Embedded Files
Pharmacologic Category
Beta2 Agonist; Beta2-Adrenergic Agonist, Long-Acting
Dosing: Adult
Note: Foradil Aerolizer is no longer available in the US.
Asthma: Oral inhalation: Note: For asthma control, long-acting beta-2 agonists (LABAs) should be used in combination with inhaled corticosteroids and not as monotherapy.
US labeling: Foradil Aerolizer: Dry powder inhaler: 12 mcg every 12 hours (maximum: 24 mcg daily).
Canadian labeling:
Foradil: Dry powder inhaler: 12 mcg every 12 hours; in severe cases, 24 mcg every 12 hours may be given (maximum: 48 mcg daily).
Oxeze Turbuhaler: Dry powder inhaler: 6 mcg or 12 mcg every 12 hours (maximum: 48 mcg daily).
Chronic obstructive pulmonary disease: Oral inhalation:
US labeling:
Foradil Aerolizer: Dry powder inhaler: 12 mcg every 12 hours (maximum dose: 24 mcg/day).
Perforomist: Nebulization solution: 20 mcg twice daily (maximum dose: 40 mcg/day).
Canadian labeling: Foradil: Dry powder inhaler: 12 mcg or 24 mcg twice daily (maximum dose: 48 mcg/day).
Exercise-induced bronchospasm: Oral inhalation: Note: If already using for asthma maintenance, then should not use additional doses for exercise-induced bronchospasm. Because LABAs may disguise poorly controlled persistent asthma, frequent or chronic use of LABAs for exercise-induced bronchospasm is discouraged by the asthma guidelines (NAEPP 2007). Tolerance to the protective effects of LABAs against exercise-induced bronchospasm may develop with greater than once-daily use (ATS [Parsons 2013]; GINA 2020).
US labeling: Foradil Aerolizer: Dry powder inhaler: 12 mcg at least 15 minutes before exercise on an occasional "as needed" basis; additional doses should not be used for another 12 hours.
Canadian labeling: Oxeze Turbuhaler: Dry powder inhaler: 6 mcg or 12 mcg at least 15 minutes before exercise on an occasional "as needed" basis (maximum: 48 mcg/24-hour period).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Dosing: Pediatric
Note: Foradil Aerolizer has been discontinued >1 year. Foradil Aerolizer and Perforomist are not interchangeable.
Asthma, maintenance treatment: Note: For asthma control, long-acting beta2-agonists (LABAs) should be used in combination with inhaled corticosteroids and not as monotherapy.
Foradil Aerolizer (12 mcg/inhalation): Children ≥5 years and Adolescents: Oral inhalation: 12 mcg every 12 hours; maximum daily dose: 24 mcg/day
Canadian labeling: Foradil 12 mcg/inhalation [Canadian product]: Oral inhalation:
Children ≥6 years and Adolescents ≤16 years: 12 mcg every 12 hours; maximum daily dose: 24 mcg/day
Adolescents ≥17 years: 12 mcg every 12 hours; in severe cases, 24 mcg every 12 hours may be necessary; maximum daily dose: 48 mcg/day
Canadian labeling: Oxeze Turbuhaler 6 mcg/inhalation and 12 mcg/inhalation [Canadian products]: Oral Inhalation:
Children ≥6 years and Adolescents ≤16 years: 6 mcg or 12 mcg every 12 hours; maximum daily dose: 24 mcg/day
Adolescents ≥17 years: 6 mcg or 12 mcg every 12 hours; in severe cases, 24 mcg every 12 hours may be necessary; maximum daily dose: 48 mcg/day
Exercise-induced bronchospasm, prevention: Note: If already using formoterol for asthma maintenance, then patients should not use additional doses for exercise-induced bronchospasm. Because long-acting beta2-agonists (LABAs) may disguise poorly-controlled persistent asthma, frequent or chronic use of LABAs for exercise-induced bronchospasm is discouraged by the NAEPP and GINA Asthma Guidelines (GINA 2017; NAEPP 2007).
Foradil Aerolizer (12 mcg/inhalation): Children ≥5 years and Adolescents: Oral Inhalation: 12 mcg 15 minutes prior to exercise on an occasional "as needed" basis; additional doses should not be used for 12 hours; maximum daily dose: 24 mcg/day
Canadian labeling: Oxeze Turbuhaler 6 mcg/inhalation and 12 mcg/inhalation [Canadian products]: Children ≥6 years and Adolescents: Oral Inhalation: 6 mcg or 12 mcg before exercise on an occasional "as needed" basis; maximum daily dose: 24 mcg/day
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing: Renal Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Use: Labeled Indications
US labeling:
Asthma: Treatment of asthma (only as concomitant therapy with an inhaled corticosteroid) in patients with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma (Foradil Aerolizer).
Chronic obstructive pulmonary disease (COPD): Maintenance treatment of bronchoconstriction in patients with COPD (Foradil Aerolizer, Perforomist).
Exercise-induced bronchospasm: Prevention of exercise-induced bronchospasm when administered on an as-needed basis (monotherapy may be indicated in patients without persistent asthma) (Foradil Aerolizer).
Canadian labeling:
Asthma: Treatment of asthma (only as concomitant therapy with an inhaled corticosteroid) in patients with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma (Foradil, Oxeze Turbuhaler).
COPD: Maintenance treatment of COPD (Foradil).
Exercise-induced bronchospasm: Prevention of exercise-induced bronchospasm when administered on an as-needed basis (monotherapy may be indicated in patients without persistent asthma) (Oxeze Turbuhaler).
* See Uses in AHFS Essentials for additional information.
Class and Related Monographs
Comparative Efficacy
Clinical Practice Guidelines
Asthma:
GINA, "Global Strategy for Asthma Management and Prevention," 2020 Update
NHLBI and NAEPP The Expert Panel Report 3: “Guidelines for the Diagnosis and Management of Asthma,” Full Report 2007
COPD:
Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD), 2018
Exercise-induced Bronchoconstriction:
AAAAI and ACAAI, “Exercise-induced Bronchoconstriction,” Update - 2016
ATS, “Exercised-induced Bronchospasm,” 2013
Administration: Inhalation
Dry powder inhaler:
Foradil Aerolizer: Remove capsule from foil blister immediately before use. Place capsule in the capsule-chamber in the base of the Aerolizer Inhaler. Capsules must not be swallowed whole; must only use the Aerolizer Inhaler. Press both buttons once only and then release. Keep inhaler in a level, horizontal position with the blue buttons to the left and right (not up and down). Exhale fully. Do not exhale into inhaler. Tilt head slightly back and inhale (rapidly, steadily, and deeply). Hold breath as long as possible. If any powder remains in capsule, exhale and inhale again. Repeat until capsule is empty. Throw away empty capsule; do not leave in inhaler. Do not use a spacer with the Aerolizer Inhaler. Always keep capsules and inhaler dry.
Oxeze Turbuhaler [Canadian product; dry powder inhaler]: Hold inhaler upright. Turn colored grip as far as it will go in one direction and then turn back to original position; a clicking sound should be heard which means the inhaler is ready for use. Exhale fully. Do not exhale into mouthpiece of inhaler. Place mouthpiece to lips and inhale forcefully and deeply. Do not chew or bite on mouthpiece. Clean outside of mouthpiece once weekly with a dry tissue. Avoid getting inhaler wet. If the inhaler is accidently dropped or shaken, or if the patient exhales into the inhaler, the dose will be lost and a new dose should be loaded.
Nebulization solution: Perforomist: Remove unit-dose vial from foil pouch immediately before use. Solution does not require dilution prior to administration; compatability with other medications (eg, budesonide) in nebulizer has been reported (Burchett 2010; Kamin 2014); also refer to institution-specific policies. Place contents of unit-dose vial into the reservoir of a standard jet nebulizer connected to an air compressor; assemble nebulizer based on the manufacturer's instructions and turn nebulizer on; breathe deeply and evenly until all of the medication has been inhaled. The average inhalation time is 9 minutes. Discard any unused medication immediately; do not ingest contents of vial. Clean nebulizer after use.
Administration: Pediatric
Foradil Aerolizer (Dry powder inhaler): Remove capsule from foil blister immediately before use. The contents of a capsule are aerosolized via a device called an Aerolizer. Place the capsule into the capsule-chamber in the base of the Aerolizer inhaler. Capsules must not be swallowed; must only use the Aerolizer Inhaler. Press both buttons once only and then release. Keep inhaler in a level, horizontal position with the blue buttons to the left and right (not up and down) to avoid displacing powder. Exhale fully (with face pointed away from inhaler). Do not exhale into inhaler as this may dislodge powder. Tilt head slightly back and inhale (rapidly, steadily, and deeply). Hold breath as long as possible. If any powder remains in capsule, exhale and inhale again. Repeat until capsule is empty. Throw away empty capsule; do not leave in inhaler. Do not use a spacer with the Aerolizer Inhaler. Always keep capsules and inhaler dry.
Oxeze Turbuhaler [Canadian product]: To prepare inhaler prior to use, load dose by holding inhaler in upright position and turn greenish-blue grip as far as it will go in one direction and then turn it as far as it will go in the other direction. Prior to first use, this procedure should be done twice; with subsequent dosing, perform this procedure once. Clicking sound means inhaler is loaded with dose and ready for use. Place mouthpiece between teeth and close lips over mouthpiece. Inhale deeply and forcefully. Do not exhale through inhaler. If the Turbuhaler is dropped, shaken, or breathed into after it is loaded, the dose will be lost and a new dose will need to be loaded. Discard device after a 0 displays in the dose window.
Storage/Stability
Foradil Aerolizer: Prior to dispensing, store in refrigerator at 2°C to 8°C (36°F to 46°F). After dispensing, store at room temperature at 20°C to 25°C (68°F to 77°F). Protect from heat and moisture. Capsules should always be stored in the blister and only removed immediately before use.
Perforomist: Prior to dispensing, store in refrigerator at 2°C to 8°C (36°F to 46°F). After dispensing, store in refrigerator at 2°C to 8°C (36°F to 46°F) or room temperature at 20°C to 25°C (68°F to 77°F) for up to 3 months. Protect from light and heat. Unit-dose vials should always be stored in the foil pouch and only removed immediately before use.
Oxeze Turbuhaler [Canadian product]: Store at 15°C to 30°C (59°F to 86°F). Protect from moisture.
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
All inhaler products:
• It is used to treat asthma.
• It is used to prevent breathing problems that happen with exercise.
Liquid for breathing in:
• It is used to treat COPD (chronic obstructive pulmonary disease).
• This drug is not approved to treat asthma. Talk with your doctor.
All products:
• This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Nausea
• Vomiting
• Anxiety
• Tremors
• Dry mouth
• Trouble sleeping
• Loss of strength and energy
• Diarrhea
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit.
• Low potassium like muscle pain or weakness, muscle cramps, or an abnormal heartbeat.
• Acidosis like confusion, fast breathing, fast heartbeat, abnormal heartbeat, severe abdominal pain, nausea, vomiting, fatigue, shortness of breath, or loss of strength and energy.
• Chest pain
• Fast heartbeat
• Abnormal heartbeat
• Severe dizziness
• Passing out
• Vision changes
• Severe headache
• Trouble breathing, wheezing, or coughing after use
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Medication Safety Issues
Sound-alike/look-alike issues:
Administration issues:
International issues:
Medication Guide and/or Vaccine Information Statement (VIS)
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Foradil Aerolizer: https://www.fda.gov/downloads/Drugs/DrugSafety/ucm088602.pdf
Perforomist: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf#page=22
Contraindications
Hypersensitivity to formoterol or any component of the formulation (Foradil Aerolizer only); treatment of status asthmaticus or other acute episodes of asthma or chronic obstructive pulmonary disease (Foradil Aerolizer only); monotherapy (without use of a concomitant inhaled corticosteroid) in the treatment of asthma.
Documentation of allergenic cross-reactivity for sympathomimetics is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Presence of tachyarrhythmias
Warnings/Precautions
Concerns related to adverse effects:
• Asthma-related deaths: Monotherapy with a long-acting beta-2 agonist (LABA) is contraindicated in the treatment of asthma. The use of LABAs as monotherapy has been associated with an increased risk of severe exacerbations and asthma-related deaths (SMART [Nelson 2006]; Walters 2007); additional data from other clinical trials suggest risk of asthma-related hospitalization may also be increased with LABA monotherapy in pediatric and adolescent patients. However, data from large, randomized, double-blind controlled trials do not show a significant increase in risk of serious asthma-related events (including hospitalizations, intubations, and death) in adults, adolescents, and pediatric patients (4 to 11 years of age) when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017). Current guidelines recommend the use of an as-needed, low-dose inhaled corticosteroid with formoterol for patients with infrequent symptoms (GINA 2020). Available data do not suggest an increased risk of death with use of LABAs in patients with chronic obstructive pulmonary disease (COPD).
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening and may occur with use of inhaled bronchodilating agents; this reaction should be distinguished from inadequate response. Discontinue immediately if paradoxical bronchospasm occurs and institute alternative therapy.
• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) have been reported.
• Serious effects/fatalities: Do not exceed recommended dose or frequency or use with other medications containing LABAs; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.
Disease-related concerns:
• Asthma: Appropriate use:
- Foradil Aerolizer: Not indicated for the initial (rescue) treatment of acute episodes of bronchospasm. Do not initiate in patients with significantly worsening or acutely deteriorating asthma; reports of severe (sometimes fatal) respiratory events have been reported when formoterol has been initiated in this situation.
- Perforomist: Not FDA approved for the treatment of asthma; safety and efficacy in asthma patients have not been established.
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, or hypertension); beta-agonists may cause elevation in blood pressure and heart rate and result in CNS stimulation/excitation. Beta-2 agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.
• Chronic obstructive pulmonary disease: Appropriate use: Do not use for acute episodes of COPD. Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Available data do not suggest an increased risk of death with use of LABAs in patients with COPD.
• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.
• Exercise-induced bronchospasm: Because LABAs may disguise poorly controlled persistent asthma, frequent or chronic use of LABAs for exercise-induced bronchospasm is discouraged by the NIH Asthma Guidelines (NIH, 2007).
• Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity.
• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (transient).
• Seizures: Use with caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation.
Special populations:
• Pediatric: Foradil Aerolizer: LABAs, when used as monotherapy, may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When LABAs are used in a fixed-dose combination with inhaled corticosteroids, data from large clinical trials in adolescents do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to inhaled corticosteroids alone.
Dosage form specific issues:
• Foradil Aerolizer: The contents of the capsules are for inhalation only via the Aerolizer device. There have been reports of incorrect administration (swallowing of the capsules).
• Lactose: Powder for oral inhalation may contain lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy.
Other warnings/precautions:
• Patient information: Patients using inhaled, short-acting beta-2 agonists should be instructed to discontinue routine use of these medications prior to beginning treatment; short-acting agents should still be provided to patients; however, use should be reserved for symptomatic relief of acute symptoms. Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use of short-acting beta-2 agonists may indicate deterioration of asthma or COPD, and medical evaluation must not be delayed.
• Tolerance/Tachyphylaxis: Tolerance to the bronchodilator effect, measured by FEV1, has been observed in studies.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
Elderly patients should be specifically counseled about the proper use of this inhaler/spacing of doses and/or the proper use of a nebulizer system. No significant difference in safety or efficacy was seen between elderly and younger patients. However, the decreased number and sensitivity of the β-adrenergic receptors could potentially have an impact on outcomes (Scarpace 1988). Monitoring for efficacy is of utmost importance in older adults. Elderly patients may be more sensitive to the side effects of β-agonists (eg, tremor, tachycardia).
Pregnancy Considerations
Maternal use of beta-2 agonists is not associated with an increased risk of fetal malformations (GINA 2020). Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes) (ERS/TSANZ [Middleton 2020]; GINA 2020).
Short-acting beta-2 agonists are preferred over long-acting agents when treatment for asthma is needed during pregnancy. Pregnant females adequately controlled on formoterol for asthma may continue therapy; if initiating treatment during pregnancy, use of an agent with more data in pregnant females may be preferred. Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]).
Beta agonists may interfere with uterine contractility if administered during labor.
Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant females in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.
Breast-Feeding Considerations
It is not known if formoterol is present in breast milk.
According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. However, females with asthma should be encouraged to breastfeed (GINA 2020). Formoterol oral inhalation is considered probably acceptable for use while breastfeeding (ERS/TSANZ [Middleton 2020]).
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
1% to 10%:
Cardiovascular: Chest pain (2% to 3%)
Central nervous system: Anxiety (2%), dizziness (2%), insomnia (2%), voice disorder (1%), headache
Dermatologic: Pruritus (2%), skin rash (1%)
Gastrointestinal: Diarrhea (5%), nausea (5%), xerostomia (1% to 3%), vomiting (2%), abdominal pain, dyspepsia, gastroenteritis
Neuromuscular & skeletal: Muscle cramps (2%), tremor
Respiratory: Respiratory tract infection (3% to 7%), exacerbation of asthma (ages 5 to 12 years: 5% to 6%; age >12 years: <4%; acute deterioration: <1%), bronchitis (5%), pharyngitis (3% to 4%), sinusitis (3%), dyspnea (2%), tonsillitis (1%)
Miscellaneous: Fever (2%)
<1%, postmarketing, and/or case reports: Agitation, anaphylaxis (including severe hypotension/angioedema), angina pectoris, atrial fibrillation, behavioral changes, cardiac arrhythmia, cough, decreased glucose tolerance, dermatitis, disturbed sleep, dysgeusia, fatigue, hyperglycemia, hypertension, hypokalemia, malaise, metabolic acidosis, muscle spasm, nervousness, palpitations, paradoxical bronchospasm, prolonged QT interval on ECG, restlessness, tachycardia, urticaria, variable blood pressure, ventricular premature contractions
* See Cautions in AHFS Essentials for additional information.
Toxicology
Metabolism/Transport Effects
Substrate of CYP2C9 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Drug Interactions Open Interactions
AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor therapy
Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Risk X: Avoid combination
Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy
Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination
Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Risk C: Monitor therapy
Caffeine and Caffeine Containing Products: May enhance the adverse/toxic effect of Formoterol. Caffeine and Caffeine Containing Products may enhance the hypokalemic effect of Formoterol. Risk C: Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Risk C: Monitor therapy
Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy
Inhalational Anesthetics: May enhance the arrhythmogenic effect of Formoterol. Risk C: Monitor therapy
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Risk D: Consider therapy modification
Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy
Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination
Methacholine: Beta2-Agonists (Long-Acting) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Risk D: Consider therapy modification
Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy
Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Risk D: Consider therapy modification
Procarbazine: May enhance the adverse/toxic effect of Sympathomimetics. Management: Consider alternatives to this combination when possible. Procarbazine prescribing information states that this combination should be avoided. Risk D: Consider therapy modification
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Theophylline Derivatives: May enhance the adverse/toxic effect of Formoterol. Theophylline Derivatives may enhance the hypokalemic effect of Formoterol. Risk C: Monitor therapy
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy
Genes of Interest
Monitoring Parameters
FEV1, peak flow, and/or other pulmonary function tests; shortness of breath; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium
Advanced Practitioners Physical Assessment/Monitoring
Do not use for acute bronchospasm. Patient should continue to use short-acting beta2-agonist (eg, albuterol) for acute symptoms and symptoms occurring between treatments. Do not stop or reduce corticosteroids when formoterol is initiated. Do not initiate formoterol therapy in patients with acutely deteriorating or acutely worsening asthma.
Consider obtaining a baseline spirometry (FEV1), 12-lead EKG prior to initiation, particularly in patients with any pre-existing history of arrhythmia. Accurate diagnosis and staging of COPD according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines will improve patient outcomes.
Nursing Physical Assessment/Monitoring
Monitor for signs of worsening asthma when initiating therapy. Patient should always be on at least one other drug to treat asthma with this drug. Monitor heart rate, blood pressure, peak-flow measurements, and blood glucose and potassium levels. Assessment and monitoring of lung exam should be on-going.
Monitor insulin and/or oral hypoglycemic therapy requirements in diabetics. Encourage patient to keep good records of home glucose monitoring, especially during initiation of drug therapy. Instruct patient to report if home glucose consistently high or if signs of hyperglycemia (eg, increased thirst, increased urination, sleepiness) occur.
Product Availability
Foradil Aerolizer is no longer available in the US.
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Nebulization Solution, Inhalation, as fumarate dihydrate:
Perforomist: 20 mcg/2 mL (2 mL)
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol Powder Breath Activated, Inhalation:
Oxeze Turbuhaler: 6 mcg/INH (51.4 g); 12 mcg/INH (51.4 g) [contains lactose]
Capsule, Inhalation, as fumarate:
Foradil: 12 mcg [contains milk protein]
Anatomic Therapeutic Chemical (ATC) Classification
- R03AC13
Generic Available (US)
No
Pricing: US
Nebulization (Perforomist Inhalation)
20 mcg/2 mL (per mL): $10.62
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Mechanism of Action
Relaxes bronchial smooth muscle by selective action on beta2 receptors with little effect on heart rate. Formoterol has a long-acting effect.
Pharmacodynamics/Kinetics
Onset of action: Dry powder inhaler: Within 3 minutes.
Peak effect: Dry powder inhaler: 80% of peak effect within 15 minutes; Nebulization solution: 2 hours.
Duration: Improvement in FEV1 observed for 12 hours in most patients.
Absorption: Rapidly into plasma.
Protein binding: 61% to 64% in vitro at higher concentrations than achieved with usual dosing.
Metabolism: Hepatic via direct glucuronidation and O-demethylation; CYP2D6, CYP2C8/9, CYP2C19, CYP2A6 involved in O-demethylation.
Half-life elimination: Dry powder inhaler: ~10 to 14 hours; Nebulization solution: ~7 hours.
Time to peak: Maximum improvement in FEV1 in 1 to 3 hours.
Excretion:
Children 5 to 12 years: Urine (7% to 9% as direct glucuronide metabolites, 6% as unchanged drug).
Adults: Urine (15% to 18% as direct glucuronide metabolites, 2% to 10% as unchanged drug).
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).
Effects on Bleeding
No information available to require special precautions
Related Information
Index Terms
Eformoterol; Formoterol Fumarate; Formoterol Fumarate Dihydrate
FDA Approval Date
February 16, 2001
References
Burchett DK, Darko W, Zahra J, Noviasky J, Probst L, Smith A. Mixing and compatibility guide for commonly used aerosolized medications. Am J Health Syst Pharm. 2010;67(3):227-230. doi:10.2146/ajhp080261[PubMed 20101066]
Cazzola M, Centanni S, Regorda C, et al, “Onset of Action of Single Doses of Formoterol Administered Via Turbuhaler in Patients With Stable COPD,” Pulm Pharmacol Ther, 2001, 14:41-45.[PubMed 11162418]
Cazzola M and Donner CF, “Long-Acting Beta2-Agonists in the Management of Stable Chronic Obstructive Pulmonary Disease,” Drugs, 2000, 60:307-20.[PubMed 10983735]
Foradil Aerolizer (formoterol) [prescribing information]. Whitehouse Station, NJ: Schering Corporation; September 2012.
Foradil Bronchodilator (formoterol) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc.; May 2013.
Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/wp-content/uploads/2020/04/GINA-2020-full-report_-final-_wms.pdf. Updated 2020. Accessed May 6, 2020.
Kamin W, Erdnüss F, Krämer I. Inhalation solutions—which ones may be mixed? Physico-chemical compatibility of drug solutions in nebulizers—update 2013. J Cyst Fibros. 2014;13(3):243‐250. doi:10.1016/j.jcf.2013.09.006[PubMed 24172851]
Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020;55(2):1901208. doi:10.1183/13993003.01208-2019[PubMed 31699837]
National Asthma Education and Prevention Program (NAEPP), Expert Panel Report 3, "Guidelines for the Diagnosis and Management of Asthma," Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 08-4051, prepublication 2007. Available at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm
Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1):15-26.[PubMed 16424409]
Oxeze Turbuhaler (formoterol) [product monograph]. Mississauga, Ontario, Canada: AstraZenecaCanada Inc; April 2018.
Parsons JP, Hallstrand TS, Mastronarde JG, et al. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013;187(9):1016‐1027. doi:10.1164/rccm.201303-0437ST[PubMed 23634861]
Perforomist (formoterol) [prescribing information]. Morgantown, WV: Mylan Specialty L.P; May 2019.
Scarpace PJ. Decreased receptor activation with age. Can it be explained by desensitization? J Am Geriatr Soc. 1988;36(11):1067-1071.[PubMed 2844878]
US Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report 2007. http://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf. Published August 28, 2007.
US Food and Drug Administration. FDA drug safety communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS). https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-review-finds-no-significant-increase-risk-serious-asthma-outcomes. Published December 2017.
Walters EH, Gibson PG, Lasserson TJ, Walters JA. Long-acting beta2-agonists for chronic asthma in adults and children where background therapy contains varied or no inhaled corticosteroid. Cochrane Database Syst Rev. 2007;(1):CD001385. doi:10.1002/14651858.CD001385.pub2[PubMed 17253458]
Brand Names: International
Acarol Dry Syrup (KR); Asmelor Novolizer (FR); Atimos (BG, EG, MT, PL, RO); Atimos Modulite (GB); Atock (JP, KR, TW); Broncoral (ES); EFO (BD); Fesema (CO); Fluir (BR); Foradil (AT, BE, BF, BJ, BR, CH, CI, CZ, DK, EE, EG, ES, ET, FI, FR, GH, GM, GN, GR, HK, IE, IL, IT, KE, LR, LT, LV, MA, ML, MR, MU, MW, MX, NE, NG, NZ, PE, PH, PL, PT, RU, SC, SD, SE, SG, SK, SL, SN, TN, TR, TZ, UG, UY, VE, ZA, ZM, ZW); Foradil Aerolizer (AE, BB, CO, CY, IQ, IR, JO, KW, LB, LY, NZ, OM, QA, SA, SY, YE); Foradil P (DE); Foradile (AU); Forasma (TW); Foratec (IN); Formatris (ES); Formoair (FR); Formohale (EG); Formorol (TW); Fortix (UA); Fortulin (HR); Kurovent (MT); Lexoma (KR); Neblik (ES); Newitock (VN); Oxis (AE, AR, AU, BF, BH, BJ, BM, BS, BZ, CH, CI, CN, CR, CU, CY, DE, DO, ET, GH, GM, GN, GT, GY, HN, HU, IE, IL, IS, JM, KE, LB, LR, MA, ML, MR, MT, MU, MW, NE, NG, NI, NL, NO, NZ, PA, PH, PR, SA, SC, SD, SE, SG, SI, SK, SL, SN, SR, SV, TN, TR, TT, TZ, UG, ZA, ZM, ZW); Oxis Turbuhaler (MX); Oxis turbuhaler (PL); Pneumera (RO); Tempus (PY); Zafiron (UA)
Last Updated 9/28/20
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