A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tamiflu Indications, Dosage, Storage, Stability - Oseltamivir Phosphate
Tamiflu Indications, Dosage, Storage, Stability - Oseltamivir Phosphate
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 adult
patients and adolescents 13 years and older.
TAMIFLU is not a substitute for early vaccination on an annual
basis as recommended by the Centers for Disease Practices Advisory Committee.
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 oral suspension for pediatric
patients 1 year and older or adult patients who cannot swallow a capsule is:
|
Body Weight in kg
|
Body Weight in lbs
|
Recommended Dose for 5 Days
|
Number of Bottles Needed to Obtain the Recommended Dose
|
|
£ 15 kg
|
£ 33 lbs
|
30 mg twice daily
|
1
|
|
>15 kg to 23 kg
|
>33 lbs to 51 lbs
|
45 mg twice daily
|
2
|
|
>23 kg to 40 kg
|
>51 lbs to 88 lbs
|
60 mg twice daily
|
2
|
|
>40 kg
|
>88 lbs
|
75 mg twice daily
|
3
|
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 £ 15kg, 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
The safety and efficacy of TAMIFLU for prophylaxis of influenza
in pediatric patients younger than 13 years of age have not been established.
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 7 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.
Special Dosage Instructions
Hepatic Impairment
The safety and pharmacokinetics in patients with hepatic impairment
have not been evaluated.
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 oral suspension 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 Oral Suspension
It is recommended that TAMIFLU 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 ORAL SUSPENSION WELL BEFORE EACH USE.
The constituted oral suspension 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.
HOW SUPPLIED
TAMIFLU Capsules
Supplied as 75-mg (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 25 mL
of suspension after constitution 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.
Manufactured by: F. Hoffmann-La Roche Ltd.
Basel, Switzerland
Distributed by: Pharmaceuticals, Rocha Laboratories
Inc. 340 Kingsland Street, Nutley, New Jersey 07110-1199
Licensor: Gilead Sciences, Inc. FosterCity,California
94404 27898808 Revised: June 2004 Copyright © 1999-2004 by Roche Laboratories
Inc. All rights reserved.
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