Ceftriaxone

Rocephin is supplied as a sterile crystalline powder in glass vials. The following packages are available:

Vials containing 500 mg equivalent of ceftriaxone. Box of 1 (NDC 0004-1963-02) and box of 10 (NDC 0004-1963-01).

Vials containing 1 gm equivalent of ceftriaxone. Box of 1 (NDC 0004-1964-04) and box of 10 (NDC 0004-1964-01).

NOTE: Rocephin sterile powder should be stored at room temperature, 77°F (25°C) or below, and protected from light.

Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ceftriaxone, there are no specific foods that you must exclude from your diet when receiving this medication.
 

Before taking ceftriaxone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to ceftriaxone or to any ingredient of ceftriaxone
• are allergic to similar antibiotics (penicillins, cephalosporins)
• have kidney problems
• have liver problems
• have gastrointestinal (stomach or bowel) problems
• have a history of seizure activity
• are receiving an infusion that contains calcium
• are pregnant or are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Rocephin is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to Rocephin therapy or of uncertain etiology, were observed:

LOCAL REACTIONS - pain, induration and tenderness was 1% overall. Phlebitis was reported in < 1% after IV administration. The incidence of warmth, tightness or induration was 17% (3/17) after IM administration of 350 mg/mL and 5% (1/20) after IM administration of 250 mg/mL.

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - injection site pain (0.6%).

HYPERSENSITIVITY - rash (1.7%). Less frequently reported ( < 1%) were pruritus, fever or chills.

INFECTIONS AND INFESTATIONS - genital fungal infection (0.1%).

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.

BLOOD AND LYMPHATIC DISORDERS - granulocytopenia (0.9%), coagulopathy (0.4%). .

GASTROINTESTINAL - diarrhea/loose stools (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 aspartate aminotransferase (AST) (3.1%) or alanine aminotransferase (ALT) (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%).

INVESTIGATIONS - blood creatinine increased (0.6%).

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 Rocephin. 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 Rocephin and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both Rocephin 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 Rocephin 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.

GASTROINTESTINAL - pancreatitis, stomatitis and glossitis.

GENITOURINARY - oliguria, ureteric obstruction, post-renal acute renal failure.

DERMATOLOGIC - exanthema, allergic dermatitis, urticaria, edema; acute generalized exanthematous pustulosis (AGEP) and isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis) have been reported.

HEMATOLOGICAL CHANGES: Isolated cases of agranulocytosis ( < 500/mm³) have been reported, most of them after 10 days of treatment and following total doses of 20 g or more.

NERVOUS SYSTEM DISORDERS: convulsion

OTHER, Adverse Reactions: symptomatic precipitation of ceftriaxone calcium salt in the gallbladder, kernicterus, oliguria, and anaphylactic or anaphylactoid reactions.

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, and superinfection.

Altered Laboratory Tests: Positive direct Coombs' test, false-positive test for urinary glucose, and elevated LDH (see PRECAUTIONS).

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.

Read the entire FDA prescribing information for Rocephin (Ceftriaxone)

Ceftriaxone for Injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R,7R)-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, 72-(Z)- (O-methyloxime), disodium salt, sesquaterhydrate.

The chemical formula of Ceftriaxone sodium is C18H16N8Na2O7S3∙3.5H2O. It has a calculated molecular weight of 661.59 and the following structural formula:

Ceftriaxone for Injection, 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. The pH of a 1% aqueous solution is approximately 6.7. The color of Ceftriaxone for Injection, USP solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.

Each Pharmacy Bulk Package is supplied as a dry powder in vials containing sterile Ceftriaxone sodium, USP equivalent to 10 grams of Ceftriaxone and is intended for intravenous infusion only. Ceftriaxone for Injection, USP contains approximately 83 mg (3.6 mEq) of sodium per gram of Ceftriaxone activity.

A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE. (See DOSAGE AND ADMINISTRATION, and DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE.)

Concretions consisting of the precipitated calcium salt of Ceftriaxone have been found in the gallbladder bile of dogs and baboons treated with Ceftriaxone.

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 has a greater plasma half-life in humans, the calcium salt of Ceftriaxone is more soluble in human gallbladder bile and the calcium content of human gallbladder bile is relatively low.

Ceftriaxone for Injection, USP is supplied as a sterile crystalline powder in glass vials. The following packages are available:

Bulk pharmacy containers

NOT FOR DIRECT ADMINISTRATION.

OTHER SIZE PACKAGE AVAILABLE

Storage Prior to Reconstitution

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

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Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Generic: 20 mg/mL (50 mL); 40 mg/mL (50 mL)

Solution Reconstituted, Injection:

Rocephin: 500 mg (1 ea [DSC]); 1 g (1 ea [DSC])

Generic: 250 mg (1 ea); 500 mg (1 ea); 1 g (1 ea); 2 g (1 ea); 100 g (1 ea)

Solution Reconstituted, Intravenous:

Generic: 1 g (1 ea); 2 g (1 ea); 10 g (1 ea)

• Rocephin [DSC]

Acute bacterial otitis media: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella catarrhalis (including beta-lactamase-producing strains).

Bacterial septicemia: Caused by Staphylococcus aureus, S. pneumoniae, Escherichia coli, H. influenzae, or Klebsiella pneumoniae.

Bone and joint infections: Caused by S. aureus, S. pneumoniae, E. coli, Proteus mirabilis, K. pneumoniae, or Enterobacter spp.

Intra-abdominal infections: Caused by E. coli, K. pneumoniae, Bacteroides fragilis, Clostridium spp., or Peptostreptococcus spp.

Lower respiratory tract infections: Caused by S. pneumoniae, S. aureus, H. influenzae, Haemophilus parainfluenzae, K. pneumoniae, E. coli, Enterobacter aerogenes, P. mirabilis, or Serratia marcescens.

Meningitis: Caused by H. influenzae, Neisseria meningitidis, or S. pneumoniae. Ceftriaxone has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis and E. coli (efficacy for these 2 organisms in this organ system was studied in fewer than 10 infections).

Pelvic inflammatory disease: Caused by N. 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 C. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added.

Skin and skin structure infections: Caused by S. aureus, S. epidermidis, Streptococcus pyogenes, viridans group streptococci, E. coli, Enterobacter cloacae, Klebsiella oxytoca, K. pneumoniae, P. mirabilis, Morganella morganii (efficacy for this organism in this organ system was studied in fewer than 10 infections), Pseudomonas aeruginosa, S. marcescens, Acinetobacter calcoaceticus, or B. fragilis (efficacy for this organism in this organ system was studied in fewer than 10 infections), or Peptostreptococcus spp.

Surgical prophylaxis: Reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (eg, vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those older than 70 years, 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 (eg, during coronary artery bypass surgery).

Uncomplicated gonorrhea (cervical/urethral and rectal): Caused by N. gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of N. gonorrhoeae.

Urinary tract infections (complicated and uncomplicated): Caused by E. coli, P. mirabilis, Proteus vulgaris, M. morganii, or K. pneumoniae.

Acute bacterial rhinosinusitis

Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults, ceftriaxone is effective and recommended for the treatment of severe ABRS requiring hospitalization.

Arthritis, septic (adults)

Data from a limited number of patients studied suggest that ceftriaxone may be beneficial for the treatment of septic arthritis in adults [Coiffier 2014], [Dalla Vestra 2008], [Harwood 2008], [Raad 2004]. Additional data may be necessary to further define the role of ceftriaxone in this condition. Clinical experience also suggests the utility of ceftriaxone for the treatment of septic arthritis.

Bacterial enteric infections in HIV-infected patients (empiric treatment) (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, cefotaxime is a recommended agent for empiric treatment of bacterial enteric infection in adolescent and adult HIV-infected patients with advanced HIV (CD4 count <200 cells/mm3 or concomitant AIDS-defining illness) and severe diarrhea (≥6 stools/day or bloody stool) and/or fever or chills.

Bite wounds (animal)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), ceftriaxone, in combination with clindamycin or metronidazole for anaerobic coverage is an effective and recommended alternative for treatment of animal bite wounds.

Brain abscess (adults)

Data from a limited number of patients studied suggest that ceftriaxone may be beneficial in adults for the empiric treatment of brain abscess. Clinical experience also suggests the utility of ceftriaxone as definitive therapy in the treatment of brain abscess caused by Enterobacteriaceae or Haemophilus spp. Combination therapy may be needed when Enterobacteriaceae or Haemophilus spp are isolated, as they are often a component of a mixed infection [Brouwer 2014], [de Louvois 2000]. Additional data may be necessary to further define the role of ceftriaxone in these conditions.

Chancroid

Based on the Centers for Disease Control and Prevention (CDC) guidelines for the treatment of sexually transmitted diseases, ceftriaxone is effective and recommended for the treatment of chancroid due to H. ducreyi.

Community-acquired pneumonia (children)

Following clinical guideline recommendations on the management of CAP reduces the incidence of morbidity and mortality related to pneumonia. Ceftriaxone is a parenteral option for empirical treatment of suspected bacterial CAP in children not fully immunized in areas where local penicillin resistance in pneumococcal strains is high, and for pathogen-directed therapy aimed at GAS in children older than 3 months of age.

Epididymitis

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, ceftriaxone is an effective and recommended agent in the treatment acute epididymitis likely caused by sexually transmitted chlamydia and gonorrhea) (in combination with doxycycline) or likely caused by sexually transmitted chlamydia and gonorrhea and enteric organisms in men who practice insertive anal sex (in combination with levofloxacin or ofloxacin).

Epiglottitis (children)

Data from case reports and a prospective, randomized trial in children support the use of ceftriaxone for the treatment of epiglottitis [Low 2003], [Sawyer 1994]. Additional trials may be necessary to further define the role of ceftriaxone in this condition.

Gonococcal bacteremia, meningitis and endocarditis

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, ceftriaxone is effective and recommended in the treatment of bacteremia (children), meningitis (adolescents and adults), and endocarditis (adolescents and adults); should be combined with azithromycin when given to adolescents and adults for meningitis or endocarditis.

Gonococcal conjunctivitis

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, ceftriaxone is an effective and recommended treatment for patients with conjunctivitis due to gonorrhea; should be combined with azithromycin when given to adolescents and adults.

Gonorrhea, disseminated infections (including arthritis and arthritis-dermatitis syndrome)

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, ceftriaxone is effective and recommended in the treatment of disseminated gonococcal infections in infants and disseminated gonococcal infections including arthritis (children, adolescents, and adults) and arthritis-dermatitis syndrome (adolescents and adults); should be combined with azithromycin when given to adolescents and adults.

Gonorrhea, infant prophylaxis (due to untreated maternal gonococcal infection)

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, ceftriaxone is effective and recommended for prophylactic treatment of gonorrhea in infants born to mothers with untreated maternal gonococcal infection.

Gonorrhea, uncomplicated infections of the pharynx and vulvovaginitis

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, ceftriaxone is effective and recommended in the treatment of uncomplicated gonococcal infections of the pharynx (children, adolescents, and adults) and vulvovaginitis (children); should be combined with azithromycin when given to adolescents and adults.

Infective endocarditis, treatment (adults)

Based on the AHA Scientific Statement for Infective Endocarditis in Adults, ceftriaxone, either as monotherapy or in combination with other antibiotics, is effective and recommended for the treatment of infective endocarditis caused by Enterococcus, HACEK organisms (Haemophilus spp., Aggregatibacter spp., Cardiobacterium hominis, Eikenella corrodens, and Kingella spp.), S. bovis, or viridans group streptococci (VGS). Recommendations regarding duration of therapy and use of concomitant antibiotics vary depending on the bacterial cause of the infection.

Infective endocarditis, treatment (children/adolescents)

The AHA recommends ceftriaxone as an alternative to treatment with penicillin, either as monotherapy or in combination with gentamicin. Recommendations for the use of ceftriaxone to treat endocarditis depend on the bacterial cause of the infection.

Infective endocarditis, prophylaxis

Based on the American Heart Association (AHA) guidelines for the prevention of infective endocarditis, ceftriaxone is effective and recommended for administration to patients with certain cardiac conditions who are unable to take oral medication or are allergic to penicillins or ampicillin and unable to take oral medication to provide prophylaxis against infective endocarditis associated with dental or respiratory tract procedures.

Lyme disease

Based on the IDSA guidelines for the Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis, ceftriaxone is effective and recommended for the treatment of Lyme disease with early neurologic disease (eg, meningitis, radiculopathy), Lyme carditis requiring hospitalization, Lyme arthritis with evidence of neurologic disease, and late Lyme disease with central or peripheral nervous system disease.

Meningococcal disease, invasive, high-risk patient contacts (chemoprophylaxis)

Based on the American Academy of Pediatrics recommendations for children and adults with close exposure to patients with invasive meningococcal disease, ceftriaxone is effective and recommended for the chemoprophylaxis of meningococcal disease [CDC 2005], [Red Book [AAP 2015]].

Neurosyphilis in penicillin-allergic patients

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, limited data suggest ceftriaxone may be effective as an alternative agent in penicillin allergic patients for the treatment of neurosyphilis.

Osteomyelitis, native vertebral

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and treatment of native vertebral osteomyelitis in adults, ceftriaxone is an effective and recommended agent for the treatment of native vertebral osteomyelitis due to beta-hemolytic streptococci, Cutibacterium acnes, or Salmonella species (if nalidixic acid resistant).

Proctitis, proctocolitis, enteritis

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, ceftriaxone, in combination with doxycycline, is effective and recommended in the treatment of acute proctitis, proctocolitis, or enteritis.

Prophylaxis against sexually transmitted diseases following sexual assault

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, ceftriaxone, in combination with azithromycin plus metronidazole (or tinidazole), is a recommended regimen for prophylaxis against sexually transmitted diseases following sexual assault in adolescents and adults.

Prosthetic joint infection (adults)

Based on the Infectious Diseases Society of America (IDSA) guidelines for prosthetic joint infection in adults, ceftriaxone is effective and recommended for the treatment of prosthetic joint infection due to beta-hemolytic streptococci [Osmon 2013].

Salmonellosis in HIV-infected patients (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, ceftriaxone is a recommended alternative agent for treatment of salmonellosis in adolescent and adult HIV-infected patients.

Shigellosis

Based on the World Health Organization guidelines for the treatment of shigellosis including epidemics due to Shigella dysenteriae type 1 in children and adults, ceftriaxone (second-line) is effective and recommended for the treatment of shigellosis.

Skin and soft tissue necrotizing infections due to Aeromonas hydrophilia or Vibrio vulnificus

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), ceftriaxone, in combination with doxycycline, is an effective and recommended treatment for necrotizing infections of the skin, fascia, and muscle caused by Aeromonas hydrophilia or Vibrio vulnificus.

Spontaneous bacterial peritonitis (prevention)

Based on the American Association for the Study of Liver Diseases (AASLD) guidelines for the management of adult patients with ascites due to cirrhosis, ceftriaxone is effective and recommended to prevent spontaneous bacterial peritonitis in patients with cirrhosis and gastrointestinal hemorrhage. Parenteral antibiotic therapy is recommended for use while patient is bleeding; patient may be transitioned to an oral antibiotic after oral intake is resumed.

Surgical site infections

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), ceftriaxone, in combination with metronidazole, is an effective and recommended option for treatment of surgical site infections occurring after intestinal or genitourinary tract surgery or surgery of the axilla or perineum. Systemic antibacterials are not routinely indicated for surgical site infections, but may be beneficial (in conjunction with suture removal plus incision and drainage) in patients with significant systemic response (eg, temperature >38.5ºC, heart rate >110 beats per minute, erythema/induration extending >5 cm from incision, WBC >12,000/mm3).

Syphilis (primary and secondary) in penicillin allergic patients

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, limited data suggest ceftriaxone may be effective as an alternative agent in penicillin allergic patients for the treatment for early (primary and secondary) syphilis; however, optimal dose and duration have not been established.

Typhoid fever

Based on the World Health Organization guidelines for the treatment of typhoid fever in children and adults, ceftriaxone is effective and recommended for the treatment of typhoid fever. It is usually reserved for fluoroquinolone-resistant cases.

Clinical experience also suggests the utility of ceftriaxone in managing/the treatment of typhoid fever in children [Stephens 2002].

Whipple disease

Data from randomized studies support the use of ceftriaxone in the initial treatment of Whipple disease [Feurle 2010], [Feurle 2013]. Additional trials may be necessary to further define the role of ceftriaxone in this condition.

Dosage range: Infants, Children, and Adolescents: Usual dose: IM, IV:

Mild to moderate infections: 50 to 75 mg/kg/day in 1 to 2 divided doses every 12 to 24 hours (maximum: 2,000 mg daily); continue until at least 2 days after signs and symptoms of infection have resolved

Serious infections: 80 to 100 mg/kg/day in 1 to 2 divided doses (maximum: 4,000 mg daily)

Acute bacterial rhinosinusitis, severe infection requiring hospitalization (off-label use): IV: 50 mg/kg/day divided every 12 hours for 10 to 14 days (Chow 2012)

Bacterial enteric infections in HIV-infected patients (empiric treatment) (off-label use): Adolescents: IV: Refer to adult dosing.

Community-acquired pneumonia (CAP) (IDSA/PIDS [Bradley 2011]) (off-label dose): Infants >3 months and Children: IV: 50 to 100 mg/kg/day once daily or divided every 12 hours (maximum: 2,000 mg daily). Note: May consider addition of vancomycin or clindamycin to empiric therapy if community-acquired MRSA suspected. Use the higher end of the range for penicillin-resistant S. pneumoniae; in children ≥5 years, a macrolide antibiotic should be added if atypical pneumonia cannot be ruled out; preferred in patients not fully immunized for H. influenzae type b and S. pneumoniae, or significant local resistance to penicillin in invasive pneumococcal strains.

Epiglottis (off-label use): IV: 100 mg/kg/day as a single dose on day 1, then 50 mg/kg as a single dose on day 2 (Sawyer 1994) or 75 mg/kg once daily for 10 to 14 days (Low 2003). Additional data may be necessary to further define the role of ceftriaxone in this condition.

Gonococcal infections:

Bacteremia (off-label use) (CDC [Workowski 2015]): IM, IV:

Children ≤45 kg: 50 mg/kg/dose once daily (maximum: 1,000 mg) for 7 days

Children >45 kg: 1,000 mg once daily for 7 days

Conjunctivitis (off-label use): IM, IV:

Neonates and Infants: 25 to 50 mg/kg/dose as a single dose (maximum dose: 125 mg) (CDC [Workowski 2015]). Note: Use contraindicated in hyperbilirubinemic neonates.

Adolescents: Refer to adult dosing.

Disseminated gonococcal infection (DGI) in infants including scalp abscess (off-label use): IM, IV:

Infants: 25 to 50 mg/kg/dose once daily for 7 days (10 to 14 days for meningitis) (CDC [Workowski 2015]); Note: Use contraindicated in hyperbilirubinemic neonates.

Disseminated gonococcal infection (arthritis, arthritis-dermatitis syndrome) (off-label use): IM, IV:

Children ≤45 kg: Arthritis: 50 mg/kg/dose once daily (maximum dose: 1,000 mg) for 7 days (CDC [Workowski 2015])

Children >45 kg: Arthritis: 1,000 mg once daily for 7 days (CDC [Workowski 2015])

Adolescents: Refer to adult dosing.

Endocarditis (off-label use):

Children ≤45 kg: IM, IV: 50 mg/kg/day divided every 12 or 24 hours (maximum: 2,000 mg daily) for at least 28 days (Red Book [AAP 2015])

Children >45 kg and Adolescents: Refer to adult dosing.

Meningitis (off-label use): IV, IM:

Infants: 25 to 50 mg/kg/day in a single daily dose for 10 to 14 days (CDC [Workowski 2015]); Note: Use contraindicated in hyperbilirubinemic neonates.

Children ≤45 kg: 50 mg/kg/day divided every 12 or 24 hours (maximum: 2,000 mg daily); usual duration of treatment is 10 to 14 days (Red Book [AAP 2015])

Children >45 kg and Adolescents: Refer to adult dosing.

Prophylactic treatment in neonates due to untreated maternal gonococcal infection (off-label use): Neonates: IM, IV: 25 to 50 mg/kg as a single dose (maximum: 125 mg) (CDC [Workowski 2015]). Note: Use contraindicated in hyperbilirubinemic neonates.

Uncomplicated gonorrhea (cervicitis, proctitis, or urethritis) (off-label population) CDC [Workowski 2015]):

Infants and Children ≤45 kg: IM, IV: 25 to 50 mg/kg/dose as a single dose (maximum dose: 125 mg IM)

Children >45 kg and Adolescents: Refer to adult dosing.

Uncomplicated gonorrhea: Pharyngitis or vulvovaginitis (off-label use) (CDC [Workowski 2015]):

Infants and Children ≤45 kg: IM, IV: 25 to 50 mg/kg/dose as a single dose (maximum dose: 125 mg IM)

Children >45 kg and Adolescents: IM: 250 mg in a single dose plus oral azithromycin

Infective endocarditis (off-label use): IM, IV:

Native valve: 100 mg/kg once daily (maximum: 2,000 mg daily) for 2 to 4 weeks; Note: If using 2-week regimen or for relatively penicillin-resistant streptococcus, concurrent gentamicin is recommended; for HACEK organisms, duration of therapy is 4 weeks (Baddour 2005)

Prosthetic valve: 100 mg/kg once daily (maximum: 2,000 mg daily) for 6 weeks (with or without gentamicin [dependent on penicillin MIC]); for HACEK organisms, duration of therapy is 4 weeks (Baddour 2005)

Enterococcus faecalis (resistant to penicillin, aminoglycoside, and vancomycin), native or prosthetic valve: 100 mg/kg/day divided every 12 hours for ≥8 weeks administered concurrently with ampicillin (Baddour 2005)

Prophylaxis: 50 mg/kg 30 to 60 minutes before procedure; maximum dose: 1,000 mg (Red Book [AAP 2015]; Wilson 2007). Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications.

Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.

Lyme disease (off-label use): IM, IV:

Atrioventricular heart block or carditis: 50 to 75 mg/kg once daily (maximum: 2,000 mg) for 14 to 21 days (Red Book [AAP 2015])

Encephalitis or other late neurologic disease: 50 to 75 mg/kg once daily (maximum: 2,000 mg) for 14 to 28 days (Red Book [AAP 2015])

Neurologic: 50 to 75 mg/kg once daily (maximum: 2,000 mg) for 14 days (Halperin 2007)

Meningitis: 50 to 75 mg/kg once daily (maximum: 2,000 mg) for 14 to 21 days (Red Book [AAP 2015])

Recurrent arthritis: 50 to 75 mg/kg once daily (maximum: 2,000 mg) for 14 to 28 days (Red Book [AAP 2015])

Meningitis (empiric treatment): IM, IV: Loading dose of 100 mg/kg (maximum: 4,000 mg), followed by:

Manufacturer's labeling: 100 mg/kg/day divided every 12 to 24 hours (maximum: 4,000 mg daily); usual duration of treatment is 7 to 14 days

Alternate dosing: 80 to 100 mg/kg/day divided every 12 to 24 hours (maximum: 4,000 mg daily) (Tunkel 2004)

Meningococcal disease, invasive, high-risk patient contacts (chemoprophylaxis) (off-label use):

Children and Adolescents <15 years: IM: 125 mg in a single dose (CDC 2005; Red Book [AAP 2015]).

Adolescents ≥15 years: Refer to adult dosing.

Otitis media: IM:

Acute: 50 mg/kg in a single dose (maximum: 1,000 mg)

Persistent or relapsing (off-label dose): 50 mg/kg once daily for 3 days (AAP 2014; Lieberthal 2013)

Prophylaxis against sexually transmitted diseases following sexual assault (off-label use): Adolescents: Refer to adult dosing.

Salmonellosis in HIV-infected patients (off-label use): Adolescents: IV: Refer to adult dosing.

Shigella dysentery type 1 (off-label dose): IM: 50 to 100 mg/kg/day for 2 to 5 days (WHO 2005)

Skin/skin structure infections: IM, IV: 50 to 75 mg/kg/day in 1 to 2 divided doses (maximum: 2,000 mg daily)

Surgical (perioperative) prophylaxis (off-label dose): Children ≥ 1 year: IV: 50 to 75 mg/kg within 60 minutes prior to surgery (maximum: 2,000 mg) (Bratzler 2013)

Typhoid fever (off-label use): IV: 80 mg/kg once daily for 14 days (Stephens 2002)

IM injection: Vials should be reconstituted with appropriate volume of diluent (including D5W, NS, SWFI, bacteriostatic water, or 1% lidocaine) to make a final concentration of 250 mg/mL or 350 mg/mL.

Volume to add to create a 250 mg/mL solution:

250 mg vial: 0.9 mL

500 mg vial: 1.8 mL

1 g vial: 3.6 mL

2 g vial: 7.2 mL

Volume to add to create a 350 mg/mL solution:

500 mg vial: 1.0 mL

1 g vial: 2.1 mL

2 g vial: 4.2 mL

IV infusion: Infusion is prepared in two stages: Initial reconstitution of powder, followed by dilution to final infusion solution.

Vials: Reconstitute powder with appropriate IV diluent (including SWFI, D5W, D10W, NS) to create an initial solution of ~100 mg/mL. Recommended volume to add:

250 mg vial: 2.4 mL

500 mg vial: 4.8 mL

1 g vial: 9.6 mL

2 g vial: 19.2 mL

Note: After reconstitution of powder, further dilution into a volume of compatible solution (eg, 50-100 mL of D5W or NS) is recommended.

Piggyback bottle: Reconstitute powder with appropriate IV diluent (D5W or NS) to create a resulting solution of ~100 mg/mL. Recommended initial volume to add:

1 g bottle:10 mL

2 g bottle: 20 mL

Note: After reconstitution, to prepare the final infusion solution, further dilution to 50 mL or 100 mL volumes with the appropriate IV diluent (including D5W or NS) is recommended.

Powder for injection: Prior to reconstitution, store at ≤25°C (≤77°F). Protect from light.

Premixed solution (manufacturer premixed): Store at -20°C; once thawed, solutions are stable for 3 days at 25°C (77°F) or for 21 days at 5°C (41°F). Do not refreeze.

Stability of reconstituted solutions:

10 to 40 mg/mL: Reconstituted in D5W, D10W, NS, or SWFI: Stable for 2 days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F). Stable for 26 weeks when frozen at -20°C when reconstituted with D5W or NS. Once thawed (at room temperature), solutions are stable for 2 days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F); does not apply to manufacturer's premixed bags. Do not refreeze. If D5NS or D51/2NS are used, solutions are only stable for 2 days at of 25°C (77°F).

100 mg/mL:

Reconstituted in D5W, SWFI, or NS: Stable for 2 days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F).

Reconstituted in lidocaine 1% solution or bacteriostatic water: Stable for 24 hours at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F).

250 to 350 mg/mL: Reconstituted in D5W, NS, lidocaine 1% solution, bacteriostatic water, or SWFI: Stable for 24 hours at room temperature of 25°C (77°F) or for 3 days when refrigerated at 4°C (39°F).

Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Calcium Salts (Intravenous): May enhance the adverse/toxic effect of CefTRIAXone. Ceftriaxone binds to calcium forming an insoluble precipitate. Management: Use of ceftriaxone with calcium-containing solutions within 48 hours of one another is contraindicated in neonates (28 days of age or younger). In older patients, flush lines with compatible fluid between administration. Consider therapy modification

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Probenecid: May increase the serum concentration of Cephalosporins. Monitor therapy

Ringer's Injection (Lactated): May enhance the adverse/toxic effect of CefTRIAXone. Ceftriaxone binds to calcium in the Lactated Ringer's forming an insoluble precipitate. Management: Use of ceftriaxone with calcium-containing solutions (including LR) within 48 hours of one another is contraindicated in neonates (28 days of age or younger). In older patients, flush lines with compatible fluid between administration. Consider therapy modification

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

>10%:

Dermatologic: Skin tightness (IM: ≤5% to ≤17%; local)

Local: Induration at injection site (≤5% to ≤17%; incidence higher with IM), warm sensation at injection site (IM: ≤5% to ≤17%)

1% to 10%:

Dermatologic: Skin rash (2%)

Gastrointestinal: Diarrhea (3%)

Hematologic & oncologic: Eosinophilia (6%), thrombocythemia (5%), leukopenia (2%)

Hepatic: Increased serum transaminases (3%)

Local: Pain at injection site (≤1%), tenderness at injection site (≤1%)

Renal: Increased blood urea nitrogen (1%)

<1% (Limited to important or life-threatening): Abdominal pain, acute generalized exanthematous pustulosis, acute renal failure (post-renal), agranulocytosis, allergic dermatitis, anaphylactoid reaction, anaphylaxis, anemia, basophilia, blood coagulation disorder, bronchospasm, candidiasis, casts in urine, choledocholithiasis, cholelithiasis, clostridium difficile associated diarrhea, colitis, decreased prothrombin time, dysgeusia, dyspepsia, edema, epistaxis, erythema multiforme, fever, flushing, gallbladder sludge, glossitis, glycosuria, granulocytopenia, headache, hematuria, hemolytic anemia, hypersensitivity pneumonitis, increased monocytes, increased serum alkaline phosphatase, increased serum bilirubin, increased serum creatinine, jaundice, kernicterus, leukocytosis, lymphocytopenia, lymphocytosis, nephrolithiasis, neutropenia, oliguria, palpitations, pancreatitis, phlebitis, prolonged prothrombin time, pseudomembranous colitis, seizure, serum sickness, Stevens-Johnson syndrome, stomatitis, thrombocytopenia, toxic epidermal necrolysis, ureteral obstruction, urogenital fungal infection, urolithiasis, vaginitis