Aztreonam (Page 5 of 5)

Intravenous Solutions

For Bolus Injection: The contents of an aztreonam for injection vial should be constituted with 6 to 10 mL Sterile Water for Injection, USP.

For Infusion: If the contents of a vial are to be transferred to an appropriate infusion solution, each gram of aztreonam should be initially constituted with at least 3 mL Sterile Water for Injection, USP. Further dilution may be obtained with one of the following intravenous infusion solutions:

Sodium Chloride Injection, USP, 0.9%

Ringer’s Injection, USP

Lactated Ringer’s Injection, USP

Dextrose Injection, USP, 5% or 10%

Dextrose and Sodium Chloride Injection, USP, 5%:0.9%, 5%:0.45%, or 5%:0.2%

Sodium Lactate Injection, USP (M/6 Sodium Lactate)

Ionosol^® B and 5% Dextrose

Isolyte^® E

Isolyte^® E with 5% Dextrose

Isolyte^® M with 5% Dextrose

Normosol^® -R

Normosol^® -R and 5% Dextrose

Normosol^® -M and 5% Dextrose

Mannitol Injection, USP, 5% or 10%

Lactated Ringer’s and 5% Dextrose Injection

Plasma-Lyte M and 5% Dextrose

Intramuscular Solutions

The contents of an aztreonam for injection vial should be constituted with at least 3 mL of an appropriate diluent per gram aztreonam. The following diluents may be used:

Sterile Water for Injection, USP

Sterile Bacteriostatic Water for Injection, USP (with benzyl alcohol or with methyl- and propylparabens)

Sodium Chloride Injection, USP, 0.9%

Bacteriostatic Sodium Chloride Injection, USP (with benzyl alcohol)

Stability of Intravenous and Intramuscular Solutions

Aztreonam solutions for intravenous infusion at concentrations not exceeding 2% w/v must be used within 48 hours following constitution if kept at controlled room temperature (20º to 25ºC/68º to 77ºF, see USP) or within 7 days if refrigerated (2º to 8ºC/ 36° to 46°F).

Aztreonam for Injection, USP, solutions at concentrations exceeding 2% w/v, except those prepared with Sterile Water for Injection, USP or Sodium Chloride Injection, USP, should be used promptly after preparation; the 2 excepted solutions must be used within 48 hours if stored at controlled room temperature or within 7 days if refrigerated.

Intravenous Administration

Bolus Injection: A bolus injection may be used to initiate therapy. The dose should be slowly injected directly into a vein, or the tubing of a suitable administration set, over a period of 3 to 5 minutes (see next paragraph regarding flushing of tubing).

Infusion: With any intermittent infusion of aztreonam and another drug with which it is not pharmaceutically compatible, the common delivery tube should be flushed before and after delivery of aztreonam with any appropriate infusion solution compatible with both drug solutions; the drugs should not be delivered simultaneously. Any aztreonam for injection infusion should be completed within a 20- to 60-minute period. With use of a Y-type administration set, careful attention should be given to the calculated volume of aztreonam solution required so that the entire dose will be infused. A volume control administration set may be used to deliver an initial dilution of aztreonam for injection (see Preparation of Parenteral Solutions: Intravenous Solutions: For Infusion) into a compatible infusion solution during administration; in this case, the final dilution of aztreonam should provide a concentration not exceeding 2% w/v.

Intramuscular Administration

The dose should be given by deep injection into a large muscle mass (such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh). Aztreonam is well tolerated and should not be admixed with any local anesthetic agent.

HOW SUPPLIED

Aztreonam for Injection, USP

Product Code	Unit of Sale	Strength	Each
PRX400120	NDC 63323-401-24 Unit of 10	1 g per vial	NDC 63323-401-41 20 mL single-dose vial
PRX400220	NDC 63323-402-24 Unit of 10	2 g per vial	NDC 63323-402-41 30 mL single-dose vial

Storage

Store in original packages at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]; avoid excessive heat.

The container closure is not made with natural rubber latex.

The brand names mentioned in this document are the trademarks of their respective owners.

PREMIERProRx^® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

Manufactured by:

FRESENIUS KABI

Lake Zurich, IL 60047

www.fresenius-kabi.com/us

451405C

Revised: March 2022

PACKAGE LABEL — PRINCIPAL DISPLAY — Aztreonam 1 gram Single Dose Vial Label

NDC 63323-401-41

PRX400120

AZTREONAM FOR INJECTION, USP

1 gram* per vial

Single-Dose Vial

For Intravenous or Intramuscular use after constitution

Rx only

PACKAGE LABEL — PRINCIPAL DISPLAY — Aztreonam 1 gram Single Dose Vial Tray Label

NDC 63323-401-24

PRX400120

AZTREONAM FOR INJECTION, USP

1 gram* per vial

For Intravenous or Intramuscular use after constitution

10 x 20 mL

Single-Dose Vials

Rx only

PACKAGE LABEL — PRINCIPAL DISPLAY — Aztreonam 2 grams Single Dose Vial Label

NDC 63323-402-41

PRX400220

AZTREONAM FOR INJECTION, USP

2 grams* per vial

Single-Dose Vial

For Intravenous or Intramuscular use after constitution

Rx only

vial

PACKAGE LABEL — PRINCIPAL DISPLAY — Aztreonam 2 grams Single Dose Vial Tray Label

NDC 63323-402-24

PRX400220

AZTREONAM FOR INJECTION, USP

2 grams* per vial

For Intravenous or Intramuscular use after constitution

10 x 30 mL

Single-Dose Vials

Rx only

vial

AZTREONAM aztreonam injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-401 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZTREONAM (AZTREONAM) AZTREONAM 1 g

Inactive Ingredients Ingredient Name Strength ARGININE 780 mg

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63323-401-24 10 VIAL in 1 TRAY contains a VIAL (63323-401-41) 1 NDC:63323-401-41 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL This package is contained within the TRAY (63323-401-24)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065439 11/05/2009

AZTREONAM aztreonam injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-402 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZTREONAM (AZTREONAM) AZTREONAM 2 g

Inactive Ingredients Ingredient Name Strength ARGININE 1.56 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63323-402-24 10 VIAL in 1 TRAY contains a VIAL (63323-402-41) 1 NDC:63323-402-41 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL This package is contained within the TRAY (63323-402-24)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065439 11/05/2009

Labeler — Fresenius Kabi USA, LLC (608775388)

Establishment
Name	Address	ID/FEI	Operations
Fresenius Kabi USA, LLC		840771732	manufacture (63323-401), analysis (63323-401), manufacture (63323-402), analysis (63323-402)

Revised: 05/2022 Fresenius Kabi USA, LLC