Ceftriaxone

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Bacterial septicemia caused by Methicillin Sensitive Staphylococcus aureus (MSSA), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae
• Meningitis caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae
• Intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Clostridium species (most Clostridium difficile are resistant) or Peptostreptococcus species
• Skin and skin structure infections caused by Methicillin Sensitive Staphylococcus aureus (MSSA), Streptococcus pyogenes, Streptococcus viridans group.  Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens or Peptostreptococcus species
• Bone and joint infections caused by Methicillin Sensitive Staphylococcus aureus (MSSA), Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species
• Renal and urinary tract infections (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae
• Respiratory tract infections caused by Streptococcus pneumoniae, Methicillin Sensitive Staphylococcus aureus (MSSA), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens
• Ear, nose and throat infections (acute bacterial otitis media) caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains)
• Uncomplicated gonorrhoea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and non-penicillinase-producing strains, and pharyngeal gonorrhoea caused by non-penicillinase-producing strains of Neisseria gonorrhoeae
• Surgical (perioperative) prophylaxis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to any other cephalosporin
• History of severe hypersensitivity to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems)
• Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)
• Contraindications to lidocaine (these must be excluded before IM injection of ceftriaxone)
• Ceftriaxone solutions containing lidocaine should never be administered IV
• Full-term neonates (up to 28 days of age):
  - with hyperbilirubinaemia, jaundice, or who are hypoalbuminaemic or acidotic
  - if they require (or are expected to require) intravenous calcium treatment, or calcium-containing infusions due to the risk of precipitation of a ceftriaxone-calcium salt (See additional prescribing points)

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Severe hepatic impairment
• History of non-severe hypersensitivity to other beta-lactam agents
• Spirochete infections
• Premature and full-term neonates aged <1 month
• Ceftriaxone must not be mixed or administered simultaneously with any calcium-containing intravenous solutions, even via different infusion lines or at different infusion sites (patients of any age)
• Prolonged use
• Patients on sodium-restricted diet
• Polymicrobial infection
• Risk factors for biliary lithiasis (especially paediatric population)
• Risk factors for biliary stasis and biliary sludge
  - Preceding major therapy
  - Severe illness
  - Total parenteral nutrition
• History of renal lithiasis
• Hypercalciuria
• May impair ability to drive and operate machinery

Forms avail in SA and covered in this monograph: inj

Dosages below include:

• General dosing range
• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Gram-positive aerobes, Staphylococcus aureus (methicillin-susceptible), Staphylococci coagulase-negative (methicillin-susceptible), Streptococcus pyogenes (Group A), Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Viridans Group Streptococci, Gram-negative aerobes, Borrelia burgdorferi, Haemophilus influenza, Haemophilus parainfluenzae, Moraxella catarrhalis, Neisseria gonorrhoea, Neisseria meningitidis, Proteus mirabilis, Providencia spp, Treponema pallidum, H. ducreyi, Kingella sp, Leptospira sp., Y. enterocolitica

General dosing range

• IV: 0.250-2g, 12-24hrly

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See additional prescribing points for administration directions

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Twice daily administration may be considered where doses greater than 2g daily are administered

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Specific doses based on individual indications:

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Pelvic inflammatory disease - stage I (Additional agent required)
Prophylaxis of sexually transmitted infections (Additional agent required) 
- Non occupational
- Sexual assault
Parents of newborn babies who develop purulent conjunctivitis after 24hrs of birth
- Due to N. gonorrhoeae and Chlamydia
Reactive arthritis with urethritis (Additional agent required)
Treatment of a new episode of more than one STI syndrome (Additional agents required)
- Male urethritis syndrome + genital ulcer syndrome
- Vaginal discharge syndrome + genital ulcer syndrome
- Lower abdominal pain + genital ulcer syndrome
- Scrotal swelling + genital ulcer syndrome
Treatment of symptomatic and asymptomatic partners for STIs
- Vaginal discharge syndrome
- Lower abdominal pain
- Male urethritis syndrome
- Scrotal swelling

• IM: 250mg, immediately as a single dose
  (STG, Adult 2019; PHC 2020)

Acute bacterial prostatitis (Additional agent required)
- With features of associated urethritis
- In men ≤35 years of age
Chemoprophylaxis for close contacts during current exposure of meningococcal meningitis
- In those who are pregnant
Male urethritis syndrome (Additional agent required)
Vaginal discharge syndrome (Additional agent required)
- If cervicitis

• IM: 250mg, as a single dose
  (STG, Adult 2019; PHC 2020)

Vaginal discharge syndrome (Additional agents required)
- With persistent cervicitis confirmed on speculum examination
Male urethritis syndrome (Additional agents required)
- With persistent urethral discharge after 7 days confirmed on examination

• IM: 1g, immediately as a single dose
  (STG, Adult 2019, PHC, 2020)

Acute inflammatory diarrhoea (dysentery)
- With signs of sepsis and severe cases or significant underlying disease
Febrile neutropenia (Additional agent required)
- Within 48hrs of admission
Spontaneous bacterial peritonitis
Pelvic inflammatory disease - stage II-V (Additional agent required)
Acute pyelonephritis with impaired renal function

•  IV: 1g, dly switch to oral therapy when clinically appropriate
  (STG, Adult 2019)

Gonococcal arthritis (Additional agent required)

•  IV: 1g, dly; Treatment duration: 7 days
  (STG, Adult 2019)

Epiglottitis

•  IV: 1g, dly; Treatment duration: 10 days
  (STG, Adult 2019)

Puerperal sepsis (Additional agent required)
Miscarriage (Additional agent required)
- If unsafe (septic) miscarriage is suspected

• IV: 1g, as a single dose (and refer)
  (STG, PHC 2020, 2023)

Acute pyelonephritis in pregnancy
- Empiric therapy

• IV: 1g, as a single dose (and refer)
  (STG, PHC 2023)
• IV: 1g, dly; Treatment duration: 48hrs or until fever subsides
  (STG, Adult 2023)

Viral haemorrhagic fever (VHF)
- Management of suspected/possible/probable VHF
Acute meningitis
- As initial treatment before transfer

• IV: 2g, immediately as a single dose (and refer)
  (STG, PHC 2020)

- Pneumococcal meningitis (if resistant to penicillin)
- Meningitis due to Haemophilus influenzae
- Bacterial meningitis (As empiric therapy until sensitivity results are available)
Enteric fever (Typhoid)

• IV: 2g, 12hrly; Treatment duration: 10 days
  (STG, Adult 2019)

Complicated bacterial sinusitis
Mastoiditis
Brain abscess (Additional agent required)

• IV: 2g, 12hrly (and refer)
  (STG, Adult 2019)

Head injury
- Penetrating brain injuries

• IV: 2g, 12hrly; Treatment duration: 7 days
  (STG, Adult 2019)

Haemorrhagic fever syndrome
Septic shock (Additional agent required)
Community acquired pneumonia
- Without features of severe pneumonia in those >65 years of age OR comorbidity (e.g., COPD, HIV, cardiac failure, diabetes)
- Severe pneumonia
Hospital-acquired pneumonia (Additional agent required)
- With no prior intravenous antibiotic use within 90 days

• IV: 2g, dly
  (STG, Adult 2019)

Bronchiectasis
- In those who are severely ill requiring hospitalisation and parenteral antibiotic therapy

• IV: 2g, dly, until patient is apyrexial for 24hrs
  (STG, Adult 2019)

Severe pneumonia
- While awaiting transfer

• IV/IM: 1g, as a single dose (and refer)
  (STG, PHC 2020)

Bacterial endophthalmitis (Additional agent required)
- Endogenous
Surgical wound infections  (Additional agent required)
- Female uro-genital tract surgery or open GIT surgery 

• IV: 2g, dly; Treatment duration: ≤7 days
  (STG, Adult 2019)

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South African registered indications and dosages

Meningitis caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae

• IV: 4g, dly

Uncomplicated gonorrhoea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and non-penicillinase-producing strains, and pharyngeal gonorrhoea caused by non-penicillinase-producing strains of Neisseria gonorrhoeae

• IM: 125mg, as a single dose

Surgical (peri-operative) prophylaxis

• IV: 1-2g, as a single dose; 30-90mins prior to surgery

Other infections caused by susceptible organisms 

• IV: 1-2g, dly; Max: 4g/24hrs

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In colorectal surgery, administration of ceftriaxone with or without a 5-nitroimidazole, e.g. ornidazole, (separate administration: see method of administration under additional prescribing points) has been proven effective

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Indications and dosages registered in other jurisdictions

Community-acquired pneumonia
Acute exacerbations of chronic obstructive pulmonary disease
Intra-abdominal infections
Complicated urinary tract infections (Including pyelonephritis)

• IV: 1-2g, dly

Hospital-acquired pneumonia
Complicated skin and soft tissue infections
Infections of bones and joints

• IV: 2g, dly

Management of neutropenic patients with fever that is suspected to be due to a bacterial infection
Bacterial endocarditis
Bacterial meningitis

• IV: 2-4g, dly

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In documented bacteraemia, the higher end of the recommended dose range should be considered

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Acute otitis media

• IM: 1-2g, as a single dose

---

For acute otitis media, limited data suggest that in cases where the child is severely ill or initial therapy has failed, ceftriaxone may be effective when given as an IM dose of 50 mg/kg daily for 3 days

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Pre-operative prophylaxis of surgical site infections

• IV: 2g, as a single dose

Gonorrhoea

• IM: 500mg, as a single dose

Syphilis

• IV: 500-1000mg, dly; Treatment duration: 10-14 days; Max: 2g/24hrs

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The general recommended dose is increased to 2g once daily for neurosyphilis

The dose recommendations in syphilis, including neurosyphilis, are based on limited data. National or local guidance should be taken into consideration

---

Disseminated Lyme borreliosis (Early [Stage II] and late [Stage III])

• IV: 2g, dly; Treatment duration; 14-21 days

---

The recommended treatment durations vary and national or local guidelines should be taken into consideration  

Paed. forms avail. in SA and covered in this monograph: inj

Paed. dosages below include:

• General dosing range
• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Gram-positive aerobes, Staphylococcus aureus (methicillin-susceptible), Staphylococci coagulase-negative (methicillin-susceptible), Streptococcus pyogenes (Group A), Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Viridans Group Streptococci, Gram-negative aerobes, Borrelia burgdorferi, Haemophilus influenza, Haemophilus parainfluenzae, Moraxella catarrhalis, Neisseria gonorrhoea, Neisseria meningitidis, Proteus mirabilis, Providencia spp, Treponema pallidum, H. ducreyi, Kingella sp, Leptospira sp., Y. enterocolitica

General dosing range

Neonates (younger than 14 days)

• IV: 20-50mg/kg, dly; Max: 50mg/kg/24hrs

Between 15 days-12 years

• IV: 20-100mg/kg, dly

Older than 12 years or >50kg

• See adult dosage

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See additional prescribing points for administration directions

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Twice daily administration may be considered where doses greater than 2g daily are administered

---

The duration of therapy varies according to the course of the disease

Treatment should be continued for 48-72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved

---

Specific doses based on individual indications:

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Pneumonia - severe (Additional agent required)

• IM: 80mg/kg/dose, immediately as a single dose (and refer)
  (STG, PHC 2020)

- Treatment

• IV: 80mg/kg/dose, dly; Treatment duration: 10 days
  (STG, Paed. 2017)

Complicated P. Falciparum malaria with concurrent bacterial sepsis - severe

• IV: 100mg/kg, dly; Treatment duration: 10 days; Max: 4g/24hrs
  (STG, Paed. 2017)

Preseptal and orbital cellulitis
- Initial management

• IV: 50mg/kg, dly (and refer)
  (STG, Paed. 2023)

Suspected staphylococcal infection (e.g. osteomyelitis) (Additional agent required)

• IV: 50mg/kg/dose, 12hrly
  (STG, Paed. 2017)

Acute osteomyelitis/ osteitis (Additional agent required)
- In infants and children

• IV: 50mg/kg/dose, 12hrly; Treatment duration: 4-6 weeks
  (STG, Paed. 2017)

Shock
- As antibiotic cover for probable septicaemia

• IM: 80mg/kg/dose, immediately as a single dose (and refer)
  (STG, PHC 2020)

- Treatment of septic shock

Older than 1 month

• IV: 50mg/kg/dose, 12hrly (and refer)
  (STG, Paed. 2017)

Chemoprophylaxis for close contacts during current exposure of meningococcal meningitis

Younger than 6 years

• IM: 125mg, as a single dose
  (STG, PHC 2020)

Chemoprophylaxis for close contacts during current exposure of N. meningitidis

Younger than 12 years

• IM: 125mg, as a single dose
  (STG, Paed. 2017)

Older than 12 years

• IM: 250mg, as a single dose
  (STG, Paed. 2017)

Aplastic anaemia (Additional agent required)
- For fever (T>38ºC) in those older than 1 month
Sickle cell anaemia (Additional agent required)
- All children with axillary temperature ≥38°C

• IV: 50-80mg/kg/dose, dly
  (STG, Paed. 2017)

Thrombotic thrombocytopaenic purpura
Haemolytic uraemic syndrome with infection

• IV: 50-80mg/kg, dly
  (STG, Paed. 2017)

Non-typhoid salmonella invasive disease
Older than 1 month

- Bacteraemia

• IV: 50-80mg/kg, dly; Treatment duration: 10-14 days
  (STG, Paed. 2017)

- Acute osteomyelitis

• IV: 50-80mg/kg, dly; Treatment duration: 4-6 weeks
  (STG, Paed. 2017)

- Meningitis

• IV: 50-80mg/kg, dly; Treatment duration: 4 weeks
  (STG, Paed. 2017)

Acute mastoiditis (Additional agent required)
- Empiric therapy

• IV: 100mg/kg, dly; Treatment duration: ≥14 days (and refer)
  (STG, Paed. 2023)

Complicated sinusitis
- Empiric therapy

• IV: 100mg/kg, dly; Treatment duration: 14 days (and refer)
  (STG, Paed. 2023)

Acute bacterial tracheitis

Older than 1 month

• IV: 80mg/kg, dly (and refer)
  (STG, Paed. 2023)

Laryngotracheo bronchitis (CROUP)
- If epiglottitis suspected

• IM: 80mg/kg/dose, immediately as a single dose (and refer)
  (STG, PHC 2020)

Epiglottitis (Additional agent may be required)

• IV: 50mg/kg/dose, dly; Treatment duration: 7 days (and refer)
  (STG, Paed. 2023)

Burns
- With signs of infection

• IV: 50mg/kg/dose, dly; Treatment duration: 5 days
  (STG, Paed. 2017)

Bacillary dysentery

Younger than 12 months

• IM: 80mg/kg/dose, immediately as a single dose (and refer)
  (STG, PHC 2020)

- Initial treatment as shigella dysentery during a Shigellosis epidemic when oral medication cannot be used

• IV: 50mg/kg, dly; Treatment duration: 5 days
  (STG, Paed. 2017)

Typhoid

• IV: 100mg/kg, dly; Treatment duration: 10 days, up to 14 days for more severe cases
  (STG, Paed. 2017)

Persistent diarrhoea (Y. enterocolitica)

• IV: 50mg/kg/dose, dly
  (STG, Paed. 2017)

Purulent pericarditis (Additional agent required)

• IV: 100mg/kg, dly; Treatment duration: 4 weeks
  (STG, Paed. 2017)

Complicated severe acute malnutrition (SAM) (Additional agent required)
- If the child has any danger signs
Acute pyelonephritis
- In ill patients awaiting transfer
Viral haemorrhagic fever (VHF)
- Management of suspected/possible/probable VHF

• IM: 80mg/kg/dose, immediately as a single dose (and refer)
  (STG, PHC 2020, 2023)

Severe acute malnutrition (SAM)
- Severely ill children or those who fail to improve after 48 hours

• IV/IM: 50mg/kg/dose, dly
  (STG, Paed. 2017)

- If meningitis is suspected

• IV/IM: 80mg/kg/dose, dly
  (STG, Paed. 2017)

Acute bacterial meningitis
- As initial treatment before transfer

• IM: 80mg/kg/dose, immediately as a single dose (and refer)
  (STG, PHC 2020)

- Culture negative OR culture positive meningitis (N meningitides)

• IV: 50mg/kg/dose, 12hrly; Treatment duration: 5 days
  (STG, Paed. 2017)

- Culture positive meningitis (S pneumoniae OR H influenza)

• IV: 50mg/kg/dose, 12hrly; Treatment duration: 10 days
  (STG, Paed. 2017)

- Culture positive meningitis (Other gram-negative bacilli)

• IV: 50mg/kg/dose, 12hrly; Treatment duration: 21 days
  (STG, Paed. 2017)

- For shunts (Additional agents required)

• IV: 50mg/kg, 12hrly
  (STG, Paed. 2017)

Sepsis
- Empiric therapy

• IV: 50mg/kg/dose, 12hrly; Treatment duration: 7 days
  (STG, Paed. 2017)

Septic arthritis
- Infants ≤2 months of age, who fulfil the IMCI criteria for “Possible serious bacterial infection" should receive a first dose, and other IMCI urgent care while arranging transfer

Younger than 2 months

• IM: 80mg/kg/dose, immediately as a single dose (and refer)
  (STG, PHC 2020)

- Treatment (Additional agent required)

Between 1-3 months

• IV: 80mg/kg/dose, 12hrly; Treatment duration: 4-6 weeks
  (STG, Paed. 2017)

Older than 3 months

- If Gram negative organisms are seen on Gram stain, or when clinically suspected, e.g., sickle cell disease (Additional agent required)

• IV: 80mg/kg/dose, 12hrly; Treatment duration: 4-6 weeks
  (STG, Paed. 2017)

Acute diarrhoea
- Neonates with severe dehydration
- Children with Severe Acute Malnutrition (SAM) AND severe dehydration or shock
Fever
- Children <2 months of age, fulfilling any criterion of possible serious bacterial infection

• IM: 80mg/kg/dose, immediately as a single dose (and refer)
  (STG, PHC 2020, 2023)

Care of sick and small neonates
- If infection is suspected and jaundice has been excluded

• IM: 80mg/kg/dose, immediately as a single dose
  (STG, PHC 2020, 2023)

Conjunctivitis of the newborn (Additional agents required)
- Purulent discharge, i.e., mild discharge without swollen eyelids and no corneal haziness

• IM: 50mg/kg, immediately as a single dose
  (STG, PHC 2020)

- Abundant purulent discharge and/or swollen eyelids and/or corneal haziness

• IM: 50mg/kg, immediately as a single dose (and refer)
  (STG, PHC 2020)

Prophylaxis for sexually transmitted infections (STIs) (Additional agents required)

• ≥45kg: IM: 80mg/kg/dose, immediately as a single dose (and refer)
  (STG, PHC 2020)

Spontaneous bacterial peritonitis (Additional agents required)

• IV: 50mg/kg/dose, 12hrly; Treatment duration: 5 days (and refer)
  (STG, Paed. 2023)

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South African registered indications and dosages

Meningitis caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae

Younger than 12 years (<50kg)

• IV: 100mg/kg, dly; Max: 4g/24hrs 

Older than 12 years (≥50kg)

• See adult dosage

Other infections caused by susceptible organisms 

Younger than 14 days

• IV: 20-50mg/kg, dly; Max: 50mg/24hrs

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It is not necessary to differentiate between premature and term infants

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Between 15 days-12 years (<50kg)

• IV: 20-80mg/kg, dly

Older than 12 years (≥50kg)

• See adult dosage

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As soon as the causative organism has been identified and its sensitivity determined, the dosage can be reduced accordingly

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Intravenous doses of ≥50mg/kg bodyweight should be given by infusion over at least 30 minutes

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Indications and dosages registered in other jurisdictions

Neonates 0-14 days

Intra-abdominal infections
Complicated skin and soft tissue infections
Complicated urinary tract infections (Including pyelonephritis)
Community-acquired pneumonia
Hospital-acquired pneumonia
Infections of bones and joints
Management of neutropenic patients with fever that is suspected to be due to a bacterial infection

• IV: 20-50mg/kg, dly; Max: 50mg/kg/24hrs

Bacterial meningitis
Bacterial endocarditis 

• IV: 50mg/kg, dly; Max: 50mg/kg/24hrs 

Acute otitis media

• IM: Initial: 50mg/kg, as a single dose

Pre-operative prophylaxis of surgical site infections

•  IV: 20-50mg/kg, as a single pre-operative dose

Syphilis

• IV: 50mg/kg, dly; Treatment duration: 10-14 days

---

The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration

---

Between 15 days-12 years (<50kg)

Intra-abdominal infections
Complicated urinary tract infections (Including pyelonephritis)
Community-acquired pneumonia
Hospital-acquired pneumonia

• IV: 50-80mg/kg, dly

Complicated skin and soft tissue infections
Infections of bones and joints
Management of neutropenic patients with fever that is suspected to be due to a bacterial infection 

• IV: 50-100mg/kg, dly; Max: 4g/24hrs 

Bacterial meningitis

• IV: 80-100mg/kg, dly; Max: 4g/24hrs 

Bacterial endocarditis

• IV: 100mg/kg, dly; Max: 4g/24hrs 

Acute otitis media

• IM: Initial: 50mg/kg, as a single dose

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For acute otitis media, limited data suggest that in cases where the child is severely ill or initial therapy has failed, ceftriaxone may be effective when given as an IM dose of 50 mg/kg daily for 3 days

---

Pre-operative prophylaxis of surgical site infections

•  IV: 50-80mg/kg, as a single pre-operative dose

Syphilis

• IV: 75-100mg/kg, dly; Treatment duration: 10-14 days; Max: 4g/24hrs 

---

The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration

---

Disseminated Lyme borreliosis (Early [Stage II] and late [Stage III])

• IV: 50-80mg/kg, dly; Treatment duration; 14-21 days

---

The recommended treatment durations vary and national or local guidelines should be taken into consideration

Pregnancy

• Caution; no evidence of risk in studies
• Ceftriaxone crosses the placental barrier. There are limited amounts of data from the use of ceftriaxone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal, perinatal and postnatal development. Ceftriaxone should only be administered during pregnancy and in particular in the first trimester of pregnancy if the benefit outweighs the risk

Breastfeeding

• Caution; not recommended
• Ceftriaxone is excreted into human milk in low concentrations but at therapeutic doses of ceftriaxone, no effects on the breastfed infants are anticipated. However, a risk of diarrhoea and fungal infection of the mucous membranes cannot be excluded. The possibility of sensitisation should be taken into account. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from ceftriaxone therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

• Reproductive studies have shown no evidence of adverse effects on male or female fertility

Renal Impairment

• Mild to moderate: No dose adjustment recommended
  No need to reduce the dosage provided the hepatic function is not impaired
• Severe: Caution; dose adjustment recommended

CrCl (ml/min)	Dosage
≥10 ml/min	No adjustment necessary
<10 ml/min	Max: IV/IM: 2g/24hrs
Peritoneal- or Haemodialysis patients	No supplementary dosing required. Close clinical monitoring for safety and efficacy is advised

Hepatic Impairment

• Mild to moderate: No dose adjustment recommended
  No need to reduce the dosage provided the renal function is not impaired
• Severe: Caution; no information available

Elderly

• No dose adjustment recommended
  Dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Seizures

Respiratory Disorders

• Bronchospasm

Gastrointestinal Disorders

• Diarrhoea
• Loose stools
• Nausea and vomiting
• Pancreatitis
• Stomatitis
• Glossitis
• Pseudomembranous colitis

Hepatobiliary Disorders

• Increased hepatic enzymes
• Gallbladder precipitation
• Kernicterus

Genitourinary Disorders

• Haematuria
• Glycosuria
• Oliguria
• Renal precipitation (reversible)
• Increased blood creatinine

Endocrine and Metabolic Disorders

• False-positive Coombs' test
• False-positive galactosaemia test
• False-positive non-enzymatic methods for glucose determination
• Falsely lower estimated blood glucose values

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Urticaria
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Erythema multiforme
• Acute generalised exanthematous pustulosis
• Drug reaction with eosinophilia and systemic symptoms (DRESS)
• Phlebitis
• Injection site pain
• Oedema

Immune, Blood and Lymphatic System Disorders

• Eosinophilia
• Leucopenia
• Thrombocytopenia
• Granulocytopenia
• Anaemia
• Coagulopathy
• Haemolytic anaemia
• Agranulocytosis
• Anaphylactic shock
• Anaphylactic reaction
• Anaphylactoid reaction
• Hypersensitivity
• Genital fungal infection
• Jarisch-Herxheimer reaction
• Superinfection
• Pyrexia
• Chills

Sensory Disorders

• Vertigo

• Calcium-containing infusions
• Intravenous calcium treatments
• Ringer's solution
• Hartmann's solution
• Total parenteral nutrition
• Oral anticoagulants
• Aminoglycosides
• Chloramphenicol

Other interactions

• Coombs tests
• Galactosaemia tests
• Non-enzymatic methods for glucose determination
  (See additional prescribing points)

None routine. Specific cases may require

• Full blood count
• Prothrombin time
• International Normalised Ratio
• Renal function
• Hepatic function
• Blood glucose
• Aminoglycoside levels

Additional observations

• Signs and symptoms of anaphylaxis

Injection 250mg, Injection 500mg, Injection 1g - EML (Primary)

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Method of administration

• Ceftriaxone must be reconstituted prior to use. Reconstituted solutions retain their physical and chemical stability for 6 hours at room temperature (or 24 hours in the refrigerator at ± 5 °C)
• As a general rule, however, the solutions should be used immediately after preparation
• The solutions range in colour from pale yellow to amber, depending on the concentration and length of storage. The colouration of the solutions is of no significance for the efficacy or tolerance of the agent

- IM injection

• Ceftriaxone 250mg or 500mg is dissolved in 2ml and ceftriaxone 1g in 3,5ml, of water for injection
• Ceftriaxone dissolved in a 1% lidocaine solution instead of water for injection can reduce pain at the site of injection. Ceftriaxone must be injected well within the body of a relatively large muscle
• It is recommended that not more than 1g be injected at one site
• Reconstitution with 1% lidocaine (without adrenaline) has no effect on the absorption or the elimination of ceftriaxone. The lidocaine solution must never be administered intravenously

- IV injection

• Ceftriaxone 250mg or 500mg is dissolved in 5ml, and ceftriaxone 1g in 10ml sterile water for injection. The intravenous administration should be given over 2-4 minutes

- Intravenous infusion

• The infusion should be given over a period of at least 30 minutes
• For IV infusion, 2g of ceftriaxone is dissolved in approximately 40 ml of one of the following calcium-free infusion solutions: Sodium chloride 0,9 %; sodium chloride 0,45 % + dextrose 2,5 %; dextrose 5 %; dextrose 10 %; dextran 6 % in dextrose 5 %; hydroxy ethyl starch 6 - 10 % infusions; sterile water for injection
• Ceftriaxone solutions should not be mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, owing to possible incompatibility

Interaction with calcium-containing products

• Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term neonates aged less than 1 month have been described
• At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines
• In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products. In vitro studies demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups
• In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing intravenous solutions, even via different infusion lines or at different infusion sites
• However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation
• In patients requiring continuous infusion with calcium-containing total parenteral nutrition (TPN) solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation
• If the use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion and the infusion lines flushed between solutions

Colitis/Overgrowth of non-susceptible microorganisms

• Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to life-threatening
• Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftriaxone
• Discontinuation of therapy with ceftriaxone and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given
• Superinfections with non-susceptible micro-organisms may occur as with other antibacterial agents

Interference with serological testing

• Interference with Coombs tests may occur, as ceftriaxone may lead to false-positive test results
• Ceftriaxone can also lead to false-positive test results for galactosaemia
• Non-enzymatic methods for the glucose determination in urine may give false-positive results
• Urine glucose determination during therapy with ceftriaxone should be done enzymatically
• The presence of ceftriaxone may falsely lower estimated blood glucose values obtained with some blood glucose monitoring systems. Please refer to instructions for use for each system. Alternative testing methods should be used if necessary

Biliary lithiasis

• When shadows are observed on sonograms, consideration should be given to the possibility of precipitates of calcium ceftriaxone
• Shadows, which have been mistaken for gallstones, have been detected on sonograms of the gallbladder and have been observed more frequently at ceftriaxone doses of 1g per day and above
• Caution should be particularly considered in the paediatric population. Such precipitates disappear after discontinuation of ceftriaxone therapy
• Rarely precipitates of calcium ceftriaxone have been associated with symptoms
• In symptomatic cases, conservative nonsurgical management is recommended and discontinuation of ceftriaxone treatment should be considered by the physician based on specific benefit-risk assessment

Ceftriaxone inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

Spectrum of activity: Gram-positive aerobes, Staphylococcus aureus (methicillin-susceptible), Staphylococci coagulase-negative (methicillin-susceptible), Streptococcus pyogenes (Group A), Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Viridans Group Streptococci, Gram-negative aerobes, Borrelia burgdorferi, Haemophilus influenza, Haemophilus parainfluenzae, Moraxella catarrhalis, Neisseria gonorrhoea, Neisseria meningitidis, Proteus mirabilis, Providencia spp, Treponema pallidum, H. ducreyi, Kingella sp, Leptospira sp., Y. enterocolitica

Injection (per vial) 250mg

• Ceftriaxone 250 Pharma-Q (Pharma-Q)
• Ceftriaxone-Safeline (Safeline)
• Fraxone 250 (Innovata Pharmaceuticals)
• Fresenius Ceftriaxone (Fresenius Kabi)
• Kocef (Dezzo Trading)
• Oframax (Ranbaxy)
• Medaxone (Specpharm)
• Rocephin (Roche) originator
• Triaphin (Dezzo Trading)

Injection (per vial) 500mg

• Adco Ceftriaxone (Adcock Ingram)
• Arrow Ceftriaxone (Arrow)
• Aspen Ceftriaxone (Litha Pharma)
• Austell Ceftriaxone ( Austell)
• Ceftriaxone 500mg Fresenius (Fresenius Kabi)
• Ceftriaxone 500 Pharma-Q (Pharma-Q)
• Ceftriaxone-Safeline (Safeline)
• Fresenius Ceftriaxone (Fresenius Kabi)
• Kocef (Dezzo Trading)
• Medaxone (Specpharm)
• Rociject 0.5mg (Litha Pharma)
• Rocephin (Roche) originator
• Rokef 0.5g (Oethmaan Biosims)
• Sandoz Ceftriaxone (Sandoz)
• Seftry 0.5 (Oethmaan Biosims)
• Triaxiphin (Be-tabs)

Injection (per vial) 1g

• Adco Ceftriaxone (Adcock Ingram)
• Arrow Ceftriaxone (Arrow)
• Aspen Ceftriaxone (Litha Pharma)
• Austell Ceftriaxone ( Austell)
• Ceftriaxone 1g Fresenius (Fresenius Kabi)
• Ceftriaxone 1000 Pharma-Q (Pharma-Q)
• Ceftriaxone-Safeline (Safeline)
• Fraxone (Innovata)
• Fresenius Ceftriaxone (Fresenius Kabi)
• Gulf Ceftriaxone (Gulf Drug)
• Kocef-1000 (Medicine Developers)
• Medaxone (Specpharm)
• Oframax (Ranbaxy)
• Rociject 1.0g  (Litha Pharma)
• Rocephin (Roche) originator
• Rokef 1g (Oethmaan Biosims)
• Sandoz Ceftriaxone (Sandoz)
• Seftry 1.0 (Oethmaan Biosims)
• Triaphin (Dezzo Trading)
• Triaxiphin (Be-tabs)

Injection (per vial) 2g

• Adco Ceftriaxone (Adcock Ingram)
• Aspen Ceftriaxone (Litha Pharma)
• Ceftriaxone 2g Fresenius (Fresenius Kabi)
• Fresenius Ceftriaxone (Fresenius Kabi)
• Rociject (Litha Pharma)
• Rocephin (Roche) originator
• Rokef 2g (Oethmaan Biosims)
• Sandoz Ceftriaxone (Sandoz)
• Seftry 2.0 (Oethmaan Biosims)