Emergency Use of Tamiflu in Infants Less than 1 Year of Age－快樂小藥師 Im pharmacist nichts glücklich

基本上這個藥物是不建議用在一歲以下的小孩的，但是如果現在真的有需要，FDA有提供治療準則

文章最近又更新了，所以我就擺在前面：

On October 30th, 2009, FDA issued an amendment to the Emergency Use Authorization for Tamiflu that included dosing recommendations based on weight for infants less than 1 year of age. This document was originally issued by FDA on 09-25-2009 and included age-based doses for treatment and prophylaxis for infants less than 1 year of age.

Tamiflu for Oral Suspension is approved for use in treatment and prophylaxis of influenza in pediatric patients 1 year of age and older. In certain cases, FDA has authorized emergency use of Tamiflu in infants less than 1 year of age.

Health care providers should be aware that there are limited data on safety and dosing when considering Tamiflu use in seriously ill, young infants with confirmed 2009 H1N1 influenza, or in one that has been exposed to a confirmed 2009 H1N1 influenza case. Infants should be carefully monitored for adverse events when Tamiflu is used.

Tamiflu should not be routinely used for prophylaxis in infants less than 3 months of age due to extremely limited pharmacokinetic data to guide dosing in this age group. Prophylaxis with Tamiflu in infants less than 3 months of age should be reserved for cases in which the exposure is significant and the risk of severe illness is considered high.

The following tables provide treatment (Table 1) and prophylaxis (Table 2) dosing recommendations for the emergency use of Tamiflu in Infants less than 1 year of age:

Table 1. Recommended Treatment Dose for Infants Less than 1 year of age Using Tamiflu Oral Suspension

Age	Recommended Treatment Dose for 5 Days (weight-based dosing)†
Less than 12 months	3 mg/kg/dose twice a day

†Weight-based dosing is preferred, however, if weight is not known, dosing by age for treatment of influenza in full-term infants younger than 1 year of age may be necessary (birth-2 months = 12 mg (1 mL) twice daily; 3-5 months = 20 mg (1.6 mL) twice daily, 6-11 months = 25 mg (2 mL) twice daily)

Table 2. Recommended Prophylaxis Dose for Infants Less than 1 year of age Using Tamiflu Oral Suspension

Age	Recommended Prophylaxis Dose for 10 Days (weight-based dosing)††
3 months to less than 12 months	3 mg/kg/dose once daily
Younger than 3 months	Not recommended unless situation judged critical due to limited data on use in this age group

††Weight-based dosing is preferred, however, if weight is not known, dosing by age for prophylaxis of influenza in full-term infants younger than 1 year of age may be necessary (3-5 months = 20 mg once daily (1.6 mL), 6-11 months = 25 mg (2 mL) once daily).

Current weight-based dosing recommendations are not intended for premature infants. Premature infants may have slower clearance of Tamiflu due to immature renal function, and doses recommended for full term infants may lead to very high drug concentrations in this age group. Very limited data from a cohort of premature infants receiving an average dose of 1.7 mg/kg twice daily demonstrated drug concentrations higher than those observed with the recommended treatment dose in term infants (3 mg/kg twice daily). Observed drug concentrations were highly variable among premature infants. These data are insufficient to recommend a specific dose of Tamiflu for premature infants.

When dispensing Tamiflu oral suspension for infants younger than 1 year of age, the oral dosing dispenser included in the product package should always be removed and replaced with an appropriate measuring device. The pharmacist or other health care provider should provide a 3 ml or 5 ml oral syringe to correctly measure the dose and counsel the caregiver on how to administer the prescribed dose.

Health care providers should be aware that there are limited data on safety and dosing when considering Tamiflu use in a seriously ill, young infant with confirmed 2009 H1N1 influenza virus infection, or in one that has been exposed to a confirmed 2009 H1N1 influenza case. Infants should be carefully monitored for adverse events when Tamiflu is used.

The pharmacokinetic data to guide dosing in infants less than 3 months of age are also extremely limited. Therefore, Tamiflu should not be routinely used for prophylaxis in this age group. Tamiflu should be reserved for cases in which the exposure is significant and the risk of severe illness is considered high.

Current age-based dosing recommendations are not intended for premature infants. Premature infants may have slower clearance of drug due to immature renal function, and doses recommended for full term infants may lead to very high drug concentrations in this age group. Dose recommendations for premature infants are currently being evaluated.

The following table provides dosing instructions for the emergency use of Tamiflu in Infants less than 1 year of age:

**Recommended Doses* for Infants Less than 1 year of age Using Tamiflu 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 mg	2 mL	2 mL twice daily	2 mL once daily
3 - 5 months	20 mg	1.6 mL	1.6 mL twice daily	1.6 mL once daily
< 3 months	12 mg	1.0 mL	1.0 mL twice daily	Not recommended unless critical

* Doses recommended for treatment of infants in the FDA Emergency Use Authorization are based on data from an ongoing NIH study evaluating treatment doses of 3.0 to 3.5 mg/kg twice daily.

When dispensing Tamiflu oral suspension for infants younger than 1 year of age, the oral dosing dispenser included in the product package should always be removed and replaced with an appropriate measuring device. The pharmacist or other health care provider should provide an oral syringe capable of accurately measuring the prescribed milliliter (mL) dose and counsel the caregiver on how to administer the prescribed dose.

其他關於Tamiflu的文章：http://mulicia.pixnet.net/blog/post/24367255