Medaxone Adverse Reactions

The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leukopenia, 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 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). (See Table 2.)

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Description of selected adverse reactions: Infections and infestations: Reports of diarrhoea following the use of ceftriaxone may be associated with Clostridium difficile. Appropriate fluid and electrolyte management should be instituted (see Precautions).
Ceftriaxone-calcium salt precipitation: Rarely, severe, and in some cases, fatal, adverse reactions have been reported in preterm 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. The high risk of precipitation in neonates is a result of their low blood volume and the longer half-life of ceftriaxone compared with adults (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Cases of ceftriaxone precipitation in the urinary tract have been reported, mostly in children treated with high doses (e.g. ≥80 mg/kg/day or total doses exceeding 10 grams) and who have other risk factors (e.g. dehydration, confinement to bed). The risk of precipitate formation is increased in immobilized or dehydrated patients. This event may be asymptomatic or symptomatic, and may lead to ureteric obstruction and post renal acute renal failure, but is usually reversible upon discontinuation of ceftriaxone (see Precautions).
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.
Precipitation is usually reversible upon discontinuation of ceftriaxone (see Precautions).
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.