ARCAPTA NEOHALER indacaterol maleate capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

INDACATEROL MALEATE (UNII: 2JEC1ITX7R) (INDACATEROL - UNII:8OR09251MQ)

Disponibil de la:

Novartis Pharmaceuticals Corporation

INN (nume internaţional):

INDACATEROL MALEATE

Compoziție:

INDACATEROL 75 ug

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

ARCAPTA NEOHALER- INDACATEROL MALEATE CAPSULE
NOVARTIS PHARMACEUTICALS CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARCAPTA NEOHALER SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARCAPTA NEOHALER.
ARCAPTA™ NEOHALER™ (INDACATEROL INHALATION POWDER)
INITIAL U.S. APPROVAL: 2011
WARNING: ASTHMA-RELATED DEATH
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
LONG-ACTING BETA -ADRENERGIC AGONISTS (LABA) INCREASE THE RISK OF
ASTHMA-RELATED DEATH (5.1).
A PLACEBO-CONTROLLED STUDY WITH ANOTHER LONG-ACTING BETA -ADRENERGIC
AGONIST (SALMETEROL) SHOWED AN
INCREASE IN ASTHMA-RELATED DEATHS IN PATIENTS RECEIVING SALMETEROL.
(5.1)
THIS FINDING OF AN INCREASED RISK OF ASTHMA-RELATED DEATH WITH
SALMETEROL IS CONSIDERED A CLASS EFFECT
OF LABA, INCLUDING INDACATEROL, THE ACTIVE INGREDIENT IN ARCAPTA
NEOHALER. THE SAFETY AND EFFICACY
OF ARCAPTA NEOHALER IN PATIENTS WITH ASTHMA HAVE NOT BEEN ESTABLISHED.
ARCAPTA NEOHALER IS
NOT INDICATED FOR THE TREATMENT OF ASTHMA. (4, 5.1)
RECENT MAJOR CHANGES
Contraindications (4) 09/2012
Warnings and Precautions, Immediate Hypersensitivity Reactions (5.4)
09/2012
INDICATIONS AND USAGE
ARCAPTA NEOHALER is a long-acting beta -adrenergic agonist indicated
for:
The long term, once-daily maintenance bronchodilator treatment of
airflow obstruction in patients with chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and/or
emphysema. (1.1)
Important limitations:
ARCAPTA NEOHALER is NOT indicated to treat acute deteriorations of
chronic obstructive pulmonary disease. (1.2)
ARCAPTA NEOHALER is NOT indicated for asthma. (1.2)
DOSAGE AND ADMINISTRATION
For oral inhalation only. DO NOT swallow ARCAPTA capsule. ARCAPTA
capsules should ALWAYS be used with the
NEOHALER inhaler ONLY.
75 mcg inhaled every day (once-daily). (2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder hard capsules: 75 mcg. (3)
CONTRAINDICATIONS
All LABA are contraindicated in patients with asthma without use