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Tamiflu (Oseltamivir Phosphate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

Limitations of Use

The following points should be considered before initiating treatment or prophylaxis with TAMIFLU:

  • Efficacy of TAMIFLU in patients who begin treatment after 48 hours of symptoms has not been established.
  • TAMIFLU is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
  • There is no evidence for efficacy of TAMIFLU in any illness caused by agents other than influenza viruses types A and B.
  • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.

DOSAGE AND ADMINISTRATION

Dosing for Treatment and Prophylaxis of Influenza

TAMIFLU may be taken with or without food [see Clinical Pharmacology]. However, when taken with food, tolerability may be enhanced in some patients.

The recommended oral treatment and prophylaxis dose of TAMIFLU for patients 1 year of age and older is shown in Table 1.

Table 1 Treatment and Prophylaxis Dosing of Oral TAMIFLU for Influenza For Patients 1 Year of Age and Older Based on Body Weight
Weight (kg) Weight (lbs) Treatment Dosing
for 5 days
Prophylaxis Dosing for 10 days Volume of
Oral Suspension
(6 mg/mL)
for each Dose
Number of Bottles of Oral Suspension to Dispense Number of Capsules and Strength to Dispense
15 kg or less 33 lbs or less 30 mg twice daily 30 mg once daily 5 mL 1 bottle 10 Capsules
30 mg
16 kg thru 23 kg 34 lbs thru 51 lbs 45 mg twice daily 45 mg once daily 7.5 mL 2 bottles 10 Capsules
45 mg
24 kg thru 40 kg 52 lbs thru 88 lbs 60 mg twice daily 60 mg once daily 10 mL 2 bottles 20 Capsules
30 mg
41 kg or more 89 lbs or more 75 mg twice daily 75 mg once daily 12.5 mL 3 bottles 10 Capsules
75 mg

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. TAMIFLU for oral suspension may be used by patients who cannot swallow a capsule (see Table 1).

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 1. For pediatric patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup, corn syrup, caramel topping, or light brown sugar (dissolved in water). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration].

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 in immunocompetent patients. The duration of protection lasts for as long as dosing is continued. Safety has been demonstrated for up to 12 weeks in immunocompromised patients. TAMIFLU for oral suspension may also be used by patients who cannot swallow a capsule (see Table 1).

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 1. For pediatric patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. If the oral suspension product is not available, TAMIFLU capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup, corn syrup, caramel topping, or light brown sugar (dissolved in water). If the appropriate strengths of TAMIFLU capsules are not available to mix with sweetened liquids and the oral suspension product is not available, then a pharmacist may compound an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Dosage and Administration].

Prophylaxis in pediatric patients following close contact with an infected individual is recommended for 10 days. Therapy should begin within 2 days of exposure. For prophylaxis in pediatric patients during a community outbreak of influenza, dosing may be continued for up to 6 weeks.

Renal Impairment

Data are available on plasma concentrations of oseltamivir carboxylate following various dosing schedules in patients with renal impairment [see Clinical Pharmacology].

Treatment of Influenza

Dose adjustment is recommended for adult 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 with end-stage renal disease undergoing routine hemodialysis or continuous peritoneal dialysis treatment.

Prophylaxis of Influenza

For the prophylaxis of influenza, dose adjustment is recommended for adult 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.

Hepatic Impairment

No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh score ≤9) [see Clinical Pharmacology].

Geriatric Patients

No dose adjustment is required for geriatric patients [see Use in Specific Populations and Clinical Pharmacology].

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:

  • a)Tap the closed bottle several times to loosen the powder.
  • b) Measure 55 mL of water in a graduated cylinder.
  • c)Add the total amount of water for constitution to the bottle and shake the closed bottle well for 15 seconds.
  • d)Remove the child-resistant cap and push bottle adapter into the neck of the bottle.
  • e)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.

Label the bottle with instructions to Shake Well before each use.

The constituted TAMIFLU for oral suspension (6 mg/mL) should be used within 17 days of preparation when stored under refrigeration or within 10 days if stored at controlled room temperature; 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 75 mg TAMIFLU Capsules (Final Concentration 6 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 (6 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 (6 mg/mL) from TAMIFLU capsules 75 mg using one of these vehicles: Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. 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 the patient (see Table 2).

Table 2 Volume of an Oral Suspension (6 mg/mL) Needed to be Compounded Based Upon the Patient's Body Weight
Weight (kg) Weight (lbs) Total Volume to Compound
per Patient (mL)
15 kg or less 33 lbs or less 75 mL
16 thru 23 kg 34 thru 51 lbs 100 mL
24 thru 40 kg 52 thru 88 lbs 125 mL
41 kg or more 89 lbs or more 150 mL

Second, determine the number of capsules and the amount of water and vehicle (Cherry Syrup, Ora-Sweet® SF, or simple syrup) that are needed to prepare the total volume (determined from Table 2: 75 mL, 100 mL, 125 mL, or 150 mL) of compounded oral suspension (6 mg/mL) (see Table 3).

Table 3 Number of TAMIFLU 75 mg Capsules and Amount of Vehicle (Cherry Syrup, Ora-Sweet® SF, or Simple Syrup) Needed to Prepare the Total Volume of a Compounded Oral Suspension (6 mg/mL)
Total Volume of Compounded Oral Suspension to be Prepared 75 mL 100 mL 125 mL 150 mL
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)
Amount of Water 5 mL 7 mL 8 mL 10 mL
Volume of Vehicle
Cherry Syrup (Humco®) OR
Ora-Sweet® SF (Paddock Laboratories) OR simple syrup
69 mL 91 mL 115 mL 137 mL

Third, follow the procedure below for compounding the oral suspension (6 mg/mL) from TAMIFLU capsules 75 mg:

  • Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 3).
  • Carefully separate the capsule body and cap and pour the contents of the required number of TAMIFLU 75 mg capsules into the PET or glass bottle.
  • Gently swirl the suspension to ensure adequate wetting of the TAMIFLU powder for at least 2 minutes.
  • Slowly add the specified amount of vehicle to the bottle.
  • Close the bottle using a child-resistant cap and shake well for 30 seconds 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 inert ingredients of TAMIFLU capsules which are insoluble in these vehicles.)
  • Put an ancillary label on the bottle indicating "Shake Well Before Use."
  • Instruct the parent or caregiver that any unused suspension remaining in the bottle 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 on the label according to storage conditions below.

Storage of the Emergency 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 glass and 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.

Dosing of the Compounded Suspension (6 mg/mL)

Refer to Table 1 for the proper dosing instructions for the pharmacy label.

DOSAGE FORMS AND STRENGTHS

Capsules: 30 mg, 45 mg, 75 mg

  • 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.
  • 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.
  • 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.

For Oral Suspension: 6 mg/mL (final concentration when constituted)

  • White powder blend for constitution to a white tutti-frutti–flavored suspension. After constitution, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL).

HOW SUPPLIED/STORAGE AND HANDLING

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 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

TAMIFLU for Oral Suspension

Supplied as a white powder blend in a glass bottle. After constitution, the powder blend produces a white tutti-frutti–flavored oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL). Each bottle is supplied with a bottle adapter and a 10 mL oral dispenser (NDC 0004-0820-09).

Storage

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

Store constituted suspension under refrigeration for up to 17 days at 2° to 8°C (36° to 46°F). Do not freeze. Alternatively, store constituted suspension for up to 10 days at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

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