Formoterol

Formoterol is a prescription medicine used to treat breathing difficulties caused by asthma, exercise induced bronchospasm (EIB), and chronic obstructive pulmonary disease (COPD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of formoterol there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your healthcare provider about all of your health conditions, including if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• are pregnant or breastfeeding 
• are allergic to formoterol or any other medications

Formoterol contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in patients who have a severe milk protein allergy.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Improvement in FEV1 observed for 12 hours in most patients

Half-Life Elimination

Powder: ~10-14 hours; Nebulized solution: ~7 hours

Protein Binding

61% to 64% in vitro at higher concentrations than achieved with usual dosing

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).

Note: Foradil Aerolizer is no longer available in the US.

Asthma: Inhalation: Note: For asthma control, long-acting beta2-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)

Exercise-induced bronchospasm: 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).

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)

COPD: Inhalation:

US labeling:

Foradil Aerolizer: Dry powder inhaler: 12 mcg every 12 hours (maximum dose: 24 mcg daily)

Perforomist: Nebulization solution: 20 mcg twice daily (maximum dose: 40 mcg daily)

Canadian labeling: Foradil: Dry powder inhaler: 12 mcg or 24 mcg twice daily (maximum dose: 48 mcg daily)

Note: Foradil Aerolizer is no longer available in the US.

Asthma: Inhalation: Note: For asthma control, long-acting beta2-agonists (LABAs) should be used in combination with inhaled corticosteroids and not as monotherapy.

US labeling: Foradil Aerolizer: Dry powder inhaler: Children ≥5 years and Adolescents: Refer to adult dosing.

Canadian labeling:

Foradil: Dry powder inhaler:

Children 6 to 16 years: 12 mcg every 12 hours (maximum dose: 24 mcg daily)

Adolescents ≥17 years: Refer to adult dosing.

Oxeze Turbuhaler: Dry powder inhaler:

Children 6 to 16 years: 6 mcg or 12 mcg every 12 hours (maximum dose: 24 mcg daily)

Adolescents ≥17 years: Refer to adult dosing.

Exercise-induced bronchospasm: 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).

US labeling: Foradil Aerolizer: Dry powder inhaler: Children ≥5 years and Adolescents: Refer to adult dosing.

Canadian labeling: Oxeze Turbuhaler: Dry powder inhaler: Children ≥6 years and Adolescents: 6 mcg or 12 mcg at least 15 minutes before exercise on an occasional "as needed" basis (maximum dose: 24 mcg/24-hour period)

Foradil Aerolizer (dry powder inhaler): 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.

Perforomist (nebulization solution): Remove unit-dose vial from foil pouch immediately before use. Solution does not require dilution prior to administration; do not mix other medications with formoterol solution. 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.

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.

AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. 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. Monitor therapy

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. Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. 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. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cocaine: 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. Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Inhalational Anesthetics: May enhance the arrhythmogenic effect of Formoterol. Monitor therapy

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

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. Consider therapy modification

Long-Acting Beta2-Agonists: May enhance the adverse/toxic effect of other Long-Acting Beta2-Agonists. Avoid combination

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. 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. Avoid combination

MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification

Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Theophylline Derivatives: May enhance the adverse/toxic effect of Formoterol. Theophylline Derivatives may enhance the hypokalemic effect of Formoterol. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

Long-acting beta-2 adrenergic agonists increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta-2 adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of long-acting beta-2 adrenergic agonists. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from long-acting beta-2 adrenergic agonists.

Because of this risk, use of formoterol inhalation powder for the treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use formoterol only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue formoterol) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use formoterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

The safety and efficacy of formoterol inhalation solution in patients with asthma have not been established.

Available data from controlled clinical trials suggest that long-acting beta-2 adrenergic agonists increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require the addition of a long-acting beta-2 adrenergic agonist to an inhaled corticosteroid, a fixed-dose combination product containing an inhaled corticosteroid and long-acting beta-2 adrenergic agonist should ordinarily be considered to ensure adherence with both drugs. In cases in which use of a separate long-term asthma control medication (eg, inhaled corticosteroid) and long-acting beta-2 adrenergic agonist is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be ensured, a fixed-dose combination product containing an inhaled corticosteroid and long-acting beta-2 adrenergic agonist is recommended.