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Black Box Warning
TITLE
See full prescribing information for complete Boxed Warning.
PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION
Overview
Ceftriaxone is a antibiotic that is FDA approved for the treatment of lower respiratory tract infections, acute bacterial otitis media, skin infections, urinary tract infections, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intraabdominal infection, meningitis, surgical prophylaxis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, pseudomembranous enterocolitis, hemolytic anemia, hypersensitivity reaction, kernicterus, renal failure, lung injury.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Before instituting treatment with ceftriaxone 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 and other antibacterial drugs, ceftriaxone for injection, USP 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, USP is indicated for the treatment of the following infections when caused by susceptible organisms:
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 for injection, USP 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 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.
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 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 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 g dose of ceftriaxone provides protection from most infections due to susceptible organisms throughout the course of the procedure.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Acute otitis media
1 to 2 g IV/IM every 24 hours or in divided doses twice a day; maximum 4 g/day.
Bacteremia associated with intravascular line
(Due to Escherichia coli and Klebsiella species, extended-spectrum beta-lactamase negative) 1 to 2 g IV daily.[1]
Bacterial endocarditis; Prophylaxis: (high-risk patients; dental, respiratory, or infected skin/skin structure or musculoskeletal tissue procedures) 1 g IV or IM 30 to 60 minutes prior to procedure [2]
Bacterial meningitis
4 g/day IV divided every 12 to 24 hours; maximum 4 g/day[3]
Bacterial musculoskeletal infection
1 to 2 g IV/IM every 24 hours or in divided doses twice a day; maximum 4 g/day
250 mg IM as a single dose plus doxycycline 100 mg ORALLY twice daily for 10 days.
Gonorrhea
Uncomplicated, 250 mg IM as a single dose plus either a single dose of azithromycin 1 g ORALLY or doxycycline 100 mg ORALLY twice daily for 7 days
Gonorrhea
Conjunctivitis, 1 g IM as a single dose
Gonorrhea
Disseminated, 1 g IV or IM every 24 hours for 24 to 48 hours after improvement begins then switch to appropriate oral therapy to complete at least 1 week of therapy
Gonorrhea
Meningitis and endocarditis, 1 to 2 g IV every 12 hours, for 10 to 14 days (meningitis) or at least 4 weeks (endocarditis)
Infection of skin AND/OR subcutaneous tissue: 1 to 2 g IV/IM every 24 hours or in divided doses twice a day; maximum 4 g/day
Infectious disease of abdomen: 1 to 2 g IV/IM every 24 hours or in divided doses twice a day; maximum 4 g/day
Infective endocarditis
(Native valve, highly penicillin-susceptible streptococci) 2 g IV/IM every 24 hours for 4 weeks[5]
Infective endocarditis: (native valve, highly penicillin-susceptible streptococci) alternative therapy, 2 g IV/IM every 24 hours AND gentamicin sulfate 3 mg/kg IV/IM in 1 dose (preferred) or in 3 equally divided doses for 2 weeks[6]
Infective endocarditis: (native valve, relatively penicillin-resistant streptococci) 2 g IV/IM every 24 hours for 4 weeks AND gentamicin sulfate 3 mg/kg IV/IM in 1 dose (preferred) or in 3 equally divided doses for 2 weeks.
Infective endocarditis
(Prosthetic valve, penicillin-susceptible streptococci) 2 g IV/IM every 24 hours for 6 weeks WITH or WITHOUT gentamicin sulfate 3 mg/kg IV/IM in 1 dose (preferred) or in 3 equally divided doses for 2 weeks.
Infective endocarditis
(Prosthetic valve, penicillin-resistant streptococci) 2 g IV/IM every 24 hours AND gentamicin sulfate 3 mg/kg IV/IM in 1 dose (preferred) or in 3 equally divided doses for 6 weeks [10][11]
Infective endocarditis: (enterococcal, strains resistant to penicillin, aminoglycoside, and vancomycin (E faecalis)) 2 g IV/IM every 12 hours AND ampicillin sodium 2 g IV every 4 hours for a minimum of 8 weeks.
Infective endocarditis
(HACEK microorganisms) 2 g IV/IM every 24 hours for 4 to 6 weeks.
Infective endocarditis
(Suspected Bartonella, culture-negative) 2 g IV/IM every 24 hours for 6 weeks AND gentamicin sulfate 1 mg/kg IV/IM every 8 hours for 2 weeks WITH or WITHOUT doxycycline 100 mg IV or ORALLY every 12 hours for 6 weeks.
Infective proctitis
250 mg IM as a single dose plus doxycycline 100 mg ORALLY twice daily for 7 days
Lower respiratory tract infection
1 to 2 g IV/IM every 24 hours or in divided doses twice a day; maximum 4 g/day
Lyme disease
2 g IV once daily for 14 days (range, 10 to 28 days) for early Lyme disease with acute neurological disease manifested by meningitis or radiculopathy, or patients with seventh-cranial-nerve palsy with CNS involvement; for 14 to 21 days for the initial treatment of hospitalized patients with Lyme carditis; for 14 to 28 days for Lyme arthritis with neurological involvement, including those refractory to oral therapy, or late neurologic Lyme disease.
Pelvic inflammatory disease
1 to 2 g IV/IM every 24 hours or in divided doses twice a day; maximum 4 g/day.
Pelvic inflammatory disease
250 mg IM as a single dose plus doxycycline 100 mg ORALLY twice daily for 14 days, with or without metronidazole 500 mg ORALLY twice daily for 14 days.
Postoperative infection; Prophylaxis
1 g IV 0.5 to 2 hours prior to surgery.
Septicemia
1 to 2 g IV every 24 hours or in divided doses twice a day; maximum 4 g/day.
Sexually transmitted infectious disease; Prophylaxis - Victim of sexual aggression
250 mg IM as a single dose plus metronidazole 2 g ORALLY as a single dose plus either azithromycin 1 g ORALLY as a single dose or doxycycline 100 mg ORALLY twice daily for 7 days.
Urinary tract infectious disease
1 to 2 g IV/IM every 24 hours or in divided doses twice a day; maximum 4 g/day.
Sexually transmitted infectious disease; Prophylaxis - Victim of sexual aggression
Typhoid fever
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
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 g.
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 g.
In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 g). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 g 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.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ceftriaxone in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ceftriaxone in pediatric patients.
Contraindications
Condition1
Warnings
TITLE
See full prescribing information for complete Boxed Warning.
PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Ceftriaxone in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Ceftriaxone in the drug label.
