HIGHLIGHTS OF PRESCRIBING INFORMATION

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8), FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B)

Saatavilla:

A-S Medication Solutions

INN (Kansainvälinen yleisnimi):

MOMETASONE FUROATE

Koostumus:

MOMETASONE FUROATE 200 ug

Antoreitti:

RESPIRATORY (INHALATION)

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

DULERA is indicated for the twice-daily treatment of asthma in patients 12 years of age and older. DULERA 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 ICS and long-acting beta2 -adrenergic agonist (LABA). Important Limitation of Use: - DULERA is NOT indicated for the relief of acute bronchospasm. DULERA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. DULERA is contraindicated in patients with known hypersensitivity to mometasone furoate, formoterol fumarate, or any of the ingredients in DULERA [see Warnings and Precautions (5.10)] . Risk Summary There are no randomized clinical studies of DULERA, mometasone furoate, or formoterol fumarate in pregnant women. There are clinical considerations with the use of DULERA in pregnant women [see Clinical Considerations] . Animal

Tuoteyhteenveto:

Product: 50090-1916 NDC: 50090-1916-0 60 AEROSOL in a CANISTER / 1 in a CARTON

Valtuutuksen tilan:

New Drug Application

Pakkausseloste

DULERA- MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE AEROSOL
A-S Medication Solutions
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Medication Guide
DULERA® [dew-LAIR-ah] 100 mcg/5 mcg
(mometasone furoate 100 mcg and formoterol fumarate dihydrate 5 mcg)
Inhalation Aerosol
DULERA® 200 mcg/5 mcg
(mometasone furoate 200 mcg and formoterol fumarate dihydrate 5 mcg)
Inhalation Aerosol
Read the Medication Guide that comes with DULERA® 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 DULERA?
DULERA 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 DULERA), have an increased risk of
death from asthma
problems. It is not known whether mometasone furoate, the other
medicine in DULERA, reduces
the risk of death from asthma problems seen with formoterol.
•
Call your healthcare provider if breathing problems worsen over time
while using
DULERA. You may need 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.
DULERA 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
DULERA. Your healthcare provider will decide if you can stop DULERA
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 DULERA?
DULERA combines an inhaled corti

Valmisteyhteenveto

DULERA- MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE AEROSOL
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DULERA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DULERA.
DULERA® (MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE)
INHALATION AEROSOL, FOR ORAL INHALATION
USE
INITIAL U.S. APPROVAL: 2010
RECENT MAJOR CHANGES
Boxed Warning (removed)
12/2017
Indications and Usage (1.1)
12/2017
Dosage and Administration (2.1, 2.2)
06/2017
Warnings and Precautions (5.1, 5.2, 5.8, 5.14)
03/2018
INDICATIONS AND USAGE
DULERA is a combination product containing a corticosteroid and a
long-acting beta -adrenergic agonist (LABA) indicated
for:
Treatment of asthma in patients 12 years of age and older. (1.1)
Important Limitation of Use:
Not indicated for the relief of acute bronchospasm. (1.1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2.1)
Treatment of asthma in patients ≥12 years: 2 inhalations twice daily
of DULERA 100 mcg/5 mcg or 200 mcg/5 mcg.
Starting dosage is based on disease severity. (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation aerosol containing a combination of mometasone furoate (100
or 200 mcg) and formoterol fumarate dihydrate (5
mcg) per actuation. (3)
CONTRAINDICATIONS
Primary treatment of status asthmaticus or acute episodes of asthma
requiring intensive measures. (4.1)
Hypersensitivity to any of the ingredients of DULERA. (4.2)
WARNINGS AND PRECAUTIONS
LABA monotherapy increases the risk of serious asthma-related events.
(5.1)
Deterioration of disease and acute episodes: Do not initiate in
acutely deteriorating asthma or to treat acute symptoms.
(5.2)
Use with additional long-acting beta -agonist: Do not use in
combination because of risk of overdose. (5.3)
Localized infections: _Candida albicans_ infection of the mouth and
throat may occur. Monitor patients periodically for
signs of adverse effects on the oral cavity. Advise patients to rinse
the mouth following inhalation. (5.4)