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Glycopyrrolate And Formoterol Fumarate (Bevespi Aerosphere)

Trade Name : BEVESPI AEROSPHERE

AstraZeneca Pharmaceuticals LP

AEROSOL, METERED

Strength 94.8 ug/1ug/1

GLYCOPYRROLATE; FORMOTEROL FUMARATE Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Glycopyrrolate And Formoterol Fumarate (Bevespi Aerosphere) which is also known as BEVESPI AEROSPHERE and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 9; 4.8 ug/1; ug/1 per ml. Read more

Glycopyrrolate And Formoterol Fumarate (Bevespi Aerosphere) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Boxed Warning, removedu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a05/2019
  • Indications and Usage ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a05/2019
  • Contraindications ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a05/2019
  • Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a05/2019
  • BEVESPIu00a0AEROSPHERE is a combination of glycopyrrolate and formoterol fumarate indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
  • Arrayn- [see Warnings and Precautions (, )]
  • BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta-adrenergic agonist (LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ()
  • u00a0
  • Limitation of Use:
  • BEVESPI AEROSPHERE (glycopyrrolate/formoterol fumarate 9 mcg/4.8 mcg) should be administered as two inhalations taken twice daily in the morning and in the evening by the orally inhaled route only. Do not take more than two inhalations twice daily.
  • BEVESPI AEROSPHERE contains 28 or 120 inhalations per canister. The canister has an attached dose indicator, which indicates how many inhalations remain. The dose indicator display will move after every tenth actuation. When nearing the end of the usable inhalations, the color behind the number in the dose indicator display window changes to red. BEVESPI AEROSPHERE should be discarded when the dose indicator display window shows zero.u00a0
  • Priming BEVESPI AEROSPHERE is essential to ensure appropriate drug content in each actuation. Prime BEVESPI AEROSPHERE before using for the first time. To prime BEVESPI AEROSPHERE, release 4 sprays into the air away from the face, shaking well before each spray. BEVESPI AEROSPHERE must be re-primed when the inhaler has not been used for more than 7 days. To re-prime BEVESPI AEROSPHERE, release 2 sprays into the air away from the face, shaking well before each spray.
  • Inhalation Aerosol: BEVESPI AEROSPHERE is a pressurized metered dose inhaler that delivers 9 mcg of glycopyrrolate and 4.8 mcg of formoterol fumarate per inhalation. Two inhalations equal one dose. BEVESPI AEROSPHERE contains 28 or 120 inhalations per canister. The canister has an attached dose indicator and is supplied with a white plastic actuator with an orange dust cap.
  • Use of a long-acting beta2-adrenergic agonist (LABA), including formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, without an inhaled corticosteroid is contraindicated in patients with asthma n n- Arrayn- BEVESPI AEROSPHERE is not indicated for the treatment of asthma.
  • BEVESPI AEROSPHERE is contraindicated in patients with hypersensitivity to glycopyrrolate, formoterol fumarate, or to any component of the product .
  • 4n- 5.5
  • No data
  • 5.3n- 7.1
  • LABAs, such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events. BEVESPI AEROSPHERE is not indicated for the treatment of asthma .
  • The following adverse reactions are described in greater detail elsewhere in the labeling:
  • Most common adverse reactions (incidence u22652% and more common than with placebo) include: urinary tract infection and cough. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No formal drug interaction studies have been performed with BEVESPI AEROSPHERE.
  • 5.3n- 7.1
  • 7.2n- 7.3
  • No data
  • u2022
  • 8.7
  • No cases of overdose have been reported with BEVESPI AEROSPHERE. BEVESPI AEROSPHERE contains both glycopyrrolate and formoterol fumarate; therefore, the risks associated with overdosage for the individual components described below apply to BEVESPI AEROSPHERE. Treatment of overdosage consists of discontinuation of BEVESPI AEROSPHERE 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 medication can produce bronchospasm. Cardiac monitoring is recommended in case of overdosage.
  • Glycopyrrolate
  • High doses of glycopyrrolate, a component of BEVESPI AEROSPHERE, may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding. However, there were no systemic anticholinergic adverse effects following single inhaled doses up to 144 mcg in subjects with COPD.
  • Formoterol Fumarate
  • An overdose of formoterol fumarate would likely lead to an exaggeration of effects that are typical for beta-agonists: seizures, angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia, hypokalemia. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of formoterol fumarate.
  • BEVESPI AEROSPHEREu00a0(glycopyrrolate and formoterol fumarate) Inhalation Aerosol is a pressurized metered-dose inhaler that contains a combination of micronized glycopyrrolate, anu00a0anticholinergic,u00a0and micronized formoterol fumarate, a long-acting beta-adrenergic agonist,u00a0for oral inhalation.u00a0
  • Glycopyrrolate is a quaternary ammonium salt with the following chemical name: ()-[3-()-Hydroxy-1,1-dimethylpyrrolidinium bromide] u03b1-cyclopentylmandelate. Glycopyrrolate is a powder that is freely soluble in water. The molecular formula is CHBrNO, and the molecular weight is 398.33 g/mol. The structural formula is as follows:
  • Glycopyrrolate contains two chiral centers (denoted by * in structure above) and is a racemate of a 1:1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate.
  • Formoterol fumarate has the chemical name -[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1- methylethyl]-amino] ethyl]phenyl] formamide, u20ac-2-butenedioate dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. The molecular formula is (CHNO).CHO.2HO and the molecular weight is 840.91 g/mol. The structural formula is as follows:u00a0
  • Formoterol fumarate contains two chiral centers (denoted by * in structure above), and consists of a single enantiomeric pair (a racemate of R,R and S,S).
  • BEVESPI AEROSPHERE is formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized metered dose inhaler containing 28 or 120 inhalations. The canister has an attached dose indicator and is supplied with a white plastic actuator body and mouthpiece with an orange dust cap.
  • After priming each actuation of the inhaler meters 10.4 mcg of glycopyrrolate (equivalent to 8.3 mcg of glycopyrronium) and 5.5 mcg of formoterol fumarate from the valve which delivers 9 mcg of glycopyrrolate (equivalent to 7.2 mcg of glycopyrronium) and 4.8 mcg of formoterol fumarate from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BEVESPI AEROSPHERE also contains porous particles that form a cosuspension with the drug crystals. The porous particles are comprised of the phospholipid, 1,2-Distearoyl--glycero-3-phosphocholine(DSPC), and calcium chloride. Porous particles and HFA 134a are excipients in the formulation.
  • Priming BEVESPI AEROSPHERE is essential to ensure appropriate drug content in each actuation. Prime BEVESPI AEROSPHERE before using for the first time. To prime BEVESPI AEROSPHERE, release 4 sprays into the air away from the face, shaking well before each spray.
  • If the product is not used for more than 7 days re-prime the device. To re-prime BEVESPI AEROSPHERE, release 2 sprays into the air away from the face, shaking well before each spray.
  • No data
  • BEVESPI AEROSPHERE:
  • Glycopyrrolate
  • Long-term studies in animals have not been performed to evaluate the carcinogenic potential of inhaled glycopyrrolate or any other formulations of glycopyrrolate.
  • Glycopyrrolate was not mutagenic in the bacterial reverse mutation assay, the u00a0mammalian cell micronucleus assay in TK6 cells or the icronucleus assay in rats.
  • In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rates of conception in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate.
  • Formoterol Fumarate
  • Long-term studies were conducted in mice using oral administration and rats using inhalation administration to evaluate the carcinogenic potential of formoterol fumarate.
  • In a 24-month carcinogenicity study in CD-1 mice, formoterol fumarate at oral doses of 0.1 mg/kg and above [approximately 25 times the maximum recommended human daily inhalation dose (MRHDID)u00a0on a mg/m basis] caused a dose-related increase in the incidence of uterine leiomyomas.
  • In a 24-month carcinogenicity study in Sprague-Dawley rats, an increased incidence of mesovarian leiomyoma and uterine leiomyosarcoma were observed at the inhaled dose of 130 mcg/kg (approximatelyu00a065 times the MRHDID on a mcg/m basis). No tumors were seen at 22 mcg/kg (approximately 10 times theu00a0MRHDID on a mcg/m basis).
  • Other beta-agonist drugs have similarly demonstrated increases in leiomyomas of the genital tract in female rodents. The relevance of these findings to human use is unknown.
  • Formoterol fumarate was not mutagenic or clastogenic in Ames /microsome plate test, mouse lymphoma test, chromosome aberration test in human lymphocytes, and rat micronucleus test.
  • A reduction in fertility and/or reproductive performance was identified in male rats treated with formoterol at an oral dose of 15 mg/kg (approximately 7600 times the MRHDID on a mg/m basis). In a separate study with male rats treated with an oral dose of 15 mg/kg (approximately 7600 times the MRHDID on a mg/m basis), there were findings of testicular tubular atrophy and spermatic debris in the testes and oligospermia in the epididymides. No such effect was seen at 3 mg/kg (approximately 1500 times the MRHDID on a mg/m basis). No effect on fertility was detected in female rats at doses up to 15 mg/kg (approximately 7600 times the MRHDID on a mg/m basis).
  • The safety and efficacy of BEVESPI AEROSPHERE was evaluated in a clinical development program that included 8 dose-ranging trials and two placebo-controlled lung function trials of 24-weeks duration that included a 28-week extension study to evaluate safety over 1 year. The efficacy of BEVESPI AEROSPHERE is based on the dose ranging trials in 822 subjects with COPD and the 2 placebo-controlled confirmatory trials in 3,705 subjects with COPD.
  • BEVESPI AEROSPHERE Inhalation Aerosolu00a0is supplied as a pressurized aluminum canister with an attached dose indicator, a white plastic actuator and mouthpiece, and an orange dust cap. Each 120 inhalation canister has a net fill weight of 10.7 grams (NDC 0310-4600-12) and each 28 inhalation canister (institutional pack) has a net fill weight of 5.9 grams (NDC 0310-4600-39). Each canister is packaged in a foil pouch with desiccant sachet and is placed into a carton. Each carton contains one canister and a Patient Information leaflet.
  • The BEVESPI AEROSPHERE canister should only be used with the BEVESPI AEROSPHERE actuator, and the BEVESPI AEROSPHERE actuator should not be used with any other inhalation drug product.
  • The correct amount of medication in each inhalation cannot be assured after the label number of inhalations from the canister have been used, when the dose indicator display window shows zero, even though the canister may not feel completely empty. BEVESPI AEROSPHERE should be discarded when the dose indicator display window shows zero or 3 months after removal from the foil pouch (3 weeks for the 28 inhalation canister), whichever comes first. Never immerse the canister into water to determine the amount remaining in the canister (u201cfloat testu201d).
  • Store at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP].
  • For best results, the canister should be at room temperature before use. Shake well before using. Keep out of reach of children.
  • CONTENTS UNDER PRESSURE
  • Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49u00b0C (120u00b0F) may cause bursting. Never throw canister into fire or incinerator.u00a0Avoid spraying in eyes.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
  • Serious Asthma-Related Events:
  • Not for Acute Symptoms:
  • Instruct patients to seek medical attention immediately if they experience any of the following:
  • Patients should not stop therapy with BEVESPI AEROSPHERE without physician/provider guidance since symptoms may recur after discontinuation.
  • Do Not Use Additional Long-Acting Beta-Agonists:
  • Instruct patients who have been taking inhaled, short-acting beta-agonists on a regular basis to discontinue the regular use of these products and use them only for the symptomatic relief of acute symptoms.
  • Paradoxical Bronchospasm:
  • Risks Associated With Beta-Agonist Therapy:
  • Worsening of Narrow Angle Glaucoma:
  • Worsening of Urinary Retention:
  • Instructions for Administering BEVESPI AEROSPHERE
  • It is important for patients to understand how to correctly administer BEVESPI AEROSPHERE .n
  • Inform patients to use 2 inhalations of BEVESPI AEROSPHERE orally twice daily (2 inhalations in the morning and 2 inhalations in the evening).
  • Instruct patients to prime BEVESPI AEROSPHERE before using it for the first time. Instruct patients to prime BEVESPI AEROSPHERE by releasing 4 sprays into the air away from their face, shaking well before each spray. Inform patients that BEVESPI AEROSPHERE must be re-primed when the inhaler has not been used for more than 7 days. Instruct patients to re-prime BEVESPI AEROSPHERE by releasing 2 sprays into the air away from their face, shaking well before each spray.
  • Inform patients that it is very important to clean BEVESPI AEROSPHERE 1 time each week so that medicine will not build up and block the spray through the mouthpiece .u00a0Instruct patients to clean BEVESPI AEROSPHERE by taking the canister out of the actuator, running warm water through the actuator, and allowing the actuator to air-dry overnight. Instruct patients to insert the canister back into the actuator after it is dry, and to re-prime BEVESPI AEROSPHERE. Instruct patients to re-prime BEVESPI AEROSPHERE by releasing 2 sprays into the air away from their face, shaking well before each spray.
  • Inform patients that if they miss a dose of BEVESPI AEROSPHERE, they should take their next dose at the usual time. Instruct patients to not use BEVESPI AEROSPHERE more often or more puffs than they have been prescribed.
  • Instruct patients not to spray BEVESPI AEROSPHERE in their eyes. Inform patients that if they accidentally get BEVESPI AEROSPHERE in their eyes, to rinse their eyes with water, and if redness or irritation persists, to consult their healthcare provider.
  • Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
  • BEVESPI, AEROSPHEREu2122u00a0and BEVESPI AEROSPHEREu2122 are trademarks of the AstraZeneca group of companies.
  • u00a9AstraZeneca 2019
  • This Patient Information has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: May 2019
  • NDC 0310-4600-39BEVESPI
  • AEROSPHEREn
  • (glycopyrrolate and formoterol
  • fumarate) Inhalation Aerosol9 mcg/4.8 mcg per inhalation
  • For Oral Inhalation only
  • RX only
  • Shake inhaler well before using
  • Inhalation Aerosol
  • 28 inhalations
  • AstraZeneca

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