Foradil

Generic Name: 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

Special Alerts:

[Posted 02/18/2010] FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all Long-Acting Beta-Agonists (LABAs). The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.

Healthcare professionals are reminded that to ensure the safe use of these products:

• 
  

  Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.

  
  


• 
  

  LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.

  
  


• 
  

  LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.

  
  


• 
  

  Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.

  
  

FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for formoterol to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of formoterol and consists of the following: communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

• 
  

  Possible increase in asthma-related deaths in patients receiving long-acting β₂-adrenergic bronchodilators (e.g., salmeterol) in addition to usual asthma therapy.^{1 40 41 a}

  
  


• 
  

  Reserve use of long-acting β₂-adrenergic agonists in patients with asthma for those whose disease is inadequately controlled with other anti-asthma therapy (e.g., low-to-medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies.^{1 39 40 41 42 a} (See Increased Risk of Asthma-related Death under Cautions.)

  
  

Introduction

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

Uses for Foradil

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Bronchospasm in Asthma

Long-term prevention of bronchospasm in patients with reversible obstructive airway disease (e.g., asthma) whose symptoms are not adequately managed with other controller therapy (e.g., low-to-medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies.^{1 39 40 41 42} Not indicated in patients whose asthma can be successfully managed with occasional use of an inhaled, short-acting β₂-adrenergic agonist or in those whose asthma can be successfully managed by inhaled corticosteroids or other controller drugs accompanied by occasional use of an inhaled, short-acting β₂-adrenergic agonist.^{1 42} (See Increased Risk of Asthma-related Death under Cautions.)

Fixed combination of formoterol and budesonide recommended in patients whose symptoms are not adequately managed with other controller therapy (e.g., low-to-medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies.^{a e}

Formoterol should not be used as initial or sole therapy for asthma and is not a substitute for corticosteroids.^{1 40 44} Corticosteroid therapy should not be stopped or reduced in dosage when formoterol is initiated.^{1 40} (See Concomitant Anti-inflammatory Therapy under Cautions.)

Not to be used for immediate relief of bronchospasm or in patients with substantially worsening or acutely deteriorating asthma.^{1 40 42 a} (See Acute Exacerbations of Asthma under Cautions.)

Exercise-induced Bronchospasm

Prevention of exercise-induced bronchospasm when administered on an occasional or as-needed basis.^{1 17}

Formoterol in fixed combination with budesonide is not indicated for prevention of exercise-induced bronchospasm.^a In patients receiving fixed combination, do not use additional formoterol or other long-acting β₂-adrenergic agonists (e.g., salmeterol) for prevention of exercise-induced bronchospasm or for any other reason.^a

COPD

Long-term treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.^{1 19 23 24}

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

Formoterol in fixed combination with budesonide is not indicated for treatment of COPD.^a

Foradil Dosage and Administration

General

• 
  

  When formoterol therapy alone or in fixed combination with budesonide is initiated, discontinue regular use of short-acting, inhaled β₂-adrenergic agonists; use such agents only for relief of acute symptoms of asthma or COPD that are not controlled by formoterol.^{1 a}

  
  


• 
  

  If a dose is missed, skip that dose and take the next dose at the usual time.^{11 44 e} Do not double the dose to replace the missed dose.^{11 44 e}

  
  


• 
  

  Failure to respond to a previously effective dosage may indicate seriously worsening asthma or destabilization of COPD that requires reevaluation.¹ Extra or increased doses are not recommended.^{1 6 10 11 40 41 a e} (See Acute Exacerbations of Asthma under Cautions.)

  
  


• 
  

  Administer a short-acting, inhaled β₂-adrenergic agonist if acute asthmatic symptoms arise despite maintenance therapy.^{1 a e} Administer a short-acting β₂-adrenergic agonist if routine therapy with formoterol is not effective for preventing exercise-induced bronchospasm.¹

  
  

Administration

Oral Inhalation

Administer oral inhalation powder using a special oral inhaler (Aerolizer) that delivers powdered drug from capsules.^{1 11} Do not take capsules orally.^{1 11 b}

Administer oral inhalation aerosol (Symbicort) using an aerosol inhaler device.^{a e}

Inhalation Powder

Administer twice daily, approximately every 12 hours (morning and evening).^{1 11 44}

For prevention of exercise-induced bronchospasm, administer ≥15 minutes before exercise, but not more often than once every 12 hours.^{1 11 44}

Do not use formoterol fumarate dry-powder capsules with any capsule inhaler other than Aerolizer.^{1 11 44} Do not swallow the dry-powder capsule.^{44 b}

If no improvement, ensure patient is using the inhaler rather than swallowing the dry-powder capsules.^b

Do not use spacer devices with the Aerolizer inhaler.⁴⁴

Inhalation Aerosol

Administer twice daily (morning and evening).^{a e}

Test spray 2 times before first use, if not used for >7 days, or if dropped.^{a e}

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

Use the actuator supplied with the product to administer formoterol in fixed combination with budesonide.^{a e}

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

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

Each dry-powder capsule contains 12 mcg of formoterol fumarate.¹ During in vitro testing, each activation of the Aerolizer inhaler delivered about 10 mcg of drug; however, the precise amount of drug delivered to the lungs depends on factors such as the patient’s inspiratory flow.¹

Dosage of formoterol fumarate dihydrate in fixed combination with budesonide (Symbicort) inhalation aerosol is expressed in mcg delivered from the mouthpiece.^a Each actuation of the Symbicort inhalation aerosol delivers 5.1 mcg of formoterol fumarate dihydrate and 91 or 181 mcg of budesonide from the valve, and 4.5 mcg of formoterol fumarate dihydrate and 80 or 160 mcg of budesonide from the actuator per metered spray.^a The amount of drug delivered to the lungs depends on factors such as the patient’s inspiratory flow.^a The aerosol inhaler delivers 60 metered sprays per 6- or 6.9-g canister and 120 metered sprays per 10.2-g canister.^a

Pediatric Patients

Asthma

Oral Inhalation Powder

Children ≥5 years of age and adolescents: 12 mcg (contents of one capsule) twice daily.^{1 11}

Formoterol/Budesonide Fixed-combination Therapy

Oral Inhalation Aerosol

Adolescents ≥12 years of age not currently receiving an orally inhaled corticosteroid: Initially, 9 mcg of formoterol fumarate dihydrate and 160 or 320 mcg of budesonide twice daily, depending on asthma severity.^a

Adolescents ≥12 years of age inadequately controlled with low-to-medium dosages of an inhaled corticosteroid: Initially, 9 mcg of formoterol fumarate dihydrate and 160 mcg of budesonide twice daily.^a

Adolescents ≥12 years of age inadequately controlled with medium-to-high dosages of an inhaled corticosteroid: Initially, 9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide twice daily.^a

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

Exercise-induced Bronchospasm

Oral Inhalation Powder

Children ≥5 years of age and adolescents: 12 mcg (contents of one capsule) administered ≥15 minutes before exercise but not more often than once every 12 hours.^{1 11}

Adults

Asthma

Oral Inhalation Powder

12 mcg (contents of one capsule) twice daily.^{1 11}

Formoterol/Budesonide Fixed-combination Therapy

Oral Inhalation Aerosol

Patients not currently receiving an orally inhaled corticosteroid: Initially, 9 mcg of formoterol fumarate dihydrate and 160 or 320 mcg of budesonide twice daily, depending on asthma severity.^a

Patients inadequately controlled with low-to-medium dosages of an inhaled corticosteroid: Initially, 9 mcg of formoterol fumarate dihydrate and 160 mcg of budesonide twice daily.^a

Patients inadequately controlled with medium-to-high dosages of an inhaled corticosteroid: Initially, 9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide twice daily.^a

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

Exercise-induced Bronchospasm

Oral Inhalation Powder

12 mcg (contents of one capsule) administered ≥15 minutes before exercise but not more often than once every 12 hours.^{1 11}

COPD

Oral Inhalation Powder

12 mcg (contents of one capsule) twice daily.¹

Prescribing Limits

Pediatric Patients

Asthma

Oral Inhalation Powder

Children ≥5 years of age and adolescents: Maximum 24 mcg daily (12 mcg every 12 hours).^{1 11}

Formoterol/Budesonide Fixed-combination Therapy

Oral Inhalation Aerosol

Adolescents ≥12 years of age: Maximum 9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide twice daily.^a

Exercise-induced Bronchospasm

Oral Inhalation Powder

Children ≥5 years of age and adolescents: Maximum 24 mcg daily (12 mcg every 12 hours).¹

Adults

Asthma

Oral Inhalation Powder

Maximum 24 mcg daily (12 mcg every 12 hours).^{1 11}

Formoterol/Budesonide Fixed-combination Therapy

Oral Inhalation Aerosol

Maximum 9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide twice daily.^a

Exercise-induced Bronchospasm

Oral Inhalation Powder

Maximum 24 mcg daily (12 mcg every 12 hours).¹

COPD

Oral Inhalation Powder

Maximum 24 mcg daily (12 mcg every 12 hours).¹

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.^{1 a} (See Special Populations under Pharmacokinetics.)

Renal Impairment

No specific dosage recommendations at this time.^{1 a}

Geriatric Patients

Fixed-combination therapy with budesonide: No dosage adjustment required.^a

Cautions for Foradil

Contraindications

• 
  

  Known hypersensitivity to formoterol fumarate or any ingredient in the formulation.^{1 a}

  
  

Warnings/Precautions

Warnings

Increased Risk of Asthma-related Death

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Large safety study (Salmeterol Multicenter Asthma Research Trial [SMART]) suggests increased risk of asthma-related life-threatening events, including death, in patients receiving long-acting β₂-adrenergic agonist salmeterol.^{29 30 36 37 38 41 a} While studies currently available do not show an increased risk of asthma-related death with formoterol, small clinical studies suggest a higher incidence of serious worsening of asthma with formoterol therapy compared with placebo.^{1 41 a} Consider possibility that all long-acting β₂-adrenergic agonists may be associated with increased risk of asthma-related death given similar basic mechanism of action.^{1 29 39 40 41 a} Long-acting β₂-adrenergic agonist bronchodilators such as formoterol should be added to asthma therapy only in case of inadequate response to other controller drugs (e.g., low- or medium-dose corticosteroids) or in patients whose disease severity warrants treatment with 2 maintenance therapies.^{40 41 42 a}

It is not known whether the rate of death is increased in patients with COPD receiving long-acting β₂-adrenergic agonists.¹

Acute Exacerbations of Asthma

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Do not initiate therapy in patients with acutely deteriorating or substantially worsening asthma, which may be life-threatening; fatalities have been reported with orally inhaled sympathomimetic drugs.^{1 7 40 41 a}

Failure to respond to a previously effective dosage may indicate substantially worsening asthma.^{1 a} 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 41 a} May require adjustment of dosage of inhaled corticosteroid or initiation of systemic corticosteroids.^{1 a} Do not use extra doses of formoterol alone or in fixed combination with budesonide or other long-acting inhaled β₂-adrenergic agonists (e.g., salmeterol) for any reason.^{44 a}

If asthma deteriorates in patients receiving formoterol in fixed combination with budesonide, prompt reevaluation of asthma therapy is required.^a Consider increasing the strength of the fixed combination (higher strengths contain higher dosages of budesonide only), adding additional inhaled corticosteroids, or initiating systemic corticosteroids.^a

Excessive Doses

Possible fatalities and/or serious exacerbations of asthma associated with excessive use of inhaled sympathomimetic drugs.^{1 a}

Patients receiving formoterol alone or in fixed combination with budesonide should not use additional formoterol or other long-acting inhaled β₂-adrenergic agonists^{1 44 a} for any reason.^{44 a}

Concomitant Anti-inflammatory Therapy

Formoterol therapy is not a substitute for inhaled or oral corticosteroids.^{1 40} Use formoterol only in patients with asthma whose symptoms are not adequately managed with other controller therapy (e.g., low-to-medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies.^{1 39 40 41 42}

Do not discontinue or reduce dosage of corticosteroids when formoterol therapy is initiated.^{1 40} Continue corticosteroid therapy even if patient feels better as a result of initiating or increasing formoterol dosage.¹ Changes in corticosteroid dosage recommended only after clinical evaluation of the patient.¹

Cardiovascular Effects

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

Nervous System Effects

Use with caution in patients with seizure disorders.^{1 a}

Paradoxical Bronchospasm

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

Sensitivity Reactions

Immediate hypersensitivity reactions (e.g., anaphylaxis, urticaria, angioedema, rash, bronchospasm) reported.^{1 a}

General Precautions

Metabolic Effects

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

Use with caution in patients with thyrotoxicosis, untreated hypokalemia, and in those who are unusually responsive to sympathomimetic amines.^{1 a}

Use of Fixed Combinations

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

Specific Populations

Pregnancy

Category C.^{1 a}

May interfere with uterine contractility.^{1 a} Carefully weigh benefit versus risk in labor.^{1 a}

Lactation

Distributed into milk in rats.¹ Not known whether formoterol is distributed into human milk.¹ Use with caution in nursing women.¹

Formoterol in fixed combination with budesonide: Discontinue nursing or the drug.^a

Pediatric Use

Formoterol: Safety and efficacy not established in children <5 years of age.¹

Formoterol in fixed combination with budesonide: Efficacy not established in children <12 years of age.^a Safety not established in children <6 years of age.^a

Geriatric Use

Formoterol: No substantial differences in safety and efficacy relative to younger adults.¹

Formoterol in fixed combination with budesonide: No substantial differences in safety relative to younger adults.^a

Common Adverse Effects

Bronchitis,¹ chest infection,¹ dyspnea,¹ chest pain,¹ tremor (dose-related),^{1 7 12} dizziness (dose-related),¹ insomnia,¹ tonsillitis,¹ rash,¹ dysphonia (dose-related).¹

Interactions for Foradil

Metabolized in the liver by CYP isoenzymes 2D6, 2C19, 2C9 and 2A6.^{1 a}

Specific Drugs

Drug	Interaction	Comments
Antidepressants, tricyclic	Potential pharmacodynamic interaction (prolongation of the QTc interval and increased risk of ventricular arrhythmias)1 a	Extreme caution is recommended during concomitant therapy1 18 a or within 2 weeks following discontinuance of a tricyclic antidepressanta
β-Adrenergic blocking agents (including ophthalmic agents)	Potential pharmacologic interaction (antagonism of pulmonary effects resulting in severe bronchospasm in asthmatic patients)1 18 a	If concomitant therapy is required, consider cautious use of cardioselective β-adrenergic blocking agents1 18 a
Corticosteroids	Potential pharmacodynamic interaction (increased risk of hypokalemia)1
Diuretics, nonpotassium-sparing	Potential pharmacodynamic interaction (additive hypokalemia and/or ECG changes), especially when the recommended β-agonist dose is exceeded1 18 a	Cautious use is recommended1 18 a
MAO Inhibitors	Potential pharmacodynamic interaction (prolongation of the QTc interval and increased risk of ventricular arrhythmias))1 a	Extreme caution is recommended during concomitant therapy1 18 a or within 2 weeks following discontinuance of an MAO inhibitora
Sympathomimetic agents	Potential pharmacodynamic interaction (additive pharmacologic and adverse effects)1	Caution recommended for concomitant use of formoterol and sympathomimetic agents administered by any route1
Xanthine derivatives	Potential pharmacodynamic interaction (increased risk of hypokalemia)1

Foradil Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following inhalation; peak plasma concentrations usually attained within 5–10 minutes.^{1 a}

Onset

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

Duration

12 hours.¹

Distribution

Extent

Distributed into milk in animals.¹ Not known if the drug crosses the placenta or distributes into milk in humans.¹

Plasma Protein Binding

46–64% bound to plasma proteins; binding to serum albumin is 31–38%.^{1 a}

Elimination

Metabolism

Metabolized in the liver by CYP isoenzymes 2D6, 2C19, 2C9 and 2A6.^{1 a}

Elimination Route

Eliminated in feces (24–34%) and in urine (59–62%).^{1 a}

Half-life

7.9–10 hours.^{1 a}

Special Populations

In severe hepatic impairment, increased exposure possible.^a

Stability

Storage

Oral Inhalation

Powder

20–25°C in a dry place; protect from excessive moisture.^{1 44} Do not remove capsules of dry powder from their foil package until just before use.⁴⁴ Discard inhaler and dry powder capsules at 4 months or by date indicated on the package, whichever is sooner; use the new inhaler provided with each new prescription.⁴⁴

Aerosol

20–25°C with mouthpiece down.^{a e}

Do not puncture aerosol containers, use or store near heat or an open flame, expose to temperatures >49°C, or place into a fire or incinerator for disposal.^{a e} Discard inhaler ≤3 months after removal from foil package.^{a e}

Actions

• 
  

  Synthetic sympathomimetic amine.^{1 6 7 15}

  
  


• 
  

  Long-acting, selective β₂-receptor agonist.^{1 6 7 15 a}

  
  


• 
  

  Stimulates β₂-adrenergic receptors with little or no effect on β₁-^{1 6 7 a} or α-adrenergic receptors.⁷

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  Prolonged therapy at greater than recommended dosages may be associated with development of tolerance to the bronchodilatory effects.^{1 17 a}

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Importance of patient reading medication guide before initiating therapy and each time the prescription is refilled.^{1 40 41 44 a}

  
  


• 
  

  Advise of potential for increased risk of asthma-related death.^{1 40 41 44 a e}

  
  


• 
  

  Importance of pediatric patients receiving therapy under adult supervision.⁴⁴

  
  


• 
  

  Importance of adequate understanding of proper storage, preparation, and use of inhalation delivery systems.^{1 11 a e}

  
  


• 
  

  Importance of correct procedure for administering formoterol-containing therapy and concomitant therapy (e.g., a short-acting β₂-adrenergic agonist).^{1 11 a b} Importance of not breathing into inhaler.^{1 44}

  
  


• 
  

  Advise patients not to swallow dry-powder capsules; use only with provided inhaler; never place capsules into inhaler mouthpiece.^{44 b}

  
  


• 
  

  Importance of adherence to dosing schedules of formoterol and concomitant therapy, including not altering the dose or frequency of use of such drugs unless otherwise instructed by a clinician.^{1 11 44 e}

  
  


• 
  

  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.^{11 44 e}

  
  


• 
  

  Importance of not using formoterol as sole therapy for asthma.^{40 44} Importance of using drug only when asthma is inadequately controlled with other controller drugs (e.g., inhaled corticosteroid) or when asthma is of sufficient severity to warrant treatment with 2 maintenance therapies.^{1 44 a e}

  
  


• 
  

  Importance of all patients being provided with a short-acting, inhaled β₂-adrenergic bronchodilator as supplemental therapy for acute asthma symptoms.^{44 a e}

  
  


• 
  

  Importance of discontinuing regular use of a short-acting, inhaled β-adrenergic bronchodilator when initiating maintenance formoterol therapy and instituting intermittent use of a short-acting bronchodilator to relieve acute symptoms of asthma.^{1 11 44 a e}

  
  


• 
  

  Importance of contacting a clinician if asthma symptoms do not improve after 1 week of therapy.^{44 e}

  
  


• 
  

  Importance of not using formoterol-containing therapy to relieve acute symptoms of asthma.^{1 5 6 8 11 40 41 a e}

  
  


• 
  

  Importance of contacting a clinician immediately if breathing problems worsen quickly or peak flow meter results decrease.^{1 44 e}

  
  


• 
  

  Importance of contacting a clinician or obtaining medical care immediately if decreased effectiveness of a short-acting β₂-adrenergic agonist (requiring use of ≥4 inhalations for ≥2 consecutive days or 1 canister in 8 weeks) for acute symptoms occurs.^{1 44 e}

  
  


• 
  

  Importance of contacting a clinician if respiratory symptoms worsen over time while using usual dosage of formoterol fumarate.^{1 44 e}

  
  


• 
  

  Importance of advising patients who are receiving formoterol-containing preparations not to use additional formoterol or other long-acting inhaled β₂-adrenergic agonists for any reason.^{1 11 44 e}

  
  


• 
  

  Importance of patients not discontinuing or changing any medications used to control breathing problems without medical supervision, since worsening of asthma may occur.^{1 44 a e}

  
  


• 
  

  Importance of administering formoterol ≥15 minutes prior to exercise for prevention of exercise-induced bronchospasm.^{1 11} Importance of not using additional doses for exercise-induced asthma while receiving maintenance therapy (twice daily) with formoterol.^{1 11 44}

  
  


• 
  

  Advise of potential for adverse effects, such as palpitations, rapid heart rate, tremor, nervousness, or chest pain.^{1 a e}

  
  


• 
  

  Importance of promptly contacting a clinician or seeking emergency medical care if symptoms of a serious allergic reaction such as rash; hives; swelling of the face, tongue, or mouth; or breathing problems develop.^{44 e}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., heart disease, hypertension, seizures, thyroid disease, diabetes, drug or food allergies).^{1 11 44 e}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 11 a e}

  
  


• 
  

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

  
  

Preparations

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

Formoterol Fumarate (Dihydrate)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation	Powder for inhalation (contained in capsules)	12 mcg (of formoterol fumarate) per capsule	Foradil Aerolizer Inhaler	Schering

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 and povidone)	AstraZeneca
		4.5 mcg (of formoterol fumarate dihydrate) with Budesonide 160 mcg per metered spray	Symbicort (with hydrofluoroalkane propellant and povidone)	AstraZeneca

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Dulera 100-5MCG/ACT Aerosol (SCHERING): 13/$219.00 or 39/$636.94

Dulera 200-5MCG/ACT Aerosol (SCHERING): 13/$229.99 or 39/$659.98

Foradil Aerolizer 12MCG Capsules (SCHERING): 60/$175.99 or 180/$485.95

Symbicort 160-4.5MCG/ACT Aerosol (ASTRAZENECA LP): 10/$229.99 or 31/$659.93

Symbicort 80-4.5MCG/ACT Aerosol (ASTRAZENECA LP): 10/$196.99 or 31/$569.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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

1. Schering. Foradil (formoterol fumarate) aerolizer inhalation powder prescribing information. Kenilworth, NJ; 2006 Jun.

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. [IDIS 421471] [PubMed 9872822]

3. National Asthma Education and