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
(click image for full-size original)

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
(click image for full-size original)

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 – Vial Label
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sticker Label

10 mg per mL

For Intravenous Use Only

For ICU Use Only

CISATRACURIUM BESYLATE INJECTION, USP

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sticker Label
(click image for full-size original)
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

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