Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED/STORAGE AND HANDLING Ceftriaxone Injection, USP is supplied premixed as a frozen, iso-osmotic, sterile, nonpyrogenic solution of ceftriaxone sodium in a case of 24 x 50 mL single dose Galaxy containers. The following strengths are available: 1 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.9 gm Dextrose Hydrous, USP, added (NDC 0338-5002-41). 2 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.2 gm Dextrose Hydrous, USP, added (NDC 0338-5003-41). NOTE: Store Ceftriaxone Injection, USP in the frozen state at or below -20°C/-4°F. See DIRECTIONS FOR USE : Handle frozen product containers with care. Product containers may be fragile in the frozen state.; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL Container Label 1 g Container Label 1 g Baxter Ceftriaxone Injection, USP (In Dextrose) 1 g GALAXY Single Dose Container 50 mL Iso-osmotic NDC 0338-5002-41 Code 2G3505 Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx. 1.9 g Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual Dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks and solution clarity. Rx only. Store at or below -20°C (-4°F). Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Baxter and GALAXY are trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA PL 2040 Plastic 07-34-63-668 *BAR CODE POSITION ONLY 303385002417 Carton Label - 1 g - Panel 1 Carton Label - 1 g - Panel 1 Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic 07-04-65-179 Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze. Rx only 1 g Baxter Healthcare Corporation Deerfield, IL 60015 USA Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic 07-04-65-179 Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze. Rx only 1 g Baxter Healthcare Corporation Deerfield, IL 60015 USA Carton Label - 1 g - Panel 2 Carton Label - 1 g - Panel 2 NDC 0338-5002-41 Code 2G3504 *FOR BAR CODE POSITION ONLY (01) 503385002412 GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx. 1.9 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. NDC 0338-5002-41 Code 2G3504 *FOR BAR CODE POSITION ONLY (01) 503385002412 GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx. 1.9 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 2 g GALAXY Single Dose Container 50 mL Iso-osmotic NDC 0338-5003-41 Code 2G3505 Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx. 1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks and solution clarity. Rx only. Store at or below -20°C (-4°F). Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Baxter and GALAXY are trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA PL 2040 Plastic 07-34-63-670 *BAR CODE POSITION ONLY 303385003414 Carton Label - 2 g - Panel 1 Carton Label - 2 g - Panel 1 Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic 07-04-65-180 Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze. Rx only 2 g Baxter Healthcare Corporation Deerfield, IL 60015 USA Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic 07-04-65-180 Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze. Rx only 2 g Baxter Healthcare Corporation Deerfield, IL 60015 USA Carton Label - 2 g - Panel 2 Carton Label - 2 g - Panel 2 NDC 0338-5003-41 Code 2G3505 *FOR BAR CODE POSITION ONLY (01) 503385003419 GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx. 1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. NDC 0338-5003-41 Code 2G3505 *FOR BAR CODE POSITION ONLY (01) 503385003419 GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx. 1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Ceftriaxone 1 g Representative Container Label NDC 0338-5002 Ceftriaxone Representative Carton Label - 1 g - Panel 1 - NDC 0338-5002 Ceftriaxone Representative Carton Label - 1 g - Panel 2 - NDC 0338-5002 Ceftriaxone 2 g Container Label NDC 0338-5003 Ceftriaxone Representative Carton Label - 2 g - Panel 1 - NDC 0338-5003 Ceftriaxone Representative Carton Label - 2 g - Panel 2 - NDC 0338-5003
- HOW SUPPLIED/STORAGE AND HANDLING Ceftriaxone Injection, USP is supplied premixed as a frozen, iso-osmotic, sterile, nonpyrogenic solution of ceftriaxone sodium in a case of 24 x 50 mL single dose Galaxy containers. The following strengths are available: 1 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.9 gm Dextrose Hydrous, USP, added (NDC 0338-5002-41). 2 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.2 gm Dextrose Hydrous, USP, added (NDC 0338-5003-41). NOTE: Store Ceftriaxone Injection, USP in the frozen state at or below -20°C/-4°F. See DIRECTIONS FOR USE : Handle frozen product containers with care. Product containers may be fragile in the frozen state.
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL Container Label 1 g Container Label 1 g Baxter Ceftriaxone Injection, USP (In Dextrose) 1 g GALAXY Single Dose Container 50 mL Iso-osmotic NDC 0338-5002-41 Code 2G3505 Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx. 1.9 g Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual Dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks and solution clarity. Rx only. Store at or below -20°C (-4°F). Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Baxter and GALAXY are trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA PL 2040 Plastic 07-34-63-668 *BAR CODE POSITION ONLY 303385002417 Carton Label - 1 g - Panel 1 Carton Label - 1 g - Panel 1 Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic 07-04-65-179 Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze. Rx only 1 g Baxter Healthcare Corporation Deerfield, IL 60015 USA Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic 07-04-65-179 Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze. Rx only 1 g Baxter Healthcare Corporation Deerfield, IL 60015 USA Carton Label - 1 g - Panel 2 Carton Label - 1 g - Panel 2 NDC 0338-5002-41 Code 2G3504 *FOR BAR CODE POSITION ONLY (01) 503385002412 GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx. 1.9 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. NDC 0338-5002-41 Code 2G3504 *FOR BAR CODE POSITION ONLY (01) 503385002412 GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx. 1.9 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 2 g GALAXY Single Dose Container 50 mL Iso-osmotic NDC 0338-5003-41 Code 2G3505 Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx. 1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks and solution clarity. Rx only. Store at or below -20°C (-4°F). Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Baxter and GALAXY are trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA PL 2040 Plastic 07-34-63-670 *BAR CODE POSITION ONLY 303385003414 Carton Label - 2 g - Panel 1 Carton Label - 2 g - Panel 1 Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic 07-04-65-180 Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze. Rx only 2 g Baxter Healthcare Corporation Deerfield, IL 60015 USA Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic 07-04-65-180 Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze. Rx only 2 g Baxter Healthcare Corporation Deerfield, IL 60015 USA Carton Label - 2 g - Panel 2 Carton Label - 2 g - Panel 2 NDC 0338-5003-41 Code 2G3505 *FOR BAR CODE POSITION ONLY (01) 503385003419 GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx. 1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. NDC 0338-5003-41 Code 2G3505 *FOR BAR CODE POSITION ONLY (01) 503385003419 GALAXY Container Sterile Nonpyrogenic Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx. 1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0. Usual dosage: See package insert. Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. Ceftriaxone 1 g Representative Container Label NDC 0338-5002 Ceftriaxone Representative Carton Label - 1 g - Panel 1 - NDC 0338-5002 Ceftriaxone Representative Carton Label - 1 g - Panel 2 - NDC 0338-5002 Ceftriaxone 2 g Container Label NDC 0338-5003 Ceftriaxone Representative Carton Label - 2 g - Panel 1 - NDC 0338-5003 Ceftriaxone Representative Carton Label - 2 g - Panel 2 - NDC 0338-5003
Overview
Ceftriaxone Injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous administration. Ceftriaxone sodium is (6 R ,7 R )-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo- as -triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7 ² -( Z )-( O -methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C 18 H 16 N 8 Na 2 O 7 S 3 •7/2 H 2 O. It has a calculated molecular weight of 661.60 and the following structural formula: Ceftriaxone Sodium, USP is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. Ceftriaxone Injection, USP contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity. Ceftriaxone Injection, USP is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution premixed in a dextrose diluent. Dextrose, USP has been added to adjust the osmolality (approximately 1.9 g and 1.2 g as dextrose hydrous to the 1 g and 2 g dosages, respectively). The pH may be adjusted with sodium hydroxide and/or hydrochloric acid. Solutions of premixed Ceftriaxone Injection, USP may range from light yellow to amber in color. After thawing, the solution is intended for intravenous use. The pH of thawed solutions may range from 6.0 to 8.0. See HOW SUPPLIED for package description. The plastic container for the frozen solution is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers as well as by tissue culture toxicity studies. Chemical formulation for ceftriaxone sodium
Indications & Usage
Before instituting treatment with Ceftriaxone Injection, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone Injection and other antibacterial drugs, Ceftriaxone 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 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. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone and the comparator. The potentially lower clinical cure rate of ceftriaxone should be balanced against the potential advantages of parenteral therapy. 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 . UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae , including both penicillinase-and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae . PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae . Ceftriaxone, 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. 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 Clostridioides difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone 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 gm 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 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 gm dose of ceftriaxone provides protection from most infections due to susceptible organisms throughout the course of the procedure.
Dosage & Administration
Ceftriaxone Injection is administered intravenously. Do not further dilute ceftriaxone injection with products containing calcium, such as Ringer’s solution or Hartmann’s solution, because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see WARNINGS ). There have been no reports of an interaction between ceftriaxone and oral calcium-containing products. Neonates Hyperbilirubinemic neonates, especially prematures, should not be treated with Ceftriaxone Injection (see CONTRAINDICATIONS ). Ceftriaxone is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see CONTRAINDICATIONS ). Pediatric Patients 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. 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. For infections caused by Staphylococcus aureus (MSSA), the recommended daily dose is 2 to 4 grams, in order to achieve >90% target attainment. The total daily dose should not exceed 4 grams. If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftriaxone 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. Generally, Ceftriaxone 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 hepatic impairment or mild to moderate renal impairment.
Warnings & Precautions
WARNINGS Hypersensitivity BEFORE THERAPY WITH CEFTRIAXONE INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE THE USE OF SUBCUTANEOUS EPINEPHRINE AND OTHER EMERGENCY MEASURES. As with other cephalosporins, anaphylactic reactions with fatal outcome have been reported, even if a patient is not known to be allergic or previously exposed. Interaction with Calcium-Containing Products Do not further dilute ceftriaxone injection with products containing calcium, such as Ringer’s solution or Hartmann’s solution, because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION ). Neurological Adverse Reactions Serious neurological adverse reactions have been reported during postmarketing surveillance with ceftriaxone use. These reactions include encephalopathy (disturbance of consciousness including somnolence, lethargy, and confusion), seizures, myoclonus, and non-convulsive status epilepticus (see ADVERSE REACTIONS ). Some cases occurred in patients with severe renal impairment who did not receive appropriate dosage adjustment. However, in other cases, neurological adverse reactions occurred in patients receiving an appropriate dosage adjustment. The neurological adverse reactions were reversible and resolved after discontinuation. If neurological adverse reactions associated with Ceftriaxone Injection therapy occur, discontinue Ceftriaxone Injection and institute appropriate supportive measures. Make appropriate dosage adjustments in patients with severe renal impairment (see DOSAGE AND ADMINISTRATION ). Clostridioides difficile Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ceftriaxone Injection, 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 two 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. Hemolytic Anemia An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials including ceftriaxone. Severe cases of hemolytic anemia, including fatalities, have been reported during treatment in both adults and children. If a patient develops anemia while on ceftriaxone, the diagnosis of a cephalosporin associated anemia should be considered and ceftriaxone stopped until the etiology is determined.
Contraindications
Ceftriaxone Injection is contraindicated in patients with known allergy to the cephalosporin class of antibiotics. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products. Neonates (≤28 days) Hyperbilirubinemic neonates, especially prematures, should not be treated with Ceftriaxone Injection. In vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin, leading to a possible risk of bilirubin encephalopathy in these patients. Ceftriaxone Injection is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see CLINICAL PHARMACOLOGY , WARNINGS and DOSAGE AND ADMINISTRATION ). A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving ceftriaxone and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both ceftriaxone and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom ceftriaxone and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates.
Adverse Reactions
Ceftriaxone is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to ceftriaxone therapy or of uncertain etiology, were observed: LOCAL REACTIONS — pain, induration and tenderness was 1% overall. Phlebitis was reported in <1% after IV administration. HYPERSENSITIVITY — rash (1.7%). Less frequently reported (<1%) were pruritus, fever or chills. HEMATOLOGIC — eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). Less frequently reported (<1%) were anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time. GASTROINTESTINAL — diarrhea (2.7%). Less frequently reported (<1%) were nausea or vomiting, and dysgeusia. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS ). HEPATIC — elevations of SGOT (3.1%) or SGPT (3.3%). Less frequently reported (<1%) were elevations of alkaline phosphatase and bilirubin. RENAL — elevations of the BUN (1.2%). Less frequently reported (<1%) were elevations of creatinine and the presence of casts in the urine. CENTRAL NERVOUS SYSTEM — headache or dizziness were reported occasionally (<1%). GENITOURINARY — moniliasis or vaginitis were reported occasionally (<1%). MISCELLANEOUS — diaphoresis and flushing were reported occasionally (<1%). Other rarely observed adverse reactions (<0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness. Postmarketing Experience In addition to the adverse reactions reported during clinical trials, the following adverse experiences have been reported during clinical practice in patients treated with ceftriaxone. Data are generally insufficient to allow an estimate of incidence or to establish causation. A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving ceftriaxone and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both ceftriaxone and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom ceftriaxone and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates. IMMUNE SYSTEM DISORDER – Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction. GASTROINTESTINAL – stomatitis and glossitis. GENITOURINARY – oliguria. DERMATOLOGIC – exanthema, allergic dermatitis, urticaria, edema. As with many medications, isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome/toxic epidermal necrolysis) have been reported. NEUROLOGIC – Encephalopathy, seizures, myoclonus, and non-convulsive status epilepticus (see WARNINGS AND PRECAUTIONS ). Cephalosporin Class Adverse Reactions In addition to the adverse reactions listed above which have been observed in patients treated with ceftriaxone, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics: Adverse Reactions Allergic reactions, drug fever, serum sickness-like reaction, renal dysfunction, toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, fall in prothrombin activity, and superinfection. Altered Laboratory Tests Positive direct Coombs’ test, false-positive test for urinary glucose, and elevated LDH. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION ). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
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