General
When initiating formoterol alone or in fixed combination with budesonide, glycopyrrolate, or mometasone, 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.   
If a formoterol dose alone or in fixed combination with budesonide, glycopyrrolate, or mometasone is missed, skip that dose and take the next dose at the usual time.    Do not double the dose to replace the missed dose.   
Failure to respond to a previously effective dosage may indicate seriously worsening asthma or destabilization of COPD that requires reevaluation.     Extra or increased doses of formoterol are not recommended.      (See Acute Exacerbations of Asthma or COPD under Cautions.)
Administer a short-acting, inhaled β2-agonist to relieve acute asthmatic or COPD symptoms.   
Administration
Oral Inhalation
Formoterol: Administer by oral inhalation as an oral inhalation solution (Perforomist) via nebulization.
Fixed combinations of formoterol/budesonide (Symbicort), formoterol/glycopyrrolate (Bevespi Aerosphere), and formoterol/mometasone (Dulera): Administer by oral inhalation using a metered-dose aerosol inhaler with hydrofluoroalkane (HFA) propellant.  
Inhalation Solution
Administer twice daily, approximately every 12 hours (morning and evening).
Store single-dose vials of oral inhalation solution in the foil pouch provided; remove immediately before use.
For administration of inhalation solution via nebulization, open a 20-mcg vial and squeeze entire contents into nebulizer reservoir. Connect reservoir to mouthpiece or face mask and then to compressor according to manufacturer’s instructions.
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.
Clean nebulizer after use according to manufacturer’s instructions.
Safety and efficacy of formoterol inhalation solution delivered from a nebulizer other than the Pari-LC Plus nebulizer or a compressor other than the PRONEB Ultra compressor not established.
Do not mix with other inhalation solutions. Do not ingest the oral inhalation solution.
Inhalation Aerosol
Administer aerosol containing formoterol/budesonide, formoterol/glycopyrrolate, or formoterol/mometasone as 2 inhalations twice daily (morning and evening).   After inhalation of formoterol/budesonide or formoterol/mometasone, rinse mouth and spit out water. 
Use actuator supplied with the product to administer formoterol in fixed combination with budesonide, glycopyrrolate, or mometasone.  
Formoterol/budesonide: 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. Shake well for 5 seconds immediately prior to use. Clean inhaler every 7 days by wiping mouthpiece with a dry cloth.
Formoterol/glycopyrrolate: Shake well before each inhalation. Prime the inhaler before first use. Test spray 4 times into the air (away from face) before initial use; if not used for >7 days, repeat priming process (using only 2 sprays instead of 4). Clean inhaler once weekly by removing the canister from the actuator; do not clean the canister or allow it to get wet. Rinse the actuator under warm water for about 30 seconds then turn upside down and rinse again.  Allow actuator to dry overnight. Repeat priming of the inhaler after cleaning by shaking well and releasing 2 test sprays into the air.
Formoterol/mometasone: Test spray 4 times into the air (away from face) before initial use or if not used for >5 days; shake well before each test spray and each inhalation. Clean inhaler every 7 days by wiping mouthpiece with a dry cloth; do not wash inhaler in water.
Dosage
Each 2-mL single-dose vial of formoterol fumarate oral inhalation solution (Perforomist) contains 20 mcg of formoterol fumarate. Dilution not required prior to administration by nebulization. Amount of drug delivered to the lungs will depend on patient factors and type of nebulization system used and its performance.
Each actuation of the oral aerosol inhaler containing formoterol/budesonide (Symbicort) delivers 5.1 mcg of formoterol fumarate dihydrate and 91 or 181 mcg of budesonide from the valve and delivers 4.5 mcg of formoterol fumarate dihydrate and 80 or 160 mcg of budesonide from the actuator per metered spray, depending on preparation used. Strength of the preparation and dosage of the drug are expressed in terms of drug delivered from mouthpiece of the actuator. Actual 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. Symbicort aerosol inhaler delivers 60 metered sprays per 6- or 6.9-g canister and 120 metered sprays per 10.2-g canister.
After priming, each actuation of the oral aerosol inhaler containing formoterol/glycopyrrolate (Bevespi Aerosphere) delivers 5.5 mcg of formoterol fumarate and 10.4 mcg of glycopyrrolate (equivalent to 8.3 mcg of glycopyrronium) from the valve and delivers 4.8 mcg of formoterol fumarate and 9 mcg of glycopyrrolate (equivalent to 7.2 mcg of glycopyrronium) from the actuator. Actual amount of drug delivered to the lungs depends on factors such as patient's coordination between actuation of the device and inspiration through the delivery system. Bevespi Aerosphere inhalation aerosol delivers 28 or 120 metered sprays per 5.9- or 10.7-g canister, respectively.
Each actuation of the oral aerosol inhaler containing formoterol/mometasone (Dulera) delivers 5.5 mcg of formoterol fumarate dihydrate and 115 or 225 mcg of mometasone furoate from the valve and delivers 5 mcg of formoterol fumarate dihydrate and 100 or 200 mcg of mometasone furoate from the actuator per metered spray, depending on preparation used. Strength of the preparation and dosage of the drug are expressed in terms of drug delivered from mouthpiece of the actuator. Actual amount of drug delivered to the lungs may depend on factors such as patient's coordination between actuation of the device and inspiration through the delivery system. Dulera aerosol inhaler delivers 60 or 120 metered sprays per 8.8- or 13-g canister, respectively.
Pediatric Patients
Asthma
Formoterol/Budesonide Fixed Combination
Children 6 to <12 years of age: 9 mcg of formoterol fumarate dihydrate and 160 mcg of budesonide (2 inhalations of preparation containing 4.5 mcg of formoterol fumarate dihydrate/80 mcg of budesonide) twice daily.
Adolescents ≥12 years of age: 9 mcg of formoterol fumarate dihydrate and 160 or 320 mcg of budesonide (2 inhalations of preparation containing 4.5 mcg of formoterol fumarate dihydrate/80 or 160 mcg of budesonide) twice daily. Base initial dosage on asthma severity.
If control of asthma in adolescents ≥12 years of age inadequate after 1–2 weeks of therapy at lower dosage, switching to higher strength of the fixed combination (higher strengths contain higher dosages of budesonide only) may provide additional asthma control.
Formoterol/Mometasone Fixed Combination
Adolescents ≥12 years of age: 10 mcg of formoterol fumarate dihydrate and 200 or 400 mcg of mometasone furoate (2 inhalations of preparation containing 5 mcg of formoterol fumarate dihydrate/100 or 200 mcg of mometasone furoate) twice daily. Select initial dosage based on asthma severity, previous asthma therapy (including previous inhaled corticosteroid dosage), current control of asthma symptoms, and risk of future asthma exacerbations.
If control of asthma inadequate after 2 weeks of therapy at lower dosage, switching to higher strength preparation of the fixed combination (higher strengths contain higher dosages of mometasone only) may provide additional asthma control.
Adults
Asthma
Formoterol/Budesonide Fixed Combination
9 mcg of formoterol fumarate dihydrate and 160 or 320 mcg of budesonide (2 inhalations of preparation containing 4.5 mcg of formoterol fumarate dihydrate/80 or 160 mcg of budesonide) twice daily. Base initial dosage on asthma severity.
If control of asthma inadequate after 1–2 weeks of therapy at lower dosage, switching to higher strength of the fixed combination (higher strengths contain higher dosages of budesonide only) may provide additional asthma control.
Formoterol/Mometasone Fixed Combination
10 mcg of formoterol fumarate dihydrate and 200 or 400 mcg of mometasone furoate (2 inhalations of preparation containing 5 mcg of formoterol fumarate dihydrate/100 or 200 mcg of mometasone furoate) twice daily. Select initial dosage based on asthma severity, previous asthma therapy (including previous inhaled corticosteroid dosage), current control of asthma symptoms, and risk of future asthma exacerbations.
If control of asthma inadequate after 2 weeks of therapy at lower dosage, switching to higher strength of the fixed combination (higher strengths contain higher dosages of mometasone only) may provide additional asthma control.
COPD
Formoterol
20 mcg (entire contents of single-dose vial) every 12 hours via nebulization.
Formoterol/Budesonide Fixed Combination
9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide (2 inhalations of preparation containing 4.5 mcg of formoterol fumarate dihydrate/160 mcg of budesonide) twice daily.
Lower dosages (i.e., 9 mcg of formoterol fumarate dihydrate and 160 mcg of budesonide twice daily) not recommended; no additional improvement in lung function (e.g., FEV1) compared with formoterol alone or placebo.
Formoterol/Glycopyrrolate Fixed Combination
9.6 mcg of formoterol fumarate and 18 mcg of glycopyrrolate (2 inhalations of preparation containing 4.8 mcg of formoterol fumarate/9 mcg of glycopyrrolate) twice daily.
Prescribing Limits
Pediatric Patients
Asthma
Formoterol/Budesonide Fixed Combination
Children 6 to <12 years of age: Maximum 9 mcg of formoterol fumarate dihydrate and 160 mcg of budesonide twice daily.
Adolescents ≥12 years of age: Maximum 9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide twice daily. 
Formoterol/Mometasone Fixed Combination
Adolescents ≥12 years of age: Maximum 10 mcg of formoterol fumarate dihydrate and 400 mcg of mometasone twice daily.
Adults
Asthma
Formoterol/Budesonide Fixed Combination
Maximum 9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide twice daily. 
Formoterol/Mometasone Fixed Combination
Maximum 10 mcg of formoterol fumarate dihydrate and 400 mcg of mometasone furoate twice daily.
COPD
Formoterol
Maximum 40 mcg daily.
Formoterol/Budesonide Fixed Combination
Maximum 9 mcg of formoterol fumarate dihydrate and 320 mcg of budesonide twice daily.
Formoterol/Glycopyrrolate Fixed Combination
Maximum 9.6 mcg of formoterol fumarate and 18 mcg of glycopyrrolate twice daily.
Special Populations
Hepatic Impairment
Formoterol: No specific dosage recommendations at this time.
Formoterol in fixed combination with budesonide, glycopyrrolate, or mometasone: Closely monitor patients with hepatic impairment.   (See Special Populations under Pharmacokinetics.)
Renal Impairment
Formoterol alone or in fixed combination with budesonide or mometasone: No specific dosage recommendations.  
Formoterol in fixed combination with glycopyrrolate: Use in patients with severe renal impairment (Clcr ≤30 mL/minute) or those with end-stage renal disease requiring dialysis only if expected benefit outweighs potential risk.
Geriatric Patients
Formoterol: No specific dosage recommendations at this time. 
Formoterol in fixed combination with budesonide, glycopyrrolate, or mometasone: No dosage adjustment required.  
 Detailed Formoterol dosage information
