Cetafor (Ceftriaxone for Injection) Indications and Dosing

Cetafor (Ceftriaxone for Injection)

Cetafor contains approximately 83 mg (3.6 mmol) of sodium per 1000 mg ceftriaxone. Pharmacotherapeutic group: Antibacterials for systemic use, Third-generation Cephalosporins. ATC code: J01DD04

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.

Resistance

Bacterial resistance to ceftriaxone may be due to one or more of the following mechanisms:

  • hydrolysis by beta-lactamases, including extended-spectrum beta-lactamases (ESBLs), carbapenemases and Amp C enzymes that may be induced or stably derepressed in certain aerobic Gram-negative bacterial species.
  • reduced affinity of penicillin-binding proteins for ceftriaxone.
  • outer membrane impermeability in Gram-negative organisms.
  • bacterial efflux pumps.

Therapeutic indications

Cetafor 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

Cetafor 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.

Cetafor should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum.

Posology and mode of 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.
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  • 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.

Adults and children over 12 years of age (≥ 50 kg)

IndicationsDose of ceftriaxoneFrequency
Community acquired pneumonia Acute exacerbations of chronic obstructive pulmonary disease. Intra-abdominal infections Complicated urinary tract infections (including pyelonephritis)1-2 gOnce daily
Hospital acquired pneumonia Complicated skin and soft tissue infections Infections of bones and joints2gOnce daily
Management of neutropenic patients with fever that is suspected to be due to a bacterial infection Bacterial endocarditis Bacterial meningitis2-4gOnce daily

Specific dosage schedules for adults and children over 12 years of age (≥ 50 kg)

  • Acute otitis media. A single intramuscular dose of Cetafor 1-2 g can be given. Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Cetafor 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.

Special populations

Older patients: The dosages recommended for adults require no modification in older people providedthat renal and hepatic function is satisfactory.

Patients with hepatic impairment: Available data do not indicate the need for dose adjustment in mild or moderate liverfunction impairment provided renal function is not impaired. There are no study datain patients with severe hepatic impairment.

Patients with renal impairment: In patients with impaired renal function, there is no need to reduce the dosage ofceftriaxone provided hepatic function is not impaired. Only in cases of preterminal renalfailure (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 gdaily. In patients undergoing dialysis no additional supplementary dosing is requiredfollowing 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 forsafety and efficacy is advised.

Neonates, infants and children 15 days to 12 years of age (< 50 kg)

IndicationsDose of ceftriaxoneFrequency
Community acquired pneumonia Hospital acquired pneumonia Intra-abdominal infections Complicated urinary tract infections (including pyelonephritis)50-80 mg/kgOnce daily
Complicated skin and soft tissue infections of bones and joints Management of neutropenic patients with fever that is suspected to be due to a bacterial infection50-100 mg/kg (max 4g)Once daily
Management of neutropenic patients with fever that is suspected to be due to a bacterial infection Bacterial endocarditis Bacterial meningitis50-100mg/kg (max 4 g)Once daily

Specific dosage schedules for neonates, infants and children 15 days to 12 years (< 50 kg)

  • Acute otitis media. For initial treatment of acute otitis media, a single intramuscular dose of Cetafor 50 mg/kg can be given. Limited data suggest that in cases where the child is severely ill or initial therapy has failed, Cetafor 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.

Method of administration

Cetafor 1000 mg IV / Cetafor 500 mg IV

Intravenous injection

  • Cetafor 1000 mg IV should be dissolved in 10 ml of water for injection, by using the solvent ampoule included in the same box. The injection should be administered over 2-4 minutes.
  • Cetafor 500 mg IV should be dissolved in 5 ml of water for injection, by using the solvent ampoule included in the same box. The injection should be administered over 2-4 minutes.

Intravenous perfusion

Concentrations between 10mg/ml and 40 mg/ml are recommended.

Cetafor 1000 IV and 500mg IV should be dissolved in one of the following solutions:

  • 0.9 % sodium chloride;
  • 5 % dextrose;
  • 10 % dextrose;
  • 5 % dextrose + 0.9 % sodium chloride;
  • 5 % dextrose + 0.45 % sodium chloride.

All these solutions should be administered immediately after reconstitution.

Solutions containing ceftriaxone should not be mixed or added to other agents. In particular, ceftriaxone is not compatible with calcium-containing solutions such as Hartmann’s solution and Ringer’s solution. Ceftriaxone should not be mixed or administered simultaneously with solutions containing calcium.

Cetafor 1000 mg IM

Intramuscular injection

  • Cetafor 1000 mg IM should be dissolved in 4 ml of sterile 1% Lidocaine hydrochloride, by using the solvent ampoule included in the same box.
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  • The solution should be administered by deep intragluteal injection and used immediately after reconstitution.

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).
  • 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, leading to a possible risk of bilirubin encephalopathy.
  • Contraindications to lidocaine must be excluded before intramuscular injection of ceftriaxone when lidocaine solution is used as a solvent in patients who have hypersensitivity to local anaesthetics and who have heart block. Ceftriaxone solutions containing lidocaine should never be administered intravenously.

Overdose

In overdose, the symptoms of nausea, vomiting and diarrhoea can occur. Ceftriaxone concentrations cannot be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdose should be symptomatic.

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