Posology : מינונים

4.2 Posology and method of administration

Posology
The dose depends on the severity, susceptibility, site and type of infection and on the age and hepatorenal 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      Treatment           Indications
Dosage*          frequency**
1-2 g            Once daily          Community acquired pneumonia

Acute exacerbations of chronic obstructive pulmonary disease
Intra-abdominal infections

Complicated urinary tract infections (including pyelonephritis)
2g               Once daily          Hospital acquired pneumonia
Complicated skin and soft tissue infections

Infections of bones and joints

Ceftriaxone        Treatment             Indications
Dosage*            frequency**
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 S.K. 1-2 g can be given.
Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Ceftriaxone S.K. 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                 Indications frequency**
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            Once daily            Complicated skin and soft tissue infections (Max 4 g)
Infections of bones and joints

Management of neutropenic patients with fever that is suspected to be due to a bacterial infection
100 mg/kg               Once daily            Bacterial meningitis
(max 4 g)
100 mg/kg               Once daily            Bacterial endocarditis
(max 4 g)
* 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 S.K. 50 mg/kg can be given. Limited data suggest that in cases where the child is severely ill or initial therapy has failed, Ceftriaxone S.K. 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.


Neonates 0-14 days
Ceftriaxone S.K. is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).

Ceftriaxone Dosage* Treatment               Indications frequency**
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 S.K. 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.

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

Intramuscular administration
Ceftriaxone S.K. can be administered by deep intramuscular injection. 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.
As the solvent used is lidocaine, 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.

Intravenous administration
Ceftriaxone S.K. can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes.
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 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.

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.

Concentrations for the intravenous injection: 100 mg/ml,

Reconstitution mediums:
Powder                   Reconstitution        Volume solvent               to be added
Intravenous           1g                    Water for             10 ml injection                                   Injections BP

Intramuscular         1g                    1.0% Lidocaine        3.5 ml injection                                   Hydrochloride BP