Japan KISSEI Bezatol SR Sustained-Release Tablets (ベザトールSR錠) 100 mg, 200 mg: 100 tablets; Treatment for Hyperlipidemia; Reduces Blood Lipids; Lowers Cholesterol
日本 KISSEI Bezatol 苯扎貝特SR緩釋片 ベザトールSR錠 100mg 200mg：100錠 高血脂症治療劑 降血溶脂 降膽固醇 - Image 2
日本 KISSEI Bezatol 苯扎貝特SR緩釋片 ベザトールSR錠 100mg 200mg：100錠 高血脂症治療劑 降血溶脂 降膽固醇 - Image 3
日本 KISSEI Bezatol 苯扎貝特SR緩釋片 ベザトールSR錠 100mg 200mg：100錠 高血脂症治療劑 降血溶脂 降膽固醇 - Image 4
日本 KISSEI Bezatol 苯扎貝特SR緩釋片 ベザトールSR錠 100mg 200mg：100錠 高血脂症治療劑 降血溶脂 降膽固醇 - Image 5

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Japan KISSEI Bezatol SR Sustained-Release Tablets (ベザトールSR錠) 100 mg, 200 mg: 100 tablets; Treatment for Hyperlipidemia; Reduces Blood Lipids; Lowers Cholesterol

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描述

Direct overseas shipping (Direct shipping from Japan)

Benzabet SR Sustained-Release Tablets; Bezator SR Tablets
KISSEI BEZATOL® SR Tablets
100 mg / 200 mg

Package Insert No. 2183005G1234_1_14 | Company Code 230034
Prepared in March 2023 (1st Edition)

Bezafibrate Extended-Release Tablets | Hyperlipidemia (including familial hyperlipidemia)

KISSEI Bezatol Benzatol SR Sustained-Release Tablets

Product Details / Approvals, etc.

Japan Standard Commodity Classification Code 872183
Pharmacological Classification Name Hyperlipidemia Treatment Agents
General Name Bezafibrate Extended-Release Tablets (Japan)
Bezafibrate
100mg BEZATOL SR Tablets 100 mg
YJ 2183005G2028
Approval 20700AMZ00421000
Sales began in June 1995
200 mg BEZATOL SR Tablets 200 mg
YJ 2183005G1234
Approval No. 21600AMZ00267000
Sales began in April 1991
Storage Instructions / Expiration Date Store at room temperature / 3 years
Regulatory Classification –
Manufacturing and Sales Yuan Kissei Pharmaceutical Co., Ltd.
19-48 Yoshino, Matsumoto City
Packaging 100 mg: PTP 100/500 tablets
200 mg: PTP 100/500/1000 tablets; bulk 1000 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. Specifications and Properties (3.2)

Strengths: 100 mg, 200 mg
Identification: K/BT100, K/BT200
Diameter: / Thickness / Weight 7.1 mm / approx. 3.4 mm / approx. 133 mg 9.1 mm / approx. 4.1 mm / approx. 265 mg
Description: White film-coated tablets. Do not split or crush; swallow whole.

2. Composition and Physical and Chemical Properties (3.1/19.)

Each tablet contains 100 mg or 200 mg of Bezafibrate (China/Japan).

C19H20ClNO4　Molecular weight: 361.82; Melting point: 181–186°C

Structural Formula

3. Mechanism of Action (18.)

Inhibits cholesterol biosynthesis (acetyl-CoA → mevalonic acid) and triglyceride biosynthesis (acetyl-CoA carboxylase). Enhances LPL/HTGL and LDL receptor activity, promoting lipoprotein metabolism. Lowers total cholesterol and triglycerides (TG), and increases HDL-C.

4. Indications and Dosage (4.–7.)

Indications:Hyperlipidemia (including familial hyperlipidemia). A diagnostic test is required before use.

Directions:The usual adult dose of bezafibrate is 400 mg per day, taken orally in two divided doses after breakfast and dinner. The dose should be reduced in patients with renal impairment and the elderly.

Serum Creatinine Ccr Dosage
Scr ≤ 1.5 mg/dL Ccr ≥ 60 mL/min 400 mg/day (200 mg × 2)
1.5 < Scr < 2.0 50 < Ccr < 60 200 mg/day (200 mg × 1)

In the elderly, adjustments should be made based on Ccr. Yasuda's formula: for men, (176 − age) × body weight / (100 × Scr); for women, (158 − age) × body weight / (100 × Scr).

5. Contraindications and Precautions (2., 8., 9.)

  1. Patients on hemodialysis (including peritoneal dialysis)
  2. Severe kidney diseases, such as kidney failure
  3. Serum creatinine ≥ 2.0 mg/dL
  4. Allergy to any ingredient in this product
  5. Pregnant women or women who may be pregnant

Begin with dietary therapy and consider exercise and risk factors for ischemic heart disease. Monitor blood lipid levels regularly; discontinue treatment if ineffective. Patients with gallstones or a history of gallstones may develop new gallstones. In patients with impaired renal function, statins should be used only when absolutely necessary; if myalgia, weakness, or elevated CK, myoglobin, or creatinine levels occur, discontinue the medication immediately.

Blood concentration (200 mg single dose): Tmax 4.5 h, Cmax 3.45 μg/mL, T1/2 Approximately 3 hours. It is primarily excreted via the kidneys.

PK

6. Clinical Summary

Domestic Phase III, double-blind, 16-week study: 701 TP3T (85/121) showed moderate or greater improvement, outperforming 421 TP3T treated with clinofibrate. All lipid profile improvements were superior to those of the control group. Adverse events: 2.11 TP3T (pruritus, upper abdominal pain, stomach pain, and nausea, each at 0.71 TP3T).

20–26. Other Official Information

20. Keep away from moisture after repackaging in bulk. Keep away from moisture after opening the PTP aluminum blister pack.

22. 100 mg: PTP 100/500 tablets; 200 mg: PTP 100/500/1,000 tablets, bulk 1,000 tablets

24. Kissei Pharmaceutical Co., Ltd. Medication Consultation Center Toll-Free Number: 0120-007-622

26. Manufacturer and Distributor: Kissei Pharmaceutical Co., Ltd., 19-48 Yoshino, Matsumoto City

※ This page was translated by Hkeemall based on PMDA Package Insert 2183005G1234_1_14; it is not a substitute for a doctor’s prescription or the original Japanese version.
Enter "Bezator" in the PMDA's "Package Insert Information" field to search for 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

KISSEI Benzabet Bezator SR Tablets 100 mg

1 review for 日本 KISSEI Bezatol 苯扎貝特SR緩釋片 ベザトールSR錠 100mg 200mg：100錠 高血脂症治療劑 降血溶脂 降膽固醇

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    KISSEI Hyperlipidemia treatment agent, lipid-lowering, cholesterol-lowering, vascular protection, green, lipid-lowering Bezatol SR sustained-release tablets 100mg: 100 tablets, hyperlipidemia treatment agent, lipid-lowering, cholesterol-lowering, vascular protection

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