Ceftriaxone-Trima

/ Trima

The dose depends on the severity, susceptibility, site and type of infection and on the age and hepatorenal function of the patient.
For full details see prescribing information.

* 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
* 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 ceftriaxone-susceptible 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.

* 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
– if they require (or are expected to require) intravenous calciumtreatment, or calcium-containing infusions due to the risk of precipitation of a ceftriaxone-calcium salt.
For full details see prescribing information.

Hypersensitivity reactions
As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. 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.
Severe cutaneous adverse reactions (Stevens Johnson syndrome or Lyell’s syndrome/toxic epidermal necrolysis) have been reported.
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 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. 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. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion and the infusion lines flushed between solutions.
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.
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.
Biliary lithiasis
When shadows are observed on sonograms, consideration should be given to the possibility of precipitates of calcium ceftriaxone. Shadows, which have been mistaken for gallstones, have been detected on sonograms of the gallbladder and have been observed more frequently at ceftriaxone doses of 1 g per day and above. Caution should be particularly considered in the paediatric population. Such precipitates disappear after discontinuation of ceftriaxone therapy. Rarely precipitates of calcium ceftriaxone have been associated with symptoms. In symptomatic cases, conservative nonsurgical management is recommended and discontinuationof ceftriaxone treatment should be considered by the physician based on specific benefit risk assessment.
Renal lithiasis
Cases of renal lithiasis have been reported, which is reversible upon discontinuation of ceftriaxone. In symptomatic cases, sonography should be performed. Use in patients with history of renal lithiasis or with hypercalciuria should be considered by the physician based on specific benefit risk assessment.
This medicinal product contains 3.6 mmol (or 83 mg) of sodium in a vial. This should be taken into consideration in patients on a controlled sodium diet.
Encephalopathy
Encephalopathy has been reported with the use of ceftriaxone, particularly in elderly patients with severe renal impairment or central nervous system disorders. If ceftriaxone-associated encephalopathy is suspected (e.g. decreased level of consciousness, altered mental state, myoclonus, convulsions), discontinuation of ceftriaxone should be considered.
For full details see prescribing information.

Common: Eosinophilia, Leucopenia, Thrombocytopenia, Diarrhoea, Loose stools, Hepatic enzyme increased, Rash.
For full details see prescribing information.

Calcium-containing diluents, such as 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. Ceftriaxone must not be administered simultaneously with calcium- containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid.
Oral anticoagulants, concomitant use may increase the anti-vitamin K effect and the risk of bleeding. It is recommended that the International Normalised Ratio (INR) is monitored frequently and the posology of the anti-vitamin K drug adjusted accordingly, both during and after treatment with ceftriaxone
Test:
In patients treated with ceftriaxone, the Coombs’ test may lead to false-positive test results.
Likewise, non-enzymatic methods for glucose determination in urine may yield false-positive results. For this reason, glucose level determination in urine during therapy with ceftriaxone should be carried out enzymatically.
Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosaemia.
For full details see prescribing information.

Pregnancy: Ceftriaxone crosses the placental barrier. There are limited amounts of data from the use of ceftriaxone in pregnant women. Ceftriaxone should only be administered during pregnancy and in particular in the first trimester of pregnancy if the benefit outweighs the risk.
Lactation: Ceftriaxone is excreted into human milk in low concentrations but at therapeutic doses of ceftriaxone no effects on the breastfed infants are anticipated. However, a risk of diarrhoea and fungal infection of the mucous membranes cannot be excluded. The possibility of sensitisation should be taken into account. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from ceftriaxone therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
Reproductive studies have shown no evidence of adverse effects on male or female fertility.
For full details see prescribing information.

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.