FORADIL- formoterol fumarate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FORMOTEROL FUMARATE (UNII: P3T5QA5J9N) (FORMOTEROL - UNII:5ZZ84GCW8B)

Available from:

Physicians Total Care, Inc.

INN (International Name):

FORMOTEROL FUMARATE

Composition:

FORMOTEROL FUMARATE 12 ug

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FORADIL AEROLIZER is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma.       Long-acting beta2 -adrenergic agonists (LABA), such as formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death (see WARNINGS). Use of FORADIL AEROLIZER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use FORADIL AEROLIZER only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g

Product summary:

FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide. Unit Dose (blister pack)             Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 54868-4972-1 FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules. Prior to dispensing: Store in a refrigerator, 2°C-8°C (36°F-46°F) After dispensing to patient: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from heat and moisture. CAPSULES SHOULD ALWAYS BE STORED IN THE BLISTER AND ONLY REMOVED FROM THE BLISTER IMMEDIATELY BEFORE USE. Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription. Keep out of the reach of children. Manufactured by: Novartis Pharma AG, Basle, Switzerland Distributed by: Schering Corporation, a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889, USA Copyright © 2011 Schering Corp., a subsidiary of MERCK & CO., INC. All rights reserved. May 2011 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146

Authorization status:

New Drug Application

Patient Information leaflet

FORADIL - FORMOTEROL FUMARATE CAPSULE
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
Foradil® [FOR-a-dil] Aerolizer®
(formoterol fumarate inhalation powder)
Important: Do not swallow FORADIL capsules. FORADIL capsules are used
only with the
Aerolizer inhaler that comes with FORADIL AEROLIZER. Never place a
capsule in the
mouthpiece of the AEROLIZER Inhaler.
Read the Medication Guide that comes with FORADIL AEROLIZER 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 health care provider about your medical condition or
treatment.
What is the most important information I should know about FORADIL
AEROLIZER?
FORADIL AEROLIZER can cause serious side effects, including:
1. People with asthma who take long-acting beta2-adrenergic agonist
(LABA) medicines, such as
formoterol fumarate inhalation powder (FORADIL AEROLIZER), have an
increased risk of death from
asthma problems.
•
Call your healthcare provider if breathing problems worsen over time
while using FORADIL
AEROLIZER. You may need a different treatment.
•
Get emergency medical care if:
•
breathing problems worsen quickly, and
•
you use your rescue inhaler medicine, but it does not relieve your
breathing problems.
2. Do not use FORADIL AEROLIZER as your only asthma medicine. FORADIL
AEROLIZER must
only be used with a long-term asthma control medicine, such as an
inhaled corticosteroid.
3. When your asthma is well controlled, your healthcare provider may
tell you to stop taking FORADIL
AEROLIZER. Your healthcare provider will decide if you can stop
FORADIL AEROLIZER without loss
of asthma control. You will continue taking your long-term asthma
control medicine, such as an inhaled
corticosteroid.
4. Children and adolescents who take LABA medicines may have an
increased risk of being
hospitalized for asthma problems.
What is FORADIL AEROLIZER?
FORADIL AEROLIZER is a long-acting beta2-agonist (LABA). LABA
medicines help the muscles
around the airway

Summary of Product characteristics

FORADIL - FORMOTEROL FUMARATE CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
FORADIL
FORADIL AEROLIZER
(FORMOTEROL FUMARATE INHALATION POWDER)
For Oral Inhalation Only
Rx only
PRESCRIBING INFORMATION
WARNING: ASTHMA RELATED DEATH
LONG-ACTING BETA -ADRENERGIC AGONISTS (LABA), SUCH AS FORMOTEROL THE
ACTIVE INGREDIENT IN
FORADIL AEROLIZER, INCREASE THE RISK OF ASTHMA-RELATED DEATH. DATA
FROM A LARGE
PLACEBO-CONTROLLED US STUDY THAT COMPARED THE SAFETY OF ANOTHER LABA
(SALMETEROL) OR
PLACEBO ADDED TO USUAL ASTHMA THERAPY SHOWED AN INCREASE IN
ASTHMA-RELATED DEATHS IN
PATIENTS RECEIVING SALMETEROL. THIS FINDING WITH SALMETEROL IS
CONSIDERED A CLASS EFFECT OF
LABA, INCLUDING FORMOTEROL (SEE WARNINGS). CURRENTLY AVAILABLE DATA
ARE INADEQUATE TO
DETERMINE WHETHER CONCURRENT USE OF INHALED CORTICOSTEROIDS OR OTHER
LONG-TERM ASTHMA
CONTROL DRUGS MITIGATES THE INCREASED RISK OF ASTHMA-RELATED DEATH
FROM LABA.
BECAUSE OF THIS RISK, USE OF FORADIL AEROLIZER FOR THE TREATMENT OF
ASTHMA WITHOUT A
CONCOMITANT LONG-TERM ASTHMA CONTROL MEDICATION, SUCH AS AN INHALED
CORTICOSTEROID, IS
CONTRAINDICATED. USE FORADIL AEROLIZER ONLY AS ADDITIONAL THERAPY FOR
PATIENTS WITH
ASTHMA WHO ARE CURRENTLY TAKING BUT ARE INADEQUATELY CONTROLLED ON A
LONG-TERM ASTHMA
CONTROL MEDICATION, SUCH AS AN INHALED CORTICOSTEROID. ONCE ASTHMA
CONTROL IS ACHIEVED AND
MAINTAINED, ASSESS THE PATIENT AT REGULAR INTERVALS AND STEP DOWN
THERAPY (E.G. DISCONTINUE
FORADIL AEROLIZER) IF POSSIBLE WITHOUT LOSS OF ASTHMA CONTROL, AND
MAINTAIN THE
PATIENT ON A LONG-TERM ASTHMA CONTROL MEDICATION, SUCH AS AN INHALED
CORTICOSTEROID. DO NOT
USE FORADIL AEROLIZER FOR PATIENTS WHOSE ASTHMA IS ADEQUATELY
CONTROLLED ON LOW OR
MEDIUM DOSE INHALED CORTICOSTEROIDS.
_PEDIATRIC AND ADOLESCENT PATIENTS_
AVAILABLE DATA FROM CONTROLLED CLINICAL TRIALS SUGGEST THAT LABA
INCREASE THE RISK OF ASTHMA-
RELATED HOSPITALIZATION IN PEDIATRIC AND ADOLESCENT PATIENTS. FOR
PEDIATRIC AND ADOLESCENT
PATIENTS WITH ASTHMA WHO REQUIRE ADDITION OF A LABA TO AN INHALED
CORTICOSTEROID, A FIXED-
DOSE CO