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Ceftriaxone is indicated for the treatment of the following infections in adults and children, including term neonates (from birth):
Ceftriaxone may be used:
Ceftriaxone should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Ceftriaxone Dosage Guidelines
Ceftriaxone is a broad-spectrum antibiotic widely used for various bacterial infections. The dosage varies based on factors like the severity of the infection, patient age, and liver and kidney function. Below are the general guidelines for dosing:
For children under 12 years of age, the dosage is typically based on body weight, with a range of 50-100 mg/kg per day. This is adjusted based on the severity of the infection and clinical response.
In neonates, the maximum dosage is 50 mg/kg per day. Particular caution is required due to contraindications in premature infants and the immaturity of their liver and kidney functions, which can impact drug clearance and safety.
The length of treatment is typically extended for 48-72 hours after the resolution of symptoms. This helps to ensure that the infection is completely eradicated and reduces the risk of recurrence.
Patients with liver or kidney dysfunction may require dose adjustments to avoid toxicity. In cases of severe impairment, careful monitoring is essential, and a lower dose may be recommended to ensure the drug is cleared appropriately.
Ceftriaxone dosing is highly individualized, especially in cases where patients have underlying organ dysfunction. Always consult local guidelines and medical professionals to tailor treatment based on specific patient conditions and regional microbial resistance patterns.
The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased.
Data to determine the frequency of ceftriaxone ADRs was derived from clinical trials.
The following convention has been used for the classification of frequency: Very common (≥ 1/10), Common (≥ 1/100 – < 1/10), Uncommon (≥ 1/1000 – < 1/100), Rare (≥ 1/10000 – < 1/1000), Not known (cannot be estimated from the available data)
Infections and Infestations
Uncommon: Genital fungal Infection; Rare: Pseudomembranous Colitis
Blood and lymphatic system disorders
Common: Eosinophilia, Leucopenia, Thrombocytopenia; Uncommon: Granulocytopenia,
Anaemia, Coagulopathy; Not knowna: Haemolytic anaemia, Agranulocytosis
Immune system disorders
Not knowna: Anaphylactic shock, Anaphylactic reaction, Anaphylactoid reaction, Hypersensitivity
Nervous system disorders
Uncommon: Headache, Dizziness; Rare: Encephalopathy
Gastrointestinal disorders
Common: Diarrhoea, Loose stools; Uncommon: Nausea, Vomiting; Not knowna: Pancreatitis, Stomatitis
Hepatobiliary disorders
Common: Hepatic enzyme increased; Not knowna: Gall bladder precipitation, Kernicterus, Hepatitisb
Skin and subcutaneous tissue disorders
Common: Rash; Not knowna: Stevens Johnson Syndrome, Toxic epidermal necrolysis
Renal and urinary disorders
Rare: Haematuria, Glycosuria; Not knowna: Oliguria, Renal precipitation (reversible)
a Based on post-marketing reports. Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
b Usually reversible upon discontinuation of ceftriaxone
Hypersensitivity reactions
As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with ceftriaxone must be discontinued immediately and adequate emergency measures must be initiated.
Immune mediated haemolytic anaemia
An immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class antibacterials including Ceftriaxone. Severe cases of haemolytic anaemia, including fatalities, have been reported during Ceftriaxone treatment in both adults and children.
Antibacterial spectrum
Ceftriaxone has a limited spectrum of antibacterial activity and may not be suitable for use as a single agent for the treatment of some types of infections unless the pathogen has already been confirmed.
Renal lithiasis
Cases of renal lithiasis have been reported, which is reversible upon discontinuation of ceftriaxone.
Jarisch-Herxheimer reaction (JHR)
Some patients with spirochete infections may experience a Jarisch-Herxheimer reaction (JHR) shortly after ceftriaxone treatment is started. JHR is usually a self – limiting condition or can be managed by symptomatic treatment. The antibiotic treatment should not be discontinued if such reaction occurs.
Encephalopathy
Encephalopathy has been reported with the use of ceftriaxone, particularly in elderly patients with severe renal impairment or central nervous system disorders.
Store below 30oC. Protect from light and moisture.
Keep the medicine out of reach of children.
10 ml Clear glass vial with bromobutyl rubber stopper, sealed with a flip-off aluminium seal.
Ceftriaxone for Injection USP 1000 mg powder for solution for injection or infusion is supplied in glass vial packed in unit carton with pack insert.
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