Ceftriaxone

CEFTRIAXONE- ceftriaxone sodium injection, powder, for solution
Samson Medical Technologies, LLC

1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection and other antibacterial drugs, Ceftriaxone for Injection 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 is indicated for the treatment of the following infections when caused by susceptible bacteria:

1.1 Lower Respiratory Tract Infections

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.

1.2 Skin and Skin Structure Infections

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 1, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis 1 or Peptostreptococcus species.

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The efficacy for these organisms in this organ system were studied in fewer than ten infections.

1.3 Complicated and Uncomplicated Urinary Tract Infections

Complicated and uncomplicated urinary tract infections caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae.

1.4 Pelvic Inflammatory Disease

Pelvic inflammatory disease caused by Neisseria gonorrhoeae. Ceftriaxone 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 is one of the suspected pathogens, appropriate antichlamydial coverage should be added.

1.5 Bacterial Septicemia

Bacterial septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae.

1.6 Bone and Joint Infections

Bone and joint infections caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species.

1.7 Intra-abdominal Infections

Intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species or Peptostreptococcus species.

1.8 Meningitis

Meningitis caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone sodium has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis and Escherichia coli ; however, the efficacy for these organisms in this organ system were studied in fewer than ten infections.

1.9 Surgical Prophylaxis

The preoperative administration of a single 1 gram dose of ceftriaxone 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 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 antibacterial in the prevention of infection following coronary artery bypass surgery.

2 DOSAGE AND ADMINISTRATION

Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak^® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak^® should not be used in patients who require less than the 1 gram dose of Ceftriaxone.

THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION WITH STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 mg per mL AND FURTHER DILUTION IN 50 mL OF A COMPATIBLE SOLUTION.

THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION

USE THIS FORMULATION OF CEFTRIAXONE ONLY IN PATIENTS WHO REQUIRE A 1 GRAM DOSE.

2.1 Adult Population

Ceftriaxone for Injection, USP, Pharmacy Bulk Package bag SmartPak^® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Ceftriaxone for Injection USP Pharmacy Bulk Package bag SmartPak^® should not be used in patients who require less than the 1 gram dose of Ceftriaxone.

Ceftriaxone for Injection should be reconstituted with Sterile Water for Injection, USP to a concentration of 100 mg per mL and further diluted in 50 mL of a compatible solution.

The recommended adult dosages are outlined in Table 1. Ceftriaxone for Injection, USP, Pharmacy Bulk Package SmartPak^® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Ceftriaxone should be administered intravenously (I.V.) over approximately 30 minutes.

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.

Table 1: Recommended Dosing Schedule for Ceftriaxone for Injection, USP

Site and Type of Infection	Dose	Frequency	Total Daily Dose
Usual Adult Dose	1 gram to 2 grams	Once a day or in equally divided doses every 12 hours	Should not exceed 4 grams*
Surgical prophylaxis	1 gram I.V. once	½ to 2 hours before surgery
Skin and Skin Structure Infections	50 to 75 mg per kg	Once a day or in equally divided doses every 12 hours	Should not exceed 2 grams
Meningitis	100 mg per kg	Once a day or in equally divided doses every 12 hours	Should not exceed 4 grams*
Serious Infections other than Meningitis	50 to 75 mg per kg	Every 12 hours	Should not exceed 2 grams
*Patients with hepatic impairment and significant renal impairment should not receive more than 2 grams per day of ceftriaxone. **This formulation of Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of ceftriaxone.