Arcapta Neohaler
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FDA Labeling Changes
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Uses
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.
History
There is currently no drug history available for this drug.
Other Information
ARCAPTA NEOHALER consists of a dry powder formulation of indacaterol maleate for oral inhalation only with the NEOHALER inhaler. The inhalation powder is packaged in clear gelatin capsules.
Each clear, hard gelatin capsule contains a dry powder blend of 75 mcg of indacaterol (equivalent to 97 mcg of indacaterol maleate) with approximately 25 mg of lactose monohydrate (which contains trace levels of milk protein) as the carrier.
The active component of ARCAPTA NEOHALER is indacaterol maleate, a (R) enantiomer. Indacaterol maleate is a selective beta2-adrenergic agonist. Its chemical name is (R)-5-[2-(5,6-Diethylindan-2-ylamino)-1-hydroxyethyl]-8-hydroxy-1H-quinolin-2-one maleate; its structural formula is
Indacaterol maleate has a molecular weight of 508.56, and its empirical formula is C24H28N2O3 • C4H4O4. Indacaterol maleate is a white to very slightly grayish or very slightly yellowish powder. Indacaterol maleate is freely soluble in N-methylpyrrolidone and dimethylformamide, slightly soluble in methanol, ethanol, propylene glycol and polyethylene glycol 400, very slightly soluble in water, isopropyl alcohol and practically insoluble in 0.9% sodium chloride in water, ethyl acetate and n-octanol.
The NEOHALER inhaler is a plastic device used for inhaling ARCAPTA. The amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow rate and inspiratory time. Under standardized in vitro testing at a fixed flow rate of 60 L/min for 2 seconds, the NEOHALER inhaler delivered 57 mcg for the 75 mcg dose strength (equivalent to 73.9 mcg of indacaterol maleate) from the mouthpiece. Peak inspiratory flow rates (PIFR) achievable through the NEOHALER inhaler were evaluated in 26 adult patients with COPD of varying severity. Mean PIFR was 95 L/min (range 52-133 L/min) for adult patients. Approximately ninety-five percent of the population studied generated a PIFR through the device exceeding 60 L/min.
Sources
Arcapta Neohaler Manufacturers
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Novartis Pharmaceuticals Corporation
![Arcapta Neohaler (Indacaterol Maleate) Capsule [Novartis Pharmaceuticals Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Arcapta Neohaler | Novartis Pharmaceuticals Corporation
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 (12.3)].
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