AAP News Vol. 30 No. 11 November 2009, p. 1
© 2009 American Academy of Pediatrics
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NEWS AND FEATURES

Adult Tamiflu capsules can be compounded for pediatric patients

John S. Bradley, M.D., FAAP, Henry H. Bernstein, D.O., FAAP and Joseph A. Bocchini, Jr., M.D., FAAP

Pediatricians should be aware that pediatric formulations of oseltamivir (Tamiflu) may be in short supply, and concerns have been raised over dosing Tamiflu oral suspension.

Due to the great demand for Tamiflu, Roche Laboratories Inc. is packaging all Tamiflu in the 75 mg capsule adult formulation. Under normal circumstances, Roche manufactures three pediatric-specific formulations of Tamiflu: a pediatric suspension, 30 mg capsules and 45 mg capsules.

Fortunately, suspensions can be created easily from the 75 mg capsules. During a local shortage of pediatric suspension, the 75 mg capsules can be crushed and mixed into an extemporaneous suspension formulated to contain 15 mg/mL for children, which is a different concentration than the manufacturer’s pediatric suspension (12 mg/mL). Any pharmacy licensed to compound medications can do this by following the Food and Drug Administration (FDA)-approved instructions on the package insert.

This alternative method for making pediatric suspension of oseltamivir should address any perceived local shortage for treating children of any age during this influenza season.

The original FDA-approved dosing for children for all influenza infections, including the new Emergency Authorization Use doses for infants younger than 1 year of age, remains unchanged (see FDA Update). Additional information on dosages and use of antiviral therapy for influenza is available on the Centers for Disease Control and Prevention Web site, www.cdc.gov/h1n1flu/recommendations.htm.

Dosing oseltamivir suspension

There also is serious concern about potential errors made by parents who use the oral dosing dispenser syringe included with the bottle of Tamiflu pediatric suspension.

Although practitioners tend to prescribe medicine by milliliters or fractions of a teaspoon, the dispensing syringe that comes packaged with the suspension bottle contains only measurement markings of 30, 45 and 60 mg. These markings coincide with the three weight-based doses of oseltamivir suspension recommended for children 1 through 12 years old (≤15 kg: 30 mg; 16-23 kg: 45 mg; 24-40 kg: 60 mg and >40 kg: 75 mg). These doses are given twice daily for five days for treatment or once daily for 10 days for prophylaxis. Therefore, when a practitioner orders the dose in mL, the parent (and pharmacist) may not realize the need to convert the mL amount to milligrams.

On the other hand, it is necessary to order the dose of oseltamivir in mL for children younger than 1 year of age (see FDA Update).

To avoid confusion and possible error, consider ordering a syringe marked in mL with proper instructions to ensure accurate dosing. In addition, pharmacies should be reminded to ensure the label instructions for use are in the same dosing units as those on the measurement device being given to the family.

Proper dosing in mL also becomes critical when there are local shortages of Tamiflu suspension. Under these circumstances, Tamiflu capsules may be crushed and suspended by the pharmacist to create an extemporaneous oseltamivir suspension, per the FDA -approved instructions on the Tamiflu package insert.

However, while the regular Tamiflu pediatric suspension concentration is 12 mg/mL, the crushed, extemporaneous suspension contains 15 mg/mL. Thus, a separately provided syringe with measurements marked in mL is required, since the oral dispensing device cannot be used to measure the extemporaneous compounded suspension.

Drs. Bradley and Bernstein are members of the AAP Committee on Infectious Diseases (COID). Dr. Bocchini is chair of COID.


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Related articles in AAP News:

FDA public health alert: potential dosing errors with Tamiflu for Oral Suspension
Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research
AAP News 2009 30: 10. [Full Text]  




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