ARCAPTA NEOHALER

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Overview

What is ARCAPTA NEOHALER?

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 beta-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 CHNO • CHO. 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 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.

What does ARCAPTA NEOHALER look like?

What are the available doses of ARCAPTA NEOHALER?

Inhalation powder hard capsules: 75 mcg. ()

What should I talk to my health care provider before I take ARCAPTA NEOHALER?

How should I use ARCAPTA NEOHALER?

ARCAPTA NEOHALER is a long-acting beta-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.

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 [].

What interacts with ARCAPTA NEOHALER?

Sorry No Records found

What are the warnings of ARCAPTA NEOHALER?

Sorry No Records found

What are the precautions of ARCAPTA NEOHALER?

Sorry No Records found

What are the side effects of ARCAPTA NEOHALER?

Sorry No records found

What should I look out for while using ARCAPTA NEOHALER?

see Warnings and Precautions ()

[see Warnings and Precautions ()].

Long-acting beta

-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a 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 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. [

See Contraindications (), Warnings and Precautions ()

].

What might happen if I take too much ARCAPTA NEOHALER?

How should I store and handle ARCAPTA NEOHALER?

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. 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. 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. Rosuvastatin Calcium Tablets, 10 mg Bottles of 30 NDC 68788-6321-3Bottles of 60 NDC 68788-6321-6Bottles of 90 NDC 68788-6321-9 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Rosuvastatin Calcium Tablets, 10 mg Bottles of 30 NDC 68788-6321-3Bottles of 60 NDC 68788-6321-6Bottles of 90 NDC 68788-6321-9 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Rosuvastatin Calcium Tablets, 10 mg Bottles of 30 NDC 68788-6321-3Bottles of 60 NDC 68788-6321-6Bottles of 90 NDC 68788-6321-9 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Rosuvastatin Calcium Tablets, 10 mg Bottles of 30 NDC 68788-6321-3Bottles of 60 NDC 68788-6321-6Bottles of 90 NDC 68788-6321-9 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Indacaterol is a long-acting beta-adrenergic agonist.

When inhaled, indacaterol acts locally in the lung as a bronchodilator. Although beta-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta-receptors are the predominant receptors in the heart, there are also beta-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 beta-adrenergic agonists may have cardiac effects.

The pharmacological effects of beta-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. studies have shown that indacaterol has more than 24-fold greater agonist activity at beta-receptors compared to beta-receptors and 20-fold greater agonist activity compared to beta-receptors. This selectivity profile is similar to formoterol. The clinical significance of these findings is unknown.

Non-Clinical Toxicology

see Warnings and Precautions ()

[see Warnings and Precautions ()].

Long-acting beta

-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a 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 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. [

See Contraindications (), Warnings and Precautions ()

].

Do not initiate in acutely deteriorating COPD patients. ()

Do not use for relief of acute symptoms. Concomitant short-acting beta-agonists can be used as needed for acute relief. ()

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. ()

Immediate hypersensitivity reactions may occur. Discontinue immediately. ()

Life-threatening paradoxical bronchospasm can occur. Discontinue immediately. ()

Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis or sensitivity to sympathomimetic drugs. (, )

Long-acting beta

-adrenergic agonists, such as ARCAPTA NEOHALER, increase the risk of asthma-related death. ARCAPTA NEOHALER is not indicated for the treatment of asthma [See

and

Warning and Precautions ()

].

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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