logo

ARCAPTA™ NEOHALER (indacaterol maleate) capsule

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  
  < Pulmonaryled  
[ Disclaimer ] <<Back [ New drug index ]

WARNINGS  top of page

WARNING: ASTHMA-RELATED DEATH

See full prescribing information for complete boxed warning

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death.

A placebo-controlled study with another long-acting beta2-adrenergic agonist (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 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.

(DESCRIPTION) top of page

DESCRIPTION

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.

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action
Indacaterol is a long-acting beta2-adrenergic agonist.

When inhaled, indacaterol acts locally in the lung as a bronchodilator. Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the heart, there are also beta2-adrenergic receptors in the human heart comprising 10%-50% of the total adrenergic receptors. The precise function of these receptors is not known, but their presence raises the possibility that even highly selective beta2-adrenergic agonists may have cardiac effects.

The pharmacological effects of beta2-adrenoceptor agonist drugs, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’, 5’-adenosine monophosphate (cyclic monophosphate). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle. In vitro studies have shown that indacaterol has more than 24-fold greater agonist activity at beta2-receptors compared to beta1-receptors and 20-fold greater agonist activity compared to beta3-receptors. This selectivity profile is similar to formoterol. The clinical significance of these

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE

ARCAPTA NEOHALER is a long-acting beta2-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.

Important limitations:
-ARCAPTA NEOHALER is NOT indicated to treat acute deteriorations of chronic obstructive pulmonary disease.
-ARCAPTA NEOHALER is NOT indicated for asthma.

CONTRAINDICATIONS top of page

CONTRAINDICATIONS
All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication. ARCAPTA NEOHALER is not indicated for the treatment of asthma.

PRECAUTIONS top of page

  • Do not initiate ARCAPTA NEOHALER in acutely deteriorating COPD patients
  • Do not use for relief of acute symptoms. Concomitant short-acting beta2-agonists can be used as needed for acute relief
  • Do not exceed the recommended dose. Excessive use of ARCAPTA NEOHALER, or use in conjunction with other medications containing long-acting beta2-agonist can result in clinically significant cardiovascular effects and may be fatal
  • Life-threatening paradoxical bronchospasm can occur. Discontinue ARCAPTA NEOHALER immediately.
  • Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis or sensitivity to sympathomimetic drugs.

ADVERSE REACTIONS top of page

Most common adverse reactions (>2% and more common than placebo) are cough, oropharyngeal pain, nasopharyngitis, headache and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION  top of page

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 is available for subjects with severe hepatic impairment

HOW SUPPLIED top of page

How Supplied
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.

REFERENCE

Package Insert data: 
Manufactured by:
Novartis Pharma Stein AG
Stein, Switzerland

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

© Novartis

T2011-95/T2011-96
July 2011/July 2011
more Career Center image description
Medical Calculators - A thru Z
Lab Values - A thru Z