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Drug Dosage form Dosage Generic/Price Other Class/Mechanism of Action Indications
(FDA-approved)
Side Effects
P = % of patients on placebo
who experienced side effect
Drug Interactions Precautions/
Contraindications
Albuterol

(Proventil HFA®)
(Ventolin HFA®)
(ProAir HFA®)
(ProAir RespiClick®) (Accuneb®)
Albuterol + ipratropium

(Combivent®)
(Duoneb®)
Inhalers
  • Proventil HFA®
  • Ventolin HFA®
  • ProAir HFA®
  • Each inhaler delivers 90 mcg of albuterol base per actuation
  • All 3 brands contain 200 actuations per inhaler. Ventolin also comes in a 60 actuation inhaler (8g size).
  • HFA stands for Hydrofluoroalkane which is the propellant used in the inhalers

ProAir® RespiClick
  • Delivers 90 mcg of albuterol in a dry powder
  • Inhaler is breath-actuated
  • Each inhaler contains 200 inhalations

Nebulizer solution
  • Albuterol 0.083% (2.5 mg/3 ml)
  • Accuneb® 0.021% (0.63 mg/3 ml)
  • Accuneb® 0.042% (1.25 mg/3 ml)

Nebulizer solution concentrate
  • Albuterol 0.50% (5 mg/1 ml of concentrate)
  • Available in 20 ml bottle
Acute bronchospasm
Inhalers (≥ 4 years)
  • 2 puffs every 4 - 6 hours as needed

Nebulizer
  • ≤ 12 years old:
    • 0.1 - 0.15 mg/kg/dose every 6 - 8 hours as needed
    • Weight 10 - 15kg: 1.25 mg
    • Weight > 15kg: 2.5 mg

  • 13 years and older:
    • 2.5 mg every 6 - 8 hours as needed

Acute Asthma Exacerbations
See Albuterol in acute exacerbation below
Prevention of exercise-induced asthma
Inhalers (≥ 4 years)
  • 2 puffs 15 - 30 minutes before exercise
Inhalers
(200 actuations)

NO/$$

Ventolin inhaler
(60 actuations)

NO/$

Nebulizer solution
YES/$

Nebulizer concentrate
YES/$

Combivent Respimat®
NO/$$$$

Duoneb®
YES/$
  • Shake inhaler well before use

  • Most inhalers need to be primed before the first use and if they have not been used for > 2 weeks

  • To prime inhalers, release 3-4 sprays into the air (see inhaler instructions for specific directions)

  • Clean inhalers and nebulizers periodically according to instructions

  • Stimulates Beta-2 adrenergic receptors which causes bronchial smooth muscle dilation
  • Asthma

  • Prevention of exercise-induced asthma

  • Relief of bronchospasm
  • Upper respiratory tract infections - 21%, P - 18%
  • Rhinitis - 16%, P - 14%
  • Nausea- 10%, P - 5%
  • Rapid heart rate - 7%, P - < 1%
  • Nervousness- 7%, P - 3%
  • Tremor- 7%, P - 2%
  • Inhalation site sensation - 6%, P - 2%
  • Allergic reactions - 6%, P - < 1%
  • Data from Proventil® PI
  • Beta blockers - Beta blockers may block the action of albuterol. Nonselective beta blockers may carry a greater risk. Recent studies have found that beta blockers may actually be beneficial in patients with COPD/asthma. See beta blockers in RAD.
  • Thiazide diuretics - albuterol may worsen hypokalemia (low potassium) caused by these drugs
  • Loop diuretics - albuterol may worsen hypokalemia (low potassium) caused by these drugs
  • Digoxin - oral and IV albuterol may decrease digoxin levels. It's unclear if inhaled albuterol has the same effect.
  • MAO inhibitors - MAO inhibitors may potentiate the cardiovascular effects of albuterol
  • Tricyclic antidepressants - Tricyclic antidepressants may potentiate the cardiovascular effects of albuterol
  • Severe allergy to milk proteins (ProAir RespiClick only ) - DO NOT USE, contains lactose
  • Hypokalemia (low potassium) - albuterol may cause potassium levels to decrease
  • Paradoxical bronchospasm - cases of paradoxical bronchospasm have been reported
  • Hyperglycemia (elevated blood sugar) - albuterol may cause an increase in blood sugars. This effect is typically insignificant.
  • Cardiovascular effects - increases in pulse and blood pressure can occur in some patients. These reactions are rare.
  • EKG changes - flattening of the T-wave, QT-interval prolongation, and ST-segment depression have been reported
  • Cardiovascular disease - use with caution in patients with cardiovascular disease
  • Heart arrhythmias - use with caution in patients with heart arrhythmias
  • Liver disease - has not been studied extensively
  • Kidney disease - may decrease albuterol clearance

Drug Dosage form Dosage Generic/Price Other Class/Mechanism of Action Indications
(FDA-approved)
Side Effects
P = % of patients on placebo
who experienced side effect
Drug Interactions Precautions/
Contraindications
Levalbuterol

(Xopenex®)
Inhalers - Xopenex-HFA®
  • Each inhaler delivers 45 mcg of levalbuterol base per actuation
  • 200 actuations per inhaler
  • HFA stands for Hydrofluoroalkane which is the propellant used in the inhalers

Nebulizer solution
  • Levalbuterol 0.0103% (0.31 mg/3 ml)
  • Levalbuterol 0.021% (0.63 mg/3 ml)
  • Levalbuterol 0.042% (1.25 mg/3 ml)

Nebulizer solution concentrate
  • Levalbuterol 0.25% (2.5 mg/1 ml of concentrate)
  • Available in 0.5 ml vial
Acute bronchospasm
Inhalers (≥ 4 years)
  • 1 - 2 puffs every 4-6 hours as needed

Nebulizer
    Age < 6 years old
    • 0.075 mg/kg/dose
    Age 6 - 11 years old
    • 0.31 mg three times a day
    Age ≥ 12 years old
    • 0.63 mg - 1.25 mg every 6-8 hrs

Acute Asthma Exacerbations
See Levalbuterol in acute exacerbation below

Inhalers
NO/$$

Nebulizer solution
YES/$$

Nebulizer concentrate
YES/$$
  • Shake inhaler well before use

  • If Xopenex inhaler has not been used for more than 3 days, then prime inhaler before use

  • To prime inhaler, release 4 sprays into the air (see inhaler instructions for specific directions)

  • Clean inhalers and nebulizers periodically according to instructions

  • Stimulates Beta-2 adrenergic receptors which causes bronchial smooth muscle dilation

  • Albuterol contains equal parts of a racemic mixture of R-enantiomers and S-enantiomers. The R-enantiomer is the active form of albuterol where the S-enantiomer is inactive. Levalbuterol contains only the R-enantiomer of albuterol.
  • Asthma

  • Relief of bronchospasm
  • Alb - % of patients on albuterol who experienced side effect
  • Viral respiratory infection - 12.3%, Alb - 12.2%, P - 9.3%
  • Muscle spasticity - 9.6%, Alb - 8.1%, P - 0%
  • Nervousness - 6.8%, Alb - 2.7%, P - 0%
  • Increased cough - 4.1%, Alb - 2.7%, P - 2.7%
  • Rapid heart rate - 2.7%, Alb - 2.7%, P - 0%
  • Tremor- 2.7%, Alb - 0%, P - 0%
  • Upset stomach - 2.7%, Alb - 1.4%, P - 1.3%
  • Beta blockers - Beta blockers may block the action of levalbuterol. Nonselective beta blockers may carry a greater risk. Recent studies have found that beta blockers may actually be beneficial in patients with COPD/asthma. See beta blockers in RAD.
  • Thiazide diuretics - levalbuterol may worsen hypokalemia (low potassium) caused by these drugs
  • Loop diuretics - levalbuterol may worsen hypokalemia (low potassium) caused by these drugs
  • Digoxin - oral and IV albuterol may decrease digoxin levels. It's unclear if inhaled levalbuterol has the same effect.
  • MAO inhibitors - MAO inhibitors may potentiate the cardiovascular effects of levalbuterol
  • Tricyclic antidepressants - Tricyclic antidepressants may potentiate the cardiovascular effects of levalbuterol
  • Hypokalemia (low potassium) - levalbuterol may cause potassium levels to decrease
  • Paradoxical bronchospasm - cases of paradoxical bronchospasm have been reported
  • Hyperglycemia (elevated blood sugar) - levalbuterol may cause an increase in blood sugars. This effect is typically insignificant.
  • Cardiovascular effects - increases in pulse and blood pressure can occur in some patients. These reactions are rare.
  • EKG changes - flattening of the T-wave, QT-interval prolongation, and ST-segment depression have been reported
  • Cardiovascular disease - use with caution in patients with cardiovascular disease
  • Heart arrhythmias - use with caution in patients with heart arrhythmias
  • Liver disease - has not been studied extensively
  • Kidney disease - may decrease levalbuterol clearance




Drug Dosage form Dosage Generic/Price Other Class/Mechanism of Action Indications
(FDA-approved)
Side Effects
P = % of patients on placebo
who experienced side effect
Drug Interactions Precautions/
Contraindications
Formoterol
and arformoterol

(Foradil®)
(Brovana®)
(Perforomist®)
Formoterol + budesonide

(Symbicort®)
Formoterol + mometasone

(Dulera®)
Inhaler - Foradil®
  • Foradil® comes in a capsule that has 12 mcg of formoterol powder in the center
  • Powder is inhaled through a device called an aerolizer
  • Capsules are available in boxes of 60

Nebulizer solution
  • Brovana® - 15 mcg of arformoterol in 2 ml of solution
  • Perforomist® - 20 mcg of formoterol fumarate in 2 ml of solution
Inhaler (Asthma and COPD)
  • ≥ 5 years old and adults
    • One capsule every 12 hours using AEROLIZER inhaler

Nebulizer (COPD only)
  • Adults
    • One treatment twice a day

Prevention of exercise-induced asthma
Inhaler (≥ 5 years)
  • One capsule at least 15 minutes before exercise
  • Protection may last up to 12 hours
  • Effect will diminish if used frequently
Inhaler
NO/$$$$

Nebulizer
NO/$$$$
  • Brovana® - store in refrigerator. May store at room temperature for up to 6 weeks. Protect from light.

  • Perforomist® - store in refrigerator before dispensing. May store at room temperature for up to 3 months. Protect from light.

  • Foradil® - store in refrigerator before dispensing. May store at room temperature. Follow patient instructions for using inhaler.

  • Stimulates Beta-2 adrenergic receptors which causes bronchial smooth muscle dilation
Foradil® inhaler
  • Treatment of asthma and prevention of bronchospasm in patients ≥ 5 years of age. Should only be used as concomitant therapy with a long-term asthma control medication like an inhaled corticosteroid
  • Prevention of exercise-induced asthma in patients ≥ 5 years of age
  • Chronic Obstructive Pulmonary Disease (COPD)
  • NOT indicated for relief of acute bronchospasm

Brovana® and Perforomist nebulizer
  • Chronic Obstructive Pulmonary Disease (COPD) in adults
  • Side effects of formoterol are similar to those seen with albuterol. In trials, formoterol was often added to albuterol, so it is difficult to discern which effects may be attributable to formoterol only.

  • See albuterol for common side effects

  • Side effects that demonstrated a dose-response to formoterol included:
    • Tremor
    • Dizziness
    • Voice impairment
    • Data from Foradil® PI
  • Beta blockers - Beta blockers may block the action of formoterol. Nonselective beta blockers may carry a greater risk. Recent studies have found that beta blockers may actually be beneficial in patients with COPD/asthma. See beta blockers in RAD.
  • Thiazide diuretics - formoterol may worsen hypokalemia (low potassium) caused by these drugs
  • Drugs that prolong the QT interval - formoterol may potentiate QT prolongation
  • Loop diuretics - formoterol may worsen hypokalemia (low potassium) caused by these drugs
  • Theophylline - may potentiate hypokalemia (low potassium)
  • Corticosteroids - may potentiate hypokalemia (low potassium)
  • MAO inhibitors - MAO inhibitors may potentiate the cardiovascular effects of formoterol
  • Tricyclic antidepressants - Tricyclic antidepressants may potentiate the cardiovascular effects of formoterol
  • Halogenated hydrocarbons - may increase risk of arrhythmia
  • Severe allergy to milk proteins (Foradil® only) - DO NOT USE, contains lactose
  • Increased risk of asthma-related death - LABAs have been associated with an increased risk of asthma-related deaths
  • Increased risk of serious asthma exacerbations - in several formoterol trials, children aged 5 - 11 years had an increased risk of severe asthma exacerbation when compared to placebo
  • Hypokalemia (low potassium) - formoterol may cause potassium levels to decrease. The effect is usually transient and insignificant.
  • Hyperglycemia (elevated blood sugar) - formoterol may cause an increase in blood sugars. This effect is typically insignificant.
  • Paradoxical bronchospasm - cases of paradoxical bronchospasm have been reported
  • Cardiovascular effects - increases in pulse and blood pressure can occur in some patients. These reactions are rare.
  • EKG changes - flattening of the T-wave, QT-interval prolongation, and ST-segment depression have been reported
  • Cardiovascular disease - use with caution in patients with cardiovascular disease
  • Heart arrhythmias - use with caution in patients with heart arrhythmias
  • Liver disease - has not been studied extensively. Use caution.
  • Kidney disease - has not been studied extensively

Drug Dosage form Dosage Generic/Price Other Class/Mechanism of Action Indications
(FDA-approved)
Side Effects
P = % of patients on placebo
who experienced side effect
Drug Interactions Precautions/
Contraindications
Indacaterol

(Arcapta®)
Arcapta NeoHaler®
  • Arcapta® comes in a capsule that has 75 mcg of indacaterol powder in the center
  • Powder is inhaled through a device called a Neohaler
  • Capsules are available in boxes of 30
COPD
  • One capsule via Neohaler once daily
NO/$$$$
  • Protect from light and moisture

  • Remove from blister pack immediately before use

  • Stimulates Beta-2 adrenergic receptors which causes bronchial smooth muscle dilation
  • Chronic Obstructive Pulmonary Disease (COPD)

  • NOT indicated for relief of acute bronchospasm
  • Cough- 6.5%, P - 4.5%
  • Nasopharyngitis- 5.3%, P - 2.7%
  • Headache- 5.1%, P - 2.5%
  • Nausea- 2.4%, P - 0.9%
  • Mouth pain - 2.2%, P - 0.7%
  • Beta blockers - Beta blockers may block the action of indacaterol. Nonselective beta blockers may carry a greater risk. Recent studies have found that beta blockers may actually be beneficial in patients with COPD/asthma. See beta blockers in RAD.
  • Thiazide diuretics - indacaterol may worsen hypokalemia (low potassium) caused by these drugs
  • Drugs that prolong the QT interval - indacaterol may potentiate QT prolongation
  • Loop diuretics - indacaterol may worsen hypokalemia (low potassium) caused by these drugs
  • Theophylline - may potentiate hypokalemia (low potassium)
  • Corticosteroids - may potentiate hypokalemia (low potassium)
  • MAO inhibitors - MAO inhibitors may potentiate the cardiovascular effects of indacaterol
  • Tricyclic antidepressants - Tricyclic antidepressants may potentiate the cardiovascular effects of indacaterol
  • Indacaterol is a CYP3A4 substrate and a minor P-gp substrate. In studies, combined inhibition of CYP3A4 and P-gp did not have a significant effect on indacaterol.
  • Severe allergy to milk proteins - DO NOT USE, contains lactose
  • Increased risk of asthma-related death - LABAs have been associated with an increased risk of asthma-related deaths. Indacaterol is not indicated for use in asthma.
  • Hypokalemia (low potassium) - indacaterol may cause potassium levels to decrease. The effect is usually transient and insignificant.
  • Hyperglycemia (elevated blood sugar) - indacaterol may cause an increase in blood sugars. This effect is typically insignificant.
  • Paradoxical bronchospasm - cases of paradoxical bronchospasm have been reported
  • Cardiovascular effects - increases in pulse and blood pressure can occur in some patients. These reactions are rare.
  • EKG changes - flattening of the T-wave, QT-interval prolongation, and ST-segment depression have been reported
  • Cardiovascular disease - use with caution in patients with cardiovascular disease
  • Heart arrhythmias - use with caution in patients with heart arrhythmias
  • Liver disease - mild-moderate - no dose adjustment necessary; severe - has not been studied
  • Kidney disease - has not been studied; indacaterol undergoes minimal kidney elimination

Drug Dosage form Dosage Generic/Price Other Class/Mechanism of Action Indications
(FDA-approved)
Side Effects
P = % of patients on placebo
who experienced side effect
Drug Interactions Precautions/
Contraindications
Olodaterol

(Striverdi Respimat®)
Striverdi Respimat® inhaler
  • Inhaler comes with cartridge that contains 60 sprays (inhalations)
COPD
  • Two inhalations once daily at the same time of the day
NO/$$$$
  • After assembly, inhaler should be discarded at the latest 3 months after first use

  • Stimulates Beta-2 adrenergic receptors which causes bronchial smooth muscle dilation
  • Chronic Obstructive Pulmonary Disease (COPD)

  • NOT indicated for relief of acute bronchospasm
  • Nasopharyngitis- 11.3%, P - 7.7%
  • Upper respiratory infection - 8.2%, P - 7.5%
  • Bronchitis- 4.7%, P - 3.6%
  • Cough - 4.2%, P - 4.0%
  • Beta blockers - Beta blockers may block the action of olodaterol. Nonselective beta blockers may carry a greater risk. Recent studies have found that beta blockers may actually be beneficial in patients with COPD/asthma. See beta blockers in RAD.
  • Thiazide diuretics - olodaterol may worsen hypokalemia (low potassium) caused by these drugs
  • Drugs that prolong the QT interval - olodaterol may potentiate QT prolongation
  • Loop diuretics - olodaterol may worsen hypokalemia (low potassium) caused by these drugs
  • Theophylline - may potentiate hypokalemia (low potassium)
  • Corticosteroids - may potentiate hypokalemia (low potassium)
  • MAO inhibitors - MAO inhibitors may potentiate the cardiovascular effects of olodaterol
  • Tricyclic antidepressants - tricyclic antidepressants may potentiate the cardiovascular effects of olodaterol
  • Olodaterol is a CYP2C9 and CYP2C8 substrate. No dose adjustment is recommended when used with inhibitors of these enzymes.
  • Increased risk of asthma-related death - LABAs have been associated with an increased risk of asthma-related deaths. Olodaterol is not indicated for use in asthma.
  • Congenital long QT syndrome - DO NOT USE. May cause QT prolongation
  • Hypokalemia (low potassium) - olodaterol may cause potassium levels to decrease. The effect is usually transient and insignificant.
  • Hyperglycemia (elevated blood sugar) - olodaterol may cause an increase in blood sugars. This effect is typically insignificant.
  • Paradoxical bronchospasm - cases of paradoxical bronchospasm have been reported
  • Cardiovascular effects - increases in pulse and blood pressure can occur in some patients. These reactions are rare.
  • EKG changes - flattening of the T-wave, QT-interval prolongation, and ST-segment depression have been reported
  • Cardiovascular disease - use with caution in patients with cardiovascular disease
  • Heart arrhythmias - use with caution in patients with heart arrhythmias
  • Liver disease - mild-moderate - no dose adjustment necessary; severe - has not been studied
  • Kidney disease - no dose adjustment necessary

Drug Dosage form Dosage Generic/Price Other Class/Mechanism of Action Indications
(FDA-approved)
Side Effects
P = % of patients on placebo
who experienced side effect
Drug Interactions Precautions/
Contraindications
Salmeterol

(Serevent®)
Salmeterol + fluticasone

(Advair®)
Inhaler - Serevent®
  • Comes as a powder that is packaged in a diskus device
  • Each dose delivers 50 mcg of salmeterol
  • Each diskus contains 60 doses
Asthma and COPD
    ≥ 4 years old and adults
    • One inhalation twice a day

Prevention of exercise-induced asthma
    ≥ 4 years old and adult
    • One inhalation at least 30 minutes before exercise
    • Protection may last up to 9 hours in adolescents and adults and up to 12 hours in patients aged 4 to 11 years
    • Effect will diminish if used frequently
NO/$$$$
  • Diskus is good for 6 weeks after removing from foil pouch

  • Store at room temperature

  • Protect from sunlight
  • Stimulates Beta-2 adrenergic receptors which causes bronchial smooth muscle dilation
  • Treatment of asthma and prevention of bronchospasm in patients ≥ 4 years of age. Should only be used as concomitant therapy with a long-term asthma control medication like an inhaled corticosteroid.

  • Prevention of exercise-induced asthma in patients ≥ 4 years of age

  • Chronic Obstructive Pulmonary Disease (COPD)

  • NOT indicated for relief of acute bronchospasm
  • Alb = % of patients on albuterol 4 times a day that experienced side effect
  • Headache- 13%, Alb - 12%, P - 9%
  • Sinus congestion - 9%, Alb - 8%, P - 6%
  • Tracheitis/Bronchitis - 7%, Alb - 3%, P - 4%
  • Runny nose - 5%, Alb - 4%, P - 4%
  • Influenza- 5%, Alb - 5%, P - 2%
  • CYP3A4 strong inhibitors - DO NOT COMBINE. Salmeterol is a CYP3A4 substrate. Strong inhibitors of CYP3A4 may increase salmeterol levels and may cause EKG changes.
  • Beta blockers - Beta blockers may block the action of salmeterol. Nonselective beta blockers may carry a greater risk. Recent studies have found that beta blockers may actually be beneficial in patients with COPD/asthma. See beta blockers in RAD.
  • Thiazide diuretics - salmeterol may worsen hypokalemia (low potassium) caused by these drugs
  • Drugs that prolong the QT interval - salmeterol may potentiate QT prolongation
  • Loop diuretics - salmeterol may worsen hypokalemia (low potassium) caused by these drugs
  • Theophylline - may potentiate hypokalemia (low potassium)
  • Corticosteroids - may potentiate hypokalemia (low potassium)
  • MAO inhibitors - MAO inhibitors may potentiate the cardiovascular effects of salmeterol
  • Tricyclic antidepressants - Tricyclic antidepressants may potentiate the cardiovascular effects of salmeterol
  • Severe allergy to milk proteins - DO NOT USE, contains lactose
  • Increased risk of asthma-related death - LABAs have been associated with an increased risk of asthma-related deaths
  • Increased risk of serious asthma exacerbations - In trials involving pediatric and adolescent patients, LABAs have been associated with an increased risk of severe asthma exacerbations
  • Hypokalemia (low potassium) - salmeterol may cause potassium levels to decrease. The effect is usually transient and insignificant.
  • Hyperglycemia (elevated blood sugar) - salmeterol may cause an increase in blood sugars. This effect is typically insignificant.
  • Paradoxical bronchospasm - cases of paradoxical bronchospasm have been reported
  • Cardiovascular effects - increases in pulse and blood pressure can occur in some patients. These reactions are rare.
  • EKG changes - flattening of the T-wave, QT-interval prolongation, and ST-segment depression have been reported
  • Cardiovascular disease - use with caution in patients with cardiovascular disease
  • Heart arrhythmias - use with caution in patients with heart arrhythmias
  • Liver disease - has not been studied extensively. Use caution.
  • Kidney disease - has not been studied extensively





Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Formoterol + budesonide

(Symbicort®)
Symbicort® Inhaler (budesonide/formoterol)
  • Symbicort® 80/4.5 - 80 mcg/4.5 mcg per actuation
  • Symbicort® 160/4.5 - 160 mcg/4.5 mcg per actuation
  • Comes in inhaler with 120 actuations
Asthma
    6 to 11 years old
    • Dose: Symbicort 80/4.5 two inhalations twice daily

    12 years of age and older
    • Dose: two inhalations twice daily
    • Starting - may start with 80/4.5 or 160/4.5, depending on severity
    • Max: Symbicort 160/4.5 two inhalations twice daily
    • Maximum benefit seen after 2 weeks

COPD
  • For patients with COPD, the recommended dose is Symbicort 160/4.5 two inhalations twice daily
NO/$$$$
  • Shake well for 5 seconds before use

  • Inhaler is good for 3 months after removal from foil pouch

  • If you do not use your inhaler for more than 7 days or if you drop it, you will need to prime again

  • See patient instructions for details
  • Maintenance treatment of Asthma

  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)

  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Formoterol + mometasone

(Dulera®)
Dulera® Inhaler (mometasone/formoterol)
  • Dulera® 100/5 - 100 mcg/5 mcg per actuation
  • Dulera® 200/5 - 200 mcg/5 mcg per actuation
  • Comes in inhaler with 120 actuations
Asthma
12 years of age and older
  • Dose: 2 inhalations twice daily
  • Medium dose corticosteroids: Dulera® 100 mcg/5 mcg, two inhalations twice daily
  • High dose corticosteroids: Dulera® 200 mcg/5 mcg, two inhalations twice daily
  • Maximum benefit seen after 2 weeks

NO/$$$$
  • Shake well before use

  • Prime inhaler by releasing 4 test sprays

  • Re-prime if not used for ≥ 5 days
  • Maintenance treatment of Asthma

  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Salmeterol + fluticasone

(Advair®)
Advair® Diskus (fluticasone/salmeterol)
  • Advair® 100/50 - 100 mcg/50 mcg per inhalation
  • Advair® 250/50 - 250 mcg/50 mcg per inhalation
  • Advair® 500/50 - 500 mcg/50 mcg per inhalation
  • Inhalation powder packaged in diskus with 60 doses

Advair® HFA (fluticasone/salmeterol)
  • Advair HFA® 45/21 - 45 mcg/21 mcg per actuation
  • Advair HFA® 115/21 - 115 mcg/21 mcg per actuation
  • Advair HFA® 230/21 - 230 mcg/21 mcg per actuation
  • Inhaler with 120 actuations per inhaler
Advair® Diskus
Asthma
  • 4 - 11 years old
    • One inhalation of 100/50 twice daily
  • 12 years of age and older
    • Dose: one inhalation twice daily
    • Starting: strength will depend on asthma severity
    • Max dose: 500/50, one inhalation twice daily
    • Maximum benefit seen after 2 weeks

COPD
  • 1 inhalation of 250/50 twice daily

Advair® HFA
Asthma in children ≥ 12 years and adults
  • Dose: two inhalations twice daily
  • Starting: strength will depend on asthma severity
  • Max dose: 230/21, two inhalations twice daily
  • Maximum benefit seen after 2 weeks

HFA and diskus
NO/$$$$
Advair® HFA
  • Shake well for 5 seconds before use
  • Prime before using for the first time by releasing 4 test sprays
  • In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 test sprays
  • Rinse mouth after use

Advair® Diskus
  • The device should be discarded 1 month after removal from the moisture-protective foil overwrap pouch
  • Rinse mouth after use
Advair® Diskus
  • Asthma in children ≥ 4 years and adults

  • Chronic Obstructive Pulmonary Disease (COPD)

  • NOT for relief of acute bronchospasm

Advair® HFA
  • Asthma in children ≥ 12 years and adults

  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Vilanterol + fluticasone

(Breo® Ellipta®)
Breo Ellipta® inhaler
  • Inhaler delivers 100 mcg of fluticasone powder and 25 mcg of vilanterol powder per inhalation
  • Inhaler comes with 30 inhalations
COPD
  • One inhalation once daily

Asthma (≥ 18 years old)
  • One inhalation once daily
NO/$$$$
  • See Breo Ellipta® PI for complete prescribing information

  • Discard inhaler 6 weeks after opening the foil tray

  • DO NOT USE in patients with severe milk allergy

  • Vilanterol is a CYP3A4 substrate. Use caution with strong CYP3A4 inhibitors.

  • DO NOT USE in patients with congenital long QT syndrome [4]
  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)

  • Asthma in patients ≥ 18 years old that is not well-controlled with other medications

  • NOT for relief of acute bronchospasm





Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Albuterol + ipratropium

(Combivent Respimat®)
(Duoneb®)
Inhaler - Combivent Respimat®
  • Device delivers 100 mcg of albuterol and 20 mcg of ipratropium per actuation (120 actuations per device)

Nebulizer solution - Duoneb®
  • Ipratropium 0.017% / Albuterol base 0.083% (0.5 mg/2.5 mg per 3 ml neb)
Acute bronchospasm
Combivent Respimat®
  • 1 inhalation four times a day
  • Max - 6 inhalations in 24 hours

Duoneb®
  • 1 neb four times a day
  • Max - 6 nebs in 24 hours

Acute asthma exacerbation
See Albuterol + ipratropium in acute exacerbation below

Combivent Respimat®
NO/$$$$

Duoneb®
YES/$
  • Combivent Respimat® is good for 3 months after first use

  • See Combivent Respimat® patient insert for priming instructions
  • Chronic Obstructive Pulmonary Disease (COPD)

  • Relief of bronchospasm


Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Formoterol + glycopyrrolate

(Bevespi Aerosphere™)
Inhaler
  • Device delivers 4.8 mcg of formoterol and 9 mcg of glycopyrrolate per actuation
  • Each inhaler contains 120 inhalations
COPD
  • 2 inhalations twice a day
NO/$$$$

  • Inhaler must be primed. See package insert for instructions.
  • See Bevespi Aerosphere PI for complete prescribing information
  • Inhaler is good for 3 months after removal from foil pouch
  • Chronic Obstructive Pulmonary Disease (COPD)
  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic Other Indications
(FDA-approved)
Indacaterol + glycopyrrolate

(Utibron® Neohaler)
Utibron® Neohaler
  • Inhaler delivers 27.5 mcg of indacaterol and 15.6 mcg of glycopyrrolate per inhalation capsule
  • Inhaler comes with 60 inhalation capsules
COPD
  • 1 inhalation twice a day
  • Use at the same time every day
NO/$$$$
  • See Utibron® PI for complete prescribing information
  • Use with caution in patients with severe milk allergy. Contains lactose.

  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)

  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic Other Indications
(FDA-approved)
Olodaterol + tiotropium

(Stiolto® Respimat)
Stiolto® Respimat inhaler
  • Inhaler delivers 3.124 mcg tiotropium (equivalent to 2.5 mcg tiotropium) and 2.736 mcg olodaterol (equivalent to 2.5 mcg olodaterol) per spray
  • Inhaler comes with 60 actuations
COPD
  • 2 inhalations once daily
  • Use at the same time every day
NO/$$$$
  • See Stiolto® PI for complete prescribing information

  • Inhaler should be primed. See patient instructions for details

  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)

  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Vilanterol + umeclidinium

(Anoro Ellipta®)
Anoro Ellipta® inhaler
  • Inhaler delivers 62.5 mcg of umeclidinium powder and 25 mcg of vilanterol powder per inhalation
  • Inhaler comes with 30 inhalations
COPD
  • One inhalation once daily
NO/$$$$
  • See Anoro Ellipta® PI for complete prescribing information

  • Discard inhaler 6 weeks after opening the foil tray

  • DO NOT USE in patients with severe milk allergy

  • Vilanterol is a CYP3A4 substrate. Use caution with strong CYP3A4 inhibitors.

  • DO NOT USE in patients with congenital long QT syndrome [4]
  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)

  • NOT for relief of acute bronchospasm





Reference [1]
Acute asthma exacerbation
Child dose
(≤ 12 years old)
Adult dose (≥ 13 years old) Other
Albuterol nebulizer
(0.63 mg/3 mL)
(1.25 mg/3 mL)
(2.5 mg/3 mL)
(5.0 mg/mL concentrate)
0.15 mg/kg (minimum dose 2.5 mg) every 20 minutes for 3 doses then 0.15 – 0.3 mg/kg up to 10 mg every 1–4 hours as needed, or 0.5 mg/kg/hour by continuous nebulization 2.5 – 5 mg every 20 minutes for 3 doses, then 2.5 – 10 mg every 1–4 hours as needed, or 10 – 15 mg/hour continuously For optimal delivery, dilute aerosols to minimum of 3 mL at gas flow of 6 – 8 L/min. Use large volume nebulizers for continuous administration. May mix with ipratropium nebulizer solution.
Albuterol inhaler
(Proventil HFA®)
(Ventolin HFA®)
(ProAir HFA®)
4 – 8 puffs every 20 minutes for 3 doses, then every 1 – 4 hours inhalation maneuver as needed. Use VHC; add mask in children < 4 years. 4 – 8 puffs every 20 minutes up to 4 hours, then every 1 – 4 hours as needed. In mild-to-moderate exacerbations, MDI plus VHC is as effective as nebulized therapy with appropriate administration technique and coaching by trained personnel.
Levalbuterol nebulizer
(0.31 mg/3 mL)
(0.63 mg/3 mL)
(1.25 mg/3 mL)
(2.5 mg/mL concentrate)
0.075 mg/kg (minimum dose 1.25 mg) every 20 minutes for 3 doses, then 0.075 – 0.15 mg/kg up to 5 mg every 1 – 4 hours as needed 1.25 – 2.5 mg every 20 minutes for 3 doses, then 1.25 – 5 mg every 1 – 4 hours as needed Levalbuterol administered in one-half the mg dose of albuterol provides comparable efficacy and safety. Has not been evaluated by continuous nebulization.
Levalbuterol inhaler
(Xopenex HFA®)
4 – 8 puffs every 20 minutes for 3 doses, then every 1 – 4 hours inhalation maneuver as needed. Use VHC; add mask in children < 4 years. 4 – 8 puffs every 20 minutes up to 4 hours, then every 1 – 4 hours as needed. In mild-to-moderate exacerbations, MDI plus VHC is as effective as nebulized therapy with appropriate administration technique and coaching by trained personnel.
Duoneb®
(0.5 mg/2.5 mg per 3 ml neb)
1.5 - 3 mL every 20 minutes for 3 doses, then as needed 3 mL every 20 minutes for 3 doses, then as needed May be used for up to 3 hours in the initial management of severe exacerbations. The addition of ipratropium to albuterol has not been shown to provide further benefit once the patient is hospitalized.
Combivent Respimat® 4 – 8 puffs every 20 minutes as needed up to 3 hours 8 puffs every 20 minutes as needed up to 3 hours Should use with VHC and face mask for children < 4 years




Study Criteria Intervention Primary outcome Results

Tiotropium
vs
LABA
in adult black asthmatics


BELT trial

JAMA 2015

PubMed abstract
Inclusion criteria:
  • Black adults 18 - 75 years old
  • Physician-diagnosed asthma
  • Taking LABA + ICS or taking ICS and having an Asthma Control Questionnaire (ACQ) score higher than 1.25

Exclusion criteria:
  • Current smoker or smoking history > 10 pack-years
  • FEV < 40% predicted
  • ICU admission for asthma in past 5 years
  • Exacerbation requiring oral steroids within 3 months

Baseline characteristics
  • Average age 45 years; female - 76%
  • Former smoker - 36%
  • FEV1: <60 - 15%, 60-79 - 37%, ≥80 - 48%
Group 1 (538 patients) - LABA + ICS

Group 2 (532 patients) - Tiotropium + ICS

  • ICS = Inhaled corticosteroid
  • LABA = Long-acting beta agonist
  • Patients continued on their current ICS
  • LABA was either salmeterol or formoterol
  • Study treatment was open-label
  • The primary outcome was time to asthma exacerbation, defined as an event of worsening asthma requiring oral or parenteral corticosteroids, such as an unscheduled physician visit, emergency department visit, hospitalization, or physician judgment of clinical asthma status over the follow-up duration of the study

  • The study also evaluated whether allelic variation at the Arg16Gly locus of the β2-adrenergic receptor (ADRB2) gene is associated with treatment response
After an average follow-up of 310 days, the following was seen:
  • Primary outcome: there was no significant difference between groups (p=0.47)
  • Average number of exacerbations per person-year: Group 1 - 0.42, Group 2 - 0.37 (rate ratio 0.90, [95% CI, 0.73 to 1.11], p=0.31)
  • Change in FEV₁ at 12 months: Group 1 - +0.003L, Group 2 - -0.018L (diff 0.020, 95%CI [−0.021 to 0.061], p=0.33)
  • Study discontinuation rates: Group 1 - 31%, Group 2 - 35% (p=0.12)
  • Arg16Gly ADRB2 alleles were not associated with differences in effects of either drug


Study Criteria Intervention Primary outcome Results
Advair®
vs
Doubling Flovent®



Am J Respir Crit Care Med
2010


PubMed abstract


Inclusion criteria:
  • Children aged 6 - 16 years with asthma
  • Symptomatic on conventional doses of ICS (up to 250 mcg fluticasone or equivalent)

  • All participants were enrolled in a 4 week run-in period where they were given fluticasone 100 mcg twice a day
  • Patients who were still symptomatic during the last 14 days of the run-in phase were randomized to treatment
Group 1 (80 patients) - Fluticasone 200 mcg twice a day for 26 weeks

Group 2 (78 patients) - Salmeterol/fluticasone (Advair®) 50/100 twice a day for 26 weeks

  • Albuterol was allowed during the study
  • Primary outcome parameter was the percentage of symptom-free days during the last 10 weeks of the treatment period.
  • After the run-in period, percentage of symptom-free days was about 32% in both groups
  • Percentage of symptom-free days during the last 10 weeks of the treatment period were ∼ 50% in both groups
  • There was no significant difference between the two groups (p-value=0.93)
  • FEV₁ measurements did not differ significantly between the two groups at the end of the study (p-value 0.39)

Study Criteria Intervention Primary outcome Results
Flovent®
vs
Advair®
vs
Flovent® + Singulair®

CARE study



NEJM
2010


PubMed abstract


Inclusion criteria:
  • Children aged 6 - 17 years with mild-moderate asthma
  • An FEV₁ of at least 60% before bronchodilation, and an increase in the FEV₁ of at least 12% (bronchodilator reversibility)

  • All participants were enrolled in a 2 - 8 week run-in period where they were given fluticasone 100 mcg twice a day
  • Patients who were still symptomatic during a 2 week period of the run-in phase were randomized to treatment
There were 3 treatment regimens and all patients received each regimen for 16 weeks in random order. A total of 165 patients were evaluated.

  • Treatment 1 - Fluticasone diskus 250 mcg twice daily for 16 weeks
  • Treatment 2 - Salmeterol 50 mcg/fluticasone 100 mcg (Advair diskus®) twice daily for 16 weeks
  • Treatment 3 - Fluticasone 100 mcg twice daily + 5 - 10 mg of montelukast (Singulair®) for 16 weeks

  • Albuterol and prednisone were allowed as needed
  • The primary outcome was the differential response to each of the three step-up therapies on the basis of fixed threshold criteria for the following three asthma-control measures: the need for treatment with oral prednisone for acute asthma exacerbations, the number of asthma control days, and the FEV₁.
  • Treatment 2 was more likely to be the best response when compared to Treatment 1 (p-value=0.002) and Treatment 3 (p-value=0.004)
  • There was no significant difference between Treatment 1 and Treatment 3
  • White race predicted a better response to Advair® (Treatment 2)
  • Black patients were least likely to have a best response to Singulair® (Treatment 3)

Study Criteria Intervention Primary outcome Results

Singulair® + Flovent®
vs
Advair®



BMJ
2003


PubMed abstract


Inclusion criteria:
  • Uncontrolled asthmatics aged 15 - 72 years
  • PFTs consistent with asthma
  • Regular ICS use

  • All participants were enrolled in a 4 week run-in period where they were given fluticasone 100 mcg twice a day
  • Group 1 (747 patients) - Montelukast 10 mg a day in addition to fluticasone for 48 weeks
  • Group 2 (743 patients) - Salmeterol 50 mcg twice a day in addition to fluticasone for 48 weeks

  • Albuterol and prednisone were allowed as needed
  • The primary endpoint was the percentage of patients with at least one asthma exacerbation, defined as worsening asthma requiring an unscheduled visit to a doctor, emergency department, or hospital or treatment with oral, intravenous, or intramuscular corticosteroids
  • In Group 1, 20.1% of patients had at least one asthma exacerbation
  • In Group 2, 19.1% of patients had at least one asthma exacerbation
  • The difference between the groups was nonsignificant (1%, CI -3.1% to 5%)
  • Group 2 had a significantly greater increase in FEV₁ than Group 1 (p-value<0.001)




Study Criteria Intervention Primary outcome Results
Advair®
vs
Serevent®
vs
Flovent®
vs
Placebo

TORCH study



NEJM
2007


PubMed abstract


Inclusion criteria:
  • Current or former smokers with at least a 10-pack-year history
  • PFTs consistent with at least moderate COPD (FEV₁ < 60% of predicted)

Exclusion criteria:
  • Long-term oral corticosteroids
  • Oxygen therapy
Patients were randomized to 1 of 4 treatments:
  • Group 1 (1533 patients) - Advair (fluticasone + salmeterol) 500/50 twice daily
  • Group 2 (1521 patients) - Salmeterol 50 mcg twice daily
  • Group 3 (1534 patients) - Fluticasone 500 mcg twice daily
  • Group 4 (1524 patients) - Placebo twice daily

  • Long-acting beta agonists and inhaled corticosteroids were discontinued in all patients before the study began
  • Other COPD meds were allowed during the study
  • The primary outcome was death from any cause over three years of follow-up
Probability of death:
  • Group 1 - 12.6%
  • Group 2 - 13.5%
  • Group 3 - 16%
  • Group 4 - 15.2%
Comparisons (Group # vs Group #, p-value):
  • 1 vs 2, p=0.48 : 1 vs 3, p=0.007 : 1 vs 4, p=0.052
  • 2 vs 1, p=0.48 : 2 vs 4, p=0.18
  • 3 vs 1, p=0.007 : 3 vs 4, p=0.53

  • Patients on fluticasone were significantly more likely to develop pneumonia (Group 1 - 19.6%, Group 3 - 18.3%) than patients not on fluticasone (Group 2 - 13.3%, Group 4 - 12.3%)



  • Long-acting beta agonists and asthma-related deaths

    • In 2006, a trial was published (the SMART study) that compared the addition of salmeterol or placebo to current asthma meds in patients with asthma who were ≥ 12 years old
    • After an interim analysis in 26,355 subjects, the trial was stopped early after a significant increase in respiratory-related deaths was noted in the salmeterol group. In subgroup analysis, risk was greater in African Americans and in patients who were not taking inhaled corticosteroids at baseline.
    • After the trial was published, the FDA placed a boxed warning about asthma-related deaths on all LABAs. The NHLBI subsequently recommended that LABAs only be added to inhaled corticosteroids, and that LABAs not be used alone for long-term control [1]
    • In 2016, three trials were published that compared the risk of serious asthma-related events between patients randomized to an inhaled corticosteroid (ICS) + LABA vs ICS alone. The trials found no increased risk in the LABA groups. One of the trials, the AUSTRI trial, is detailed below along with the SMART trial.

      • SMART Study - Salmeterol vs Placebo in Asthma, CHEST (2006) [PubMed abstract]
        • The SMART trial enrolled 26,355 asthmatics who were ≥ 12 years old
        • Main inclusion criteria: age ≥ 12 years; diagnosis of asthma per investigator judgement; receiving prescription asthma medication(s)
        • Main exclusion criteria: previous use of LABA; current use of a beta blocker
        • Baseline characteristics: average age 39 years; female sex - 64%; Caucasian - 71%, African American - 18%, Hispanic - 8%; average duration of asthma - 16 years; baseline ICS use - 47%; average PEF% - 84%
        • Patients were randomized to 1 of 2 groups:
          • Group 1 (13,176 patients): Salmeterol 42 mcg via MDI twice daily for 28 weeks
          • Group 2 (13,179 patients): Placebo inhaler twice daily for 28 weeks
          • Study drug was added to current asthma medications
          • Patients who were not currently on a SABA were given albuterol inhalers
        • PRIMARY OUTCOME: Occurrence of combined respiratory-related deaths or respiratory-related life-threatening experiences (defined as intubation and mechanical ventilation)
        • After an interim analysis in 26,355 subjects, the trial was stopped early due to findings in African American patients:
          • Primary outcome (Overall): Group 1 - 50 events, Group 2 - 36 events (RR 1.4, 95%CI [0.91 - 2.1], p>0.05)
          • Primary outcome (Caucasians): Group 1 - 29 events, Group 2 - 28 events (RR 1.05, 95%CI [0.62 - 1.76], p>0.05)
          • Primary outcome (African Americans): Group 1 - 20 events, Group 2 - 5 events (RR 4.1, 95%CI [1.54 - 11.0], p<0.05)
          • Primary outcome (ICS at baseline, Overall): Group 1 - 23 events, Group 2 - 19 events (RR 1.21, 95%CI [0.66 - 2.22], p>0.05)
          • Primary outcome (No ICS at baseline, Overall): Group 1 - 27 events, Group 2 - 17 events (RR 1.60, 95%CI [0.87 - 2.92], p>0.05)
          • Primary outcome (ICS at baseline, African American): Group 1 - 9 events, Group 2 - 3 events (RR 3.01, 95%CI [0.82 - 11.11], p>0.05)
          • Primary outcome (No ICS at baseline, African American): Group 1 - 11 events, Group 2 - 2 events (RR 5.61, 95%CI [1.25 - 25.26], p<0.05) [2]

      • AUSTRI trial - Fluticasone + Salmeterol vs Fluticasone only, NEJM (2016) [PubMed abstract]
        • The AUSTRI trial enrolled 11,679 asthmatics with moderate-to-severe asthma that required daily controller medications
        • Main inclusion criteria: age ≥ 12 years; 1-year history of asthma requiring daily medications; hospitalization or systemic steroids for an asthma exacerbation within last 12 months (excluding previous 30 days)
        • Main exclusion criteria: history of life-threatening asthma (defined as asthma that required invasive or noninvasive ventilatory support); history of unstable asthma (uncontrolled asthma in the 7 days before randomization); hospitalization or systemic steroids for an asthma exacerbation within last 30 days
        • Baseline characteristics: average age 43 years; black race - 15%
        • Patients were randomized to 1 of 2 groups:
          • Group 1 (5834 patients): fluticasone + salmeterol
          • Group 2 (5845 patients): fluticasone only
          • Salmeterol dose was 50 mcg twice daily
          • Fluticasone dose ranged from 100 - 500 mcg twice daily depending on asthma severity and was not blinded
          • All other asthma meds were stopped at randomization. Albuterol was allowed on an as needed basis. Leukotriene inhibitors, anticholinergics, and methylxanthines were allowed on a short-term basis for exacerbations.
        • PRIMARY OUTCOMES:
          • Primary safety outcome - first serious asthma-related event, a composite endpoint that included death, endotracheal intubation, and hospitalization
          • Primary efficacy outcome - first severe asthma exacerbation, which was defined as asthma deterioration that led to the use of systemic glucocorticoids for at least 3 days or an asthma related hospitalization or emergency department visit that led to the use of systemic glucocorticoids
        • After 26 weeks, the following was seen:
          • Primary safety outcome: Group 1 - 36 events, Group 2 - 38 events (HR [Group 1 vs Group 2] 1.03, 95%CI [0.64 - 1.66])
          • Primary efficacy outcome: Group 1 - 8%, Group 2 - 10% (HR 0.79, 95%CI [0.70 - 0.89], p<0.001)
          • No asthma-related deaths occurred in the trial
          • In subgroup analyses, no significant difference in risk for the primary safety outcome was noted between races and age groups

      • StraightHealthcare analysis:
        • The SMART study results led to recommendations that LABAs only be used in patients who are on current ICS therapy
        • The AUSTRI trial and two other studies (PMID 27579634, PMID 27579635) found that the addition of a LABA to current ICS therapy is both safe and effective, thus supporting the current recommendation



  • PRICING

    • $ = 0 - $50
    • $$ = $51 - $100
    • $$$ = $101 - $150
    • $$$$ = > $151

    • Pricing based on one month of therapy at standard dosing in an adult
    • Pricing based on survey of GoodRX.com®, HEB®, and Costco®, [accessed 1/2015]
    • Pricing may vary by region and availability


  • References:

  • 1 - NHLBI 2007 asthma guidelines
  • 2 - PMID 16424409
  • 3 - Manufacturer's package insert
  • 4 - CredibleMeds