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
Serevent Diskus Indications, Dosage, Storage, Stability - Salmeterol Xinafoate (inhalation powder)
Serevent Diskus Indications, Dosage, Storage, Stability - Salmeterol Xinafoate (inhalation powder)
INDICATIONS
SEREVENT DISKUS inhalation
powder is indicated for
long-term, twice-daily (morning and evening) administration
in the maintenance treatment
of asthma and in the prevention
of bronchospasm
in patients 4 years of age
and older with reversible
obstructive airway disease,
including patients with symptoms of nocturnal
asthma, who require regular
treatment with inhaled,
short-acting beta2-agonists. It is not indicated for patients whose
asthma can be managed
by occasional use of inhaled, short-acting beta2-agonists.
SEREVENT DISKUS is also indicated for prevention
of exercise-induced bronchospasm in patients 4 years of age
and older.
SEREVENT DISKUS may be used with or without concurrent inhaled
or systemic corticosteroid therapy.
DOSAGE AND ADMINISTRATION
SEREVENT DISKUS inhalation
powder should be administered
by the orally inhaled route only (see PATIENT’S INSTRUCTIONS FOR
USE). For maintenance of bronchodilatation
and prevention of
symptoms of asthma, including
the symptoms of nocturnal
asthma, the usual dosage
for adults and children 4 years of age
and older is one inhalation
(50 mcg) twice daily (morning and evening, approximately 12 hours
apart). Adverse effects are more likely to occur with higher doses
of salmeterol, and more frequent administration or administration
of a larger number of
inhalations is not recommended.
To gain full therapeutic
benefit, SEREVENT DISKUS should be administered twice daily (morning
and evening) in the treatment
of reversible airway
obstruction. The patient
must not exhale into the device
and the device should only be activated and used in a level, horizontal
position.
If a previously effective dosage
regimen fails to provide
the usual response, medical
advice should be sought immediately as this is often a sign
of destabilization of asthma. Under these circumstances, thetherapeutic
regimen should be reevaluated and additional therapeutic
options, such as inhaled or systemic
corticosteroids, should be considered. If symptoms arise in the
period between doses,
an inhaled, short-acting beta2-agonist should be taken for immediate
relief.
Geriatric Use
In studies where geriatric patients (65 years of age
or older, see PRECAUTIONS)
have been treated with SEREVENT inhalation
powder, efficacy and
safety of 50 mcg given twice
daily (morning and evening) did not differ from that in younger
patients. Consequently, no
dosage adjustment
is recommended.
Prevention of Exercise-Induced Bronchospasm (EIB)
One inhalation of
SEREVENT DISKUS inhalation
powder at least 30 minutes
before exercise has
been shown to protect patients against EIB. When used intermittently
as needed for prevention
of EIB, this protection may last up to 9 hours in adolescents and
adults and up to 12 hours in patients 4 to 11 years of age. Additional
doses of SEREVENT should not be used for 12 hours after the administration
of this drug. Patients who are receiving SEREVENT DISKUS inhalation
powder twice daily should
not use additional SEREVENT for prevention
of EIB. If regular, twice-daily dosing is not effective in preventing
EIB, other appropriate
therapy for EIB should
be considered.
HOW SUPPLIED
SEREVENT DISKUS inhalation
powder is supplied as
a disposable, teal green colored device
containing 60 blisters. The DISKUS inhalation
device is packaged within a teal green
colored, plastic-coated foil
pouch(NDC 0173-0521-00).
SEREVENT DISKUS is also supplied in an institutional pack
of one teal green colored, disposable DISKUS inhalation
device containing 28
blisters. The DISKUS inhalation
device is packaged within
a teal green colored,
plastic-coated foil pouch
(NDC 0173-0520-00).
Storage
Store at controlled room
temperature, 20° to 25° C (68° to 77° F) in a dry
place away from direct heat
or sunlight. Keep out of reach of children. The DISKUS inhalation
device is not reusable
and should be discarded after every blister
has been used (when the dose
indicator reads “0”) or 6 weeks after removal from the moisture-protective
foil overwrap pouch, whichever
comes first. Do not attempt
to take the device
apart.
Rx only
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