Dosing, Administration and Storage

Extemporaneous Preparation

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

  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

 
  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.

*Humco® is a registered trademark of Humco Holding Group, Inc.
†Ora-Sweet® SF is a registered trademark of Paddock Laboratories

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Important Safety Information

Indications

TAMIFLU is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients 1 year and older who have been symptomatic for no more than 2 days.

TAMIFLU is also indicated for the prophylaxis of influenza in patients 1 year and older.

TAMIFLU is not a substitute for early and annual vaccination as recommended by the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP).

Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.

Safety Information

There is no evidence for efficacy against any illness caused by agents other than influenza types A and B.

Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population.

No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization.

Efficacy of TAMIFLU has not been established in immunocompromised patients.

Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving TAMIFLU. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on TAMIFLU usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of TAMIFLU to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with TAMIFLU.

The most common adverse events reported >1% of patients treated with TAMIFLU and more commonly than in patients treated with placebo are:

  • Treatment of adult and pediatric patients - nausea, vomiting.
  • Prophylaxis of adult and pediatric patients - nausea, vomiting, abdominal pain.

Vaccination is considered the first line of defense against influenza.

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