ADVAIR DISKUS- fluticasone propionate and salmeterol powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT), FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)

Available from:

Dispensing Solutions Inc.

INN (International Name):

SALMETEROL XINAFOATE

Composition:

SALMETEROL XINAFOATE 50 ug

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ADVAIR DISKUS is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients aged 4 years and older. Long-acting beta2 -adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, may increase the risk of asthma-related death [see Warnings and Precautions (5.1)] . Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Important Limitations of Use: - ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm. - ADVAIR DISKUS is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2 -agonists. ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in

Product summary:

ADVAIR DISKUS 100/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch. ADVAIR DISKUS 100/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch. ADVAIR DISKUS 250/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 68258-3031-1). ADVAIR DISKUS 250/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch. ADVAIR DISKUS 500/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch. ADVAIR DISKUS 500/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch. They are supplied by Dispensing Solutions Inc. as follows: This product was Manufactured By: GlaxoSmithKline Research Triangle Park, NC 27709 And Relabeled By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States Store at controlled room temperature (see USP), 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. The device should be discarded 1 month after removal from the moisture-protective foil overwrap pouch or after all blisters have been used (when the dose indicator reads “0”), whichever comes first. Do not attempt to take the device apart.

Authorization status:

New Drug Application

Patient Information leaflet

ADVAIR DISKUS- FLUTICASONE PROPIONATE AND SALMETEROL POWDER
Dispensing Solutions Inc.
----------
MEDICATION GUIDE
ADVAIR [ad′ vair] DISKUS® 100/50
(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation
powder)
ADVAIR DISKUS® 250/50
(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation
powder)
ADVAIR DISKUS® 500/50
(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation
powder)
Read the Medication Guide that comes with ADVAIR DISKUS before you
start using it and each time
you get a refill. There may be new information. This Medication Guide
does not take the place of talking
to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about ADVAIR
DISKUS?
•
ADVAIR DISKUS contains 2 medicines:
•
fluticasone propionate (the same medicine found in FLOVENT®), an
inhaled
corticosteroid medicine. Inhaled corticosteroids help to decrease
inflammation in the lungs.
Inflammation in the lungs can lead to asthma symptoms.
•
salmeterol (the same medicine found in SEREVENT®), a long-acting
beta2-agonist
medicine or LABA. LABA medicines are used in patients with asthma and
chronic
obstructive pulmonary disease (COPD). LABA medicines help the muscles
around the
airways in your lungs stay relaxed to prevent symptoms, such as
wheezing and shortness of
breath. These symptoms can happen when the muscles around the airways
tighten. This
makes it hard to breathe. In severe cases, wheezing can stop your
breathing and cause
death if not treated right away.
•
In patients with asthma, LABA medicines, such as salmeterol (one of
the medicines in ADVAIR
DISKUS), may increase the chance of death from asthma problems. In a
large asthma study, more
patients who used salmeterol died from asthma problems compared with
patients who did not use
salmeterol. It is not known whether fluticasone propionate, the other
medicine in ADVAIR
DISKUS, changes your chance of death from asthma problems seen with
salmeterol. Talk with
your healthcare provid

Summary of Product characteristics

ADVAIR DISKUS- FLUTICASONE PROPIONATE AND SALMETEROL POWDER
DISPENSING SOLUTIONS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADVAIR DISKUS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR ADVAIR DISKUS.
ADVAIR DISKUS 100/50
(FLUTICASONE PROPIONATE 100 MCG AND SALMETEROL 50 MCG INHALATION
POWDER)
ADVAIR DISKUS 250/50
(FLUTICASONE PROPIONATE 250 MCG AND SALMETEROL 50 MCG INHALATION
POWDER)
ADVAIR DISKUS 500/50
(FLUTICASONE PROPIONATE 500 MCG AND SALMETEROL 50 MCG INHALATION
POWDER)
FOR ORAL INHALATION
INITIAL U.S. APPROVAL: 2000
WARNING: RISK OF ASTHMA-RELATED DEATH
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
LONG-ACTING BETA -ADRENERGIC AGONISTS, SUCH AS SALMETEROL, ONE OF THE
ACTIVE INGREDIENTS IN ADVAIR
DISKUS, MAY INCREASE THE RISK OF ASTHMA-RELATED DEATH. A US STUDY
SHOWED AN INCREASE IN ASTHMA-
RELATED DEATHS IN PATIENTS RECEIVING SALMETEROL (13 DEATHS OUT OF
13,176 PATIENTS TREATED FOR 28 WEEKS
ON SALMETEROL VERSUS 3 OUT OF 13,179 PATIENTS ON PLACEBO). (5.1)
WHEN TREATING PATIENTS WITH ASTHMA, ONLY PRESCRIBE ADVAIR DISKUS FOR
PATIENTS NOT ADEQUATELY
CONTROLLED ON OTHER ASTHMA-CONTROLLER MEDICATIONS OR WHOSE DISEASE
SEVERITY CLEARLY WARRANTS
INITIATION OF TREATMENT WITH 2 MAINTENANCE THERAPIES. (1.1, 5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Reduction in Bone Mineral Density (5.13)
March 2009
INDICATIONS AND USAGE
ADVAIR DISKUS is a combination product containing a corticosteroid and
a long-acting beta -adrenergic agonist indicated
for: (1)
Maintenance treatment of asthma in patients aged 4 years and older.
(1.1)
Maintenance treatment of airflow obstruction and reducing
exacerbations in patients with chronic obstructive
pulmonary disease (COPD). (1.2)
Important limitations: (1)
Not indicated for patients whose asthma can be managed by inhaled
corticosteroids with occasional use of inhaled short-
acting beta -agonists. (1.1)
Not indicated for the relief of acute bronchospasm. (1.1, 1.2)
DOSAGE AN