Tricexone Special Precautions

In suspected or proven infections with Pseudomonas aeruginosa, high resistance rates (>60%) for Ceftriaxone in at least some European countries should be taken into consideration. In infections caused by Pseudomonas aeruginosa with proven sensitivity to Ceftriaxone a combination with amino-glycosides is warranted to avoid secondary resistance.
In infections caused by other bacteria in patients with neutropenic fever interventional treatment with Ceftriaxone should be combined with an aminoglycoside. Special caution is required to determine any other type of previous hypersensitivity reactions to penicillin or to other beta-lactam-medicinal products because patients hypersensitive to these medicines may be hypersensitive to Ceftriaxone as well (cross-allergy).
Hypersensitivity reactions against Ceftriaxone are more likely in patients with any other type of hypersensitivity reaction or asthma bronchiale. Injections with Ceftriaxone should be used with special caution in patients with allergic diathesis, because hypersensitivity reactions emerge faster and proceed more severely after intravenous injection.
Hypersensitivity reactions may occur in all degrees of severity up to anaphylactic shock. In severe renal impairment accompanied by hepatic insufficiency, dosage reduction is required.
In case of simultaneous impairment of renal and liver function, serum-level of Ceftriaxone should be monitored in regular intervals.
Monitoring of renal and hepatic function and haematological parameters at regular intervals is indicated during long-term treatment.
Each administration of antibiotics can lead to multiplication of pathogens resistant to the active substance used. Signs of consecutive secondary infections with such pathogens (including candida and fungi) are to be heeded. Secondary infections are to be treated accordingly.
Antibiotic-associated diarrhoea, colitis and pseudomembranous colitis have all been reported with the use of Ceftriaxone. These diagnoses should be considered in any patient who develops diarrhoea during or shortly after treatment. Ceftriaxone should be discontinued if severe and/or bloody diarrhoea occurs during treatment and appropriate therapy instituted. Drugs that inhibit peristalsis must not be given.
Ceftriaxone should be used with caution in individuals with a previous history of gastro-intestinal disease, particularly colitis.
Ceftriaxone may precipitate in the gallbladder and kidneys and then be detectable as shadows on ultrasound. This can happen in patients of any age, but is more likely in infants and small children who are usually given a larger dose of Ceftriaxone on a body weight basis. In children, doses greater than 80 mg/kg body weight should be avoided - except for meningitis - because of the increased risk of biliary precipitates. There is no clear evidence of gallstones or of acute cholecystitis developing in children or infants treated with Ceftriaxone, and conservative management of Ceftriaxone precipitate in the gallbladder is recommended.
Cases of pancreatitis, possibly of biliary obstruction aetiology, have been rarely reported in patients treated with Ceftriaxone. Most patients presented with risk factors for biliary stasis and biliary sludge, e.g. preceding major therapy, severe illness and total parenteral nutrition. A trigger or cofactor role of Ceftriaxone-related biliary precipitation cannot be ruled out.
Cephalosporins as a class tend to be absorbed onto the surface of the red cell membranes and react with antibodies directed against the medicinal product to produce a positive Coombs' test and occasionally a rather mild haemolytic anaemia. In this respect, there may be some cross-reactivity with penicillins. In vivo and in vitro studies have shown that Ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin. Clinical data obtained in neonates have confirmed this finding.
Ceftriaxone should therefore not be used in jaundiced newborns or in those who are hypoalbuminaemic or acidotic, in whom bilirubin binding is likely to be impaired. Particular caution should be exercised in babies born prematurely.
As with other antibiotics, incidental occurrences of vitamin K-deficiency should be considered. High intravenous doses (>1 g or ≥50 mg/kg bodyweight) of Ceftriaxone should be administered slowly (over a minimum period of 30 minutes) in order to avoid high concentrations in the bile.
This medicinal product contains 3.6 mmol (82.8 mg) sodium per vial. To be taken into consideration by patients on a controlled sodium diet.