BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE aerosol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X), FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B)

Available from:

A-S Medication Solutions

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is indicated for the treatment of asthma in patients 6 years of age and older. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA). Important Limitations of Use: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is also indicated to reduce exacerbations of COPD. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is the only strength indicated for the treatment of COPD. Important Limitat

Product summary:

Product: 50090-6382 NDC: 50090-6382-0 120 AEROSOL in a CANISTER / 1 in a CARTON

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

DIHYDRATE AEROSOL
A-S Medication Solutions
----------
Medication Guide
SYMBICORT (SIM-bi-kort)
(budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg)
Inhalation Aerosol
SYMBICORT (SIM-bi-kort)
(budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg)
Inhalation Aerosol
What is the most important information I should know about SYMBICORT?
SYMBICORT can cause serious side effects, including:
1.
People with asthma who take long-acting beta2-adrenergic agonist
(LABA) medicines such as
formoterol (one of the medicines in SYMBICORT) have an increased risk
of death from asthma
problems. It is not known whether budesonide, the other medicine in
SYMBICORT, reduces the
risk of death from asthma problems seen with formoterol.
Call your healthcare provider if breathing problems worsen over time
while using SYMBICORT.
You may need different treatment.
Get emergency medical care if:
•
your breathing problems worsen quickly.
•
you use your rescue inhaler medicine, but it does not relieve your
breathing problems.
2.
SYMBICORT should be used only if your healthcare provider decides that
your asthma is not well
controlled 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
SYMBICORT. Your healthcare provider will decide if you can stop
SYMBICORT without loss of
asthma control. Your healthcare provider may prescribe a different
long-term asthma-control
medicine for you, 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 SYMBICORT?
SYMBICORT combines an inhaled corticosteroid medicine, budesonide and
a LABA medicine,
formoterol.
•
Inhaled corticosteroids help to decrease inflammation in the lungs.
Inflammation in the lungs can
lead to breathing problems.
•
LABA medicines are used in people with chronic obstructive pulmonary
disease (COPD) and
asthma. LABA medicines help the muscles aro

Summary of Product characteristics

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE- BUDESONIDE AND
FORMOTEROL FUMARATE DIHYDRATE AEROSOL
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE AND
FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BUDESONIDE AND FORMOTEROL FUMARATE
DIHYDRATE
INHALATION AEROSOL.
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL, FOR
ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a
combination product
containing a corticosteroid and a long-acting beta -adrenergic agonist
indicated for:
•
•
Important limitations:
•
DOSAGE AND ADMINISTRATION
For oral inhalation only.
•
•
•
DOSAGE FORMS AND STRENGTHS
Metered-dose inhaler containing a combination of budesonide (80 or 160
mcg) and formoterol (4.5 mcg)
as an inhalation aerosol. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
2
Treatment of asthma in patients 6 years of age and older. (1.1)
Maintenance treatment of airflow obstruction and reducing
exacerbations in patients with chronic
obstructive pulmonary disease (COPD) including chronic bronchitis
and/or emphysema. (1.2)
Not indicated for the relief of acute bronchospasm. (1.1, 1.2)
Treatment of asthma in patients 12 years and older: 2 inhalations of
BUDESONIDE AND FORMOTEROL
FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 or 160/4.5 twice daily.
Starting dosage is based
on asthma severity. (2.2)
Treatment of asthma in patients aged 6 to less than 12 years: 2
inhalations of BUDESONIDE AND
FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 twice daily.
(2.2)
Maintenance treatment in COPD: 2 inhalations of BUDESONIDE AND
FORMOTEROL FUMARATE
DIHYDRATE INHALATION AEROSOL 160/4.5 twice daily. (2.3)
Primary treatment of status asthmaticus or acute episodes of asthma or
COPD requiring intensive
measures. (4)
Hypersensitivity to any