PERFOROMIST- formoterol fumarate dihydrate solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B)

Tilgjengelig fra:

Mylan Specialty L.P.

INN (International Name):

FORMOTEROL FUMARATE

Sammensetning:

FORMOTEROL FUMARATE ANHYDROUS 20 ug in 2 mL

Administreringsrute:

RESPIRATORY (INHALATION)

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

PERFOROMIST (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2)]. PERFOROMIST Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma have not been established. Use of a LABA, including PERFOROMIST, without an inhaled corticosteroid is contraindicated in patients with asthma [see WARNINGS and PRECAUTIONS (5.1)] . PERFOROMIST is not indicated for the treatment of asthma. There are limited available data with PERFOROMIST Inhalation Solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Beta-agonists may interfere w

Produkt oppsummering:

PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as a 2 mL sterile solution for nebulization in 2.5 mL low-density polyethylene unit dose vials. Each vial is overwrapped in a foil pouch and supplied in cartons as listed below. Carton of 30 individually wrapped unit dose vials, NDC 49502-605-30 Carton of 60 individually wrapped unit dose vials, NDC 49502-605-61 Storage and Handling: Prior to dispensing to the patient : Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Protect pouch from light and heat. After dispensing to the patient:  Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and heat.

Autorisasjon status:

New Drug Application

Informasjon til brukeren

These highlights do not include all the information
needed to use PERFOROMIST INHALATION SOLUTION safely and
effectively. See full prescribing information for PERFOROMIST
INHALATION SOLUTION. PERFOROMIST® (formoterol fumarate)
Inhalation Solution Initial U.S. Approval: 2001

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PERFOROMIST- formoterol
fumarate dihydrate solution  Mylan
Specialty L.P.
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MEDICATION GUIDE
PERFOROMIST® (Per-FOR-o-mist) (formoterol fumarate) Inhalation Solution

PERFOROMIST Inhalation Solution is only
for use with a nebulizer.
Read the Medication Guide that comes with PERFOROMIST
Inhalation Solution 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

Les hele dokumentet

Preparatomtale

PERFOROMIST- FORMOTEROL FUMARATE DIHYDRATE SOLUTION
MYLAN SPECIALTY L.P.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PERFOROMIST INHALATION SOLUTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PERFOROMIST INHALATION SOLUTION.
PERFOROMIST (FORMOTEROL FUMARATE) INHALATION SOLUTION
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Boxed Warning Removed-5/2019
Contraindications, revised (4) 5/2019
Warnings and Precautions, revised 5/2019
Serious Asthma-Related Events – Hospitalizations, Intubations, Death
(5.1) 5/2019
INDICATIONS AND USAGE
PERFOROMIST Inhalation Solution is a long-acting beta -adrenergic
agonist (beta -agonist) indicated for:
•
Important limitations of use:
•
•
DOSAGE AND ADMINISTRATION
For oral inhalation only.
•
•
DOSAGE FORMS AND STRENGTHS
Inhalation Solution (unit dose vial for nebulization); 20 mcg/2 mL
solution (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (>2% and more common than placebo) are
diarrhea, nausea, nasopharyngitis, dry mouth,
vomiting, dizziness, and insomnia (6.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
®
2
2
Long-term, twice daily (morning and evening) administration in the
maintenance treatment of bronchoconstriction in
patients with chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and emphysema. (1.1)
PERFOROMIST Inhalation Solution is not indicated to treat acute
deteriorations of chronic obstructive pulmonary
disease. (1.2, 5.2)
PERFOROMIST Inhalation Solution is not indicated to treat asthma.
(1.2)
One 20 mcg/2 mL vial every 12 hours (2)
For use with a standard jet nebulizer (with a facemask or mouthpiece)
connected to an air compressor (2)
Use of a LABA, including PERFOROMIST, without an inhaled
corticosteroid is contraindicated in patients with asthma.
(4)
LABA as monotherapy (without inhaled corticosteroid) for as