1. Geosalud
2. Enfermedades Infecciosas
3. Oral Suspension TAMIFLU

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

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)

Then, follow the procedure below for compounding the oral suspension (15 mg/mL) from TAMIFLU Capsules 75 mg

1. Carefully separate the capsule body and cap and transfer the contents of the required number of TAMIFLU 75 mg Capsules into a clean mortar.
2. Triturate the granules to a fine powder.
3. Add one-third (1/3) of the specified amount of vehicle to the mortar and triturate the powder until a uniform suspension is achieved.
4. Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle. A funnel may be used to eliminate any spillage.
5. 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.
6. Repeat the rinsing (Step 5) with the remainder of the vehicle.
7. Close the bottle using a child-resistant cap.
8. 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.)
9. 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.
10. 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.
11. 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.

12. 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

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.

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• Swine Flu: Information for Concerned Parents and Caregivers

Fuente
Texas, Department of Health Services
http://www.dshs.state.tx.us