Friday, June 5, 2009

Friday June 5, 2009 (pediatric pearl)
Concurrent use of intravenous ceftriaxone and calcium-containing solutions in the newborn and young infant may result in a life-threatening adverse drug reaction

The concurrent use of intravenous ceftriaxone and calcium-containing solutions in the newborn and young infant may result in a life-threatening adverse drug reaction. On September 11, 2007, the US Food and Drug Administration (FDA) issued an alert that highlighted important revisions to the prescribing information for ceftriaxone (Rocephin; Roche Pharmaceuticals, Nutley, NJ) for young infants.

Ceftriaxone is known to form precipitates when administered with
calcium-containing solutions such as Ringer’s Lactate
. Currently the exact mechanism is unknown but it is biologically plausible, however, to assume that ceftriaxone given to a young infant at higher than a routinely prescribed dose and administered intravenously together with a calcium-containing solution could also cause precipitate formation. These calcium precipitates might act as emboli, resulting in vascular spasm or infarction. It is this precaution that is being shared with clinicians.

Eight of the reported 9 cases (7 were less than/= 2 months of age) represented possible or probable adverse drug events. There were 7 deaths. None of the cases were reported from the United States. The dosage of ceftriaxone that was administered to 4 of 6 infants for whom this information was available was between 150 and 200 mg/kg per day. The rate of occurrence of these serious adverse drug reactions cannot be accurately determined from available data. Contributing factors for infants in this report may include the use of ceftriaxone at dosages higher than those approved by the Food and Drug Administration, intravenous “push” administration, and administration of the total daily dosage as a single infusion.



Intravenous Ceftriaxone and Calcium in the Neonate: Assessing the Risk for Cardiopulmonary Adverse Events - Pediatrics 2009;123:e609–e613

No comments:

Post a Comment