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
Nasacort Indications, Dosage, Storage, Stability - Triamcinolone Acetonide
Nasacort Indications, Dosage, Storage, Stability - Triamcinolone Acetonide
INDICATIONS AND USAGE
Nasacort HFA Nasal Aerosol is indicated for the treatment of
the nasal symptoms of allergic rhinitis (seasonal and perennial) in adults and
children 6 years of age and older.
Safety and effectiveness of Nasacort HFA Nasal Aerosol in children
below 6 years of age have not been adequately established.
DOSAGE AND ADMINISTRATION
Recommended Doses
Adults and Adolescents 12 years of age and older: The recommended
starting dose of Nasacort HFA Nasal Aerosol is 220 mcg per day given as 2 sprays
(55 mcg/spray) in each nostril once daily. If needed, the dose may be increased
to 440 mcg per day given as 4 sprays (55 mcg/spray) in each nostril once daily.
Once the maximal effect has been achieved, it is always desirable to titrate
the patient to the minimum effective dose. Children 6 through 11 years of age:
The recommended dose of Nasacort HFA Nasal Aerosol is 220 mcg per day given
as 2 sprays (55 mcg/spray) in each nostril once daily. Once the maximal effect
has been achieved, it is always desirable to titrate the patient to the minimum
effective dose.
Safety and effectiveness have not been established in pediatric
patients below the age of 6 years (see PRECAUTIONS,
Pediatric Use).
Directions for Use
Illustrated PATIENT’S INSTRUCTIONS FOR USE accompanies each package.
HOW SUPPLIED
Nasacort HFA Nasal Aerosol is supplied with an aerosol canister
which provides 100 metered dose actuations. The correct amount of medication
delivered per actuation cannot be assured after 100 actuations have been dispensed,
after which the unit should be discarded. Each actuation delivers 55 mcg triamcinolone
acetonide through the nasal actuator. The Nasacort HFA Nasal Aerosol canister
and accompanying nasal actuator are designed to be used together. The Nasacort
HFA Nasal Aerosol canister should not be used with other nasal actuators and
the supplied nasal actuator should not be used with other ters. Nasacort HFA
Nasal Aerosol is supplied with a molecular sieve sachet as a propellant adsorbent
and a white plastic protective cap, and enclosed in a foil laminate overwrap
pouch. Patient instructions are also provided. Net weight of the canister contents
is 9.3 grams.
NDC 0075-9403-43
CONTENTS UNDER PRESSURE
Avoid spraying in eyes.
Do not puncture. Do not use or store near heat or open flame.
Exposure to temperatures above 120° F may cost
bursting. Never throw container into fire or incinerator. Store at controlled
room temperature, 20 to 25°C(68 to 77° F) [see
USP]
Keep out of reach of children.
Rev. April 2004c Manufactured for: Aventis
Pharmaceuticals Inc. Bridgewater, NJ 08807 Manufactured by: Aventis Pharma Ltd.
Holmes Chapel, Cheshire CW4 8BE United Kingdom NASHFA-APRIL04c-F-A
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