HTB

Caution in dosing paediatric oral solution of Kaletra

On 6 August 2007, Abbott Laboratories sent out a Dear Healthcare Provider Letter internationally to physicians and pharmacists that prescribe and/or distribute Kaletra Oral Solution.

The letter informed healthcare professionals of an accidental overdose that occurred with a paediatric patient taking Kaletra Oral Solution.

The infant received a significantly large dose of Kaletra and subsequently died.

In summary, the letter was to highlight that Kaletra Oral Solution is highly concentrated, containing 80 mg lopinavir and 20 mg ritonavir per mL (not per bottle). Also, that childrenÂ’s dosages are calculated on body weight. A child should receive less than 5 mL oral solution per dose unless they are also receiving certain concomitant medicines. Further reference should be made to the full prescribing information.

Healthcare professionals should pay special attention to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimise the risk for medication errors.

Source: FDA list serve 14.08.07

Link to letter: (PDF file)
http://www.fda.gov/medwatch/safety/2007/Kaletra_DHCP.pdf

Link to US Prescribing Information: (PDF file)
http://www.fda.gov/medwatch/safety/2007/Mar_PI/Kaletra_PI_200703.pdf

Links to other websites are current at date of posting but not maintained.