Treatment of Influenza

TAMIFLU is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days.

Prophylaxis of Influenza

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

TAMIFLU is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.

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

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

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:

1. Tap the closed bottle several times to loosen the powder.
2. Measure 23 mL of water in a graduated cylinder.
3. Add the total amount of water for constitution to the bottle and shake the closed bottle well for 15 seconds.
4.  Remove the child-resistant cap and push bottle adapter into the neck of the bottle.
5. 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

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)

Third, 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 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 vehicle 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 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.)
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.]
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).

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

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.

TAMIFLU Capsules

30-mg capsules (30 mg free base equivalent of the phosphate salt): light yellow hard gelatin capsules. "ROCHE" is printed in blue ink on the light yellow body and "30 mg" is printed in blue ink on the light yellow cap. Available in blister packages of 10 (NDC 0004-0802-85).

45-mg capsules (45 mg free base equivalent of the phosphate salt): grey hard gelatin capsules. "ROCHE" is printed in blue ink on the grey body and "45 mg" is printed in blue ink on the grey cap. Available in blister packages of 10 (NDC 0004-0801-85).

75-mg capsules (75 mg free base equivalent of the phosphate salt): grey/light yellow hard gelatin capsules. "ROCHE" is printed in blue ink on the grey body and "75 mg" is printed in blue ink on the light yellow cap. Available in blister packages of 10 (NDC 0004-0800-85).

Storage

Store the capsules at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature]

TAMIFLU for Oral Suspension

Supplied as a white powder blend for constitution to a white tutti-frutti–flavored suspension. Available in glass bottles containing approximately 33 mL of suspension after constitution. Each bottle delivers 25 mL of suspension equivalent to 300 mg oseltamivir base. Each bottle is supplied with a bottle adapter and 1 oral dispenser (NDC 0004-0810-95).

Storage

Store dry powder at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature]

Store constituted suspension under refrigeration at 2º to 8ºC (36º to 46ºF). Do not freeze.

Humco® is a registered trademark of Humco Holding Group, Inc. Ora-Sweet® SF is a registered trademark of Paddock Laboratories. Distributed by: Pharmaceuticals Roche Laboratories Inc. 340 Kingsland Street Nutley, New Jersey 07110-1199. Gilead Sciences, Inc. Foster City, California 94404 Rev. January, 2008. FDA Rev date: 1/17/2008

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