Eperisone

Overview

Eperisone is an antispasmodic drug which relaxes both skeletal muscles and vascular smooth muscles, and demonstrates a variety of effects such as reduction of myotonia, improvement of circulation, and suppression of the pain reflex. It is not approved for use in the United States, but is available in other countries like India, South Korea, and Bangladesh.

Indication

可用于改善下列疾病的肌紧张状态：颈肩腕综合征、肩周炎、腰痛症；也可用于改善下列疾病所致的痉挛性麻痹：脑血管障碍、痉挛性脊髓麻痹，颈椎病，手术后遗症（包括脑、脊髓肿瘤），外伤后遗症（脊髓损伤、头部外伤），肌萎缩性侧索硬化症，婴儿大脑性轻瘫，脊髓小脑变性症，脊髓血管障碍，亚急性脊髓神经症（SMON）及其他脑脊髓疾病。

Associated Conditions

Back Pain Lower Back
Neck Pain
Shoulder Pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Radial Extracorporeal Shock Wave Therapy for Chronic Non-specific Low Back Pain	2017/11/09	NCT03337607	Not Applicable	Completed	First Affiliated Hospital of Zhejiang University
Study to Compare Pharmacokinetic Characteristics of Eperisone and Aceclofenac With NVP-1203	2014/11/13	NCT02289274	Phase 1	Withdrawn	NVP Healthcare
A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions (Study 013-10)	2011/03/01	NCT01306318	Not Applicable	Completed	Eisai Co., Ltd.
A Clinical Trial to Study the Effects of a Fixed Dose Combination of Diclofenac and Eperisone Hydrochloride With Plain Eperisone Hydrochloride in Patients With Low Back Pain	2011/02/21	NCT01300312	Phase 3	Completed	Eisai Co., Ltd.
Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain - A Double Blind, Randomised, Placebo Controlled Clinical Trial	2006/05/18	NCT00327730	Phase 3	Completed	Eisai Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
MYONAL TABLET 50 mg	BUSHU PHARMACEUTICALS LTD.	SIN06292P	TABLET, SUGAR COATED	50 mg	6/21/1991

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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