Recent Reformulation of Infant Acetaminophen Products

by Illinois Poison Center
November 18, 2011

From the Illinois Poison Center

11-Nov 2011

The recent changes to the concentration of brand and generic pediatric acetaminophen products have led to several phone calls to the Illinois Poison Center involving therapeutic errors and patient or health care provider confusion.  These products were previously available in a concentration of 80mg per 0.8 ml (500mg per 5ml) in various sizes.  Recently the infant acetaminophen products have been reformulated such that they are now equivalent to children's acetaminophen liquid concentrations (160mg/5ml).

As the transition between the differing formulation advances, both concentrations of infant's acetaminophen products may be intermingled on store shelves.

The Illinois Poison Center staff is noticing two types of therapeutic errors with the formulation change:

1) A clinician recommends dosing liquid infant acetaminophen drops based on the 80mg/0.8 ml while the parent or caregiver uses the "new" 160mg/5ml concentration--the child will receive less than a therapeutic dose (under-dose by about 66%).

2) A clinician recommends dosing liquid infant acetaminophen drops based on the "new" 160mg/5ml, while the parent or caregiver uses the "old" 80mg/0.8ml formulation--the child is at a risk of acute or chronic overdose of acetaminophen.

During this time of product transition we urge all pharmacists, physicians and nurses to ensure patients and caregivers carefully check product concentration and closely follow dosing instructions either on the package itself or as directed by a health care professional.  Patients or caregivers should be counseled to consult their primary care provider or pharmacist if there are any questions or confusion during product purchase or administration. 

Should an error occur during administration of any medication, the Illinois Poison Center is available to health care providers and/or the general public for consultation 24 hours a day, 365 days a year at 1-800-222-1222. 

Click here for a chart entitled “Call the Illinois Poison Center for…” which will reacquaint you and your professional colleagues with the full spectrum of poison center services we provide.  Please feel free to forward it to your colleagues and post a hard copy at all workstations for quick reference.  We look forward to a continued working relationship with you in the future!

Arthur Kubic PharmD
Anthony Burda BPharm, DABAT
Michael Wahl MD, FACEP
Carol DesLauriers PharmD, DABAT

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