| Label: Refrigerate.
Usually restricted to one of the following: (1) Gram negative infections (primarily Pseudomonas) in penicillin allergic patients. (2) Patients at increased risk of aminoglycoside toxicity (poor renal function or rapidly changing renal function) with a gram negative infection. ***Lacks anaerobe coverage***
||Intravenous infusion solutions of AZACTAM not exceeding 2% w/v prepared with Sodium Chloride Injection, USP 0.9% or Dextrose Injection, USP 5%, to which clindamycin phosphate, gentamicin sulfate, tobramycin sulfate, or cefazolin sodium have been added at concentrations usually used clinically, are stable for up to 7 days
Ampicillin sodium admixtures with aztreonam in Sodium Chloride Injection, USP 0.9% are stable for 48 hours
Dextrose Injection, USP 5% is 8 hours
|Store in original packages at 20º to 25ºC (68º to 77ºF); avoid excessive heat.
Intravenous infusion solutions of AZACTAM not exceeding 2% w/v prepared with Sodium Chloride Injection, USP 0.9% or Dextrose Injection, USP 5%, to which clindamycin phosphate, gentamicin sulfate, tobramycin sulfate, or cefazolin sodium have been added at concentrations usually used clinically, are stable for up to 48 hours
Ampicillin sodium admixtures with aztreonam in Sodium Chloride Injection, USP 0.9% are stable for 24 hours
Dextrose Injection, USP 5% is 2 hours
||03 02 15
||Store in a freezer capable of maintaining a temperature of –20°C (–4°F).
The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 14 days (2°C-8°C/36°F-46°F)
|The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 48 hours (25°C/77°F)
||06 17 13
|Notes: Thaw frozen container at room temperature, 25°C (77°F) or in a refrigerator, 2°C to 8°C (36°F-46°F). After thawing is complete, invert the container to assure a well-mixed solution. (DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.)
Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.
The container should be visually inspected. Thawed solutions should not be used unless clear; solutions will be colorless to yellow. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. If after visual inspection the solution remains discolored, cloudy, or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.
CAUTION: Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
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. 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.
| AZACTAM DOSAGE GUIDELINES
|Type of Infection
|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
||6 or 8
| *Maximum recommended dose is 8 g per day.
Because of the serious nature of infections due to Pseudomonas aeruginosa, dosage of 2 g every 6 or 8 hours is recommended, at least upon initiation of therapy, in systemic infections caused by this organism in adults.
Renal Impairment in Adult Patients
Prolonged serum levels of aztreonam may occur in patients with transient or persistent renal insufficiency. Therefore, the dosage of AZACTAM should be halved in patients with estimated creatinine clearances between 10 mL/min/1.73 m2 and 30 mL/min/1.73 m2 after an initial loading dose of 1 g or 2 g.
When only the serum creatinine concentration is available, the following formula (based on sex, weight, and age of the patient) may be used to approximate the creatinine clearance (Clcr). The serum creatinine should represent a steady state of renal function.
Males: Clcr = [weight (kg) × (140-age)]/ 72× serum creatinine (mg/dL)
Females: 0.85 × above value
In patients with severe renal failure (creatinine clearance less than 10 mL/min/1.73 m2), such as those supported by hemodialysis, the usual dose of 500 mg, 1 g or 2 g should be given initially. The maintenance dose should be one-fourth of the usual initial dose given at the usual fixed interval of 6, 8 or 12 hours. For serious or life-threatening infections, in addition to the maintenance doses, one-eighth of the initial dose should be given after each hemodialysis session.
Renal Dosing:>30/ no change || 10-30/ 50% of usual dose q6-8h || <10/ 25% of usual dose q6-8h || HD/PD: see <10 guidelines. (HD: 500mg AD) Give loading dose of 1-2g before starting regimens above.
Preparation Of Parenteral Solutions
Upon the addition of the diluent to the container, contents should be shaken immediately and vigorously. Constituted solutions are not for multiple-dose use; should the entire volume in the container not be used for a single dose, the unused solution must be discarded.
Depending upon the concentration of aztreonam and diluent used, constituted AZACTAM yields a colorless to light straw yellow solution which may develop a slight pink tint on standing (potency is not affected). Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.
Admixtures With Other Antibiotics
Intravenous infusion solutions of AZACTAM not exceeding 2% w/v prepared with Sodium Chloride Injection, USP 0.9% or Dextrose Injection, USP 5%, to which clindamycin phosphate, gentamicin sulfate, tobramycin sulfate, or cefazolin sodium have been added at concentrations usually used clinically, are stable for up to 48 hours at room temperature or 7 days under refrigeration. Ampicillin sodium admixtures with aztreonam in Sodium Chloride Injection, USP 0.9% are stable for 24 hours at room temperature and 48 hours under refrigeration; stability in Dextrose Injection, USP 5% is 2 hours at room temperature and 8 hours under refrigeration.
Aztreonam-cloxacillin sodium and aztreonam-vancomycin hydrochloride admixtures are stable in Dianeal 137 (Peritoneal Dialysis Solution) with 4.25% Dextrose for up to 24 hours at room temperature.
Aztreonam is incompatible with nafcillin sodium, cephradine, and metronidazole.
Other admixtures are not recommended since compatibility data are not available.
Intravenous (IV) Solutions
For Bolus Injection: The contents of an AZACTAM (aztreonam for injection, USP) 15 mL capacity vial should be constituted with 6 mL to 10 mL Sterile Water for Injection, USP.
For Infusion: If the contents of a 15 mL capacity 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 with 5% Dextrose
Isolyte® M with 5% Dextrose
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 (IM) Solutions
The contents of an AZACTAM 15 mL capacity 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)
---- Storage/Stability ----
Stability Of IV And IM Solutions
AZACTAM solutions for IV infusion at concentrations not exceeding 2% w/v must be used within 48 hours following constitution if kept at controlled room temperature (59°- 86° F/15°- 30° C) or within 7 days if refrigerated (36°- 46° F/2°- 8° C).
AZACTAM 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 two excepted solutions must be used within 48 hours if stored at controlled room temperature or within 7 days if refrigerated.
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 AZACTAM (aztreonam for injection, USP) 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 AZACTAM into a compatible infusion solution during administration; in this case, the final dilution of aztreonam should provide a concentration not exceeding 2% w/v.
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. IM (preparation): 500mg/1.5 ml; 1 gram/ 3 ml; 2 grams/6 ml H20, BS-H20, NS. Greater volumes may be used.
AZACTAM® (aztreonam for injection, USP)
Single-dose 15 mL capacity vials:
1 g/vial: Packages of 10 NDC 51479-041-15
2 g/vial: Packages of 10 NDC 51479-042-15
Store original packages at room temperature; avoid excessive heat.
ALSO SUPPLIED AS:
AZACTAM® (aztreonam injection) in GALAXY plastic container (PL 2040) as a frozen, 50 mL single-dose intravenous solution as follows:
1 g aztreonam/50 mL container: Packages of 24 NDC 51479-048-01
2 g aztreonam/50 mL container: Packages of 24 NDC 51479-049-01
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
Elan Pharmaceuticals Inc.
San Diego, CA 92121 USA
Made in Italy
© 2004 Elan Pharmaceuticals, Inc.
Revised January 2007