| Customization: | Available |
|---|---|
| CAS No.: | 144060-53-7 |
| Type: | Pharmaceutical Intermediates |
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| product name | Febuxostat |
| CAS NO. | 144060-53-7 |
| Specification | 99% |
| Appearance | white powder |
| Package | 1KG/Bag,25kg/drum |
| MOQ | 100G |
Febuxostat is a drug used to treat hyperuricemia and gout. It inhibits the production of uric acid and effectively reduces the uric acid content in the blood, thereby preventing and treating gout and other related diseases.
The main ingredient of Febuxostat is Febuzocastat, whose chemical name is 2-[(3-cyano-4-isobutyloxy)phenyl]-4-methyl-5-thiazolecarboxylic acid. It is a xanthine oxidase (XO) inhibitor and is suitable for the long-term treatment of hyperuricemia with gout symptoms.
The latest Febuxostat tablets (Febuli) to enter China were approved by the National Medical Products Administration for listing in the Chinese market on September 4, 2018.
| Items | Standards | Results |
| Physical Analysis | ||
| Description | white powder | Complies |
| Specification | 99% | Complies |
| Mesh Size | 100 % pass 80 mesh | Complies |
| Ash | ≤ 5.0% | 0.0285 |
| Loss on Drying | ≤ 5.0% | 0.0285 |
| Chemical Analysis | ||
| Heavy Metal | ≤ 10.0 mg/kg | Complies |
| Pb | ≤ 2.0 mg/kg | Complies |
| As | ≤ 1.0 mg/kg | Complies |
| Hg | ≤ 0.1 mg/kg | Complies |
| Microbiological Analysis | ||
| Total Plate Count | ≤ 1000cfu/g | Complies |
| Yeast&Mold | ≤ 100cfu/g | Complies |
| E.coil | Negative | Negative |
| Salmonella | Negative | Negative |
| Conclusion | Conform with specification | |
Recommended dose
The starting dose is 20 mg, once a day. A high dose may cause a rapid decrease in blood uric acid levels and induce gouty arthritis (gout attack). After taking 20 mg of Febuxostat for 4 weeks, patients can gradually increase the dose according to the blood uric acid level under the guidance of a doctor, with each increase of 20 mg.
The maximum daily dose is 80 mg. After the blood uric acid level reaches the target value (less than 6 mg/dL or 360 μmol/L), maintain the lowest effective dose. When administering, there is no need to consider the effects of food and antacids. Please follow the doctor's advice for details.
Special populations
Elderly patients: No dose adjustment is required.
Patients with mild to moderate liver dysfunction: No dose adjustment is required.
Patients with mild to moderate renal dysfunction: No dose adjustment is required.
Patients with chronic kidney disease (CKD) stage 4-5: The recommended starting dose is 20 mg/day and the maximum dose is 40 mg/day.
Children: The safety and effectiveness of Febuxostat for pediatric patients are currently unknown. If medication is required, please use it under the guidance of a doctor and adult supervision.
Serum uric acid can be retested after 2 weeks of treatment with this product. The goal of treatment is to reduce and maintain serum uric acid levels below 6 mg/dL.
It is recommended to use this product for at least 6 months to prevent acute gout attacks (see [Precautions]).
Gout Attacks
Changing serum uric acid levels can lead to the activation of deposited urate, so starting this product can lead to gout attacks.
It is recommended to use this product with nonsteroidal anti-inflammatory drugs (NSAIDs) to prevent gout attacks. It is recommended to use this product for at least 6 months to prevent acute gout attacks.
Secondary Hyperuricemia
There are no studies on the administration of this product to patients with secondary hyperuricemia (including organ transplant patients); this product is not recommended for patients with increased urate production (such as malignant diseases and their treatment, Levy-Naphthalene syndrome). In rare cases, the concentration of xanthines in urine will increase significantly and deposit in the urinary tract.
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