AZTREONAM How Supplied/Storage and Handling (aztreonam for injection, USP) | Pfizer Medical Information - US

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HOW SUPPLIED

Aztreonam for Injection, USP single-dose vials are supplied as follows:

Unit of Sale	Strength	Each
NDC 0409-0829-01 Carton containing 10	1 gram/vial	NDC 0409-0829-11 Single-dose vial
NDC 0409-0830-01 Carton containing 10	2 grams/vial	NDC 0409-0830-11 Single-dose vial

Storage

Store original package at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]; avoid excessive heat.

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aztreonam for Injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or...

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DOSAGE AND ADMINISTRATION

Dosage in Adult Patients

Aztreonam for Injection may be administered intravenously or by intramuscular injection. Dosage and route of...

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CONTRAINDICATIONS

This preparation is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation.

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WARNINGS

Both animal and human data suggest that aztreonam for injection is rarely cross-reactive with other beta-lactam antibiotics and weakly immunogenic. Treatment with aztreonam can result in hypersensitivity reactions...

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ADVERSE REACTIONS

Local reactions such as phlebitis/thrombophlebitis following intravenous administration, and discomfort/swelling at the injection site following intramuscular administration occurred at rates of...

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OVERDOSAGE

If necessary, aztreonam may be cleared from the serum by hemodialysis and/or peritoneal dialysis.

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DESCRIPTION

Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal...

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CLINICAL PHARMACOLOGY

Single 30-minute intravenous infusions of 500 mg, 1 g, and 2 g doses of aztreonam for injection in healthy subjects produced aztreonam peak serum levels of 54 mcg/mL, 90 mcg/mL, and 204 mcg/mL,...

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CLINICAL STUDIES

A total of 612 pediatric patients aged 1 month to 12 years were enrolled in uncontrolled clinical trials of aztreonam in the treatment of serious Gram-negative infections, including urinary tract, lower...

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HOW SUPPLIED

Aztreonam for Injection, USP single-dose vials are supplied as follows:

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Rx only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection and other antibacterial...

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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.