azactam
Azactam (Aztreonam) is a medication used to treat Cellulitis, Endometritis, Pseudomonas Infections, Respiratory Tract Infections.
Aztreonam · by Labs Delbert
Key facts
- Active ingredient
- Aztreonam
- Form
- Injectable
- Strength
- Aztreonam 1GM/VIAL · Aztreonam 2GM/VIAL · Aztreonam 500MG/VIAL **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons**
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- cellulitis, endometritis, pseudomonas infections
- Manufacturer
- Labs Delbert
- FDA application
- NDA050580
What is Azactam?
From the FDA label:AZACTAM ® (aztreonam for injection, USP) contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum . It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (eg, penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula: C 13 H 17 N 5 O 8 S 2 MW 435.44 AZACTAM is a sterile, nonpyrogenic, sodium-free, white powder containing 0.78 grams arginine per 1 gram of aztreonam and 1.54 grams arginine per 2 grams of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5. Sructural Formula Aztreonam.jpg
How to use
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 becomes asymptomatic or evidence of bacterial eradication has been obtained. Persistent infections may require treatment for several weeks. Doses smaller than those indicated should not be used. Renal Impairment in Adult…
Side effects
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 (ventricular bigeminy and PVC), flushing Respiratory —wheezing, dyspnea, chest pain Hepatobiliary —hepatitis, jaundice Nervous System —seizure, confusion, encephalopathy, vertigo, paresthesia, insomnia, dizziness…
Warnings
Important safety information
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 nearly all antibacterial agents, including AZACTAM, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Rare cases of toxic epidermal necrolysis have been reported in association with aztreonam in patients undergoing bone marrow transplant with multiple risk factors including sepsis, radiation therapy, and other concomitantly administered drugs associated with toxic epidermal necrolysis.
Who should not take Azactam
This preparation is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation.
Overdose — what happens if you take too much
If necessary, aztreonam may be cleared from the serum by hemodialysis and/or peritoneal dialysis.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Azactam treat?
- Azactam (Aztreonam) may be used to treat cellulitis, endometritis, pseudomonas infections, respiratory tract infections, urinary tract infections, sepsis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Azactam?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Azactam. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Azactam?
- Azactam is marketed by Labs Delbert. You can see Labs Delbert's full profile, rating, and other products on pharmaranks.
- Is Azactam a brand-name or generic drug?
- Azactam is a brand-name product with the active ingredient Aztreonam.
- Is Azactam available over the counter?
- No. Azactam is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Azactam come in?
- Azactam is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Azactam FDA-registered?
- Azactam is on record with the U.S. FDA under application number NDA050580. You can verify this on its official FDA label.
- Is Azactam safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Azactam. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Azactam?
- Azactam's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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