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Physician Blog : Pediatric Perspectives
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This blog for physicians will provide you with practical information you can use in your office while highlighting new techniques and programs available at Helen DeVos Children's Hospital.


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photo Dominic Sanfilippo, MD
photo James Fahner, MD
photo William Stratbucker, MD
Wednesday, January 25, 2012
Changing Concentrations for Infant Acetaminophen
by Pediatric Perspectives at 12:31 PM

Morgan R. Cole, PharmD, BCPS, Pharmacy Manager
Helen DeVos Children’s Hospital, Grand Rapids, MI

In case you (or, more likely, the parents in your practice) haven’t heard, new guidelines from the Food and Drug Administration (FDA) on dosing for infant acetaminophen are finally hitting the shelves. The new recommendations came after reports of overdosing in children who received high doses of the more concentrated infant formulation, leading to liver toxicity.

The take-home message - infant and children’s acetaminophen are now the same concentration: 160 mg/5 ml (32mg/ml). With the concentration change, infants will receive more liquid by the same amount of active ingredient. So, for instance, children weighing 6 to 11 pounds receiving a 40 mg dose will now receive 1.25 ml in the syringe versus the half dropper (0.4 ml) they would receive with the more concentrated formulation. This new, unconcentrated formulation is easy to spot—it’s packaged with a syringe dosing device instead of a dropper.

It’s important that parents hear about this change from you since they may not read the small print on the bottles. Plus, the switch is voluntary—not all manufacturers may do it. Even if they all conform, it may still be confusing for a while as stores carry both dosages while switching over. Plus, parents may have old products available at home they’re still using.

The concern is that if you prescribe a 5-ml dose of the less-concentrated liquid acetaminophen but parents administer a 5-ml dose of the more concentrated liquid acetaminophen, the child could receive a potentially fatal overdose; conversely, if the dose is based on the “old” formulation and the child receives the new formulation, the effective medication may not be enough to fight a fever.

The FDA also required a labeling change noting that the maximum dose per day should be 3,000 mg, down from the previous 4000 mg. Thus, while children may still receive up to five doses a day, the total amount should not exceed 3,000 mg/day.

Brand names for children’s acetaminophen include Tylenol®, Little Fevers®, Triaminic Infant/Pain Reliever, Pedia Care®, and Triaminic Infants’ Syrup Fever Reducer Pain Reliever®. The ruling also affects all store brands (Rite Aid, CVS, Walgreens, etc.).

You can read more about the FDA’s decision and recommendations here.

Acetaminophen Change at Spectrum Health
On January 16, 2012, Helen DeVos Children’s Hospital and Spectrum Health made our conversion to the new product.

Morgan R. Cole, PharmD, BCPS, is the pharmacy manager at Helen DeVos Children’s Hospital in Grand Rapids, MI

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