DOSAGE AND ADMINISTRATION
TAMIFLU may be taken with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics). However, when taken with food, tolerability may be enhanced in some patients.
Standard Dosage — Treatment of Influenza
Adults and Adolescents
The recommended oral dose of TAMIFLU for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. Treatment should begin within 2 days of onset of symptoms of influenza.
Pediatric Patients
TAMIFLU is not indicated for treatment of influenza in pediatric patients younger than 1 year.
The recommended oral dose of TAMIFLU for pediatric patients 1 year and older is shown in Table 5. TAMIFLU for Oral Suspension may also be used by patients who cannot swallow a capsule. For pediatric patients who cannot swallow capsules, TAMIFLU for Oral Suspension is the preferred formulation. If the for Oral Suspension product is not available, TAMIFLU Capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup.
Table 5 Oral Dose of TAMIFLU for Treatment of Influenza in Pediatric Patients by Weight | Body Weight (kg) | Body Weight (lbs) | Recommended Dose for 5 Days | Number of Bottles of TAMIFLU for Oral Suspension Needed to Obtain the Recommended Doses for a 5 Day Regimen | Number of TAMIFLU Capsules Needed to Obtain the Recommended Doses for a 5 Day Regimen |
| ≤15 kg | ≤33 lbs | 30 mg twice daily | 1 | 10 TAMIFLU Capsules (30 mg) |
| >15 kg to 23 kg | >33 lbs to 51 lbs | 45 mg twice daily | 2 | 10 TAMIFLU Capsules (45 mg) |
| >23 kg to 40 kg | >51 lbs to 88 lbs | 60 mg twice daily | 2 | 20 TAMIFLU Capsules (30 mg) |
| >40 kg | >88 lbs | 75 mg twice daily | 3 | 10 TAMIFLU Capsules (75 mg) |
An oral dosing dispenser with 30 mg, 45 mg, and 60 mg graduations is provided with the oral suspension; the 75 mg dose can be measured using a combination of 30 mg and 45 mg. It is recommended that patients use this dispenser. In the event that the dispenser provided is lost or damaged, another dosing syringe or other device may be used to deliver the following volumes: 2.5 mL (1/2 tsp) for children ≤15 kg, 3.8 mL (3/4 tsp) for >15 to 23 kg, 5.0 mL (1 tsp) for >23 to 40 kg, and 6.2 mL (1 1/4 tsp) for >40 kg.
Standard Dosage — Prophylaxis of Influenza
Adults and Adolescents
The recommended oral dose of TAMIFLU for prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual is 75 mg once daily for at least 10 days. Therapy should begin within 2 days of exposure. The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks. The duration of protection lasts for as long as dosing is continued.
Pediatric Patients
The safety and efficacy of TAMIFLU for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established.
The recommended oral dose of TAMIFLU for pediatric patients 1 year and older following close contact with an infected individual is shown in Table 6. TAMIFLU for Oral Suspension may also be used by patients who cannot swallow a capsule. For pediatric patients who cannot swallow capsules, TAMIFLU for Oral Suspension is the preferred formulation. If the for Oral Suspension product is not available, TAMIFLU Capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup.
Table 6 Oral Dose of TAMIFLU for Prophylaxis of Influenza in Pediatric Patients by Weight | Body Weight (kg) | Body Weight (lbs) | Recommended Dose for 10 Days | Number of Bottles of TAMIFLU for Oral Suspension Needed to Obtain the Recommended Doses for a 10 Day Regimen | Number of TAMIFLU Capsules Needed to Obtain the Recommended Doses for a 10 Day Regimen |
| ≤15 kg | ≤33 lbs | 30 mg once daily | 1 | 10 TAMIFLU Capsules (30 mg) |
| >15 kg to 23 kg | >33 lbs to 51 lbs | 45 mg once daily | 2 | 10 TAMIFLU Capsules (45 mg) |
| >23 kg to 40 kg | >51 lbs to 88 lbs | 60 mg once daily | 2 | 20 TAMIFLU Capsules (30 mg) |
| >40 kg | >88 lbs | 75 mg once daily | 3 | 10 TAMIFLU Capsules (75 mg) |
An oral dosing dispenser with 30 mg, 45 mg, and 60 mg graduations is provided with the oral suspension; the 75 mg dose can be measured using a combination of 30 mg and 45 mg. It is recommended that patients use this dispenser. In the event that the dispenser provided is lost or damaged, another dosing syringe or other device may be used to deliver the following volumes: 2.5 mL (1/2 tsp) for children ≤15 kg, 3.8 mL (3/4 tsp) for >15 to 23 kg, 5.0 mL (1 tsp) for >23 to 40 kg, and 6.2 mL (1 1/4 tsp) for >40 kg.
Prophylaxis in pediatric patients following close contact with an infected individual is recommended for 10 days. Prophylaxis in patients 1 to 12 years of age has not been evaluated for longer than 10 days duration. Therapy should begin within 2 days of exposure.
Special Dosage Instructions
Hepatic Impairment
No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh score ≤9) (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Special Populations).
Renal Impairment
For plasma concentrations of oseltamivir carboxylate predicted to occur following various dosing schedules in patients with renal impairment, see CLINICAL PHARMACOLOGY: Pharmacokinetics: Special Populations.
Treatment of Influenza
Dose adjustment is recommended for patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU for the treatment of influenza. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU once daily for 5 days. No recommended dosing regimens are available for patients undergoing routine hemodialysis and continuous peritoneal dialysis treatment with end-stage renal disease.
Prophylaxis of Influenza
For the prophylaxis of influenza, dose adjustment is recommended for patients with creatinine clearance between 10 and 30 mL/min receiving TAMIFLU. In these patients it is recommended that the dose be reduced to 75 mg of TAMIFLU every other day or 30 mg TAMIFLU every day. No recommended dosing regimens are available for patients undergoing routine hemodialysis and continuous peritoneal dialysis treatment with end-stage renal disease.
Geriatric Patients
No dose adjustment is required for geriatric patients (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Special Populations and PRECAUTIONS).
Preparation of TAMIFLU for Oral Suspension
It is recommended that TAMIFLU for Oral Suspension be constituted by the pharmacist prior to dispensing to the patient:
- Tap the closed bottle several times to loosen the powder.
- Measure 23 mL of water in a graduated cylinder.
- Add the total amount of water for constitution to the bottle and shake the closed bottle well for 15 seconds.
- Remove the child-resistant cap and push bottle adapter into the neck of the bottle.
- Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.
NOTE: SHAKE THE TAMIFLU FOR ORAL SUSPENSION WELL BEFORE EACH USE.
The constituted TAMIFLU for Oral Suspension (12 mg/mL) should be used within 10 days of preparation; the pharmacist should write the date of expiration of the constituted suspension on a pharmacy label. The patient package insert and oral dispenser should be dispensed to the patient.
Emergency Compounding of an Oral Suspension from TAMIFLU Capsules
(Final Concentration 15 mg/mL)
The following directions are provided for use only during emergency situations. These directions are not intended to be used if the FDA-approved, commercially manufactured TAMIFLU for Oral Suspension is readily available from wholesalers or the manufacturer.
Compounding an oral suspension with this procedure will provide one patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.
Commercially manufactured TAMIFLU for 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 TAMIFLU for 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) (Paddock Laboratories). Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved TAMIFLU for Oral Suspension is commercially available.
First, calculate the Total Volume of an 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 7.
Table 7 Volume of an 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 | ≤33 lbs | 30 mL |
| 16 to 23 kg | 34 to 51 lbs | 40 mL |
| 24 to 40 kg | 52 to 88 lbs | 50 mL |
| ≥41 kg | ≥89 lbs | 60 mL |
Second, 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 7: 30 mL, 40 mL, 50 mL, or 60 mL) of compounded oral suspension (15 mg/mL). Refer to Table 8.
Table 8 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 |
Third, 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 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 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 9 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 9 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) |
| Note: 1 teaspoon = 5 mL |
| ≤15 kg | ≤33 lbs | 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 | ≥89 lbs | 75 mg | 5 mL | 5 mL two times a day | 5 mL once daily |
Consider dispensing the suspension with a graduated oral syringe 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 for each patient. The dosing device dispensed with the commercially available TAMIFLU for Oral Suspension should NOT be used with the compounded suspension since they have different concentrations.
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