Aztreonam (Page 6 of 6)

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 (20° to 25°C/68° to 77°F, see USP) or within 7 days if refrigerated (2° to 8°C/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

ProductCode Unit of Sale Strength Each
PRX400120 63323-401-24Unit of 10 1 g per vial 63323-401-4120 mL singledose vial
PRX400220 63323-402-24Unit of 10 2 g per vial 63323-402-4130 mL singledose vial

Storage

Store in original packages at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; avoid excessive heat. This container closure is not made with natural rubber latex.

REFERENCES:

  1. Naber KG, Dette GA, Kees F, Knothe H, Grobecker H. Pharmacokinetics, in vitro activity, therapeutic efficacy, and clinical safety of aztreonam vs. cefotaxime in the treatment of complicated urinary tract infections. J Antimicrob Chemother 1986; 17:517-527.
  2. Creasey WA, Platt TB, Frantz M, Sugerman AA. Pharmacokinetics of aztreonam in elderly male volunteers. Br J Clin Pharmacol 1985; 19:233-237.
  3. Meyers BR, Wilkinson P, Mendelson MH, et al. Pharmacokinetics of aztreonam in healthy elderly and young adult volunteers. J Clin Pharmacol 1993; 33:470-474.
  4. Sattler FR, Schramm M, Swabb EA. Safety of aztreonam and SQ 26,992 in elderly patients with renal insufficiency. Rev Infect Dis 1985; 7 (suppl 4):S622-S627.
  5. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard -Ninth Edition. CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
  6. National Committee for Clinical Laboratory Standards . Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically —Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2, NCCLS, Wayne, PA, January 2000.
  7. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition CLSI document M02-A11, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
  8. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement. CLSI document M100-S23, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013.
  9. Deger F, Douchamps J, Freschi E, et al. Aztreonam in the treatment of serious gram-negative infections in the elderly. Int J Clin Pharmacol Ther and Toxicol 1988; 26: 22-26.
  10. Knockaert DC, Dejaeger E, Nestor L, et al. Aztreonam-flucloxacillin double beta-lactam treatment as empirical therapy of serious infections in very elderly patients. Age and Aging 1981; 20:135-139.
  11. Roelandts F. Clinical use of aztreonam in a psychogeriatric population. Acta Clin Belg 1992; 47:251-255.
  12. Andrews R, Fasoli R, Scoggins WG, et al. Combined aztreonam and gentamicin therapy for pseudomonal lower respiratory tract infections. Clin Therap 1994;16:236-252.

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

451405B

Revised: April 2021

logologo

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

vial
(click image for full-size original)

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

vial
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)
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: 06/2021 Fresenius Kabi USA, LLC

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