enzymes involved in the synthesis and metabolism of purines and pyrimidines. (See instructions for details)

The active ingredient of this product is febuxostat.

This product is a film-coated tablet, which appears off-white after removing the coating.

It is suitable for long-term treatment of hyperuricemia in patients with gout, but is not recommended for hyperuricemia without clinical symptoms.

The recommended oral dose of Febuxostat tablets is 40 mg or 80 mg once daily. The recommended starting dose of Febuxostat tablets is 40 mg once daily. If the blood uric acid level is still not lower than 6 mg/dl (about 360 μmol/L) after 2 weeks, the recommended dose is increased to 80 mg once daily. When administering, there is no need to consider the effects of food and antacids. Special populations: Patients with hepatic impairment: Patients with mild to moderate hepatic impairment (Child-Pugh A.B grade) do not need to adjust the dose. The efficacy and safety of Febuxostat in patients with severe hepatic impairment (Child-Pugh C grade) has not been studied. Therefore, Febuxostat should be used with caution in such patients. Patients with renal impairment: Mild to moderate renal impairment (Clcr 30-89 ml/min)

The following information is reported in foreign literature: 1. Clinical trial experience Since clinical trials are conducted under a wide variety of conditions, the incidence of adverse reactions of a drug observed in a clinical trial cannot be directly compared with that of another drug in a clinical trial, nor can it reflect the incidence in clinical practice. (See instructions for details)

This product is contraindicated in patients who are receiving azathioprine or mercaptopurine.

Precautions for children: The safety and effectiveness of this product for the treatment of patients under 18 years of age have not been established. Precautions for pregnancy and lactation: Pregnant women are classified as Category C by the FDA: no adequate controlled studies have been conducted in pregnant women. Therefore, febuxostat can only be used during pregnancy when the potential benefits are confirmed to outweigh the risks to the fetus. When febuxostat was orally administered to rats and rabbits at 48 mg/kg (40 and 51 times the plasma exposure at a human dose of 80 mg/d, respectively, based on body surface area), no teratogenicity was shown during the organogenesis period. However, during the organogenesis period and lactation period, oral doses of 48 mg/kg (40 times the plasma exposure at a human dose of 80 mg/d, based on body surface area) in rats can lead to increased mortality and reduced weight gain in newborn rats. Studies on rats in lactating women have found that febuxostat can be excreted in breast milk. However, it is not yet known. Precautions for the elderly: No dose adjustment is required for elderly patients. According to foreign literature reports, in clinical studies of Febuxostat, subjects aged 65 and above accounted for 16% of the total number of subjects, and subjects aged 75 and above accounted for 4%. Comparing subjects of different age groups, there was no clinically significant difference in efficacy and safety, but it cannot be ruled out that some elderly patients are more sensitive to this product. After multiple oral administrations of Febuxostat to elderly subjects (65 years and above), Cmax and AUC24 were similar to those of young subjects (18-40 years old).

1. Xanthine oxidase substrate drugs Febuxostat is a xanthine oxidase (XO) inhibitor. Based on a drug interaction study conducted on healthy subjects, febuxostat alters the metabolism of theophylline (a substrate of XO) in humans. Therefore, caution should be exercised when febuxostat is used in combination with theophylline. There are no studies on the interaction between febuxostat and other drugs metabolized by XO (such as azathioprine and mercaptopurine). XO inhibition caused by febuxostat may increase the plasma concentrations of these drugs, leading to toxicity. Therefore, febuxostat is contraindicated in patients receiving azathioprine or mercaptopurine. 2. Cytotoxic chemotherapy drugs No interaction studies have been conducted between febuxostat and cytotoxic chemotherapy drugs. Safety data for the use of febuxostat during chemotherapy with cytotoxic drugs

Light-proof and sealed.

40mg

24 months

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

• Founded in:

  1997-04-28

• Address:

  No. 38 Huanghe Road, Lianyungang Economic and Technological Development Zone

• Tax NO.:

  9132070070404786XB

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  6,379,002,274 yuan

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