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[e-med] (4)Tamiflu suspension (Information mise à jour)

[Etant à l'étranger, j'ai eu quelques difficultés à faire la modération de 
e-med la semaine dernière. De plus,j'ai pris un peu de temps par rapport à 
votre message car je voulais vérifier les sources et voir pourquoi vous aviez 
fait 2 messages mais j'ai été interrompu par des problèmes d'accès à internet, 
merci pour vos explications.CB]


Bonjour à tous,

1/ 

J'ai répondu à votre message depuis le 23 février 2010 à 22h 54 (le même jour 
où il a été posté) et je constate que  le message n'a été posté sur le forum 
qu'aujourd'hui le 26 février 2010.

Tout ce que j'ai vu, c'est un message qui dit que "La société française de 
pédiatrie a fortement décommandé l'usage du Tamiflu pour les enfants car cela 
induit des vomissements et les risques sont nettement plus élevés que les 
bénéfices."  Garance UPHAM (fannie.upham@gmail.com) 
 
Je suis du Niger et je réside aux USA. J'ai trouvé une réponse à la question 
posée selon les réalités américaines et je pense que nous pouvons parfaitement 
l'adapter à nos valeurs en Afriques. En pharmacie, la problématique 
risque-bénéfice a toujours existé. 
 
Dans les tous cas aux USA, en cas d'urgence, cette pratique est validée par le 
FDA (Food and Drug Administration) qui est une institution fédérale.

 

2/ 

Je pense aussi qu'il faudrait respecter l'ordre des messages qui vous arrivent.


Le message que j'ai mis à jour se trouve en dessous du premier. Cela n'est pas 
bien pour les lecteurs car ils peuvent être induits en erreur.

Note pour les lecteurs : Veuillez utiliser le message sur "Tamiflu  suspension" 
contenant la parenthèse (Information mise à jour)


Voici l'Information mise à jour.


Vous trouvez la procédure et les correspondances en terme d'équivalence.
 
En effet, en cas d'urgence, vous pouvez le faire: La concentration finale doit 
être de 15mg/ml dans du sirop de cerise ou du sirop simple (non sucré).
 
J'ai pu vous trouver la fiche en anglais que j'ai essayée de traduire cela en 
fraçais avec google. La traduction est très fidèle dans les chiffres. C'est 
juste les articles devant les mots qui varient souvent. Il suffit de cliquer 
sur ce lien pour trouver la version traduite en fraçais : 
http://translate.google.com/translate?js=y&prev=_t&hl=en&ie=UTF-8&layout=1&eotf=1&u=http%3A%2F%2Fwww.tamiflu.com%2Fhcp%2Fdosing%2Fextprep.aspx&sl=en&tl=fr
 

Mais, par prudence, je vous colle la copie en anglais et le lien est : 
http://www.tamiflu.com/hcp/dosing/extprep.aspx


Directions for the Emergency Compounding of an Oral Suspension from TAMIFLU 
Capsules (Final Concentration = 15 mg/mL) 1 
 
In November 2006, the FDA approved the addition of directions for the emergency 
compounding of a TAMIFLU oral suspension from TAMIFLU Capsules (15 mg/mL) to 
the label. These directions are provided for use only during emergency 
situations. They are not intended to be used if the FDA-approved, commercially 
manufactured TAMIFLU Oral Suspension is readily available from wholesalers or 
the manufacturer. 
Commercially manufactured TAMIFLU Oral Suspension (12 mg/mL) is the preferred 
product: 




For pediatric and adult patients who have difficulty swallowing capsules or 
Where lower doses are needed
In the event that the commercially manufactured TAMIFLU Oral Suspension is not 
available, the pharmacist may compound a suspension (15 mg/mL) from TAMIFLU 
(oseltamivir phosphate) Capsules 75 mg using either of two vehicles: Cherry 
Syrup (Humco®)* or Ora-Sweet® SF (sugar-free). † Other vehicles have not been 
studied. 
This compounded suspension should not be used for convenience or when the 
FDA-approved TAMIFLU Oral Suspension is commercially available. 
Compounding an oral suspension with this procedure will provide one patient 
with enough medication for: 


a 5-day course of treatment (twice–daily administration) or 
a 10-day course of prophylaxis (once–daily administration)
Compounding Procedure
First, calculate the Total Volume of oral suspension needed to be compounded 
and dispensed for each patient. The Total Volume required is determined by the 
weight of each patient. Refer to Table 5. Please note that the table numbers 
included in these directions (Tables 5, 6, and 7) correspond to the table 
numbers in the TAMIFLU package insert. 

Table 5
Volume of oral suspension (15 mg/mL) needed to be compounded based upon the 
patient's weight 





 


 
Body Weight (kg)
Body Weight (lbs)
Total Volume to Compound per patient (mL) 
 


 
 
 


 
15 kg or less
33 lbs or less
30 mL
 

 
16 to 23 kg 
34 to 51 lbs
40 mL
 

 
24 to 40 kg
52 to 88 lbs
50 mL
 

 
41 kg or more 
89 lbs or more
60 mL
 
Next, determine the number of capsules and the amount of vehicle (Cherry Syrup 
or Ora-Sweet SF) that are needed to prepare the Total Volume (calculated from 
Table 5: 30 mL, 40 mL, 50 mL, or 60 mL) of compounded oral suspension (15 
mg/mL). Refer to Table 6. 

Table 6
Number of TAMIFLU 75 mg Capsules and Amount of Vehicle (Cherry Syrup OR 
Ora-Sweet SF) Needed to Prepare the Total Volume of a Compounded Oral 
Suspension (15 mg/mL) 





 


 
Total Volume of Compounded Oral Suspension needed to be Prepared
30 mL
40 mL
50 mL
60 mL
 


 
 
 


 
Required number of TAMIFLU 75 mg Capsules
6 capsules (450 mg oseltamivir)
8 capsules (600 mg oseltamivir)
10 capsules (750 mg oseltamivir)
12 capsules (900 mg oseltamivir)
 

 
Required volume of vehicle
Cherry Syrup (Humco) OR Ora-Sweet SF (Paddock Laboratories) 
29 mL
38.5 mL
48 mL
57 mL
 
Then, follow the procedure below for compounding the oral suspension (15 mg/mL) 
from TAMIFLU Capsules 75 mg 


Carefully separate the capsule body and cap and transfer the contents of the 
required number of TAMIFLU 75 mg Capsules into a clean mortar. 
Triturate the granules to a fine powder. 
Add one-third (1/3) of the specified amount of vehicle as follows: Slowly add a 
small amount of vehicle (~1 mL per 6 capsule contents) to the triturated 
Tamiflu powder and levigate well with the pestle (~2-3 minutes) to a smooth 
mass. Very slowly, continue adding the remainder of one-third (1/3) amount of 
vehicle in 3 small portions to the mortar while triturating with the pestle 
until a uniform suspension is achieved each time.‡ 
Transfer the suspension to an amber glass or amber polyethyleneterephthalate 
(PET) bottle. A funnel may be used to eliminate any spillage. 
Add another one-third (1/3) of the vehicle to the mortar, rinse the pestle and 
mortar by a triturating motion and transfer the vehicle into the bottle. 
Repeat the rinsing (Step 5) with the remainder of the vehicle. 
Close the bottle using a child-resistant cap. 
Shake well to completely dissolve the active drug and to ensure homogeneous 
distribution of the dissolved drug in the resulting suspension. (Note: The 
active drug, oseltamivir phosphate, readily dissolves in the specified 
vehicles. The suspension is caused by some of the inert ingredients of TAMIFLU 
Capsules which are insoluble in these vehicles.) 
Put an ancillary label on the bottle indicating "Shake Gently Before Use". 
[This compounded suspension should be gently shaken prior to administration to 
minimize the tendency for air entrapment, particularly with the Ora-Sweet SF 
preparation.] 
Instruct the parent or guardian that any remaining material following 
completion of therapy must be discarded by either affixing an ancillary label 
to the bottle or adding a statement to the pharmacy label instructions. 
Place an appropriate expiration date label according to storage condition (see 
below). 



STORAGE OF THE PHARMACY-COMPOUNDED SUSPENSION:Refrigeration: Stable for 5 weeks 
(35 days) when stored in a refrigerator at 2° to 8°C (36° to 46°F). Room 
Temperature: Stable for five days (5 days) when stored at room temperature, 
25°C (77°F).
Note: The storage conditions are based on stability studies of compounded oral 
suspensions, using the above mentioned vehicles, which were placed in amber 
glass and amber polyethyleneterephthalate (PET) bottles. Stability studies have 
not been conducted with other vehicles or bottle types. 


Place a pharmacy label on the bottle that includes the patient's name, dosing 
instructions, and drug name and any other required information to be in 
compliance with all State and Federal Pharmacy Regulations. Refer to Table 7 
for the proper dosing instructions. 

 
Note: This compounding procedure results in a 15 mg/mL suspension, which is 
different from the commercially available TAMIFLU for Oral Suspension, which 
has a concentration of 12 mg/mL. 

Table 7
Dosing Chart for Pharmacy-Compounded Suspension from TAMIFLU Capsules 75 mg





 


 
Body Weight (kg)
Body Weight (lbs)
Dose (mg)
Volume per Dose 15 mg/mL
Treatment Dose (for 5 days)
Prophylaxis Dose (for 10 days)
 


 
 
 


 
15 kg or less
33 lbs or less
30 mg
2 mL
2 mL two times a day
2 mL once daily
 

 
16 to 23 kg
34 to 51 lbs
45 mg
3 mL
3 mL two times a day
3 mL once daily
 

 
24 to 40 kg
52 to 88 lbs
60 mg
4 mL
4 mL two times a day
4 mL once daily
 

 
41 kg or more
89 lbs or more
75 mg
5 mL
5 mL two times a day
5 mL once daily
 
Note: 1 teaspoon = 5 mL 
Oral Dosing Device: Consider dispensing the suspension with an oral dosing 
device (a graduated oral syringe or spoon) suitable for measuring small amounts 
of suspension. If possible, mark or highlight the graduation corresponding to 
the appropriate dose (2 mL, 3 mL, 4 mL, or 5 mL) on the oral syringe or spoon 
for each patient. The dosing device dispensed with the commercially available 
TAMIFLU for Oral Suspension should NOT be used with the compounded suspension 
since it has a different concentration (concentration = 12 mg/mL) than the 
suspension prepared through the emergency compounding procedure described here 
(concentration = 15 mg/mL). 
While preparing TAMIFLU prescriptions for your patients, please remember:


To ensure the conformity of TAMIFLU Oral Suspension prescribed does with oral 
dispenser to patient/caregiver: 

If prescribed does conform with the dosing dispenser in TAMIFLU Oral Suspension 
commercial packaging (provided dispenser is marked in mg), please dispense the 
TAMIFLU-packaged oral dispenser 
If prescribed does not conform with dosing dispenser in TAMIFLU Oral Suspension 
commercial packaging (provided dispenser is marked in mg), please discard the 
TAMIFLU-packaged oral dispenser and provide an oral dispenser that conforms 
with the prescribed dose
Pharmacy-compounded TAMIFLU Oral Suspension results in a 15mg.mL concentration 
(commercially-available TAMIFLU Oral Suspension is a 12mg/mL concentration)
This completes the review of the directions for the emergency compounding of an 
oral suspension of TAMIFLU from the oral 75 mg capsules. Healthcare 
professionals should access the TAMIFLU Package Insert, which contains these 
directions and all tables needed to complete the emergency compounding 
procedure. 



*Humco® is a registered trademark of Humco Holding Group, Inc.
†Ora-Sweet® SF is a registered trademark of Paddock Laboratories
‡ Data on file 
 
http://www.tamiflu.com/hcp/dosing/extprep.aspx
 
Je souhaite que ce document apporte un début de solution au problème posé.
 
Merci et bon courage à vous.









************************************* 
Mamane N. GARBA, Pharm.D.
Guest Researcher
CDC/CCID/NCZVED/DPD/MB/LRDU

B-109, R-1118.8 MS F- 36
4770 Buford Highway,
NE Atlanta, GA 30341

Cell: +1-504-343-4472

 

Office: +1-770-488-3772
Laboratory: +1-770-488-4969
Fax: +1-770-488-4253

mgarba@cdc.gov
meidaphar@yahoo.fr
  
> From: onppc@intnet.ne
> To: e-med@healthnet.org
> Date: Mon, 22 Feb 2010 15:09:22 +0100
> Subject: [e-med] Tamiflu suspension
> 
> Bonjour à tous,
> Nous étions confrontés au cours de la semaine écoulée à une penurie de 
> suspension buvable d'Oseltamivir car nous avons eu des cas d'enfants entre 
> 7mois et 6ans. En effet un stock constitué à travers l'OMS étant arrivé à 
> péremption récemment. Si pour les grands enfants ils peuvent avaler les 
> gelules sans problemes ; ce n'est pas le cas pour les tous petits. Alors il 
> existent des gelules de 50mg et de 30mg que nous avons decider d'acquérir 
> mais par contre nous avons des difficultés pour trouver la suspension 
> (12mg/ml). Etant donné que la suspension est sous forme de poudre à 
> reconstituer, peut- on alors essayer d'obtenir la concentration à partir du 
> contenu de la gelule qu'on pourra diluer dans un liquide de choix (sirop 
> simple,eau ou autre....).Y aura t il pas un problème de saveur, d'irritation 
> gastrique ou d'inactivation du PA?
> Je ne trouve pas assez d'information; alors pouvez nous aider à résoudre ce 
> cas pratique que nous venons de vivre ?
> Connaissez vous des fournisseurs capables de nous approvisionner très 
> rapidement en formes infantiles?
> Dr SAMBO MARIAMA
> DG/ONPPC/NIGER
> TEL:227 20 74 27 81/20 74 26 68
> Email:onppc@intnet.ne
> _______________________________________________
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