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Formoterol Fumarate

Class: Selective beta-2-Adrenergic Agonists
VA Class: RE102
Chemical Name: (±)-2′-Hydroxy-5′-[(R*)-1-hydroxy-2-[[(R*)-p-methoxy-α-methylphenethyl]amino]ethyl]formanilide fumarate
Molecular Formula: C19H24N2O4)2•C4H4O4
CAS Number: 43229-80-7

Medically reviewed on Oct 15, 2018

Warning

  • Monotherapy with long-acting β2-adrenergic agonists (e.g., formoterol) increases the risk of asthma-related death and may increase the risk of asthma-related hospitalization in children and adolescents.1 41 51 (See Asthma-related Death and Serious Asthma-related Events under Cautions.)

  • Increased risk of asthma-related death considered class effect of long-acting β2-adrenergic agonists, including formoterol.1

  • Use of formoterol for treatment of asthma without concomitant use of long-term asthma controller therapy (e.g., inhaled corticosteroids) is contraindicated.1 41 (See Contraindications under Cautions.)

Introduction

Bronchodilator; a relatively selective, long-acting β2-adrenergic agonist.1

Uses for Formoterol Fumarate

Bronchospasm in Asthma

Formoterol is used only concomitantly with long-term asthma controller therapy (e.g., inhaled corticosteroids) for prevention of bronchospasm in patients with reversible obstructive airway disease (e.g., asthma).7 15 16 18 19

Monotherapy with long-acting β2-adrenergic agonists (e.g., formoterol) increases the risk of asthma-related death and may increase the risk of asthma-related hospitalization in children and adolescents.1 41 51 Use of formoterol for treatment of asthma without concomitant use of long-term asthma controller therapy (e.g., inhaled corticosteroids) is contraindicated.1 41 (See Boxed Warning and also Asthma-related Death and Serious Asthma-related Events under Cautions.)

Formoterol in fixed combination with budesonide is used only in patients with asthma not responding adequately to long-term asthma controller therapy (e.g., inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting β2-adrenergic agonist.48

Once asthma control achieved and maintained, assess patient at regular intervals and step down therapy (e.g., discontinue formoterol or formoterol in fixed combination with budesonide) if possible without loss of asthma control, and maintain patient on long-term asthma controller therapy (e.g., inhaled corticosteroids).41 48

Do not use formoterol in fixed combination with budesonide in patients with asthma adequately controlled on low or medium dosage of inhaled corticosteroids.48

Do not initiate formoterol in patients with substantially worsening or acutely deteriorating COPD; do not use to treat acute symptoms.1 Formoterol in fixed combination with budesonide not indicated for relief of acute bronchospasm; do not initiate in patients with rapidly deteriorating or potentially life-threatening episodes of asthma.48 (See Acute Exacerbations of Asthma or COPD under Cautions.)

Bronchospasm in COPD

Formoterol alone or in fixed combination with budesonide is used for long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.1 19 23 24 48

Use of long-acting β2 agonists with or without inhaled corticosteroids for acute exacerbations of COPD not evaluated.35 Use a short-acting inhaled β2-adrenergic agonist intermittently (as needed) for acute symptoms of COPD.1 33 34 35

Formoterol Fumarate Dosage and Administration

General

  • When initiating formoterol alone or in fixed combination with budesonide, discontinue regular use of short-acting, oral or inhaled β2-adrenergic agonists; use such agents only for relief of acute symptoms of asthma or COPD not controlled by formoterol.1 48

  • If a formoterol dose alone or in fixed combination with budesonide is missed, skip that dose and take the next dose at the usual time.1 48 Do not double the dose to replace the missed dose.1 48

  • Failure to respond to a previously effective dosage may indicate seriously worsening asthma or destabilization of COPD that requires reevaluation.1 18 48 Extra or increased doses of formoterol are not recommended.1 6 10 48 (See Acute Exacerbations of Asthma under Cautions.)

  • Administer a short-acting, inhaled β2-agonist to relieve acute asthmatic symptoms.1 48

Administration

Oral Inhalation

Administer formoterol as an oral inhalation solution (Perforomist) via nebulization.1 Administer oral inhalation aerosol (Symbicort) using an aerosol inhaler device with hydrofluoroalkane (HFA) propellant.48

Inhalation Solution

Administer twice daily, approximately every 12 hours (morning and evening).1

Store single-dose vials of oral inhalation solution in the foil pouch provided; remove immediately before use.1

For administration of inhalation solution via nebulization, open a 20-mcg vial and squeeze entire contents into nebulizer reservoir.1 Connect reservoir to mouthpiece or face mask and then to compressor according to manufacturer’s instructions.1

Instruct patient to sit in an upright, comfortable position and then to breathe as calmly, deeply, and evenly as possible through the mouth using the mouthpiece or face mask of the nebulizer until device stops producing mist, about 9 minutes.1

Clean nebulizer after use according to manufacturer’s instructions.1

Safety and efficacy of formoterol fumarate inhalation solution delivered from a nebulizer other than the Pari-LC Plus nebulizer or a compressor other than the PRONEB Ultra compressor not established.1

Do not mix with other inhalation solutions.1 Do not ingest the oral inhalation solution.1

Inhalation Aerosol

Administer twice daily (morning and evening).48

Test spray 2 times into the air (away from face) before first use, if not used for >7 days, or if dropped; shake well for 5 seconds before each spray.48

Shake well for 5 seconds immediately prior to use.48 Clean inhaler every 7 days by wiping mouthpiece with a dry cloth.48

After inhalation, rinse mouth and spit out water.48

Use actuator supplied with the product to administer formoterol in fixed combination with budesonide.48

Dosage

Available as formoterol fumarate dihydrate; dosage expressed in terms of anhydrous drug salt.1 Available as fixed combination containing formoterol fumarate dihydrate and budesonide; dosage expressed in terms of hydrated drug.48

Each 2-mL single-dose vial of formoterol fumarate oral inhalation solution contains 20 mcg of formoterol fumarate.1 Dilution not required prior to administration by nebulization.1 Amount of drug delivered to the lungs will depend on patient factors and type of nebulization system used and its performance.1

Each actuation of the oral aerosol inhaler containing the fixed combination of formoterol fumarate and budesonide (Symbicort) delivers 5.1 mcg of formoterol fumarate dihydrate and 91 or 181 mcg of budesonide from the valve.48 Dosage of the fixed combination is expressed in terms of drug delivered from the mouthpiece; each actuation of the oral aerosol inhaler delivers 4.5 mcg of formoterol fumarate dihydrate and 80 or 160 mcg of budesonide from the actuator per metered spray.48 Amount of drug delivered to the lungs depends on factors such as patient’s coordination between actuation of the inhaler and inspiration through the delivery system.48

Commercially available Symbicort aerosol inhaler delivers 60 metered sprays per 6- or 6.9-g canister and 120 metered sprays per 10.2-g canister.48

Pediatric Patients

Asthma
Formoterol/Budesonide Fixed-combination Therapy
Oral Inhalation Aerosol

Children 6 to <12 years of age: 9 mcg of formoterol fumarate dihydrate and 160 mcg of budesonide (2 inhalations) twice daily.51

Adolescents ≥12 years of age: 9 mcg of formoterol fumarate dihydrate and 160 or 320 mcg of budesonide (2 inhalations) twice daily; recommended initial dosage is based on patient’s asthma severity.48

If control of asthma in adolescents ≥12 years of age is inadequate after 1–2 weeks of therapy at the lower dosage, increasing the strength of the fixed combination (higher strengths contain higher dosages of budesonide only) may provide additional asthma control.48

Adults

Asthma
Formoterol/Budesonide Fixed-combination Therapy
Oral Inhalation Aerosol

9 mcg of formoterol fumarate dihydrate and 160 or 320 mcg of budesonide (2 inhalations) twice daily; recommended initial dosage is based on patient’s asthma severity.48

If control of asthma is inadequate after 1–2 weeks of therapy at the lower dosage, increasing the strength of the fixed combination (higher strengths contain higher dosages of budesonide only) may provide additional asthma control.48

COPD
Formoterol Therapy
Oral Inhalation Solution

20 mcg (entire contents of vial) every 12 hours via nebulization.1

Formoterol/Budesonide Fixed-combination Therapy
Oral Inhalation Aerosol

9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide (2 inhalations) twice daily.48

Lower dosages (i.e., 9 mcg of formoterol fumarate dihydrate and 160 mcg of budesonide twice daily) produced no additional improvement in lung function (e.g., FEV1) and are not recommended.48

Prescribing Limits

Pediatric Patients

Asthma
Formoterol/Budesonide Fixed-combination Therapy
Oral Inhalation Aerosol

Children 6 to <12 years of age: Maximum 9 mcg of formoterol fumarate dihydrate and 160 mcg of budesonide (2 inhalations) twice daily.51

Adolescents ≥12 years of age: Maximum 9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide (2 inhalations) twice daily.48 49

Adults

Asthma
Formoterol/Budesonide Fixed-combination Therapy
Oral Inhalation Aerosol

Maximum 9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide (2 inhalations) twice daily.48 49

COPD
Formoterol Therapy
Oral Inhalation Solution

Maximum 40 mcg daily.1

Formoterol/Budesonide Fixed-combination Therapy
Oral Inhalation Aerosol

Maximum 9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide (2 inhalations) twice daily.48

Special Populations

The following information addresses dosage of formoterol fumarate in special populations.1 When formoterol fumarate dihydrate is used in fixed combination with budesonide, dosage requirements for budesonide should be considered.48

Hepatic Impairment

Formoterol fumarate: No specific dosage recommendations at this time.1

Formoterol fumarate in fixed combination with budesonide: Closely monitor patients with hepatic impairment.48 (See Special Populations under Pharmacokinetics.)

Renal Impairment

No specific dosage recommendations at this time.1 48

Geriatric Patients

Formoterol fumarate: No specific dosage recommendations at this time.1

Formoterol fumarate in fixed combination with budesonide: No dosage adjustment required.48

Cautions for Formoterol Fumarate

Contraindications

  • Formoterol: Contraindicated for treatment of asthma without concomitant use of long-term asthma controller therapy (e.g., inhaled corticosteroids) because of risk of asthma-related death and hospitalization.1 (See Boxed Warning and also Asthma-related Death and Serious Asthma-related Events under Cautions.)

  • Known hypersensitivity to formoterol or any ingredient in the formulation.48

  • Formoterol in fixed combination with budesonide (Symbicort): Contraindicated as primary treatment of status asthmaticus or other acute episodes of asthma or COPD when intensive measures required.48

Warnings/Precautions

Warnings

Use of Fixed Combinations

When used in fixed combination with budesonide, consider the cautions, precautions, contraindications, and interactions associated with budesonide.48

Asthma-related Death and Serious Asthma-related Events

Increased risk of asthma-related death reported with long-acting β2-adrenergic agonists (e.g., formoterol) when used as monotherapy.1 41 48 50 51 Data from clinical trials also suggest that use of long-acting β2-adrenergic agonists as monotherapy increases the risk of asthma-related hospitalization in children and adolescents.41 51 (See Boxed Warning.)

Use of long-acting β2-adrenergic agonists, including formoterol, alone for treatment of asthma without concomitant use of long-term asthma controller therapy (e.g., inhaled corticosteroids) is contraindicated because of increased risk of asthma-related death and hospitalization.1 41

Use long-acting β2-adrenergic agonists, including formoterol, only as additional therapy in patients with asthma currently receiving long-term asthma controller therapy (e.g., inhaled corticosteroids) but whose disease is inadequately controlled with such therapy.41

Use formoterol in fixed combination with budesonide only in patients with asthma not responding adequately to long-term asthma controller therapy, (e.g., inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting β2-adrenergic agonist.48 (See Bronchospasm in Asthma under Uses.)

Large safety study (Salmeterol Multicenter Asthma Research Trial [SMART]) showed an increase in asthma-related deaths in patients receiving salmeterol.1 29 30 36 37 38 48 While no adequate studies conducted to determine whether the rate of asthma-related death is increased with formoterol, data suggest a higher incidence of serious asthma exacerbations with formoterol compared with placebo.1 48 Increased risk of asthma-related death with use of salmeterol as monotherapy is considered a class effect of the long-acting β2-adrenergic agonists, including formoterol.1 51

Based on review of 4 clinical trials (3 in adults and adolescents and 1 in children), FDA concluded there is no clinically important increased risk of serious asthma-related events (i.e., asthma-related hospitalization, intubation, death) associated with use of fixed-combination therapy with long-acting β2-adrenergic agonists and inhaled corticosteroids compared with use of inhaled corticosteroids alone for the treatment of asthma.50 51 52 53 These studies also showed that fixed-combination therapy with long-acting β2-adrenergic agonists and inhaled corticosteroids reduced the incidence of asthma exacerbations compared with use of inhaled corticosteroids alone.50 51 52 53

No adequate studies conducted to determine whether the rate of death is increased in patients with COPD receiving long-acting β2-adrenergic agonists.1

Acute Exacerbations of Asthma or COPD

Do not initiate formoterol therapy in patients with acutely deteriorating or substantially worsening asthma, which may be life-threatening; fatalities reported with orally inhaled sympathomimetic drugs.1 7 Do not initiate formoterol in fixed combination with budesonide in patients with rapidly deteriorating or potentially life-threatening episodes of asthma or COPD.48

Failure to respond to a previously effective dosage may indicate substantially worsening asthma or destabilization of COPD that requires prompt reevaluation.1 18 48 Promptly reevaluate asthma therapy if inadequate control of symptoms persists despite supplemental short-acting β2-agonist bronchodilator therapy (i.e., need to increase dose or frequency of administration).1 6 10 Reevaluation of asthma therapy may require dosage adjustment of inhaled corticosteroid or initiation of systemic corticosteroids.6 10 Do not use extra or increased doses of formoterol in such situations.1

If asthma deteriorates in patients receiving formoterol in fixed combination with budesonide, prompt reevaluation of asthma therapy is required with special consideration given to the possible need for increasing the strength of the fixed combination (higher strengths contain higher dosages of budesonide only), adding additional inhaled corticosteroids, or initiating systemic corticosteroids; do not increase the frequency of administration of formoterol in fixed combination with budesonide.48

Do not use formoterol in fixed combination with budesonide to relieve symptoms of acute asthma.5 6 8 48 Use a short-acting, inhaled β2-adrenergic agonist intermittently (as needed) for acute symptoms of asthma or COPD.1 18 31 33 34

When initiating formoterol alone or in fixed combination with budesonide, discontinue regular use (e.g., 4 times daily) of short-acting, inhaled β2-agonists and use only for relief of acute asthma symptoms.1 48

Serious exacerbations, including fatalities, reported in patients receiving formoterol.1

Excessive Doses

Possible fatalities and/or serious exacerbations of asthma associated with excessive use of inhaled sympathomimetic drugs.1 48

Patients receiving formoterol alone or in fixed combination with budesonide should not use additional formoterol or other long-acting inhaled β2-adrenergic agonists for any reason.1 48

Concomitant Anti-inflammatory Therapy

No data available demonstrating clinical anti-inflammatory effects of formoterol expected to substitute for or allow reduction in dosage of corticosteroids.6 13 15

Particular care is needed for patients transferring from systemic to orally inhaled corticosteroids since death resulting from adrenal insufficiency occurred in some asthmatic patients during and after such transfer.48

Cardiovascular Effects

Possible clinically important changes in SBP and/or DBP, heart rate, and ECG (e.g., flattening of T wave, prolongation of QTc interval, ST-segment depression) changes.1 7 17 48 May require discontinuance of the drug.1 48 Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.1 48

Nervous System Effects

Use with caution in patients with seizure disorders.1 48

Paradoxical Bronchospasm

Possible acute, life-threatening bronchospasm may occur immediately upon inhalation of formoterol.1 48 Discontinue therapy immediately and institute alternative therapy.1 48

Sensitivity Reactions

Immediate hypersensitivity reactions (e.g., anaphylaxis, urticaria, angioedema, rash, bronchospasm) reported.1 48

General Precautions

Metabolic Effects

Possible clinically important changes in blood glucose; possible clinically important decreases in serum potassium.1 48 Hypokalemia is usually transient, not requiring supplementation.1 48

Use with caution in patients with thyrotoxicosis and in those unusually responsive to sympathomimetic amines.1 48

Specific Populations

Pregnancy

Category C.48

May interfere with uterine contractility.1 Carefully weigh benefit versus risk in labor.1

Lactation

Distributed into milk in rats.1 51 Not known whether formoterol is distributed into human milk.1 51 Data also not available on the drug’s effects on the breast-fed child or milk production.1 51

When using formoterol alone or in fixed combination with budesonide, consider benefits of breast-feeding and importance of the drug to the woman; also consider any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.1 51

Pediatric Use

Formoterol: Not indicated for use in children.1 Safety and efficacy not established in children.1

Formoterol in fixed combination with budesonide: Safety and efficacy in children ≥12 years of age with asthma established in studies of up to 12 months’ duration.51 Safety and efficacy in children 6 to <12 years of age with asthma established in studies of up to 12 weeks’ duration.51 Safety and efficacy in children <6 years of age not established.51 (See Bronchospasm in Asthma under Uses.)

Available data suggest that monotherapy with long-acting β2-adrenergic agonists may increase the risk of asthma-related death and hospitalization in children and adolescents.51 (See Boxed Warning and also Asthma-related Death and Serious Asthma-related Events under Cautions.)

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1 48 (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Patients with COPD (formoterol): Diarrhea,1 nausea,1 vomiting,1 nasopharyngitis,1 dry mouth,1 dizziness,1 insomnia.1

Patients with asthma (formoterol/budesonide): Nasopharyngitis,51 headache,51 upper respiratory tract infection,51 pharyngolaryngeal pain,51 sinusitis,51 influenza,51 back pain,51 nasal congestion,51 stomach discomfort,51 vomiting,51 oral candidiasis.51

Patients with COPD (formoterol/budesonide): Nasopharyngitis,51 oral candidiasis,51 bronchitis,51 sinusitis,51 upper respiratory tract infection.51

Interactions for Formoterol Fumarate

The following information addresses potential interactions with formoterol.1 When formoterol is used in fixed combination with budesonide, consider interactions associated with budesonide.48 No formal drug interaction studies have been performed to date with the fixed-combination.48

Metabolized in the liver by CYP isoenzymes 2D6, 2C19, 2C9, and 2A6.1 48

Drugs that Prolong QT Interval

Potential pharmacologic interaction (increased risk of ventricular arrhythmias and possible potentiation of formoterol effects on cardiovascular system).1 Use extreme caution during concomitant therapy.1

Specific Drugs

Drug

Interaction

Comments

Antidepressants, tricyclic

Possible potentiation of formoterol effects on cardiovascular system1 48

Extreme caution recommended during concomitant therapy1 48 or within 2 weeks following discontinuance of a tricyclic antidepressant48

β-Adrenergic blocking agents (including ophthalmic agents)

Potential antagonism of pulmonary effects and production of severe bronchospasm in asthmatic patients1 48

If concomitant therapy required, consider cautious use of cardioselective β-adrenergic blocking agents1 48

Corticosteroids

Potential increased risk of hypokalemia1

Diuretics, non-potassium-sparing

Potential additive hypokalemia and/or ECG changes, especially when recommended β-agonist dose is exceeded1 48

Cautious use recommended1 48

MAO Inhibitors

Possible potentiation of formoterol effects on cardiovascular system1 48

Extreme caution recommended during concomitant therapy1 48 or within 2 weeks following discontinuance of an MAO inhibitor48

Sympathomimetic agents

Potential additive pharmacologic and adverse effects1

Caution recommended for concomitant use of formoterol and sympathomimetic agents administered by any route1

Xanthine derivatives

Potential increased risk of hypokalemia1

Formoterol Fumarate Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following inhalation; peak plasma concentrations usually attained within 5–10 minutes.51

Onset

Maximum improvement in forced expiratory volume in 1 second (FEV1): 2–3 hours.1 51

Duration

12 hours.1 51

Distribution

Extent

Distributed into milk in animals.1 Not known if distributed into milk in humans.1 51

Plasma Protein Binding

46–64% bound to plasma proteins; binding to serum albumin is 31–38%.1 51

Elimination

Metabolism

Metabolized in the liver by CYP isoenzymes 2D6, 2C19, 2C9, and 2A6.1 48

Elimination Route

Eliminated in feces (24–34%) and in urine (59–62%).48

Half-life

7 hours.1

Special Populations

Possible increased exposure in patients with severe hepatic impairment.48

Stability

Storage

Oral Inhalation

Solution

Prior to dispensing, 2–8°C; protect from light and heat.1

After dispensing, 2–8°C until drug expires or at 20–25°C up to 3 months; protect from light and heat.1

Do not remove single-use vials from their foil pouch until immediately before use.1

Aerosol

20–25°C with mouthpiece down.48

Contents under pressure; do not puncture, use or store near heat or an open flame, or place into a fire or incinerator.48 Exposure to temperatures >49°C may cause canister to burst.48 Discard inhaler when labeled number of inhalations used or within 3 months after removal from foil package.48 Never immerse canister in water to determine amount of drug remaining (“float test”).48

Actions

  • Synthetic sympathomimetic amine.6 7 15

  • Long-acting, selective β2-receptor agonist.1 6 7 15 48

  • Stimulates β2-adrenergic receptors with little or no effect on β1-1 6 7 48 or α-adrenergic receptors.7

  • Activates adenyl cyclase and stimulates production of cyclic adenosine-3′,5′-monophosphate (cAMP).1 48 Increased concentrations of cAMP relax bronchial smooth muscle and inhibit release of proinflammatory mast-cell mediators (e.g., histamine, leukotrienes).1 48

  • Inhibits allergen-induced infiltration of eosinophils into airways and reduces extravasation of plasma proteins (e.g., albumin).1 2 7 13 48 Does not possess clinically important anti-inflammatory effects.6 13 15

  • Prolonged therapy at greater than recommended dosages may be associated with development of tolerance to the bronchodilatory effects.17 48

Advice to Patients

  • When used in fixed combination with budesonide, importance of informing patients of important cautionary information about budesonide.48

  • A copy of the manufacturer’s patient information (medication guide) for formoterol alone or in fixed combination with budesonide must be provided to all patients with each prescription of the drug.1 40 42 48 Importance of instructing patients to read the medication guide prior to initiation of therapy and each time prescription is refilled.1 42 48

  • Importance of informing patients that monotherapy with long-acting β2-adrenergic agonists, including formoterol, increases risk of asthma-related death and may increase risk of asthma-related hospitalization in children and adolescents.1 48 51

  • Importance of informing patients that long-term asthma controller drugs must be continued when formoterol is added to the treatment regimen.51

  • Importance of children receiving therapy under adult supervision.51

  • Importance of adequate understanding of proper storage, preparation, and use of inhalation delivery systems.1 48

  • Importance of correct procedure for administering formoterol-containing therapy and concomitant therapy (e.g., a short-acting β2-adrenergic agonist).1 48 Importance of not breathing into inhaler.51

  • Importance of adherence to dosing schedules of formoterol alone or in fixed combination with budesonide and any concomitant therapy, including not altering the dose or frequency of use of such drugs unless otherwise instructed by a clinician.1 48

  • Importance of advising patients that if a dose of formoterol alone or in fixed combination with budesonide is missed, the next dose should be taken at the regularly scheduled time; the dose should not be doubled.1 48

  • Importance of informing patients of adverse effects associated with long-acting β2-adrenergic agonists such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.1 48

  • Importance of understanding that formoterol-containing therapy does not relieve acute symptoms of asthma or COPD.1 48 Importance of all patients being provided with and instructed in the use of a short-acting, inhaled β2-adrenergic bronchodilator as supplemental therapy for acute asthma symptoms.1 48

  • Importance of discontinuing regular use of a short-acting, inhaled β-adrenergic bronchodilator when initiating therapy with formoterol and instituting intermittent use of a short-acting bronchodilator (not formoterol) to relieve acute symptoms of asthma.1 48

  • Importance of contacting a clinician if respiratory symptoms worsen or are not relieved by usual dosage of formoterol fumarate.1 48 Importance of contacting a clinician or obtaining emergency medical care if 4 or more inhalations of a short-acting β2-agonist are required daily for 2 or more consecutive days, an entire canister of the short-acting β2-agonist is used in 8 weeks, peak flow meter results decrease, or asthma symptoms do not improve after 1 week of formoterol therapy.48

  • Importance of instructing patients to seek emergency medical care if breathing problems worsen rapidly and usual doses of a short-acting bronchodilator do not relieve acute asthma symptoms.1 48

  • Importance of advising patients receiving formoterol-containing preparations not to use additional formoterol or other long-acting inhaled β2-adrenergic agonists for any reason.1 48

  • Importance of patients not discontinuing formoterol-containing therapy and not discontinuing or reducing concomitant asthma therapy without medical supervision, since symptoms may worsen.48

  • Importance of promptly contacting clinicians or seeking emergency medical care if symptoms of a serious allergic reaction (e.g., rash, hives, swelling of the face, tongue or mouth, breathing problems) develop.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses (e.g., heart disease, hypertension, seizures, thyroid problems, diabetes mellitus, drug or food allergies).1 48

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 48

  • Importance of informing patients of other important precautionary information.1 48 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Formoterol Fumarate (Dihydrate)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral Inhalation

Solution, for nebulization

10 mcg (of formoterol fumarate) per mL

Perforomist (available as polyethylene vials)

Mylan

Formoterol Fumarate (Dihydrate) Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral Inhalation

Aerosol

4.5 mcg (of formoterol fumarate dihydrate) with Budesonide 80 mcg per metered spray

Symbicort (with hydrofluoroalkane propellant)

AstraZeneca

4.5 mcg (of formoterol fumarate dihydrate) with Budesonide 160 mcg per metered spray

Symbicort (with hydrofluoroalkane propellant)

AstraZeneca

AHFS DI Essentials™. © Copyright 2018, Selected Revisions October 15, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

1. Mylan. Perforomist (formoterol fumarate) inhalation solution prescribing information. Morgantown, WV; 2018 Mar.

2. Wallin A, Sandstrom T, Soderberg M et al. The effects of regular inhaled formoterol, budesonide, and placebo on mucosal inflammation and clinical indices in mild asthma. Am J Respir Crit Care Med. 1999; 159:79-86. http://www.ncbi.nlm.nih.gov/pubmed/9872822?dopt=AbstractPlus

3. National Asthma Education and Prevention Program. Expert panel report II: guidelines for the diagnosis and management of asthma. 1997 Feb.

4. Palmqvist M, Persson G, Lazer L et al. Inhaled dry-powder formoterol and salmeterol in asthmatic patients: onset of action, duration of effect and potency. Eur Respir J. 1997; 10:2484-9. http://www.ncbi.nlm.nih.gov/pubmed/9426083?dopt=AbstractPlus

5. Boulet LP, Becker A, Berube D et al. Summaryof recommendations from the Canadian Asthma Consensus Report, 1999. CMAJ. 1999; 161(Suppl.11):S1-S12.

6. Moore RH, Khan A, Dickey BF et al. Long-acting inhaled β2-agonists in asthma therapy. Chest. 1998; 113:1095-1108. http://www.ncbi.nlm.nih.gov/pubmed/9554653?dopt=AbstractPlus

7. Bartow RA, Brogden RN. Formoterol. An update of its pharmacological properties and therapeutic efficacy in the management of asthma. Drugs. 1998; 55:303-22. http://www.ncbi.nlm.nih.gov/pubmed/9506248?dopt=AbstractPlus

8. GlaxoWellcome. Serevent Diskus (salmeterol xinafoate inhalation powder) prescribing information. Research Triangle Park, NC; 2001 Mar.

9. Beasley R, Pearce N, Crane J et al. β-agonists: what is the evidence that their use increases the risk of asthma morbidity and mortality? J Allergy Clin Immunol. 1999; 103:S18-30. (IDIS 435471)

10. Tattersfield AE, Postma DS, Barnes PJ et al. Exacerbations of asthma: a descriptive study of 425 severe exacerbations. Am J Respir Crit Care Med. 1999; 160:594-9. http://www.ncbi.nlm.nih.gov/pubmed/10430734?dopt=AbstractPlus

12. Bensch G, Lapidus RJ, Levine BE et al. A randomized, 12-week, double-blind, placebo-controlled study comparing formoterol dry powder inhaler with albuterol metered-dose inhaler. Ann Allergy Asthma Immunol. 2001; 86L19-27. (IDIS 458307)

13. Pauwels RA, Lofdahl CG, Postma DS et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. N Engl J Med. 1997; 337:1405-11. http://www.ncbi.nlm.nih.gov/pubmed/9358137?dopt=AbstractPlus

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