FDA發佈嬰兒緊急使用Oseltamivir配製指引


  September 29, 2009 — 美國食品藥物管理局(FDA)核准年齡一歲以下小兒病患緊急使用Oseltamivir phosphate 12 mg/ml口服懸浮液(Tamiflu,Hoffmann-LaRoche有限公司)指引,以及當無法取得原始配方時配製15 mg/ml產品的方法。
  
  FDA在一項新聞稿中表示,Oseltamivir使用於2009 H1N1新型流感確診重症嬰兒病患,或那些顯著暴露於確診病例嬰兒的安全性與劑量資訊非常有限。以年齡為基礎的劑量建議是取自於國家衛生研究院的研究,劑量範圍從每公斤3.0~3.5 mg每天兩次,應該慎用並且小心監測不良反應。出生未滿三個月的兒童不應該接受Oseltamivir常規預防;對早產兒使用這個藥物目前正在評估中。
  
  【一歲以下嬰兒使用Oseltamivir口服懸浮液的建議劑量】

年齡

劑量(mg)

每個劑量容積(12 mg/mL)

治療劑量( 使用五天 )

預防劑量( 使用十天 )

6 – 11 個月

25

2 毫升

2 毫升每天兩次

2 毫升一天一次

3 – 5 個月

20

1.6 毫升

1.6 毫升每天兩次

1.6 毫升一天一次

<3 個月

12

1.0 毫升

1.0 毫升每天兩次

除非重症,否則並不建議


  
  當對一歲以下嬰兒調配Oseltamivir口服懸浮液時,應以能正確調配處方毫升劑量的適當測量裝置取代包裝內含的針筒。
  
  FDA也發佈使用75 mg膠囊與櫻桃糖漿或Ora-Sweet無糖糖漿(Paddock實驗室有限公司)配製15 mg/ml Oseltamivir口服懸浮液的指引。配製的產品應該保留到無法取得廠商製造的12 mg/ml藥品,且應該以可量測毫升刻度的裝置調配。
  
  下列的表格是由Oseltamivir膠囊配製成懸浮液(15 mg/ml),根據病患體重計算,整個療程所需的體積以及投予劑量表。羅氏藥廠網站上的專業調配資訊中有調配指引。
  
  【正確劑量所需的懸浮液總體積】

體重 ( 公斤 )

體重 ( 英鎊 )

每位病患所需的總體積 ( 毫升 )

≦ 15

≦ 33

30

16 – 23

34 – 51

40

24 – 40

52 – 88

50

≧ 41

≧ 89

60


  
  
  【藥局調配Oseltamivir的給藥劑量表】

體重( 公斤 )

體重( 英鎊 )

劑量( 毫克 )

每次劑量體積  ( 15 m g/mL)

治療劑量( 使用五天 )

預防劑量( 使用十天 )

≦ 15

≦ 33

30

2 毫升

2 毫升每天兩次

2 毫升每天一次

16 – 23

34 – 51

45

3 毫升

3 毫升每天兩次

3 毫升每天一次

24 – 40

52 – 88

60

4 毫升

4 毫升每天兩次

4 毫升每天一次

≧ 41

≧ 89

75

5 毫升

5 毫升每天兩次

5 毫升每天一次


  
  
  Oseltamivir適用於治療一歲以上流感造成的非複雜性急性疾患,且於症狀發生兩天內投予。這個藥物也被核准用於一歲以上兒童預防流感。由FDA發佈的緊急授權,Oseltamivir可能可以使用於一歲以下兒童、症狀超過兩天以及症狀嚴重到需要住院的病患。
  

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.

    
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