Azactam

Azactam Manufacturers

• Cardinal Health
  

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  Azactam | Cardinal Health

  

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  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.

  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.

                                               weight (kg) × (140−age)
                 Males: Clcr = ———————————————
                                            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.

  Dosage in the Elderly

  Renal status is a major determinant of dosage in the elderly; these patients in particular may have diminished renal function. Serum creatinine may not be an accurate determinant of renal status. Therefore, as with all antibiotics eliminated by the kidneys, estimates of creatinine clearance should be obtained and appropriate dosage modifications made if necessary.

  Dosage in Pediatric Patients

  AZACTAM should be administered intravenously to pediatric patients with normal renal function. There are insufficient data regarding intramuscular administration to pediatric patients or dosing in pediatric patients with renal impairment. (See PRECAUTIONS: Pediatric Use.)

  AZACTAM DOSAGE GUIDELINES Type of Infection Dose Frequency
  (hours) ADULTS* 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    * Maximum recommended dose is 8 g per day. PEDIATRIC PATIENTS** Mild to moderate infections 30 mg/kg 8 Moderate to severe infections 30 mg/kg 6 or 8    ** Maximum recommended dose is 120 mg/kg/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.

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• E.r. Squibb & Sons, L.l.c.
  

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  Azactam | E.r. Squibb & Sons, L.l.c.

  

  ---

  Dosage in Adult Patients

  AZACTAM, an intravenous solution in GALAXY plastic containers (PL 2040), is intended for intravenous use only. Dosage should be determined by susceptibility of the causative organisms, severity and site of infection, and the condition of the patient.

  Table 4: Azactam Dosage Guidelines for Adults* Type of Infection Dose Frequency
  (hours) * Maximum recommended dose is 8 g per day. 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 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 and 30 mL/min/1.73 m2 after an initial loading dose of 1 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.

                                               weight (kg) × (140−age)
                 Males: Clcr = ———————————————
                                            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.

  Dosage in the Elderly

  Renal status is a major determinant of dosage in the elderly; these patients in particular may have diminished renal function. Serum creatinine may not be an accurate determinant of renal status. Therefore, as with all antibiotics eliminated by the kidneys, estimates of creatinine clearance should be obtained and appropriate dosage modifications made if necessary.

  Dosage in Pediatric Patients

  AZACTAM should be administered intravenously to pediatric patients with normal renal function. There are insufficient data regarding intramuscular administration to pediatric patients or dosing in pediatric patients with renal impairment. (See PRECAUTIONS: Pediatric Use.)

  Table 5: Azactam Dosage Guidelines for Pediatric Patients* Type of Infection Dose Frequency
  (hours) * Maximum recommended dose is 120 mg/kg/day. Mild to moderate infections 30 mg/kg 8 Moderate to severe infections 30 mg/kg 6 or 8 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 respiratory tract, skin and skin-structure, and intra-abdominal infections.

  Directions for Use of AZACTAM (aztreonam injection) in GALAXY Plastic Container (PL 2040).

  AZACTAM is to be administered as an intermittent intravenous infusion only.

  Storage

  Store in a freezer capable of maintaining a temperature of –20°C (–4°F).

  Thawing of Plastic Containers

  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.

  DO NOT ADD SUPPLEMENTARY MEDICATION.

  The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for either 14 days under refrigeration (2°C-8°C/36°F-46°F) or for 48 hours at room temperature (25°C/77°F). DO NOT REFREEZE THAWED ANTIBIOTICS.

  Preparation for Intravenous Administration

  Use aseptic technique.

  Suspend container(s) from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set.

  Additives or other medication should not be added to AZACTAM or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, it should be flushed before and after infusion of AZACTAM with an infusion solution compatible with AZACTAM (aztreonam injection) in GALAXY plastic container (PL 2040)* and any other drug(s) administered via this common line.

  It is recommended that the intravenous administration apparatus be replaced at least once every 48 hours.

  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.

  Intravenous Administration

  Infusion of AZACTAM should be completed within a 20- to 60-minute period. The plastic container is a single-dose unit; discard any unused portion remaining in the container.

  *The following infusion solutions are compatible with AZACTAM (aztreonam injection) in GALAXY plastic container (PL 2040):

    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   Isolyte ® E with 5% Dextrose   Isolyte ® M with 5% Dextrose   Normosol ®-R   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 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 respiratory tract, skin and skin-structure, and intra-abdominal infections.

  Directions for Use of AZACTAM (aztreonam injection) in GALAXY Plastic Container (PL 2040).

  AZACTAM is to be administered as an intermittent intravenous infusion only.

  Preparation for Intravenous Administration

  Use aseptic technique.

  Suspend container(s) from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set.

  Additives or other medication should not be added to AZACTAM or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, it should be flushed before and after infusion of AZACTAM with an infusion solution compatible with AZACTAM (aztreonam injection) in GALAXY plastic container (PL 2040)* and any other drug(s) administered via this common line.

  It is recommended that the intravenous administration apparatus be replaced at least once every 48 hours.

  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.

  Intravenous Administration

  Infusion of AZACTAM should be completed within a 20- to 60-minute period. The plastic container is a single-dose unit; discard any unused portion remaining in the container.

  *The following infusion solutions are compatible with AZACTAM (aztreonam injection) in GALAXY plastic container (PL 2040):

    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   Isolyte ® E with 5% Dextrose   Isolyte ® M with 5% Dextrose   Normosol ®-R   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

  Close
  No Recall

  More Info
• E.r. Squibb & Sons, L.l.c.
  

  ×

  Azactam | E.r. Squibb & Sons, L.l.c.

  

  ---

  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 4: Azactam Dosage Guidelines for Adults* Type of Infection Dose Frequency
  (hours) * Maximum recommended dose is 8 g per day. 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 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 and 30 mL/min/1.73 m2 after an initial loading dose of 1 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.

                                               weight (kg) × (140−age)
                 Males: Clcr = ———————————————
                                            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.

  Dosage in the Elderly

  Renal status is a major determinant of dosage in the elderly; these patients in particular may have diminished renal function. Serum creatinine may not be an accurate determinant of renal status. Therefore, as with all antibiotics eliminated by the kidneys, estimates of creatinine clearance should be obtained and appropriate dosage modifications made if necessary.

  Dosage in Pediatric Patients

  AZACTAM should be administered intravenously to pediatric patients with normal renal function. There are insufficient data regarding intramuscular administration to pediatric patients or dosing in pediatric patients with renal impairment. (See PRECAUTIONS: Pediatric Use.)

  Table 5: Azactam Dosage Guidelines for Pediatric Patients* Type of Infection Dose Frequency
  (hours) * Maximum recommended dose is 120 mg/kg/day. Mild to moderate infections 30 mg/kg 8 Moderate to severe infections 30 mg/kg 6 or 8 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 respiratory tract, skin and skin-structure, and intra-abdominal infections.

  Preparation of Parenteral Solutions General

  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 Solutions

  For Bolus Injection: The contents of an AZACTAM 15 mL capacity vial should be constituted with 6 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   Isolyte ® E with 5% Dextrose   Isolyte ® M with 5% Dextrose   Normosol ®-R   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 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) Stability of Intravenous and Intramuscular Solutions

  AZACTAM solutions for intravenous infusion at concentrations not exceeding 2% w/v must be used within 48 hours following constitution if kept at controlled room temperature (59°F-86°F/15°C-30°C) or within 7 days if refrigerated (36°F-46°F/2°C-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 2 excepted solutions must be used within 48 hours if stored at controlled room temperature or within 7 days if refrigerated.

  Intravenous Administration

  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 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 (see Preparation of Parenteral Solutions: Intravenous Solutions: For Infusion) into a compatible infusion solution during administration; in this case, the final dilution of aztreonam should provide a concentration not exceeding 2% w/v.

  Intramuscular Administration

  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.

  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 4: Azactam Dosage Guidelines for Adults* Type of Infection Dose Frequency
  (hours) * Maximum recommended dose is 8 g per day. 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 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 and 30 mL/min/1.73 m2 after an initial loading dose of 1 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.

                                               weight (kg) × (140−age)
                 Males: Clcr = ———————————————
                                            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.

  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 respiratory tract, skin and skin-structure, and intra-abdominal infections.

  Preparation of Parenteral Solutions General

  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 Solutions

  For Bolus Injection: The contents of an AZACTAM 15 mL capacity vial should be constituted with 6 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   Isolyte ® E with 5% Dextrose   Isolyte ® M with 5% Dextrose   Normosol ®-R   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 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) Stability of Intravenous and Intramuscular Solutions

  AZACTAM solutions for intravenous infusion at concentrations not exceeding 2% w/v must be used within 48 hours following constitution if kept at controlled room temperature (59°F-86°F/15°C-30°C) or within 7 days if refrigerated (36°F-46°F/2°C-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 2 excepted solutions must be used within 48 hours if stored at controlled room temperature or within 7 days if refrigerated.

  Intravenous Administration

  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 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 (see Preparation of Parenteral Solutions: Intravenous Solutions: For Infusion) into a compatible infusion solution during administration; in this case, the final dilution of aztreonam should provide a concentration not exceeding 2% w/v.

  Intramuscular Administration

  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.

  General

  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 Solutions

  For Bolus Injection: The contents of an AZACTAM 15 mL capacity vial should be constituted with 6 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   Isolyte ® E with 5% Dextrose   Isolyte ® M with 5% Dextrose   Normosol ®-R   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

  For Bolus Injection: The contents of an AZACTAM 15 mL capacity vial should be constituted with 6 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   Isolyte ® E with 5% Dextrose   Isolyte ® M with 5% Dextrose   Normosol ®-R   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 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) Stability of Intravenous and Intramuscular Solutions

  AZACTAM solutions for intravenous infusion at concentrations not exceeding 2% w/v must be used within 48 hours following constitution if kept at controlled room temperature (59°F-86°F/15°C-30°C) or within 7 days if refrigerated (36°F-46°F/2°C-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 2 excepted solutions must be used within 48 hours if stored at controlled room temperature or within 7 days if refrigerated.

  Intravenous Administration

  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 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 (see Preparation of Parenteral Solutions: Intravenous Solutions: For Infusion) into a compatible infusion solution during administration; in this case, the final dilution of aztreonam should provide a concentration not exceeding 2% w/v.

  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 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 (see Preparation of Parenteral Solutions: Intravenous Solutions: For Infusion) into a compatible infusion solution during administration; in this case, the final dilution of aztreonam should provide a concentration not exceeding 2% w/v.

  Intramuscular Administration

  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.

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