BEVESPI AEROSPHERE- glycopyrrolate and formoterol fumarate aerosol, metered

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D), FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B)

Dostępny od:

AstraZeneca Pharmaceuticals LP

INN (International Nazwa):

GLYCOPYRROLATE

Skład:

GLYCOPYRROLATE 9 ug

Droga podania:

RESPIRATORY (INHALATION)

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

BEVESPI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: BEVESPI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.2)] . BEVESPI AEROSPHERE is contraindicated in: Risk Summary   There are no adequate and well-controlled trials of BEVESPI AEROSPHERE or its individual components, glycopyrrolate and formoterol fumarate, in pregnant women to inform a drug-associated risk. In animal reproduction studies, glycopyrrolate alone, administered by the subcutaneous route in rats and rabbits, did not cause structural abnormalities or affect fetal survival at exposures approximately 2700 and 5400 times from the maximum recommended human daily inhalation dose (MRHDID), respectively. Glycopyrrolate had no effects on the physical, functional, and behavioral development of rat pups with exposures up to 2700 times the MRHDID. Formoterol fumarate alone, admin

Podsumowanie produktu:

BEVESPI AEROSPHERE Inhalation Aerosol: The BEVESPI AEROSPHERE canister should only be used with the BEVESPI AEROSPHERE actuator, and the BEVESPI AEROSPHERE actuator should not be used with any other inhalation drug product. The correct amount of medication in each inhalation cannot be assured after the label number of inhalations from the canister have been used, when the dose indicator display window shows zero, even though the canister may not feel completely empty. BEVESPI AEROSPHERE should be discarded when the dose indicator display window shows zero or 3 months after removal from the foil pouch, whichever comes first. Never immerse the canister into water to determine the amount remaining in the canister (“float test”). Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP]. For best results, the canister should be at room temperature before use. Shake well before using. Keep out of reach of children. CONTENTS UNDER PRESSURE Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator. Avoid spraying in eyes.

Status autoryzacji:

New Drug Application

Ulotka dla pacjenta

AstraZeneca Pharmaceuticals LP
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PATIENT INFORMATION
BEVESPI AEROSPHERE®
(be-VES-pee AIR-oh-sfeer)
(glycopyrrolate and formoterol fumarate)
inhalation aerosol, for oral inhalation use
What is BEVESPI AEROSPHERE?
BEVESPI AEROSPHERE combines an anticholinergic, glycopyrrolate, and a
long-acting beta2-
adrenergic agonist (LABA) medicine, formoterol fumarate.
•
Anticholinergic and LABA medicines help the muscles around the airways
in your lungs stay
relaxed to prevent symptoms such as wheezing, cough, chest tightness,
and shortness of breath.
These symptoms can happen when the muscles around the airways tighten.
This makes it hard to
breathe.
•
BEVESPI AEROSPHERE is a prescription medicine used to treat COPD. COPD
is a chronic lung
disease that includes chronic bronchitis, emphysema, or both.
•
BEVESPI AEROSPHERE is used long term as 2 inhalations, 2 times each
day in the morning and
in the evening, to improve symptoms of COPD for better breathing.
•
BEVESPI AEROSPHERE is not for use to treat sudden symptoms of COPD.
Always have a rescue
inhaler (an inhaled, short-acting bronchodilator) with you to treat
sudden symptoms. If you do not
have a rescue inhaler, contact your healthcare provider to have one
prescribed for you.
•
BEVESPI AEROSPHERE is not for the treatment of asthma. It is not known
if BEVESPI
AEROSPHERE is safe and effective in people with asthma.
•
BEVESPI AEROSPHERE should not be used in children. It is not known if
BEVESPI
AEROSPHERE is safe and effective in children.
Do not use BEVESPI AEROSPHERE if you:
•
are allergic to glycopyrrolate, formoterol fumarate, or to any of the
ingredients in BEVESPI
AEROSPHERE. See the end of this Patient Information leaflet for a
complete list of ingredients.
•
have asthma.
Before using BEVESPI AEROSPHERE, tell your healthcare provider about
all of your medical
conditions, including if you:
•
have heart problems
•
have high blood pressure
•
have seizures
•
have thyroid problems
•
have diabetes
•
have liver problems
•
have eye prob

Charakterystyka produktu

BEVESPI AEROSPHERE- GLYCOPYRROLATE AND FORMOTEROL FUMARATE AEROSOL,
METERED
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BEVESPI AEROSPHERE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BEVESPI
AEROSPHERE.
BEVESPI AEROSPHERE
(GLYCOPYRROLATE AND FORMOTEROL FUMARATE) INHALATION AEROSOL, FOR
ORAL INHALATION USE
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
BEVESPI AEROSPHERE is a combination of glycopyrrolate, an
anticholinergic, and formoterol fumarate, a
long-acting beta -adrenergic agonist (LABA) indicated for the
maintenance treatment of patients with
chronic obstructive pulmonary disease (COPD). (1)
Limitations of Use: Not indicated for the relief of acute bronchospasm
or for the treatment of asthma.
(1, 5.1, 5.2)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥2% and more common than
with placebo) include: urinary
tract infection and cough. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1-800-236-9933 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
®
2
For oral inhalation only.
Maintenance treatment of COPD: 2 inhalations of BEVESPI AEROSPHERE
twice daily by oral inhalation.
(2)
Inhalation aerosol: pressurized metered dose inhaler containing a
combination of glycopyrrolate (9
mcg) and formoterol fumarate (4.8 mcg) per inhalation.
Use of a LABA, including formoterol fumarate, one of the active
ingredients in BEVESPI AEROSPHERE,
without an inhaled corticosteroid is contraindicated in patients with
asthma. (4)
Hypersensitivity to glycopyrrolate, formoterol fumarate, or to any
component of this product. (4, 5.5)
LABA as monotherapy (without an inhaled corticosteroid) for asthma
increases the risk of serious
asthma-related events. (5.1)
Do not initiate in acutely deteriorating COPD or to treat acute
symptoms. (