Teijin (Japan) Feburic / Febuxostat (Febuxostat) Feburic Tablets 10 mg, 20 mg, 40 mg Teijin Gout Medicine Treatment for High Uric Acid: 100 tablets

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描述

Direct Shipping from Overseas (Direct Shipping from Japan)

Teijin Gout Medication: Febuxostat, Febric Tablets
Feburic® Tablet
10 mg / 20 mg / 40 mg

Package Insert No. 3949003F1023_1_18 | Company Code 470310
Revised in June 2023 (5th Edition—Changes to Dosage and Administration) / Revised in September 2024 (6th Edition)

Hyperuricemia Treatment | Febuxostat | Gout and Chemotherapy-Related Hyperuricemia

Febuxostat

Product Details / Approvals, etc.

Japan Standard Commodity Classification Code 873949
Pharmacological Classification Name Non-purine selective xanthine oxidase inhibitors
Medications for Hyperuricemia
General Name Febuxostat
Febuxostat (Japanese Pharmacopoeia)
10mg Feburic Tablets 10 mg
YJ 3949003F1023
Approved 22300AMX00419000
Sales began in May 2011
20 mg Feburic Tablets 20 mg
YJ 3949003F2020
Approval 22300AMX00421000
Sales began in May 2011
40 mg Feburic Tablets 40 mg
YJ 3949003F3026
Approval 22300AMX00420000
Sales began in May 2011
Storage Instructions / Expiration Date Store at room temperature / 3 years
Regulatory Classification –
Manufacturing and Sales Yuan Teijin Pharma Co., Ltd.
3-2-1 Kasumigaseki, Chiyoda Ward, Tokyo
Packaging 10/20 mg: PTP blisters of 100 and 500 tablets, and bottles of 500 tablets
40 mg: 100 PTP tablets
Shipping method Direct overseas shipping (Direct shipping from Japan)
Preparation and shipping time After verifying payment and prescription eligibility,
Orders are typically shipped within 4 to 7 business days.

1. Conditions for Recognition

A drug risk management plan must be developed and properly implemented.

2. Product Characteristics and Mechanism of Action (18.)

Febuxostat inhibits both the oxidized form (Ki 0.6 nmol/L) and the reduced form (Ki 3.1 nmol/L) of xanthine oxidase, thereby reducing uric acid production. It has no effect on other major purine/pyrimidine metabolic enzymes and is a selective XO inhibitor.

3. Specifications and Properties (3.2)

White to slightly yellow, round, scored, film-coated tablets. 10/20 mg: approx. 7 mm × 3 mm × 132 mg; 40 mg: approx. 9 mm × 4 mm × 261 mg. Imprinted with “Febrik” and the dosage.

4. Ingredient Information (3.1/19.)

1 tablet of Febuxostat 10/20/40 mg (China and Japan).

19. Molecular formula C16H16N2O3S Molecular weight 316.37; melting point approximately 209 °C (decomposes).

Structural Formula

5. Indications and Usage (4./5.)

Gout, hyperuricemia Patients requiring medication should be selected in accordance with the latest treatment guidelines.

Hyperuricemia associated with cancer chemotherapy: The risk of tumor lysis syndrome must be considered. This product does not break down uric acid that has already been produced, so a rapid reduction in uric acid levels cannot be expected. The efficacy and safety of this product for hyperuricemia that has developed following chemotherapy have not been established.

6. Dosage and Administration (6./7.)

Gout, Hyperuricemia—Adults Start with 10 mg once daily. Gradually increase the dose after confirming uric acid levels. The maintenance dose is typically 40 mg once daily, with a maximum of 60 mg once daily. Recommendation: Increase to 20 mg starting 2 weeks after initiation and to 40 mg starting 6 weeks after initiation.

Children Body weight < 40 kg: Start with 5 mg per day; maintenance dose is typically 20 mg, with a maximum of 30 mg. Body weight ≥ 40 kg: Same starting, maintenance, and maximum doses as for adults.

Chemotherapy Is Associated with High Uric Acid Levels The usual dose for adults is 60 mg once daily.

7. Contraindications and Precautions (2.)

  1. Allergy to any ingredient in this product
  2. Currently taking mercaptopurine hydrate or azathioprine

A sudden drop in uric acid levels early in treatment may trigger gouty arthritis; therefore, the dose must be increased gradually. This product does not break down uric acid that has already formed.

Plasma Concentration / Uric Acid Trends During Chemotherapy:

PK
Chemotherapy and Uric Acid

22–26. Other Official Information

22. 10/20 mg: PTP blisters of 100 and 500 tablets; bottles of 500 tablets 40 mg: PTP blisters of 100 tablets

24. Teijin Pharma Co., Ltd. Medical Information Group Toll-Free Number: 0120-189-315

26. Manufacturer and Distributor: Teijin Pharma Ltd., 3-2-1 Kasumigaseki, Chiyoda-ku, Tokyo

※ This page was translated by Hkeemall based on PMDA Package Insert 3949003F1023_1_18; it is not a substitute for a doctor’s prescription or the original Japanese version.
Enter "Febric" in the PMDA's "Package Insert Information" search field to find the original version.

[Disclaimer]

  1. The information regarding medications, treatments, or health management contained in this article is compiled from international authoritative medical journals and official clinical literature, and is intended for general science and educational reference only.
  2. The indications, side effects, and contraindications of related medications may vary depending on national regulations and individual physical conditions. Do not blindly take medication on your own or change your treatment plan.
  3. The author and publishing platform assume no legal liability for any medical delays, adverse reactions, or direct or indirect losses caused by the use of the information in this article. All medical decisions should be discussed with your attending physician before being made.

Additional information

Specifications

Teijin Febuxostat Febric Tablets 10 mg, Teijin Febuxostat Febric Tablets 20 mg, Teijin Febuxostat Febric Tablets 40 mg

1 review for 日本帝人 Feburic / Febuxostat 非布司他 (非布索坦) フェブリク錠 10mg 20mg 40mg 帝人痛風藥 高尿酸治愈:100錠

4.00

Average of 1 review

  1. Ann Chan –

    After taking it for a little over a month, my uric acid levels dropped significantly, and joint pain occurred less often. It really works effectively.

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