MedPath

Formoterol

Generic Name
Formoterol
Brand Names
Bevespi, Breyna, Breztri, Duaklir, Duaklir Genuair, Dulera, Foradil, Oxeze, Perforomist, Symbicort, Zenhale
Drug Type
Small Molecule
Chemical Formula
C19H24N2O4
CAS Number
73573-87-2
Unique Ingredient Identifier
5ZZ84GCW8B

Overview

Formoterol is an inhaled beta-agonist used in the management of COPD and asthma that was first approved for use in the United States in 2001. It acts on bronchial smooth muscle to dilate and relax airways, and is administered as a racemic mixture of its active (R;R)- and inactive (S;S)-enantiomers. A major clinical advantage of formoterol over other inhaled beta-agonists is its rapid onset of action (2-3 minutes), which is at least as fast as salbutamol, combined with a long duration of action (12 hours) - for this reason, treatment guidelines for asthma recommend its use as both a reliever and maintenance medication. It is available as a single-entity product and in several formulations in combination with both inhaled corticosteroids and long-acting muscarinic antagonists.

Background

Formoterol is an inhaled beta-agonist used in the management of COPD and asthma that was first approved for use in the United States in 2001. It acts on bronchial smooth muscle to dilate and relax airways, and is administered as a racemic mixture of its active (R;R)- and inactive (S;S)-enantiomers. A major clinical advantage of formoterol over other inhaled beta-agonists is its rapid onset of action (2-3 minutes), which is at least as fast as salbutamol, combined with a long duration of action (12 hours) - for this reason, treatment guidelines for asthma recommend its use as both a reliever and maintenance medication. It is available as a single-entity product and in several formulations in combination with both inhaled corticosteroids and long-acting muscarinic antagonists.

Indication

Formoterol is indicated in various formulations for the treatment of asthma and COPD. For the treatment of COPD, formoterol is available as a single-entity inhalation solution, in combination with the long-acting muscarinic antagonists (LAMAs) aclidinium and glycopyrronium, and in combination with the corticosteroid budesonide. For the treatment of asthma, formoterol is available in combination with mometasone furoate for patients 5 years and older and with budesonide for patients 6 years and older. Formoterol may also be used on an as-needed basis for prophylaxis against exercise-induced bronchospasm.

Associated Conditions

  • Asthma
  • Bronchial Asthma
  • Bronchoconstriction
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Exercise-Induced Bronchospasm
  • Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

FDA Approved Products

Budesonide and Formoterol Fumarate Dihydrate
Manufacturer:A-S Medication Solutions
Route:RESPIRATORY (INHALATION)
Strength:4.5 ug in 1 1
Approved: 2019/07/24
NDC:50090-6327
DUAKLIR PRESSAIR
Manufacturer:AstraZeneca Pharmaceuticals LP
Route:RESPIRATORY (INHALATION)
Strength:12 ug in 1 1
Approved: 2022/01/25
NDC:0310-0900
SYMBICORT
Manufacturer:A-S Medication Solutions
Route:RESPIRATORY (INHALATION)
Strength:4.5 ug in 1 1
Approved: 2023/10/17
NDC:50090-1403
Formoterol fumarate
Manufacturer:Bryant Ranch Prepack
Route:RESPIRATORY (INHALATION)
Strength:20 ug in 2 mL
Approved: 2021/09/13
NDC:63629-8814
arformoterol tartrate
Manufacturer:Cipla USA Inc.
Route:RESPIRATORY (INHALATION)
Strength:15 ug in 2 mL
Approved: 2022/07/14
NDC:69097-168

Singapore Approved Products

SYMBICORT RAPIHALER SUSPENSION FOR INHALATION 80/4.5 mcg/actuation
Manufacturer:AstraZeneca Dunkerque Production (AZDP)
Form:AEROSOL, METERED
Strength:4.5 mcg/actuation
Online:Yes
Approved: 2016/02/24
Approval:SIN14962P
DUORESP® SPIROMAX® DRY POWDER FOR INHALATION 320 MCG/9 MCG
Manufacturer:Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland
Form:POWDER, METERED
Strength:9 mcg / inhalation
Online:Yes
Approved: 2020/12/07
Approval:SIN16057P
FOSTER NEXTHALER INHALATION POWDER 100 MCG/6 MCG PER DOSE
Manufacturer:Chiesi Farmaceutici SpA
Form:POWDER, METERED
Strength:6mcg/dose
Online:Yes
Approved: 2017/09/19
Approval:SIN15332P
DUORESP® SPIROMAX® DRY POWDER FOR INHALATION 160 MCG/4.5 MCG
Manufacturer:Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland
Form:POWDER, METERED
Strength:4.5 mcg / inhalation
Online:Yes
Approved: 2020/12/07
Approval:SIN16056P
SYMBICORT RAPIHALER SUSPENSION FOR INHALATION 80/2.25 mcg/actuation
Manufacturer:AstraZeneca Dunkerque Production (AZDP)
Form:AEROSOL, METERED
Strength:2.25 mcg/actuation
Online:Yes
Approved: 2016/02/24
Approval:SIN14963P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath