Compounding Guidelines for Oseltamivir－PDCAR預見未來PDCAR

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FDA Issues Emergency Infant-Use, Compounding Guidelines for Oseltamivir

By Yael Waknine
Medscape Medical News

September 29, 2009 — The US Food and Drug Administration (FDA) has approved guidelines for emergency use of oseltamivir phosphate 12-mg/mL oral suspension (Tamiflu, Hoffmann-LaRoche Inc) in pediatric patients younger than 1 year, as well as instructions for compounding a 15-mg/mL product when the original formula is not available.

Limited information is available on the safety and dosing of oseltamivir in seriously ill young infants with confirmed 2009 H1N1 influenza infection and those with significant exposure to confirmed cases, the FDA said in a news release. The age-based dosing recommendations given here are derived from an ongoing National Institutes of Health study of doses ranging from 3.0 to 3.5 mg/kg twice daily and should be used with caution and with careful monitoring for adverse events. Children younger than 3 months should not receive routine prophylaxis with oseltamivir; use of the product in premature infants is currently under evaluation.

Recommended Doses for Infants Younger Than 1 year Using Oseltamivir Oral Suspension

Age	Dose (mg)	Volume per Dose (12 mg/mL)	Treatment Dose Required (for 5 Days)	Prophylaxis Dose Required (for 10 Days)
6 – 11 months	25	2 mL	2 mL twice daily	2 mL once daily
3 – 5 months	20	1.6 mL	1.6 mL twice daily	1.6 mL once daily
<3 months	12	1.0 mL	1.0 mL twice daily	Not recommended unless critical

When dispensing oseltamivir oral suspension for infants younger than 1 year, the syringe included in the product package should be replaced with an appropriate measuring device capable of accurately dispensing the prescribed milliliter dose.

The FDA has also issued guidelines for compounding a 15-mg/mL formulation of oseltamivir oral suspension using 75-mg capsules and cherry syrup or Ora-Sweet sugar-free syrup (Paddock Laboratories, Inc). The compounded product should be reserved for use when the manufactured 12-mg/mL product is unavailable and should be dispensed using an appropriate measuring device with milliliter gradations.

The following tables indicate the volume of compounded suspension (15 mg/mL) made from oseltamivir capsules needed for a full treatment course based on the patient's weight and the dosing chart for its administration. Compounding instructions are included in the professional prescribing information, available online on the Roche Web site.

Total Volume of Suspension Needed for Correct Dosing

Body Weight (kg)	Body Weight (lbs)	Total Volume to Compound per Patient (mL)
?15	?33	30
16 – 23	34 – 51	40
24 – 40	52 – 88	50
?41	?89	60

Dosing Chart for Pharmacy-Compounded Oseltamivir

Body Weight (kg)	Body Weight (lbs)	Dose (mg)	Volume per Dose (15 mg/mL)	Treatment Dose Required (for 5 Days)	Prophylaxis Dose Required (for 10 Days)
?15	?33	30	2 mL	2 mL twice daily	2 mL once daily
16 – 23	34 – 51	45	3 mL	3 mL twice daily	3 mL once daily
24 – 40	52 – 88	60	4 mL	4 mL twice daily	4 mL once daily
?41	?89	75	5 mL	5 mL twice daily	5 mL once daily

Oseltamivir is indicated for the treatment of uncomplicated acute illness resulting from influenza infection in patients aged 1 year and older who have been symptomatic for no more than 2 days. It may also be used for the prophylaxis of influenza in patients aged 1 year and older. Under the emergency authorization granted by the FDA, oseltamivir may also be used in patients less than 1 year old, those symptomatic for more than 2 days, and patients sick enough to require hospitalization.