Rx Item-Arcapta 75mcg Cap 30 by Novartis

ARCAPTA NEOHALER- indacaterol maleate capsule
Novartis Pharmaceuticals Corporation

WARNING ASTHMA-RELATED DEATH
Long-acting beta -adrenergic agonist (LABA) increase the risk of asthma-related death.Data from large placebo-controlled US study that compared the safety of another long-acting beta -adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered 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
ARCAPTA NEOHALER consists of 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 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, (R) enantiomer. Indacaterol maleate is 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;
Mechanism of Action
Indacaterol is long-acting beta2 -adrenergic agonist.
When inhaled, indacaterol acts locally in the lung as 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.
INDICATIONS AND USAGE
1.1 Maintenance Treatment of COPD
ARCAPTA NEOHALER is 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.
1.2 Important Limitations of Use
ARCAPTA NEOHALER is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see arnings and Precautions ].
ARCAPTA NEOHALER is not indicated to treat asthma. The safety and effectiveness of ARCAPTA NEOHALER in asthma have not been established.
2 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 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) ].
3 DOSAGE FORMS AND STRENGTHS
Inhalation powder:
75 mcg: hard gelatin capsule with black product code ?IDL 75? above bar printed on one side of the capsule and the logo printed on the other side.
CONTRAINDICATIONS
All LABA are contraindicated in patients with asthma without use of long-term asthma control medication. [see arnings and recautions ]. ARCAPTA NEOHALER is not indicated for the treatment of asthma.
? ARCAPTA NEOHALER is contraindicated in patients with history of hypersensitivity to indacaterol or to any of the ingredients. [see Warnings and Precautions
Pregnancy
Teratogenic Effects: Pregnancy Category C.
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 lister cards with capsules each) NDC 0078-0619-15
The NEOHALER inhaler consists of white protective cap and base with mouthpiece, capsule chamber and two translucent red push buttons.
16.2 Storage and Handling
Store in 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.

Arcapta 75mcg Cap 30 by Novartis
NDC No.00078-0619-15 UPC/GTIN No.3-00780-61915-8 MPN 61915 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapis

AmericanPharmaWholesale.com
Novartis Pharma Corp

INDACATEROL MALEATE INHAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.