MedPath

Cisatracurium

Generic Name
Cisatracurium
Brand Names
Nimbex
Drug Type
Small Molecule
Chemical Formula
C53H72N2O12
CAS Number
96946-41-7
Unique Ingredient Identifier
QX62KLI41N

Overview

Cisatracurium is a non-depolarising neuromuscular blocking agent of the benzylisoquinolinium class, available in its salt form, cisatracurium besylate. Cisatracurium has an intermediate duration of action and is one of the most commonly used neuromuscular blocking agents in intensive care.. Cisatracurium acts on cholinergic receptors, blocking neuromuscular transmission. This action is antagonized by acetylcholinesterase inhibitors such as neostigmine. Cisatracurium is an R-cis-R-cis isomer of atracurium and has approximately 3 times its neuromuscular blocking potency. Compared to atracurium, cisatracurium produces a lower degree of histamine release.

Indication

Cisatracurium is indicated as an adjunct to general anesthesia to facilitate tracheal intubation in adults and pediatric patients 1 month to 12 years of age. Cisatracurium is also indicated to provide skeletal muscle relaxation during surgery in adults and pediatric patients 2 to 12 years of age as a bolus or infusion maintenance and for mechanical ventilation in the ICU in adults.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/07/23
Not Applicable
Recruiting
Southeast University, China
2024/01/19
Not Applicable
Completed
Watim Medical & Dental College
2024/01/12
Not Applicable
Recruiting
2023/10/26
N/A
Completed
Institut Jantung Negara
2023/03/09
Not Applicable
Recruiting
Yangzhou University
2022/11/22
Phase 4
Not yet recruiting
Second Affiliated Hospital of Nanchang University
2022/09/02
Not Applicable
Completed
Second Affiliated Hospital of Nanchang University
2022/04/04
Not Applicable
Completed
Chang Gung Memorial Hospital
2021/12/29
Not Applicable
UNKNOWN
2021/12/10
Phase 4
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Zydus Lifesciences Limited
72785-0009
INTRAVENOUS
10 mg in 1 mL
11/5/2022
Meitheal Pharmaceuticals Inc.
71288-712
INTRAVENOUS
10 mg in 5 mL
4/20/2023
Teva Parenteral Medicines, Inc.
0703-2045
INTRAVENOUS
200 mg in 20 mL
11/28/2023
Eugia US LLC
55150-284
INTRAVENOUS
10 mg in 5 mL
4/27/2023
Sandoz Inc
0781-3150
INTRAVENOUS
2 mg in 1 mL
4/26/2017
Hospira, Inc.
0409-7083
INTRAVENOUS
2 mg in 1 mL
12/5/2022
Meitheal Pharmaceuticals Inc.
71288-714
INTRAVENOUS
20 mg in 10 mL
5/31/2019
PIRAMAL CRITICAL CARE INC
66794-246
INTRAVENOUS
200 mg in 20 mL
8/9/2023
PIRAMAL CRITICAL CARE INC
66794-245
INTRAVENOUS
10 mg in 5 mL
8/9/2023
Somerset Therapeutics, LLC
70069-161
INTRAVENOUS
2 mg in 1 mL
6/7/2023

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
Nimbex Forte Injection 150 mg/30 ml
SIN14310P
INJECTION, SOLUTION
150 mg/30 ml
2/5/2013
Nimbex Injection 2 mg/ml
SIN14309P
INJECTION, SOLUTION
2 mg/ml
2/5/2013

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.

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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