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Ceftriaxone

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Ceftriaxone

Indications
Dosage
How Supplied

INDICATIONS

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection and Dextrose Injection and other antibacterial drugs 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.

Ceftriaxone for Injection and Dextrose Injection is indicated for the treatment of the following infections when caused by susceptible organisms:

LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens.

SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, * Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis* or Peptostreptococcus species.

URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae.

PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis one of the suspected pathogens, appropriate antichlamydial coverage should be added.

BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae.

BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species.

INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species.

MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis*and Escherichia coli.* '

* Efficacy for this organism in this organ system was studied in fewer than ten infections.

SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of Ceftriaxone (ceftriaxone sodium and dextrose injection ) for Injection and. Dextrose Injection may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years.of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery.

When administered prior to surgical procedures for which it is indicated, a single 1 g dose of Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) provides protection from most infections due to susceptible organisms throughout the course of the procedure.

Before instituting treatment with Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) , appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility tothe drug. Therapy may be instituted prior to obtaining results of susceptibility testing.

DOSAGE AND ADMINISTRATION

Ceftriaxone Injection and Dextrose Injection is intended for intravenous administration only.

ADULTS: The usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. The total daily dose should not exceed 4 grams.

If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium has no activity against this organism. For preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended.

PEDIATRIC PATIENTS: Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftriaxone (ceftriaxone sodium and dextrose injection ) . To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of ceftriaxone (ceftriaxone sodium and dextrose injection ) .

For the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). The total daily dose should.not exceed 2 grams.

For the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The total daily dose should not exceed 2 grams.

In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 grams daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hours). The usual duration of therapy is 7 to 14 days.

Generally, Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.

No dosage adjustment is necessary for patients with impairment of renal or hepatic function; however, blood levels should be monitored in patients with severe renal impairment [e.g., dialysis patients) and in patients with both renal and hepatic dysfunctions.

Vancomycin and fluconazole are physically incompatible with ceftriaxone (ceftriaxone sodium and dextrose injection ) in admixtures. When either of these drugs is to be administered concomitantly with ceftriaxone (ceftriaxone sodium and dextrose injection ) by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations.

After the indicated stability time periods, unused portions of solutions should be discarded. CAUTION: Do not use plastic containers in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

NOTE: Parenteral drug products should be inspected visually for particulate matter before administration.

Directions for Use of DUPLEX® Drug Delivery System

Removal from Multi-Pack Tray

  • Tear tape strips from one or both sides of the tray. Remove top tray.
  • To avoid inadvertent activation, DUPLEX Container should remain in the folded position until activation is intended.

Patient Labeling and Drug Powder/Diluent Inspection

  • Apply patient-specific label on foil side of container. USE CARE to avoid activation. Do not cover any portion of foil strip with patient label.
  • Unlatch side tab and unfold DUPLEX Container. (See Diagram 1.)
  • Diluent Inspection - illustration 1

  • Visually inspect diluent chamber for particulate matter.
  • Use only if container and seals are intact.
  • To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber. (See Diagram 2.)
  • Diluent Inspection - illustration 2

  • Protect.from light after removal of foil strip.
    • Note: If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date.
  • The product should be re-folded and the side tab latched until ready to activate.

Reconstitution (Activation)

  • Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use.
  • Unfold the DUPLEX Container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber. (See Diagram 3.)
  • Reconstitution (Activation) - illustration 3

  • Agitate the liquid-powder mixture until the drug powder is completely dissolved.

Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration.

Administration

  • Visually inspect the reconstituted solution for particulate matter.
  • Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port. (See Diagram 4.)
  • Administration - illustration 4

  • Prior to' attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired.
  • Using aseptic technique, remove the set port cover from the set port and attach sterile administration set.
  • Refer to Directions for Use accompanying the administration set.

Precautions

  • As with other cephalosporins, reconstituted Ceftriaxone (ceftriaxone sodium and dextrose injection ) for Injection and Dextrose Injection tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected.
  • Use only if prepared solution is clear and free from particulate matter.
  • Do not use in series connection.
  • Do not introduce additives into the DUPLEX Container.
  • Do not freeze.

Animal Pharmacology

Concretions consisting of the precipitated calcium salt of ceftriaxone (ceftriaxone sodium and dextrose injection ) have been found in the gallbladder bile of dogs and baboons treated with ceftriaxone (ceftriaxone sodium and dextrose injection ) .

These appeared as a gritty sediment in dogs that received 100 mg/kg/day for 4 weeks. A similar phenomenon has been observed in baboons but only after a protracted dosing period (6 months) at higher dose levels (335 mg/kg/day or more). The likelihood of this occurrence in humans is considered to be low, since ceftriaxone (ceftriaxone sodium and dextrose injection ) has a greater plasma half-life in humans, the calcium salt of ceftriaxone (ceftriaxone sodium and dextrose injection ) is more soluble in human gallbladder bile and the calcium content of human gallbladder bile is relatively low.

HOW SUPPLIED

Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) in the DUPLEX® Drug Delivery System is a flexible dual chamber container supplied in two concentrations. After reconstitution, the concentrations are equivalent to 1 g and 2 g ceftriaxone (ceftriaxone sodium and dextrose injection ) . The diluent chamber contains approximately 50 mL of Dextrose Injection. Dextrose injection has been adjusted to 3.74% and 2.22% for the 1 g and 2 g doses, respectively, such that the reconstituted solution is iso-osmotic.

Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) is supplied sterile and nonpyrogenic in the DUPLEX Drug Delivery System containers packaged 12 units per tray, 2 trays per case.

NDG Cat. No. Dose Volume
Ceftriaxone for Injection and Dextrose Injection
0264-3153-11 3153-11 1g 50 mL
Ceftriaxone for Injection and Dextrose Iniection
0264-3155-11 3155-11 2g 50 mL

Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).

DUPLEX® is a registered trademark of B. Braun Medical Inc. Revised: January 2007 B. Braun Medical Inc. Irvine, CA, USA 92614-5895. FDA Rev date: 9/10/2007

Last reviewed on RxList: 10/3/2007
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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