"The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease ("...
Maintenance Treatment of COPD
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.
Important Limitations of Use
ARCAPTA NEOHALER is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS].
ARCAPTA NEOHALER is not indicated to treat asthma. The safety and effectiveness of ARCAPTA NEOHALER in asthma have not been established.
DOSAGE AND ADMINISTRATION
DO NOT SWALLOW ARCAPTA CAPSULES
FOR USE WITH NEOHALER DEVICE ONLY
FOR ORAL INHALATION ONLY
ARCAPTA capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of ARCAPTA capsules are only for oral inhalation and should only be used with the NEOHALER device.
The recommended dosage of ARCAPTA NEOHALER is the once-daily inhalation of the contents of one 75 mcg ARCAPTA capsule using the NEOHALER inhaler.
ARCAPTA NEOHALER should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use ARCAPTA NEOHALER more than one time every 24 hours.
ARCAPTA capsules must always be stored in the blister, and only removed IMMEDIATELY BEFORE USE. No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients.
No data are available for subjects with severe hepatic impairment [see CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
75 mcg: hard gelatin capsule with black product code “IDL 75” above a bar printed on one side of the capsule and the logo printed on the other side.
75 mcg ARCAPTA NEOHALER contains ARCAPTA (indacaterol inhalation powder) capsules packaged in aluminum blister cards, one NEOHALER inhaler, and an FDA approved Medication Guide.
Unit Dose (blister pack), Box of 30 (5 blister cards with 6 capsules each) NDC 0078-0619-15
The NEOHALER inhaler consists of a white protective cap and a base with mouthpiece, capsule chamber and two translucent red push buttons.
Storage and Handling
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.
- ARCAPTA capsules should be used with the NEOHALER inhaler only. The NEOHALER inhaler should not be used with any other capsules.
- Capsules should always be stored in the blister and only removed from the blister immediately before use.
- Always use the new NEOHALER inhaler provided with each new prescription. Keep out of the reach of children.
Manufacturer details: n.a. Revised: 09/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/15/2012
Additional Arcapta Neohaler Information
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