Cisatracurium Besylate (Page 9 of 9)

14.3 Skeletal Muscle Relaxation in ICU Patients

Long-term infusion (up to 6 days) of cisatracurium besylate during mechanical ventilation in the ICU was evaluated in two studies.

Study 8 was a randomized, double-blind study using presence of a single twitch during train-of-four (TOF) monitoring to regulate dosage. Patients treated with cisatracurium besylate (n = 19) recovered neuromuscular function (T₄ :T₁ ratio ≥ 70%) following termination of infusion in approximately 55 minutes (range: 20 to 270).

In Study 9, cisatracurium besylate patients recovered neuromuscular function in approximately 50 minutes (range: 20 to 175; n = 34).

16 HOW SUPPLIED/STORAGE AND HANDLING

Cisatracurium Besylate Injection, USP is a clear solution supplied as follows:

NDC	Cisatracurium Besylate Injection, USP (2 mg per mL)	Package Factor
25021-670-10	20 mg per 10 mL Multi-Dose Vial	10 vials per carton
25021-668-05	10 mg per 5 mL Single-Dose Vial	10 vials per carton

NOTE: Multiple-Dose Vial contains 0.9% w/v benzyl alcohol as a preservative [see Warnings and Precautions (5.2)].

NDC	Cisatracurium Besylate Injection, USP (10 mg per mL)	Package Factor
25021-669-20	200 mg per 20 mL Single-Dose Vial*	1 vial per carton

^* Intended only for use in the ICU.

Storage

Refrigerate Cisatracurium Besylate Injection, USP at 2° to 8°C (36° to 46°F) in the carton to preserve potency. Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use Cisatracurium Besylate Injection, USP within 21 days even if re-refrigerated.

Do not freeze.

Protect from light. Retain in carton until time of use.

Single-Dose Vials: Preservative-free. Discard unused portion.

Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Hypersensitivity Reactions Including Anaphylaxis

Advise the caregiver and/or family that severe hypersensitivity reactions have occurred with cisatracurium besylate [see Warnings and Precautions (5.4)].

SAGENT^®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in India©2020 Sagent Pharmaceuticals, Inc.

September 2020

SAGENT Pharmaceuticals^®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-668-05

Rx only

Cisatracurium Besylate Injection, USP

10 mg (base) per 5 mL

(2 mg per mL)

WARNING: Paralyzing Agent

For Intravenous Injection

5 mL Single-Dose Vial

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-669-20

Rx only

Cisatracurium Besylate Injection, USP

200 mg (base) per 20 mL

(10 mg per mL)

WARNING: Paralyzing Agent

For ICU use only

For Intravenous Injection

20 mL Single-Dose Vial

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

Paralyzing Agent

NDC 25021-670-10

Rx only

Cisatracurium Besylate Injection, USP

20 mg (base) per 10 mL

(2 mg per mL)

0.9 % benzyl alcohol

(added as a preservative)

For Intravenous Injection

10 mL Multi-Dose Vial

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sticker Label

2 mg per mL

For Intravenous Use Only

Contains Benzyl Alcohol

CISATRACURIUM BESYLATE INJECTION, USP

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sticker Label

2 mg per mL

For Intravenous Use Only

CISATRACURIUM BESYLATE INJECTION, USP

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sticker Label

10 mg per mL

For Intravenous Use Only

For ICU Use Only

CISATRACURIUM BESYLATE INJECTION, USP

CISATRACURIUM BESYLATE cisatracurium besylate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-668 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cisatracurium besylate (cisatracurium) cisatracurium 2 mg in 1 mL

Inactive Ingredients Ingredient Name Strength benzenesulfonic acid

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25021-668-05 10 VIAL in 1 CARTON contains a VIAL 1 5 mL in 1 VIAL This package is contained within the CARTON (25021-668-05)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201836 11/01/2021

CISATRACURIUM BESYLATE cisatracurium besylate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-669 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cisatracurium besylate (cisatracurium) cisatracurium 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength benzenesulfonic acid

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25021-669-20 1 VIAL in 1 CARTON contains a VIAL 1 20 mL in 1 VIAL This package is contained within the CARTON (25021-669-20)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201836 11/01/2021

CISATRACURIUM BESYLATE cisatracurium besylate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-670 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cisatracurium besylate (cisatracurium) cisatracurium 2 mg in 1 mL

Inactive Ingredients Ingredient Name Strength benzyl alcohol benzenesulfonic acid

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25021-670-10 10 VIAL in 1 CARTON contains a VIAL 1 10 mL in 1 VIAL This package is contained within the CARTON (25021-670-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201851 11/01/2021

Labeler — Sagent Pharmaceuticals (796852890)

Revised: 09/2020 Sagent Pharmaceuticals