ARCAPTA NEOHALER- indacaterol maleate capsule

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Sunovion Pharmaceuticals Inc.

INN (International Nazwa):

INDACATEROL MALEATE

Skład:

INDACATEROL 75 ug

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

ARCAPTA NEOHALER is a long-acting beta2 -agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ARCAPTA NEOHALER is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see Warnings and Precautions (5.2) ]. ARCAPTA NEOHALER is not indicated to treat asthma. The safety and effectiveness of ARCAPTA NEOHALER in asthma have not been established. Use of a LABA, including ARCAPTA NEOHALER, without an inhaled corticosteroid is contraindicated in patients with asthma [see Warnings and Precautions (5.1) ]. ARCAPTA NEOHALER is not indicated for the treatment of asthma. ARCAPTA NEOHALER is contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients [see Warnings and Precautions (5.4)]. Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies with ARC

Podsumowanie produktu:

75 mcg ARCAPTA NEOHALER contains ARCAPTA (indacaterol) inhalation powder capsules packaged in aluminum blister cards, one NEOHALER inhaler, and an FDA-approved Patient Information. Unit Dose (blister pack), Box of 30 (5 blister cards with 6 capsules each) NDC 63402-675-30. The NEOHALER inhaler consists of a white protective cap and a base with mouthpiece, capsule chamber and two translucent red push buttons. Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature]. 75 mcg: Protect capsule from light and moisture. Keep out of the reach of children.

Status autoryzacji:

New Drug Application

Ulotka dla pacjenta

ARCAPTA NEOHALER- INDACATEROL MALEATE CAPSULE
Sunovion Pharmaceuticals Inc.
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Instructions for Use
ARCAPTA® (ar-CAP-ta) NEOHALER®
(indacaterol) inhalation powder
Do not swallow ARCAPTA capsules.
Follow the instructions below for using ARCAPTA NEOHALER. You will
breathe-in (inhale) the medicine
in the ARCAPTA capsules from the NEOHALER inhaler. If you have any
questions, ask your healthcare
provider or pharmacist.
ARCAPTA NEOHALER
ARCAPTA NEOHALER consists of both the inhaler and the blister-packaged
capsules. Each package
contains ARCAPTA capsules and a NEOHALER inhaler.
•
ARCAPTA capsules come in blister cards (see figure above).
•
NEOHALER inhaler consists of a cap and a base (see figure above).
Your inhaler is made to give you the medicine contained in the
capsules.
Do not use ARCAPTA capsules with any other capsule inhaler, and do not
use NEOHALER inhaler to take
any other capsule medicine.
How to use your inhaler
Figure A
Step 1. Pull off cap. See Figure A
Figure B
Step 2. Open inhaler: See Figure B
Hold the base of the inhaler firmly and tilt the mouthpiece
to open the inhaler.
Figure C
Step 3. Prepare capsule: See Figure C
Separate one of the blisters from the blister card by tearing
along the perforation.
Take one blister and peel away the protective backing to
expose the foil.
Figure D
Step 4. Remove an ARCAPTA capsule: See Figure D
Capsules should always be stored in the blister and only
removed immediately before use.
With dry hands, remove one capsule from the blister by
pushing the ARCAPTA capsule through the foil.
Do not swallow ARCAPTA capsule.
Figure E
Step 5. Insert capsule: See Figure E
Place the capsule into the capsule chamber.
Do not place a capsule directly into the mouthpiece.
Figure F
Step 6. Close the inhaler: See Figure F
Close the inhaler fully. You should hear a ‘click’ as it fully
closes.
Figure G
Step 7. Pierce the capsule: See Figure G
Hold the inhaler upright.
Press both buttons fully one time. You should hear a ‘click’
as the capsule is being pierced.
Do not

Charakterystyka produktu

ARCAPTA NEOHALER- INDACATEROL MALEATE CAPSULE
SUNOVION PHARMACEUTICALS INC.
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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
RECENT MAJOR CHANGES
Box Warning,
Removed 05/2019
Contraindications, revised (4)
05/2019
Warnings and Precautions, revised
Serious Asthma-Related Events –
Hospitalizations, Intubations, Death (5.1)
05/2019
INDICATIONS AND USAGE
ARCAPTA NEOHALER is a long-acting beta -adrenergic agonist indicated
for:
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
Use of a LABA, including ARCAPTA NEOHALER, without an inhaled
corticosteroid is contraindicated in patients with
asthma. (4)
ARCAPTA NEOHALER is contraindicated in patients with a history of
hypersensitivity to indacaterol or to any of the
ingredients. (4)
WARNINGS AND PRECAUTIONS
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 patients. (5.2)
Do not use for relief of acute symptoms. Concomitant short-acting beta
-agonists can be used as needed for acute
relief. (5.2)
Do not exceed the recommended dose. Excessive use or use in
conjunction with other medications containing LABA
can result in clinically significant cardiovascular effects and may be
fatal. (5.3)
Immediate hypersensitivity reactions may occur. Discontinue
immediately. (5.4)
Life-threatening paradoxical bronc