| Application: | Internal Medicine |
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| Usage Mode: | I.M./I.V. |
| Suitable for: | Elderly, Children, Adult |
| State: | Solid |
| Shape: | Powder |
| Type: | Organic Chemicals |
| Samples: |
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| Customization: |
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Audited Supplier Ceftriaxone 1 g powder for solution for injection/infusion
Each vial Ceftriaxone contains 1.196 g of ceftriaxone sodium, equivalent to 1g of ceftriaxone.
Excipient with known effect: Sodium
1g vial contains 3.6 mmol (or 83 mg) of sodium per vial.
For a full list of excipients, see section 6.1.
Powder for solution for injection/infusion.
White to pale yellow powder.
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 |
Once daily |
Community acquired pneumonia |
|
Acute exacerbations of chronic obstructive pulmonary disease |
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|
Intra-abdominal infections |
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|
Complicated urinary tract infections (including pyelonephritis) |
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|
2 g |
Once daily |
Hospital acquired pneumonia |
|
Complicated skin and soft tissue infections |
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|
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 local guidelines should be taken into consideration.
Paediatric population
Neonates, infants and children 15 days to 12 years of age (< 50 kg)
For children with bodyweight of 50 kg or more, the usual adult dosage should be given.
|
Ceftriaxone dosage* |
Treatment frequency** |
Indications |
|
50-80 mg/kg |
Once daily |
Intra-abdominal infections |
|
Complicated urinary tract infections (including pyelonephritis) |
||
|
Community acquired pneumonia |
||
|
Hospital acquired pneumonia |
||
|
50-100 mg/kg (Max 4 g) |
Once daily |
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 |
||
|
80-100 mg/kg (max 4 g) |
Once daily |
Bacterial meningitis |
|
100 mg/kg (max 4 g) |
Once daily |
Bacterial endocarditis |
* 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 neonates, infants and children 15 days to 12 years (< 50 kg) that require specific dosage schedules:
Acute otitis media
For initial treatment of acute otitis media, a single intramuscular dose of Ceftriaxone 50 mg/kg can be given. 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 intramuscular dose of 50 mg/kg daily for 3 days.
Pre-operative prophylaxis of surgical site infections
50-80 mg/kg as a single pre-operative dose.
Syphilis
The generally recommended doses are 75-100 mg/kg (max 4 g) once daily for 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.
Disseminated Lyme borreliosis (early [Stage II] and late [Stage III])
50-80 mg/kg once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.
Indications for neonates at age of 0-14 days that require specific dosage schedules
Neonates 0-14 days
Ceftriaxone is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)
|
Ceftriaxone dosage* |
Treatment frequency |
Indications |
|
20-50 mg/kg |
Once daily |
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 |
||
|
50 mg/kg |
Once daily |
Bacterial meningitis |
|
Bacterial endocarditis |
* In documented bacteraemia, the higher end of the recommended dose range should be considered. A maximum daily dose of 50 mg/kg should not be exceeded.
Indications for neonates 0-14 days that require specific dosage schedules:
Acute otitis media
For initial treatment of acute otitis media, a single intramuscular dose of Ceftriaxone 50 mg/kg can be given.
Pre-operative prophylaxis of surgical site infections
20-50 mg/kg as a single pre-operative dose.
Syphilis
The generally recommended dose is 50 mg/kg once daily for 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.
Duration of therapy
The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued for 48-72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved.
Older people
The dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory.
Patients with hepatic impairment
Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment provided renal function is not impaired.
There are no study data in patients with severe hepatic impairment (see section 5.2).
Patients with renal impairment
In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is not impaired. Only in cases of preterminal renal failure (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily.
In patients undergoing dialysis no additional supplementary dosing is required following the dialysis. Ceftriaxone is not removed by peritoneal- or haemodialysis. Close clinical monitoring for safety and efficacy is advised.
Patients with severe hepatic and renal impairment
In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised.
Method of administration
Ceftriaxone can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes, or by deep intramuscular injection. Intravenous intermittent injection should be given over 5 minutes preferably in larger veins. Intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be given by infusion. In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy (see section 4.3 and 4.4). Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site. Intramuscular administration should be considered when the intravenous route is not possible or less appropriate for the patient. For doses greater than 2 g intravenous administration should be used.
If lidocaine is used as a solvent, the resulting solution should never be administered intravenously (see section 4.3). The information in the Summary of Product Characteristics of lidocaine should be considered.
Ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium (see section 4.3).
Diluents containing calcium, (e.g. Ringer's solution or Hartmann's solution), should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously (see sections 4.3, 4.4 and 6.2).
For pre-operative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes prior to surgery.
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