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Ceftriaxone

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Perth Children’s Hospital

Children’s Antimicrobial Management


Program (ChAMP)

MONOGRAPH

Ceftriaxone Monograph - Paediatric


Scope (Staff): Clinical Staff- Medical, Nursing, Pharmacy
Scope (Area): Perth Children’s Hospital (PCH)

This document should be read in conjunction with this DISCLAIMER

 Ceftriaxone is a bactericidal broad spectrum third generation


DESCRIPTION cephalosporin antibiotic.
 It interferes with bacterial cell wall peptidoglycan synthesis by
binding to penicillin-binding proteins resulting in cell lysis.(1-5)
IV: Monitored (orange) antibiotic
INDICATIONS AND  If the use is consistent with a standard approved indication,
RESTRICTIONS this must be communicated to ChAMP by documenting that
indication on all prescriptions (inpatient and outpatient).
 The ChAMP team will review if ongoing therapy is required
and/or if the order does not meet ChAMP Standard Indications.
 If use is not for a standard approved indication, phone approval
must be obtained from ChAMP before prescribing.
 Ceftriaxone is a broad spectrum cephalosporin and is active
against the majority of community-associated enteric Gram-
negative rods, beta-haemolytic Streptococci and Streptococcus
pneumoniae.(3) Ceftriaxone also has significant activity against
gram negative organisms and also penetrates the CSF.(6)

 Ceftriaxone is contraindicated in patients with a history of


CONTRAINDICATIONS severe allergy to ceftriaxone, other cephalosporins or a severe
or intermediate reaction to a penicillin antibiotic.
 Care should also be taken with carbapenems as cross
reactivity may occur between penicillins, cephalosporins and
carbapenems.(1)
 Ceftriaxone is contraindicated in neonates receiving calcium
containing fluids (including parenteral nutrition, Hartmann’s or
Ringers solution).(7)
Neonates less than 28 days of age:
PRECAUTIONS  Ceftriaxone has been associated with fatal systemic calcinosis
in neonates.
 It is highly protein bound and may displace bilirubin from

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Ceftriaxone Monograph - Paediatric
albumin in neonates.(3)
 Cefotaxime is therefore the preferred third-generation
cephalosporin in this age group.
 If ceftriaxone must be used, do NOT administer ceftriaxone
and IV calcium containing products within 48 hours of each
other (via the same OR separate infusion lines/sites).(2, 7-9)
Patients older than 28 days:
 Ceftriaxone and calcium containing solutions may be
administered sequentially (or concurrently if using completely
separate lines) as long as the lines are flushed well with a
compatible fluid between infusions.(2, 7, 8)
 IV aminoglycoside antibiotics are inactivated by IV penicillins
and cephalosporins.
 Aminoglycoside antibiotics are rapidly bactericidal and should
be administered first. The line should then be flushed well with
a compatible fluid and the cephalosporin administered.(9)
 Rapid IV infusion of high doses may result in seizures,
especially in patients with renal impairment.(1)

Available at PCH:
FORMULATIONS
 Ceftriaxone (AFT) 1g Vial
 Ceftriaxone (Alphapharm) 2g Vial
Other formulations available:
 Ceftriaxone powder for injection 1g and 2g vial (multiple
generic brands)

The doses listed below fall within the standard range.


DOSAGE
Higher doses may be prescribed for certain situations in
consultation with Infectious Diseases or Clinical Microbiologists.
Neonates:
 Ceftriaxone should be avoided in neonates (<1 month). If a
third-generation cephalosporin is required, cefotaxime should
be prescribed. Please refer to Neonatal Medication Protocols
IV or IM:
Post exposure prophylaxis or treatment in neonates:
 50mg/kg (to a maximum of 125mg) as a single dose in
discussion with Infectious diseases or clinical microbiology.
IV or IM:
 Usual dose: 50mg/kg/dose (to a maximum of 2 grams) 24
hourly.(1, 4, 10)
 Meningitis or severe sepsis: 100mg/kg/dose (to a maximum
of 4grams) 24 hourly OR 50mg/kg/dose (to a maximum of

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Ceftriaxone Monograph - Paediatric
2grams) 12 hourly.(1, 4, 10)

IM:
Meningococcal prophylaxis:
 Children ≥ 1 month and < 12 years of age: 125mg as a single
dose
 Children ≥ 12 years of age: 250mg as a single dose(1)

Haemophilus influenzae type b (Hib) prophylaxis:


 Children ≥ 1 month: 50mg/kg/dose (to a maximum of 1gram)
once daily for TWO days.(1)

Post exposure prophylaxis or treatment of confirmed


Gonococcal disease:
 Children ≥ 1 month: 50mg/kg (to a maximum of 500mg) as a
single dose.

 Refer to the Medical Prophylaxis ChAMP empiric guidelines


and Prescribing chemoprophylaxis to contacts of
meningococcal disease for further information on the use of
ceftriaxone for medical prophylaxis

Dose reduction required in renal impairment:


DOSAGE
ADJUSTMENT  Dose reduction may be required in cases of significant renal
impairment with a creatinine clearance of less than
10mL/minute.
 Maximum recommended daily dose of 50mg/kg/DAY or 2
grams per day (whichever is less). Contact Pharmacy for
advice.(4, 6, 8)
Dosage reduction required in hepatic impairment:
 No dosage adjustment is required in hepatic impairment unless
in conjunction with severe renal impairment. Contact Pharmacy
for advice.(4, 6, 8)

IV:
RECONSTITUTION
Vial size Volume Concentration
1 gram 9.6mL 100mg/mL
2 gram 19.2mL 100mg/mL

 Further dilution with a compatible fluid to a final concentration


of 40mg/mL or less is required prior to administration.(7-9)

Children’s Antimicrobial Management Program (ChAMP) Page 3 of 7


Ceftriaxone Monograph - Paediatric

IM:
 Reconstitute each 1gram vial with 2.1mL of lidocaine
(lignocaine) 1% (10mg/mL) or water for injection. This results
in a final concentration of 350mg/mL.(11)
Note: Preparations with lidocaine (lignocaine) 1% (10mg/mL)
as diluent must NEVER be given intravenously.(5, 7, 8)

IV infusion (preferred):
ADMINISTRATION
 Dilute the required dose to a final concentration of 40mg/mL or
weaker and infuse over 30 minutes.(4, 7, 8)
 In emergency situations or where there is a clinical need (e.g.
HiTH) faster infusion times have been used.(4, 7, 8) It should be
noted that the faster infusion times have been associated with
increased risk of seizures.(1)
IV push:
 Dilute the required dose to a final concentration of 40mg/mL or
weaker and administer as a push over 5 to 15 minutes.(1, 4, 8)
IM injection:
 Administer up to 1gram with a maximum concentration of
350mg/mL via deep injection into a large muscle mass e.g.
thigh, buttocks.
 For doses higher than 1gram, the dose must be split between
2 sites.(7, 8)

Renal, hepatic and haematological function should be monitored


MONITORING weekly with prolonged therapy (i.e. longer than 7 days) and/or with
high dose treatment.(1)

Common: diarrhoea, nausea, vomiting, pain and inflammation at


ADVERSE EFFECTS injection site, rash, headache, dizziness, allergy, Clostridium
difficile-associated disease.(1)
Rare: neurotoxicity (e.g. confusion, seizures, encephalopathy),
blood dyscrasias (e.g. neutropenia), thrombocytopenia, bleeding,
renal impairment, pancreatitis, cholecystitis, pseudolithiasis
(reversible biliary sludge formation due to calcium-ceftriaxone
complex), nephrolithiasis (formation of calcium-ceftriaxone renal
stones).
Immunologic reactions including eosinophilia, drug fever,
anaphylaxis, angioedema, urticaria, haemolytic anaemia, Stevens-
Johnson syndrome, toxic epidermal necrolysis, interstitial nephritis,
arthritis, serum sickness-like syndrome.(1)

 Sodium chloride 0.9%,


COMPATIBLE FLUIDS
 Glucose 5% and 10%
 Glucose/sodium chloride solutions

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Ceftriaxone Monograph - Paediatric
 Mannitol 10%(7, 9)
Ceftriaxone is INCOMPATIBLE with calcium containing
intravenous solutions including parenteral nutrition, Ringer’s
and Hartmann’s solution because precipitation may occur. (7-9)
Store vials below 25˚C(5)
STORAGE Store syringes prepared by PCS between 2 and 8˚C.(7)
Ceftriaxone has drug interactions; please consult PCH
INTERACTIONS approved references (such as Clinical Pharmacology), your
ward pharmacist or Pharmacy on extension 60190 for more
information.
 Ceftriaxone is incompatible with calcium containing
intravenous solutions because precipitation may occur. Refer
to precautions section for further information.(7, 8)
 IV aminoglycoside antibiotics are inactivated by IV penicillins
and cephalosporins.
 Aminoglycoside antibiotics are rapidly bactericidal and should
be administered first. The line should then be flushed well with
a compatible fluid and the cephalosporin administered.(4, 7)
 The use of ceftriaxone in conjunction with warfarin may
increase INR and increase the risk of bleeding.(1, 6)
 Ciclosporin (cyclosporin) levels may increase if ceftriaxone is
added. There is limited information on this interaction, close
monitoring of ciclosporin (cyclosporin) levels is required.(6)
 The addition of furosemide (frusemide) to ceftriaxone may
increase the risk of nephrotoxicity, especially in patients with
renal impairment (including minor or transient renal
impairment)(6)

Each 1 gram vial contains 83mg (3.6mmol) of sodium.(1)


COMMENTS
To access to the Manufacturer SDS for this product, use the
MANUFACTURER following link to ChemAlert.
SAFETY DATA SHEET
(SDS)
**Please note: The information contained in this guideline is to assist with the preparation and administration
of ceftriaxone. Any variations to the doses recommended should be clarified with the prescriber prior to
administration**

Children’s Antimicrobial Management Program (ChAMP) Page 5 of 7


Ceftriaxone Monograph - Paediatric

Related internal policies, procedures and guidelines

Antimicrobial Stewardship Policy

ChAMP Empiric Guidelines

Useful resources

KEMH Neonatal Medication Protocols

References

1. Rossi S, editor. Australian Medicines Handboook. Adelaide, S. Aust.: Australian


Medicines Handbook; 2018.
2. Paediatric Formulary Committee. BNF for Children: 2017. London: BMJ Group
Pharmaceutical Press; 2017.
3. Antibiotic Writing Group. eTG complete. West Melbourne: Therapeutic Guidelines Ltd;
2018. Available from: https://tgldcdp-tg-org-au.pklibresources.health.wa.gov.au/etgAccess.
4. Taketomo CK, Hodding JH, Kraus DM. Pediatric and Neonatal dosage handbook with
international trade names index. 24th edition ed. Ohio: Lexi-comp; 2017-2018.
5. MIMS Australia. MIMS online [full product information]. St Leonards, N.S.W: CMP
Medica Australia.; 2018. p. 1v. (various pagings).
6. Clinical Pharmacology [Internet]. Elsvier BV. 2018 [cited 11/09/2018]. Available from:
http://www.clinicalpharmacology-ip.com.pklibresources.health.wa.gov.au/default.aspx.
7. Burridge N. Symons K. (editors). Australian injectable drugs handbook. Collingwood:
The Society of Hospital Pharmacists of Australia; 2017.
8. Phelps S Hagemann T Lee K Thompson A. Pediatric Injectable Drugs: The Teddy Bear
Book. 11th Edition ed. Maryland: American Society of Health-System Pharmacists.
9. Lilley L, Legge D. Paediatric Injectable Guidelines 5th ed. 5th edition ed. Melbourne:
Royal Children's Hospital Melbourne; 2016.
10. Royal Australian College of General Practitioners, Pharmaceutical Society of Australia,
Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists.
AMH: Children's Dosing Companion. Adelaide: Australian Medicines Handbook Pty
Ltd; 2017.
11. McEvoy Ge, editor. Handbook on Injectable Drugs 60th Edition. 60th Edition ed.
Maryland: American Society of Health-System Pharmacists; 2018.

Children’s Antimicrobial Management Program (ChAMP) Page 6 of 7


Ceftriaxone Monograph - Paediatric

This document can be made available in


alternative formats on request for a person
with a disability.

File Path: W:\Safety & Quality\CAHS\CLOVERS MEDICAL Pharmacy\Procedures Protocols and


Guidelines\ChAMP\PDFs\Monographs
Document Owner: Head of Department – Infectious Diseases
Reviewer / Team: Children’s Antimicrobial Management Program Pharmacist
Date First Issued: April 2013 Last Reviewed: November 2018 Review Date: November 2021
th
Approved by: Drug and Therapeutics Committee Date: 19 November 2018
th
Endorsed by: Drug and Therapeutics Committee Date: 19 November 2018
Standards Applicable:
NSQHS Standards:
Printed or personally saved electronic copies of this document are considered uncontrolled

Children’s Antimicrobial Management Program (ChAMP) Page 7 of 7

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