Emergency
Compounding of an Oral Suspension
from TAMIFLU Capsules
April 29, 2009
Extemporaneous
Preparation
Directions for
the Emergency Compounding of an Oral Suspension from TAMIFLU Capsules
(Final Concentration = 15 mg/mL)
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 to the mortar and triturate
the powder until a uniform suspension is achieved.
- 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 contents 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 insure 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. The need to shake the compounded oral
suspension gently prior to administration should be reviewed with
the parent or guardian when the suspension is dispensed.
- 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).
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.
Fuente
Texas, Department of Health Services
http://www.dshs.state.tx.us
|
SUSCRIBASE 
