UTIBRON NEOHALER- indacaterol and glycopyrrolate capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

INDACATEROL MALEATE (UNII: 2JEC1ITX7R) (INDACATEROL - UNII:8OR09251MQ), GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)

제공처:

Novartis Pharmaceuticals Corporation

INN (국제 이름):

INDACATEROL MALEATE

구성:

INDACATEROL 27.5 ug

관리 경로:

RESPIRATORY (INHALATION)

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

UTIBRONTM NEOHALER® is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Important Limitations of Use: UTIBRON NEOHALER is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.2)] . All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication [see Warnings and Precautions (5.1)] . UTIBRON NEOHALER is not indicated for the treatment of asthma. UTIBRON NEOHALER is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients [see Warnings and Precautions (5.5)] . Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies with UTIBRON NEOHALER or its individual components, indacaterol and glycopyrrolate, in pregnant women

제품 요약:

How Supplied UTIBRON NEOHALER contains UTIBRON (indacaterol/glycopyrrolate, (27.5 mcg, 15.6 mcg) inhalation powder) in hypromellose (HPMC) capsule with yellow transparent cap and uncolored transparent body, with capsules packaged in aluminum blister cards, one NEOHALER device, and an FDA approved Medication Guide. Unit Dose (blister pack), Box of 60 (10 blister cards with 6 yellow transparent capsules each)     NDC 0078-0664-19 Unit Dose (blister pack), Box of 6 (1 blister card with 6 yellow transparent capsules each)     NDC 0078-0664-06 The NEOHALER device consists of a white protective cap and a base with mouthpiece, capsule chamber and 2 yellow push buttons. Storage and Handling Store in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children.

승인 상태:

New Drug Application

환자 정보 전단

Novartis Pharmaceuticals Corporation
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
January 2017
MEDICATION GUIDE
UTIBRONTM NEOHALER®
(yoo-TEE-bron)
(indacaterol and glycopyrrolate)
inhalation powder, for oral inhalation use
Important: Do not swallow UTIBRON capsules. UTIBRON capsules are used
only with the
NEOHALER inhaler that comes with UTIBRON NEOHALER. Do not place a
capsule in the
mouthpiece of the NEOHALER inhaler.
Read the Medication Guide that comes with UTIBRON NEOHALER 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 UTIBRON
NEOHALER?
UTIBRON NEOHALER has been approved for Chronic Obstructive Pulmonary
Disease (COPD).
UTIBRON NEOHALER is NOT indicated for use in asthma.
UTIBRON NEOHALER may cause serious side effects, including:
•
People with asthma who take long-acting beta2-adrenergic agonist
(LABA) medicines, such as
indacaterol (one of the medicines in UTIBRON NEOHALER), have an
increased risk of death
from asthma problems.
•
It is not known if LABA medicines, such as indacaterol (one of the
medicines in UTIBRON
NEOHALER), increase the risk of death in people with COPD.
•
Call your healthcare provider if breathing problems worsen over time
while using UTIBRON
NEOHALER. You may need a different treatment.
•
Get emergency medical care if:
•
breathing problems worsen quickly
•
you use your rescue inhaler medicine, but it does not relieve your
breathing problems
What is UTIBRON NEOHALER?
UTIBRON NEOHALER combines a LABA medicine (indacaterol) and an
anticholinergic medicine
(glycopyrrolate).
•
LABA and anticholinergic 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.
This makes it hard to breathe.
•
UTIBRON NEO

제품 특성 요약

UTIBRON NEOHALER- INDACATEROL AND GLYCOPYRROLATE CAPSULE
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
UTIBRON NEOHALER SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR UTIBRON NEOHALER.
UTIBRON NEOHALER (INDACATEROL AND GLYCOPYRROLATE) INHALATION POWDER, FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2015
WARNING: ASTHMA-RELATED DEATH
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LONG-ACTING BETA -ADRENERGIC AGONISTS (LABAS), SUCH AS INDACATEROL,
ONE OF THE ACTIVE INGREDIENTS IN
UTIBRON NEOHALER, INCREASE THE RISK OF ASTHMA-RELATED DEATH. A
PLACEBO-CONTROLLED STUDY WITH
ANOTHER LABA (SALMETEROL) SHOWED AN INCREASE IN ASTHMA-RELATED DEATHS
IN PATIENTS RECEIVING
SALMETEROL. THIS FINDING OF AN INCREASED RISK OF ASTHMA-RELATED DEATH
WITH SALMETEROL IS CONSIDERED A
CLASS EFFECT OF ALL LABAS, INCLUDING INDACATEROL. (5.1)
THE SAFETY AND EFFICACY OF UTIBRON NEOHALER IN PATIENTS WITH ASTHMA
HAVE NOT BEEN ESTABLISHED.
UTIBRON NEOHALER IS NOT INDICATED FOR THE TREATMENT OF ASTHMA. (5.1)
INDICATIONS AND USAGE
UTIBRON NEOHALER is a combination of indacaterol, a long-acting beta
-adrenergic agonist (LABA), and glycopyrrolate,
an anticholinergic, indicated for the long-term, maintenance treatment
of airflow obstruction in 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
FOR ORAL INHALATION ONLY. DO NOT SWALLOW UTIBRON CAPSULES. ONLY USE
UTIBRON CAPSULES WITH THE
NEOHALER DEVICE. (2)
Maintenance treatment of COPD: The inhalation of the powder contents
of one UTIBRON capsule twice-daily. (2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: UTIBRON capsules contain 27.5 mcg of indacaterol
and 15.6 mcg glycopyrrolate inhalation powder
for use with the NEOHALER device. (3)
CONTRAINDICATIONS
All LABAs are contraindicated in patients with asthma wit