unhurt [65:65 years was similar to that of the general patient population. Hepatic Impairment Patients with mild and moderate hepatic impairment showed no relevant changes in C max or AUC, nor did protein binding differ between mild and moderate hepatically impaired subjects and their healthy controls. Studies in subjects with severe hepatic impairment were not performed. Renal Impairment Due to the very low contribution of the urinary pathway to total body elimination, a study in renally impaired subjects was not performed. Overdosage Human Experience In COPD patients single doses of 40 times the 75 mcg dose were associated with moderate increases in pulse rate, systolic blood pressure and QTc interval. The expected signs and symptoms associated with overdosage of Arcapta Neohaler are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 bpm, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of Arcapta Neohaler. Treatment of overdosage consists of discontinuation of Arcapta Neohaler together with institution of appropriate symptomatic and supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Arcapta Neohaler. Cardiac monitoring is recommended in cases of overdosage. Arcapta Neohaler 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 beta 2 -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 C 24 H 28 N 2 O 3 C 4 H 4 O 4 . 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. Arcapta Neohaler - Clinical Pharmacology Mechanism of Action Indacaterol is a long-acting beta 2 -adrenergic agonist. When inhaled, indacaterol acts locally in the lung as a bronchodilator. Although beta 2 -receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 -receptors are the predominant receptors in the heart, there are also beta 2 -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 2 -adrenergic agonists may have cardiac effects. The pharmacological effects of beta 2 -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 beta 2 -receptors compared to beta 1 -receptors and 20-fold greater agonist activity compared to beta 3 -receptors. This selectivity profile is similar to formoterol. The clinical significance of these findings is unknown. Pharmacodynamics Systemic Safety The major adverse effects of inhaled beta 2 -adrenergic agonists occur as a result of excessive activation of systemic beta-adrenergic receptors. The most common adverse effects in adults include skeletal muscle tremor and cramps, insomnia, tachycardia, decreases in serum potassium and increases in plasma glucose. Changes in serum potassium and plasma glucose were evaluated in COPD patients in double-blind Phase III studies. In pooled data, at the recommended 75 mcg dose, at 1 hour post-dose at week 12, there was no change compared to placebo in serum potassium, and change in mean plasma glucose was 0.07 mmol/L. Electrophysiology The effect of Arcapta Neohaler on the QT interval was evaluated in a double-blind, placebo- and active (moxifloxacin)-controlled study following multiple doses of indacaterol 150 mcg, 300 mcg or 600 mcg once-daily for 2 weeks in 404 healthy volunteers. Fridericia's method for heart rate correction was employed to derive the corrected QT interval (QTcF). Maximum mean prolongation of QTcF intervals were] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA WADA Class Anti-Doping Classification Manufacturer Sunovion Pharmaceuticals Inc. Drug Class Adrenergic bronchodilators Related Drugs adrenergic bronchodilators albuterol , ProAir HFA , Ventolin , Ventolin HFA , EpiPen , epinephrine COPD, Maintenance Symbicort , Spiriva , albuterol , ProAir HFA , Advair Diskus , ipratropium , Breo Ellipta , Ventolin , Ventolin HFA , tiotropium , Combivent , DuoNeb , albuterol / ipratropium , Proventil , Anoro Ellipta , Xopenex , Atrovent , Combivent Respimat , fluticasone / salmeterol , Proventil HFA , budesonide / formoterol , levalbuterol , Stiolto Respimat , Spiriva Respimat , Advair HFA , More... 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