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Budesonide, glycopyrrolate (glycopyrronium), and formoterol: Drug information

Budesonide, glycopyrrolate (glycopyrronium), and formoterol: Drug information
(For additional information see "Budesonide, glycopyrrolate (glycopyrronium), and formoterol: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Breztri Aerosphere
Brand Names: Canada
  • Breztri Aerosphere
Pharmacologic Category
  • Anticholinergic Agent;
  • Anticholinergic Agent, Long-Acting;
  • Beta2 Agonist;
  • Beta2-Adrenergic Agonist, Long-Acting;
  • Corticosteroid, Inhalant (Oral)
Dosing: Adult
Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease: Metered-dose inhaler (budesonide 160 mcg/glycopyrrolate 9 mcg/formoterol 4.8 mcg per actuation): Oral inhalation: 2 inhalations twice daily; maximum dose: 2 inhalations twice daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl >45 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

CrCl ≤45 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, systemic glycopyrrolate exposure may be increased; use with caution.

End-stage renal disease requiring dialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, systemic glycopyrrolate exposure may be increased; use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, systemic budesonide and formoterol exposure may be increased in patients with severe impairment; use with caution and monitor closely.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. See individual agents.

1% to 10%:

Gastrointestinal: Diarrhea (2%), oral candidiasis (3%)

Genitourinary: Urinary tract infection (3%)

Infection: Influenza (3%)

Nervous system: Voice disorder (3%)

Neuromuscular & skeletal: Back pain (3%), muscle spasm (3%)

Ophthalmic: Cataract (≤1%)

Respiratory: Cough (3%), pneumonia (2% to 5%), sinusitis (3%), upper respiratory tract infection (6%)

Frequency not defined: Respiratory: Paradoxical bronchospasm

Contraindications

Hypersensitivity to budesonide, glycopyrrolate, formoterol, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections. Do not use this product to transfer patients from oral corticosteroid therapy.

• Asthma-related deaths: The use of long-acting beta-2 agonists (LABAs) as monotherapy has been associated with an increased risk of severe exacerbations and asthma-related deaths (SMART [Nelson 2006]; Walters 2007); additional data from other clinical trials suggest risk of asthma-related hospitalization may also be increased with LABA monotherapy in pediatric and adolescent patients. However, data from large, randomized, double-blind controlled trials do not show a significant increase in risk of serious asthma-related events (including hospitalizations, intubations, and death) in adults, adolescents, and pediatric patients (4 to 11 years of age) when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017).

• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents and may be life-threatening; this should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue and institute alternative therapy.

• Hypersensitivity: Immediate hypersensitivity reactions (eg, urticaria, angioedema, rash) have been reported; discontinue if a hypersensitivity reaction occurs and institute alternative therapy.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use, if possible, in patients with ocular herpes; tuberculosis (TB) infection (latent TB) or disease (active TB) of the respiratory tract; or untreated viral, fungal, or bacterial or parasitic systemic infections. Exposure to chickenpox or measles should be avoided; if the patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin or pooled IV immunoglobulin may be indicated; if chickenpox develops, treatment with antiviral agents may be considered. If exposure to measles occurs, prophylaxis with pooled IM immunoglobulin may be indicated.

• Lower respiratory infections: Pneumonia and other lower respiratory tract infections have been reported in patients with COPD following the use of inhaled corticosteroids; monitor COPD patients closely since pneumonia symptoms may overlap symptoms of exacerbations.

• Oral candidiasis: Local oropharyngeal Candida infections may occur; treat appropriately while either continuing or interrupting (if necessary) therapy.

• Serious effects/fatalities: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

Disease-related concerns:

• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, antiseizure medications, oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease, especially coronary insufficiency, arrhythmias, and hypertension; beta-agonists may cause elevation in BP, heart rate, and increase risk of arrhythmias (eg, supraventricular tachycardia, extrasystoles); may also cause ECG changes (eg, flattening of the T wave, QTc prolongation, ST segment depression).

• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.

• Hepatic impairment: Budesonide and formoterol exposure may be increased in patients with severe hepatic impairment; use with caution in patients with severe impairment and monitor closely.

• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (effect is usually transient).

• Ocular disease: Use with caution in patients with increased intraocular pressure, cataracts, and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use of inhaled corticosteroids. Consider routine eye exams in chronic users.

• Prostatic hyperplasia/bladder neck obstruction: Glycopyrrolate may worsen the symptoms of prostatic hyperplasia and/or bladder neck obstruction (eg, painful urination, difficulty passing urine); use with caution.

• Renal impairment: Use with caution in patients with severe renal impairment, including end-stage renal disease requiring dialysis; systemic exposure to glycopyrrolate may be increased.

• Seizure disorders: Use with caution in patients with seizure disorders.

• Thyrotoxicosis: Use with caution in patients with thyrotoxicosis.

Other warnings/precautions:

• Appropriate use: Do not use for acute episodes of COPD. Do not initiate in patients with significantly worsening, potentially life-threatening, or acutely deteriorating COPD. Do not exceed the recommended dose. After initiation of therapy, patients should use short-acting bronchodilators only on an as needed basis for acute symptoms.

• Discontinuation of systemic corticosteroids: Withdraw systemic corticosteroid therapy with gradual tapering of dose (eg, patients on prednisone may decrease dose by 2.5 mg weekly during inhaled corticosteroid therapy). Monitor lung function, beta-agonist use, and COPD symptoms, and for signs and symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea and vomiting, hypotension) during withdrawal.

• Transfer to oral inhaler: When transferring to oral inhaler, previously suppressed allergic conditions (eg, arthritis, rhinitis, conjunctivitis, eczema, eosinophilic conditions) may be unmasked.

Dosage Forms Considerations

Breztri Aerosphere 10.7 g canisters contain 120 inhalations; 5.9 g canisters contain 28 inhalations.

In the United States, each metered dose per actuation contains budesonide 182 mcg, glycopyrrolate 10.4 mcg (equivalent to glycopyrronium 8.2 mcg), and formoterol fumarate 5.5 mcg (equivalent to formoterol 4.7 mcg). However, each actuation of the inhaler delivers budesonide 160 mcg, glycopyrrolate 9 mcg (equivalent to 7.2 mcg glycopyrronium), and formoterol fumarate 4.8 mcg (equivalent to formoterol 4.1 mcg) from the mouthpiece. Dosing is based on the amounts delivered per actuation.

In Canada, each metered dose per actuation contains budesonide 182 mcg, glycopyrrolate 10.4 mcg (equivalent to glycopyrronium 8.2 mcg), and formoterol fumarate dihydrate 5.8 mcg (equivalent to formoterol fumarate 5.5 mcg). However, each actuation of the inhaler delivers budesonide 160 mcg, glycopyrrolate 9 mcg, and formoterol fumarate 4.8 mcg from the mouthpiece. Dosing is based on the amounts delivered per actuation.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol, Inhalation:

Breztri Aerosphere: Budesonide 160 mcg, glycopyrrolate 9 mcg, and formoterol fumarate 4.8 mcg per actuation (5.9 g, 10.7 g)

Generic Equivalent Available: US

No

Pricing: US

Aerosol (Breztri Aerosphere Inhalation)

160-9-4.8 mcg/ACT (per gram): $72.36

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol, Inhalation:

Breztri Aerosphere: Budesonide 182 mcg, glycopyrrolate 8.2 mcg, and formoterol fumarate 5.8 mcg per actuation (1 ea)

Administration: Adult

Metered-dose inhaler: For oral inhalation only; administer every morning and evening. Prior to first use, prime inhaler by releasing 4 test sprays into the air; shake well before each spray. Inhaler must be reprimed by releasing 2 test sprays into the air if not used for >7 days, if it has been dropped, or after weekly cleaning. Shake inhaler well before each use. Rinse mouth with water (spit out without swallowing) after each use. Clean inhaler (remove canister out of actuator) 1 time each week by running warm water through the actuator for ~30 seconds then turn actuator upside down and run warm water through it again for ~30 seconds and allow to air dry completely. Discard 3 weeks (28-inhalation cannister) or 3 months (120-inhalation cannister) after removal from the foil pouch or when the counter reads “0”, whichever comes first.

Delivery of dose: Instruct patient to shake well and then place mouthpiece gently between teeth, closing lips around inhaler. Instruct patient to inhale deeply, press the top counter, and hold breath for up to 10 seconds or as long as they comfortably can. Remove mouthpiece from mouth prior to exhalation. Patient should not breathe out through the mouthpiece.

Use: Labeled Indications

Chronic obstructive pulmonary disease: Maintenance treatment of patients with chronic obstructive pulmonary disease.

Limitations of use: Not indicated for the relief of bronchospasm or for the treatment of asthma.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Anticholinergic Agents: May enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Atomoxetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor therapy

Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Risk X: Avoid combination

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Caffeine and Caffeine Containing Products: May enhance the adverse/toxic effect of Formoterol. Caffeine and Caffeine Containing Products may enhance the hypokalemic effect of Formoterol. Risk C: Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification

Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Budesonide (Oral Inhalation). Management: Consider alternatives to this combination when possible. If combined, monitor for increased corticosteroid adverse effects during coadministration of inhaled budesonide and strong CYP3A4 inhibitors. Risk D: Consider therapy modification

Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Methacholine: Beta2-Agonists (Long-Acting) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Risk D: Consider therapy modification

Methacholine: Long-acting muscarinic antagonists (LAMAs) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting muscarinic antagonists (LAMAs) for at least 7 days before methacholine use. Risk D: Consider therapy modification

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May increase the serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

Rivastigmine: Anticholinergic Agents may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Anticholinergic Agents. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Theophylline Derivatives: Beta2-Agonists may enhance the adverse/toxic effect of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Theophylline Derivatives may enhance the hypokalemic effect of Beta2-Agonists. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Risk C: Monitor therapy

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Pregnancy Considerations

Refer to individual monographs.

Breastfeeding Considerations

Budesonide is present in breast milk following oral inhalation; excretion of formoterol and glycopyrrolate are not known.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Refer to individual monographs for additional information.

Monitoring Parameters

FEV1, peak flow, and/or other pulmonary function tests; bone mineral density; hypothalamic-pituitary-adrenal axis suppression; BP, heart rate; serum potassium; serum glucose; ocular changes; signs/symptoms of oral or systemic infection.

Mechanism of Action

Budesonide: A corticosteroid that controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes/fibroblasts, and reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation.

Formoterol: Relaxes bronchial smooth muscle by selective action on beta-2 receptors with little effect on heart rate; formoterol has a long-acting effect.

Glycopyrrolate: Competitively and reversibly inhibits the action of acetylcholine at muscarinic receptor subtypes 1 to 3 (greater affinity for subtypes 1 and 3) in bronchial smooth muscle thereby causing bronchodilation.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Breztri aerosphere;
  • (AR) Argentina: Breztri aerosphere;
  • (AT) Austria: Trixeo aerosphere;
  • (AU) Australia: Breztri aerosphere;
  • (BD) Bangladesh: Tribrez;
  • (BE) Belgium: Trixeo aerosphere;
  • (BG) Bulgaria: Trixeo aerosphere;
  • (CH) Switzerland: Trixeo aerosphere;
  • (CN) China: Budesonide, glycopyrronium bromide and formoterol fumarate;
  • (CZ) Czech Republic: Trixeo aerosphere;
  • (DE) Germany: Trixeo aerosphere;
  • (EE) Estonia: Trixeo aerosphere;
  • (ES) Spain: Trixeo aerosphere;
  • (FI) Finland: Trixeo aerosphere;
  • (FR) France: Trixeo aerosphere;
  • (GB) United Kingdom: Trixeo aerosphere;
  • (GR) Greece: Trixeo aerosphere;
  • (IE) Ireland: Trixeo aerosphere;
  • (IN) India: Airz fb | Forglyn plus;
  • (IT) Italy: Trixeo aerosphere;
  • (JP) Japan: Breztri aerosphere;
  • (LT) Lithuania: Trixeo aerosphere;
  • (LU) Luxembourg: Trixeo aerosphere;
  • (LV) Latvia: Trixeo aerosphere;
  • (MX) Mexico: Trixeo aerosphere;
  • (NL) Netherlands: Trixeo aerosphere;
  • (NO) Norway: Trixeo aerosphere;
  • (PL) Poland: Trixeo aerosphere;
  • (PR) Puerto Rico: Breztri aerosphere;
  • (PT) Portugal: Riltrava aerosphere | Trixeo aerosphere;
  • (RO) Romania: Trixeo aerosphere;
  • (SE) Sweden: Riltrava aerosphere | Trixeo aerosphere
  1. Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; January 2022.
  2. Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol) [product monograph]. Mississauga, Ontario, Canada: AstraZeneca Canada Inc; July 2021.
  3. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/gina-reports/. Updated 2022. Accessed October 11, 2022.
  4. Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1):15-26. doi:10.1378/chest.129.1.15 [PubMed 16424409]
  5. US Food and Drug Administration. FDA drug safety communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS). https://www.fda.gov/Drugs/DrugSafety/ucm589587.htm. Published December 2017.
  6. Walters EH, Gibson PG, Lasserson TJ, Walters JA. Long-acting beta2-agonists for chronic asthma in adults and children where background therapy contains varied or no inhaled corticosteroid. Cochrane Database Syst Rev. 2007;(1):CD001385. doi:10.1002/14651858.CD001385.pub2. [PubMed 17253458]
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