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UTIBRON NEOHALER
Overview
What is UTIBRON NEOHALER?
UTIBRON NEOHALER consists of a dry powder formulation for delivery of a combination of indacaterol and glycopyrrolate to patients by oral inhalation only with the NEOHALER device. The inhalation powder is packaged in hypromellose (HPMC) capsules with yellow transparent cap and uncolored transparent body.
Each capsule contains a dry powder blend of 27.5 mcg/15.6 mcg of indacaterol/glycopyrrolate with approximately 24.9 mg of lactose monohydrate (which contains trace levels of milk protein) and 0.03 mg of magnesium stearate.
One active component of UTIBRON 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 C24H28N2O3 • C4H4O4. Indacaterol maleate is a white to very slightly grayish or very slightly yellowish powder. Indacaterol maleate is slightly soluble in ethanol and very slightly soluble in water.
The other active component of UTIBRON NEOHALER is glycopyrrolate, which is chemically described as (3RS)-3-[(2SR)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl) oxy]-1,1-dimethylpyrrolidinium bromide. This synthetic quaternary ammonium compound acts as a competitive antagonist at muscarinic acetylcholine receptors, also referred to as anticholinergic. Glycopyrrolate, CHBrNO, is a white powder that is freely soluble in water and sparingly soluble in absolute ethanol. It has a molecular mass of 398.33. The structural formula is:
The NEOHALER device is a plastic inhalation device used to inhale the dry powder within the UTIBRON capsule. 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 90 L/min for 1.3 seconds, the NEOHALER inhaler delivered 20.8 mcg of indacaterol and 12.8 mcg glycopyrrolate for the 27.5 mcg/15.6 mcg dose strength (equivalent to 27.5 mcg/12.5 mcg of indacaterol/glycopyrronium) from the mouthpiece. This in vitro testing revealed that the NEOHALER device had a specific resistance of 0.059 cm HO/L/min. Peak inspiratory flow rates (PIFR) achievable through the NEOHALER device were evaluated in 26 adult patients with COPD of varying severity. Mean PIFR was 95 L/min (range 52 to 133 L/min) for adult patients. Twenty-five of 26 patients (96%) in this study generated a PIFR through the device exceeding 60 L/min.
What does UTIBRON NEOHALER look like?
What are the available doses of UTIBRON NEOHALER?
Inhalation powder: UTIBRON NEOHALER consists of UTIBRON capsules containing indacaterol/glycopyrrolate powder for oral inhalation and the NEOHALER device. UTIBRON capsules contain 27.5 mcg/15.6 mcg of indacaterol/glycopyrrolate in a hypromellose capsule with yellow transparent cap and uncolored transparent body with black “” logo on the cap and black product code “IGP27.5_15.6” under the black bar on the body.
What should I talk to my health care provider before I take UTIBRON NEOHALER?
How should I use UTIBRON NEOHALER?
UTIBRON™ NEOHALER is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
For oral inhalation only. Do not swallow UTIBRON capsules, as the intended effects on the lungs will not be obtained. UTIBRON capsules should only be used with the NEOHALER device
[see Overdosage ()].
The recommended dosage of UTIBRON NEOHALER is the inhalation of the contents of one UTIBRON capsule twice-daily using the NEOHALER device.
UTIBRON NEOHALER should be administered at the same time of the day (1 capsule in the morning and 1 capsule in the evening) every day. More frequent administration or a greater number of inhalations (more than 1 capsule twice-daily) of UTIBRON NEOHALER is not recommended.
Store UTIBRON capsules in the blister, and only remove IMMEDIATELY BEFORE USE with the NEOHALER device.
No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or patients with mild to moderate renal impairment.
What interacts with UTIBRON NEOHALER?
Sorry No Records found
What are the warnings of UTIBRON NEOHALER?
Sorry No Records found
What are the precautions of UTIBRON NEOHALER?
Sorry No Records found
What are the side effects of UTIBRON NEOHALER?
Sorry No records found
What should I look out for while using UTIBRON NEOHALER?
All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication . UTIBRON NEOHALER is not indicated for the treatment of asthma.
UTIBRON NEOHALER is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients .
Long-acting beta
-adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large, placebo-controlled U.S. study that compared the safety of another LABA (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 all LABAs, including indacaterol, one of the active ingredients in UTIBRON NEOHALER.
The safety and efficacy of UTIBRON NEOHALER in patients with asthma have not been established. UTIBRON NEOHALER is not indicated for the treatment of asthma
[see Warnings and Precautions ()].
What might happen if I take too much UTIBRON NEOHALER?
In COPD patients, doses of up to 600/124.8 mcg UTIBRON NEOHALER were inhaled over 2 weeks and there were no relevant effects on heart rate, QTc interval, blood glucose or serum potassium. There was an increase in ventricular ectopies after 14 days of dosing with 300/124.8 mcg and 600/124.8 mcg UTIBRON NEOHALER, but low prevalence and small patient numbers (N=49 and N=51 for 600/124.8 mcg and 300/124.8 mcg UTIBRON NEOHALER, respectively) precluded accurate analysis. In a total of four patients, non-sustained ventricular tachycardia was recorded, with the longest episode recorded being 9 beats (4 seconds).
In healthy volunteers, single dose administration of UTIBRON NEOHALER at up to a dose of 440/499.2 mcg indacaterol/glycopyrrolate was well-tolerated without clinically significant effects on the ECG, serum potassium or blood glucose.
UTIBRON NEOHALER contains both indacaterol and glycopyrrolate; therefore, the risks associated with overdosage for the individual components described below apply to UTIBRON NEOHALER. Treatment of overdosage consists of discontinuation of UTIBRON NEOHALER together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage.
How should I store and handle UTIBRON NEOHALER?
Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children. Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children. Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children. Azelastine Hydrochloride Nasal Spray (137 mcg per spray) is supplied as a 30-mL package (NDC 68382-415-06) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azelastine Hydrochloride Nasal Spray should not be used after the expiration date "EXP" printed on the medicine label and carton. StorageStore upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing. Keep bottle upright, tightly closed, and away from children.Azelastine Hydrochloride Nasal Spray (137 mcg per spray) is supplied as a 30-mL package (NDC 68382-415-06) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azelastine Hydrochloride Nasal Spray should not be used after the expiration date "EXP" printed on the medicine label and carton. StorageStore upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing. Keep bottle upright, tightly closed, and away from children.Azelastine Hydrochloride Nasal Spray (137 mcg per spray) is supplied as a 30-mL package (NDC 68382-415-06) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azelastine Hydrochloride Nasal Spray should not be used after the expiration date "EXP" printed on the medicine label and carton. StorageStore upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing. Keep bottle upright, tightly closed, and away from children.Azelastine Hydrochloride Nasal Spray (137 mcg per spray) is supplied as a 30-mL package (NDC 68382-415-06) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azelastine Hydrochloride Nasal Spray should not be used after the expiration date "EXP" printed on the medicine label and carton. StorageStore upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing. Keep bottle upright, tightly closed, and away from children.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
UTIBRON NEOHALER contains both indacaterol and glycopyrrolate. The mechanisms of action described below for the individual components apply to UTIBRON NEOHALER. These drugs represent 2 different classes of medications (a LABA and an anticholinergic) that have different and additive effects on clinical and physiological indices.
Indacaterol:
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 and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro 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. The clinical significance of these findings is unknown.
Glycopyrrolate:
Non-Clinical Toxicology
All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication . UTIBRON NEOHALER is not indicated for the treatment of asthma.UTIBRON NEOHALER is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients .
Long-acting beta
-adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large, placebo-controlled U.S. study that compared the safety of another LABA (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 all LABAs, including indacaterol, one of the active ingredients in UTIBRON NEOHALER.
The safety and efficacy of UTIBRON NEOHALER in patients with asthma have not been established. UTIBRON NEOHALER is not indicated for the treatment of asthma
[see Warnings and Precautions ()].
Limited clinical data on potential drug interactions are available.
Do not initiate in acutely deteriorating COPD or to treat acute symptoms. ()
Do not use in combination with an additional medicine containing LABA because of risk of overdose. (, )
If paradoxical bronchospasm occurs, discontinue UTIBRON NEOHALER immediately and institute alternative therapy. ()
Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, sensitivity to sympathomimetic drugs, diabetes mellitus, and ketoacidosis. (, , )
Worsening of narrow-angle glaucoma or urinary retention may occur. Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction and instruct patients to contact a physician immediately if symptoms occur. (, )
Be alert to hypokalemia and hyperglycemia. ()
LABAs, such as indacaterol, one of the active ingredients in UTIBRON NEOHALER, increase the risk of asthma-related death. UTIBRON NEOHALER is not indicated for the treatment of asthma
The following adverse reactions are described in greater detail in other sections:
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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