AZACTAM 2 g/1
AZTREONAM · INJECTION, POWDER, FOR SOLUTION · E.R. Squibb & Sons, L.L.C.
AZACTAM is a injection, powder, for solution containing aztreonam at 2 g/1, taken intramuscular. Manufactured by E.R. Squibb & Sons, L.L.C..
Key Facts
- Brand Name
- AZACTAM
- Generic Name
- AZTREONAM
- NDC Code (Product)
0003-2570- Manufacturer
- E.R. Squibb & Sons, L.L.C.
- Strength
- 2 g/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- NDA050580
- Drug Class
- Monobactam Antibacterial [EPC]
- Marketing Start
- 04/01/2010
Recall History
Sentara Enterprises
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection, USP) and other antibacterial drugs, AZACTAM should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. AZACTAM is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms: Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , Pseudomonas aeruginosa , Enterobacter cloacae , Klebsiella oxytoca *, Citrobacter species*, and Serratia marcescens *. Lower Respiratory Tract Infections , including pneumonia and bronchitis caused by Escherichia coli , Klebsiella pneumoniae , Pseudomonas aeruginosa , Haemophilus influenzae , Proteus mirabilis …
Dosage & Administration
DOSAGE AND ADMINISTRATION Dosage in Adult Patients AZACTAM may be administered intravenously or by intramuscular injection. Dosage and route of administration should be determined by susceptibility of the causative organisms, severity and site of infection, and the condition of the patient. Table 2: AZACTAM Dosage Guidelines for Adults* * Maximum recommended dose is 8 g per day. Type of Infection Dose Frequency (hours) Urinary tract infections 500 mg or 1 g 8 or 12 Moderately severe systemic infections 1 g or 2 g 8 or 12 Severe systemic or life-threatening infections 2 g 6 or 8 Because of the serious nature of infections due to Pseudomonas aeruginosa , dosage of 2 g every six or eight hours is recommended, at least upon initiation of therapy, in systemic infections caused by this organism. The intravenous route is recommended for patients requiring single doses greater than 1 g or those with bacterial septicemia, localized parenchymal abscess (eg, intra-abdominal abscess), peritonitis, or other severe systemic or life-threatening infections. The duration of therapy depends on the severity of infection. Generally, AZACTAM should be continued for at least 48 hours after the patient b…
Warnings
WARNINGS Both animal and human data suggest that AZACTAM (aztreonam for injection, USP) is rarely cross-reactive with other beta-lactam antibiotics and weakly immunogenic. Treatment with aztreonam can result in hypersensitivity reactions in patients with or without prior exposure. (See CONTRAINDICATIONS .) Careful inquiry should be made to determine whether the patient has any history of hypersensitivity reactions to any allergens. While cross-reactivity of aztreonam with other beta-lactam antibiotics is rare, this drug should be administered with caution to any patient with a history of hypersensitivity to beta-lactams (eg, penicillins, cephalosporins, and/or carbapenems). Treatment with aztreonam can result in hypersensitivity reactions in patients with or without prior exposure to aztreonam. If an allergic reaction to aztreonam occurs, discontinue the drug and institute supportive treatment as appropriate (eg, maintenance of ventilation, pressor amines, antihistamines, corticosteroids). Serious hypersensitivity reactions may require epinephrine and other emergency measures. (See ADVERSE REACTIONS .) Clostridium difficile –associated diarrhea (CDAD) has been reported with use of …
Contraindications
CONTRAINDICATIONS This preparation is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation.
Adverse Reactions
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 approximately 1.9% and 2.4%, respectively. Systemic reactions (considered to be related to therapy or of uncertain etiology) occurring at an incidence of 1% to 1.3% include diarrhea, nausea and/or vomiting, and rash. Reactions occurring at an incidence of less than 1% are listed within each body system in order of decreasing severity: Hypersensitivity —anaphylaxis, angioedema, bronchospasm Hematologic —pancytopenia, neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosis Gastrointestinal —abdominal cramps; rare cases of C. difficile –associated diarrhea, including pseudomembranous colitis, or gastrointestinal bleeding have been reported. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS .) Dermatologic —toxic epidermal necrolysis (see WARNINGS ), purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis Cardiovascular —hypotension, transient ECG changes …
Frequently Asked Questions
What is AZACTAM used for?
AZACTAM contains AZTREONAM. It is a injection, powder, for solution taken intramuscular. Consult your doctor for specific uses.
Is AZACTAM a controlled substance?
AZACTAM is not classified as a controlled substance by the DEA.
What is the generic name for AZACTAM?
The generic name for AZACTAM is AZTREONAM. There are 6 other brand versions of AZTREONAM.
What is the NDC code for AZACTAM 2 g/1?
The NDC (National Drug Code) for AZACTAM 2 g/1 is 0003-2570, listed by E.R. Squibb & Sons, L.L.C..