Overview
A monocyclic beta-lactam antibiotic originally isolated from Chromobacterium violaceum. It is resistant to beta-lactamases and is used in gram-negative infections, especially of the meninges, bladder, and kidneys. It may cause a superinfection with gram-positive organisms.
Indication
For the treatment of the following infections caused by susceptible gram-negative microorganisms: urinary tract infections, lower respiratory tract infections, septicemia, skin and skin-structure infections, intra-abdominal infections, and gynecologic infections.
Associated Conditions
- Bone and Joint Infections
- Cystic Fibrosis (CF)
- Febrile Neutropenia
- Gynecological Infection
- Intraabdominal Infections
- Lower Respiratory Tract Infection (LRTI)
- Osteomyelitis
- Septic Arthritis
- Septicemia
- Skin Infections
- Urinary Tract Infection
- Uncomplicated Gonorrhea
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/05/09 | Not Applicable | Recruiting | Qianfoshan Hospital | ||
2023/03/21 | Phase 1 | Recruiting | |||
2019/06/06 | Phase 1 | Completed | |||
2019/03/08 | Phase 2 | Completed | |||
2018/11/21 | Phase 2 | Terminated | Hospital Universitari Joan XXIII de Tarragona. | ||
2018/10/04 | Phase 2 | Recruiting | |||
2017/12/18 | Phase 1 | Completed | |||
2017/07/17 | Phase 3 | Terminated | |||
2017/05/17 | Phase 4 | Terminated | |||
2016/09/09 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 63323-402 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 5/6/2022 | |
| Fresenius Kabi USA, LLC | 63323-402 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 5/18/2021 | |
| Hospira, Inc. | 0409-0830 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 1 1 | 1/9/2024 | |
| Hospira, Inc. | 0409-0829 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 1 1 | 1/9/2024 | |
| Fresenius Kabi USA, LLC | 63323-402 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 7/1/2021 | |
| Fresenius Kabi USA, LLC | 63323-401 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 1 1 | 7/1/2021 | |
| E.R. Squibb & Sons, L.L.C. | 0003-2570 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 9/27/2022 | |
| Fresenius Kabi USA, LLC | 63323-401 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 1 1 | 5/18/2021 | |
| Fresenius Kabi USA, LLC | 63323-401 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 1 1 | 5/6/2022 | |
| E.R. Squibb & Sons, L.L.C. | 0003-2560 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 9/27/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/22/2024 | ||
Authorised | 9/21/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AZACTAM FOR INJECTION 1 g/vial | SIN00556P | INJECTION, POWDER, FOR SOLUTION | 1 g/vial | 4/29/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Hospira Aztreonam for Injection USP 1 gram/vial | 379671 | Medicine | A | 11/30/2021 | |
| Hospira Australia Emblaveo for Injection Aztreonam and Avibactam (1.5g/0.5g) Powder for Solution for Injection Single-Dose Vial | 490652 | Medicine | A | 6/3/2025 | |
| Azactam 1g powder for injection vial | 14032 | Medicine | A | 9/5/1991 | |
| Hospira Aztreonam for Injection USP 2 gram/vial | 379672 | Medicine | A | 11/30/2021 | |
| Lyophilized Aztreonam Lysine for export | 197216 | Medicine | A | 5/4/2012 | |
| Emblaveo powder for concentrate for solution for infusion Aztreonam and Avibactam 1.5 g/0.5 g vial | 456351 | Medicine | A | 7/25/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CAYSTON | gilead sciences canada inc | 02329840 | Powder For Solution - Inhalation | 75 MG / VIAL | 11/11/2009 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CAYSTON 75 mg POLVO Y DISOLVENTE PARA SOLUCION PARA INHALACION POR NEBULIZADOR | 09543002 | POLVO PARA SOLUCIÓN PARA INHALACIÓN POR NEBULIZADOR | Uso Hospitalario | Commercialized | |
| AZACTAM 1g POLVO PARA SOLUCION INYECTABLE | Bristol Myers Squibb S.A. | 57781 | POLVO PARA SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| EMBLAVEO 1,5 G/0,5 G POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION | 1241808001 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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