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CEFTRIAXONE ENEXI is a brand name for Ceftriaxone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's MHRA label. Tap a section to expand.
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 Community acquired pneumonia Acute exacerbations of chronic obstructive pulmonary disease Intra-abdominal infections 1-2 g Once daily Complicated urinary tract infections (including pyelonephritis) Hospital acquired pneumonia Complicated skin and soft tissue infections 2 g Once daily Infections of bones and joints Management of neutropenic patients with fever that is suspected to be due to a bacterial infection Bacterial endocarditis 2-4 g Once daily 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 Intra-abdominal infections Complicated urinary tract infections (including pyelonephritis) Community acquired pneumonia 50-80 mg/kg Once daily Hospital acquired pneumonia Complicated skin and soft tissue infections Infections of bones and joints 50-100 mg/kg (Max 4 g) Once daily 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.
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) System Organ Class Common Uncommon Rare Not Knowna Infections and infestations Genital fungal infection Pseudo- membranous colitisb Superinfectio nb Blood and lymphatic system disorders Eosinophilia Leucopenia Thrombocytopen ia Granulocytopen ia Anaemia Coagulopathy Haemolytic anaemiab Agranulocyto sis Immune system disorders Anaphylactic shock Anaphylactic reaction Anaphylactoi d reaction Hypersensitiv ityb Jarisch- Herxheimer reactionb.
Nervous Headache Encephalopath Convulsion system disorders Dizziness y Ear and labyrinth disorders Vertigo Respiratory, thoracic and mediastinal disorders Bronchospasm Gastrointestin al disorders Diarrhoeab Loose stools Nausea Vomiting Pancreatitisb Stomatitis Glossitis Hepatobiliary disorders Hepatic enzyme increased Gall bladder precipitationb Kernicterus Hepatitisc Hepatitis cholestaticb,c Skin and subcutaneous tissue disorders Rash Pruritus Urticaria Stevens Johnson Syndromeb Toxic epidermal necrolysisb Erythema multiforme Acute generalised exanthemato us pustulosis; Drug reaction with eosinophilia and systemic symptoms (DRESS) b.
Renal and urinary disorders Haematuria Glycosuria Oliguria Renal precipitation (reversible) General disorders and administration site conditions Phlebitis Injection site pain Pyrexia Oedema Chills Investigations Blood creatinine Coombs test false increased positiveb Galactosaemi a test false positiveb Non enzymatic methods for glucose determination false positiveb a.
8). In case of severe hypersensitivity reactions, treatment with ceftriaxone must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftriaxone, to other cephalosporins or to any other type of beta-lactam agent.
Caution should be used if ceftriaxone is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents. 8). Interaction with calcium containing products Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term neonates aged less than 1 month have been described.
At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products.
In vitro studies demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups. In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing intravenous solutions, even via different infusion lines or at different infusion sites.
However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation.
In patients requiring continuous infusion with calcium-containing total parenteral nutrition (TPN) solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation.
Hypersensitivity to ceftriaxone or to any other cephalosporin. g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems). 2). *In vitro studies have shown that ceftriaxone can displace bilirubin from its serum albumin binding sites leading to a possible risk of bilirubin encephalopathy in these patients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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** 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. 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 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 20-50 mg/kg Once daily 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 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.
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 […]
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. 4 c. Usually reversible upon discontinuation of ceftriaxone Description of selected adverse reactions Infections and infestations Reports of diarrhoea following the use of ceftriaxone may be associated with Clostridium difficile.
4). Ceftriaxone-calcium salt precipitation Rarely, severe, and in some cases, fatal, adverse reactions have been reported in pre- term and full-term neonates (aged < 28 days) who had been treated with intravenous ceftriaxone and calcium.
Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem. 2). g. g. fluid restrictions or confinement to bed). 4). Precipitation of ceftriaxone calcium salt in the gallbladder has been observed, primarily in patients treated with doses higher than the recommended standard dose.
In children, prospective studies have shown a variable incidence of precipitation with intravenous application - above 30 % in some studies. The incidence appears to be lower with slow infusion (20 - 30 minutes). This effect is usually asymptomatic, but the precipitations have been accompanied by clinical symptoms such as pain, nausea and vomiting in rare cases.
Symptomatic treatment is recommended in these cases. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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If the use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites. 2). 2). Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin.
3). 8). Severe cases of haemolytic anaemia, including fatalities, have been reported during Ceftriaxone treatment in both adults and children. If a patient develops anaemia while on ceftriaxone, the diagnosis of a cephalosporin- associated anaemia should be considered and ceftriaxone discontinued until the aetiology is determined.
Long term treatment During prolonged treatment complete blood count should be performed at regular intervals. Colitis/Overgrowth of non-susceptible microorganisms Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to life-threatening.
8). Discontinuation of therapy with ceftriaxone and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given. Superinfections with non-susceptible micro-organisms may occur as with other antibacterial agents.
2). Interference with serological testing Interference with Coombs tests may occur, as Ceftriaxone may lead to false-positive test results. 8). Non-enzymatic methods for the glucose determination in urine may give false- positive results.
8). The presence of ceftriaxone may falsely lower estimated blood glucose values obtained with some blood glucose monitoring systems. Please refer to instructions for use for each system. Alternative testing methods should be used if necessary.
15% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 2). In polymicrobial infections, where suspected pathogens […]