Indicatios:

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.

Dosage and administration：

Posology

The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient.

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.

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.

Contraindications:

Hypersensitivity to ceftriaxone, to any other cephalosporin or to any of the excipients.

History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).

Ceftriaxone is contraindicated in:

Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)*

Full-term neonates (up to 28 days of age):

- with hyperbilirubinaemia, jaundice, or who are hypoalbuminaemic or acidotic because these are conditions in which bilirubin binding is likely to be impaired

- if they require (or are expected to require) intravenous calcium treatment, or calcium-containing infusions due to the risk of precipitation of a ceftriaxonecalcium salt.

Precautions:

Hypersensitivity reactions

Interaction with calcium containing products

Paediatric population

Immune mediated haemolytic anaemia

Long term treatment

Colitis/Overgrowth of non-susceptible microorganism

Severe renal and hepatic insufficiency

Interference with serological testing

Sodium

Antibacterial spectrum

Biliary lithiasis

Renal lithiasis

Drug interactions:

Calcium-containing diluents

Concomitant use with oral anticoagulants may increase the anti-vitamin K effect and the risk of bleeding.

There is conflicting evidence regarding a potential increase in renal toxicity of aminoglycosides when used with cephalosporins.   The recommended monitoring of aminoglycoside levels (and renal function) in clinical practice should be closely adhered to in such cases.

There have been no reports of an interaction between ceftriaxone and oral calcium- containing products or interaction between intramuscular ceftriaxone and calcium- containing products (intravenous or oral).

Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosaemia.

No impairment of renal function has been observed after concurrent administration of large doses of ceftriaxone and potent diuretics (e.g. furosemide).

Simultaneous administration of probenecid does not reduce the elimination of ceftriaxone.

Storage:

Unopened: do not store above 25°C.

Keep container in the outer carton.

After reconstitution: store at 2-8°C.