Ceftriaxone 1g Powder for Solution for Injection or Infusion
Ceftriaxone sodium equivalent to 1g ceftriaxone per vial.
Each gram of ceftriaxone sodium contains approximately 3.6 mmol sodium.
1 g Powder for solution for injection or infusion
Powder for solution for injection or infusion.
Ceftriaxone is indicated for the treatment of the following infections in adults and children including term neonates (from birth):
• Bacterial Meningitis
• Community acquired pneumonia
• Hospital acquired pneumonia
• Acute otitis media
• Intra-abdominal infections
• Complicated urinary tract infections (including pyelonephritis)
• Infections of bones and joints
• Complicated skin and soft tissue infections
• Gonorrhoea
• Syphilis
• Bacterial endocarditis.
Ceftriaxone may be used:
For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults
For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age.
For pre-operative prophylaxis of surgical site infections.
In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Ceftriaxone should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4).
Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
Posology
The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient.
The doses recommended in the tables below are the generally recommended doses in these indications. In particularly severe cases, doses at the higher end of the recommended range should be considered.
Adults and children over 12 years of age (≥ 50 kg)
|
Ceftriaxone Dosage*
|
Treatment frequency**
|
Indications
|
|
1 - 2 g
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Once daily
|
Community acquired pneumonia
|
|
Acute exacerbations of chronic obstructive pulmonary disease
|
|
Intra-abdominal infections
|
|
Complicated urinary tract infections (including pyelonephritis)
|
|
2 g
|
Once daily
|
Hospital acquired pneumonia
|
|
Complicated skin and soft tissue infections
|
|
Infections of bones and joints
|
|
2 – 4 g
|
Once daily
|
Management of neutropenic patients with fever that is suspected to be due to a bacterial infection
|
|
Bacterial endocarditis
|
|
Bacterial meningitis
|
* In documented bacteraemia, the higher end of the recommended dose range should be considered.
** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.
Indications for adults and children over 12 years of age (≥ 50 kg) that require specific dosage schedules:
Acute otitis media
A single intramuscular dose of Ceftriaxone 1-2 g can be given. Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Ceftriaxone may be effective when given as an intramuscular dose of 1-2 g daily for 3 days.
Pre-operative prophylaxis of surgical site infections
2 g as a single pre-operative dose.
Gonorrhoea
500 mg as a single intramuscular dose.
Syphilis
The generally recommended doses are 500 mg -1 g once daily increased to 2 g once daily for neurosyphilis for 10-14 days. 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])
2 g once daily for 14-21 days. The recommended treatment durations vary and national or loc
