Dosing & Uses
Dosage Forms & Strengths
aerosol metered-dose inhaler
- 90mcg (base)/actuation (equivalent to 108mcg albuterol sulfate)
powder metered-dose inhaler
- 90mcg (base)/actuation (equivalent to 108mcg albuterol sulfate); ProAir RespiClick
powder metered-dose inhaler with electronic module
- 90mcg (base)/actuation (equivalent to 108mcg albuterol sulfate); ProAir Digihaler
tablet
- 2mg
- 4mg
tablet, extended release
- 4mg
- 8mg
nebulizer solution
- 1.25mg/3mL (contains 1.50 mg albuterol sulfate/3 mL)
- 0.63mg/3mL (contains 0.75 mg albuterol sulfate/3 mL)
syrup
- 2mg/5mL
Bronchospasm
Indicated for treatment or prevention of bronchospasm in patients with reversible obstructive airway disease
Nebulizer solution: 2.5 mg BID/TID PRN; 1.25 - 5 mg q4-8hr PRN for quick relief
Aerosol metered-dose inhaler: 180 mcg (2 puffs) inhaled PO q4-6hr; not to exceed 12 inhalations/24 hr
Powder metered-dose inhaler (ProAir RespiClick or ProAir Digihaler): 180 mcg (2 puffs) inhaled PO q4-6hr; not to exceed 12 inhalations/24 hr; in some patients 1 inhalation (90 mcg) q4hr may be sufficient
Tablet and syrup: 2-4 mg PO q6-8hr; not to exceed 32 mg/day
Extended-release tablets: 8 mg PO q12hr; in some patients 4 mg PO q12hr sufficient; not to exceed 32 mg/day
Acute or Severe Bronchospasm
Nebulizer solution: 2.5-5 mg q20min for 3 doses; follow with 2.5-10 mg q1-4hr PRN or 10-15 min by continuous nebulization
Metered-dose inhaler: 4-8 puffs inhaled q20min for up to 4 hr and then q1-4hr PRN
Exercise-induced Bronchospasm
Indicated for prevention of exercise-induced bronchospasm
Aerosol or powder metered-dose inhaler: 180 mcg (2 puffs) inhaled 15-30 min before exercise
Spinal Cord Injury (Orphan)
Prevention of paralysis caused by spinal cord injury
Orphan indication sponsor
- MotoGen, Inc, 3 Pine View Road, Mount Kisco, NY 10549
Dosing Considerations
ProAir Digihaler: Contains a QR code and a built-in electronic module which automatically detects, records, and stores data on inhaler events, including peak inspiratory flow rate (L/min)
Dosage Forms & Strengths
aerosol metered-dose inhaler
- 90mcg (base)/actuation (equivalent to 108mcg albuterol sulfate)
powder metered-dose inhaler
- 90mcg (base)/actuation (equivalent to 108mcg abluterol sulfate); ProAir RespiClick
powder metered-dose inhaler with electronic module
- 90mcg (base)/actuation (equivalent to 108mcg albuterol sulfate); ProAir Digihaler
tablet
- 2mg
- 4mg
tablet, extended-release
- 4mg
- 8mg
nebulizer solution
- 1.25mg/3mL (contains 1.50 mg albuterol sulfate/3 mL)
- 0.63mg/3mL (contains 0.75 mg albuterol sulfate/3 mL)
syrup
- 2mg/5mL
Bronchospasm
Treatment and prevention of bronchospasm associated with obstructive airway disease
Aerosol metered-dose inhaler
- <4 years: Safety and efficacy not established
- ≥4 years: 90-180 mcg (1-2 puffs) inhaled PO q4-6 hr
Powder metered-dose inhaler (ProAir RespiClick or ProAir Digihaler)
- <4 years: Safety and efficacy not established
- ≥4 years: 180 mcg (2 puffs) inhaled PO q4-6hr; not to exceed 12 inhalations/24 hr
- In some patients 1 inhalation (90 mcg) q4hr may be sufficient
Nebulizer solution
- <2 years (off-label): 0.2-0.6 mg/kg/day divided q4-6hr
- 2-12 years and <15 kg: 2.5 mg/0.5mL (0.5 % solution) q6-8hr; not to exceed 10 mg (4 vials)/24hr
- 2-12 years and >15 kg: 1 vial (2.5 mg/3mL) q6-8hr; not to exceed 10 mg (4 vials)/24hr
- >12 years: 2.5 mg (1 vial) q6-8hr PRN; not to exceed 10 mg/24hr
- Flow rate of delivery adjusted over period of 5-15 minutes
AccuNeb
- <2 years: Safety and efficacy not established
- 2-12 years 1 vial (1.25 or 0.63 mg/vial) q6-8hr inhaled PO via nebulizer over 5-15 min; 4 vials (5 mg)/24 hr
- >12 years: Not studied
Tablet
- <6 years: 0.3-0.6 mg/kg/day PO divided q8hr; not to exceed 12 mg/day
- 6-12 years: 2 mg PO q6-8hr; may be gradually increased to ≤24 mg/day in divided doses
- >12 years: 2-4 mg PO q6-8hr; not to exceed 32 mg/day
Extended-release Tablet
- <6 years: Safety and efficacy not established
- 6-12 years: 4 mg PO q12hr; not to exceed 24 mg/day
- >12 years: 8 mg PO q12hr; in some patients 4 mg q12hr sufficient
Syrup
- 2-6 years: 0.1 mg (0.25 mL)/kg PO q8hr initially, not to exceed 2 mg (5 mL) q8hr; if necessary, may be increased to 0.2 mg/kg PO q8hr, not to exceed 4 mg (10 mL) q8hr
- 6-14 years: 2 mg (5 mL) PO q6-8hr; may be gradually increased to ≤24 mg/day in divided doses
- >14 years: 2-4 mg PO q6-8hr; not to exceed 32 mg/day
Exercise-induced Bronchospasm Prevention
Aerosol metered-dose inhaler
- <4 years: Safety and efficacy not established
- ≥4 years: 180 mcg (2 puffs) inhaled 15-30 min before exercise
Powder metered-dose inhaler (ProAir RespiClick or ProAir Digihaler)
- <4 years: Safety and efficacy not established
- ≥4 years: 180 mcg (2 puffs) inhaled 15-30 min before exercise
Dosing Considerations
Potential toxic dose for children <6 years: 1 mg/kg
ProAir Digihaler: Contains a QR code and a built-in electronic module which automatically detects, records, and stores data on inhaler events, including peak inspiratory flow rate (L/min)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Tremor (20%)
Nervousness in children aged 2-6 years (20%)
Insomnia in children aged 6-12 years receiving 4-12 mg q12hr (11%)
1-10%
Nausea (10%)
Fever (1.6-9%)
Bronchospasm (8%)
Vomiting (7%)
Headache (4-7%)
Dizziness (1-7%)
Cough (5%)
Allergic reactions (4%)
Otitis media (3.3%)
Epistaxis in children (3%)
Increased appetite (3%)
Urinary tract infection (3%)
Dry mouth (<3%)
Eructation or flatulence (<3%)
Increased sweating (<3%)
Pain (2.7%)
Dyspepsia (1-2%)
Hyperactivity (1-2%)
Chills (<2%)
Lymphadenopathy (<2%)
Ocular pruritus (<2%)
Sweating (<2%)
Conjunctivitis in children aged 2-6 years (1%)
Dysphonia (>1%)
Flu syndrome
Nervousness
<1%
Epigastric pain
Epistaxis in adults
Hyperactivity in children
Frequency Not Defined
Adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, metabolic acidosis, and drying or irritation of oropharynx
Hypersensitivity
Hypokalemia
Increased blood glucose levels
Prolonged QT interval and ST-segment depression
Sleeplessness
Tachycardia (incidence varies with formulation)
Urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema (rare)
Warnings
Contraindications
Hypersensitivity to albuterol
Severe hypersensitivity to milk proteins
Cautions
Some inhalers use hydrofluoroalkane (HFA) as propellant instead of chlorofluorocarbons (CFCs); otherwise, devices are equivalent
Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema
Paradoxical bronchospasm may occur
Need for more doses than usual may be a sign of deterioration of asthma and requires reevaluation of treatment
Use with caution in patients with cardiovascular disease, asthma, glaucoma, diabetes, hypokalemia, hyperthyroidism, or seizures
Use face mask in children <4 years
Excessive use may be fatal; do not exceed recommended dose; serious adverse effects occur when administered dose exceeds recommended dose
May exacerbate heart failure in patients with reduced ejection fraction (dose related increased risk for hospital admission)
Use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma; consider adding anti-inflammatory agents (eg, corticosteroids) to therapy
May produce significant hypokalemia, possibly through intracellular shunting, which potentially produces adverse cardiovascular effects
Drug interactions overview
- Do not use other short-acting sympathomimetic bronchodilators concomitantly with an albuterol inhaler
- Additional adrenergic drugs by any route should be used with caution to avoid deleterious cardiovascular effects
- ECG changes and/or hypokalemia which may result from coadministration of non-potassium sparing diuretics (eg, loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when recommended dose of beta-agonist is exceeded
- Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single dose IV and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days; clinical significance is unclear; carefully evaluate serum digoxin levels in patients who are concurrently receiving digoxin and albuterol inhaler
- Use extreme caution in patients being treated with monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (TCAs), or within 2 weeks of discontinuation of such agents, because coadministration may potentiate cardiovascular effects of albuterol; consider alternative therapy in patients taking MAOIs or TCAs
Pregnancy & Lactation
Pregnancy
There are no randomized clinical studies of use during pregnancy
Available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage
In animal reproduction studies, when administered SC to pregnant mice there was evidence of cleft palate at ≤9x the maximum recommended human daily inhalation dose (MRHDID)
Clinical considerations
- Disease-associated maternal and/or embryo/fetal risk
- In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate
- Closely monitor pregnant women and adjust medications as necessary to maintain optimal control
- Labor or delivery
- Because of potential for beta-agonist interference with uterine contractility, restrict use for relief of bronchospasm during labor to those patients in whom the benefits clearly outweigh the risk
Lactation
There are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Beta2 receptor agonist with some beta1 activity; relaxes bronchial smooth muscle with little effect on heart rate
Absorption
Onset: 25 min (Ventolin HFA); 0.5-2 hr (nebulization); 2-3 hr (PO)
Duration: 4-6 hr (PO);
Peak plasma time: Inhalation, 2-5 hr; PO, 2-2.5 hr
Distribution
Protein bound: 10%
Metabolism
Metabolized in liver
Elimination
Half-life: 3-8 hr (inhalation); 3.7-5 hr (PO)
Excretion: Urine
Administration
Oral Inhalation Administration
For oral inhalation only
Nebulizer solution
- Remove one vial from foil pouch
- Twist cap off vial and squeeze contents into nebulizer reservoir
- Attach mouthpiece/face mask and compressor to nebulizer
- Sit in a comfortable, upright position; place the mouthpiece in your mouth or put on mask, and turn on compressor
- Calmly breathe and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (~5-15 minutes)
- Clean nebulizer according to manufacturer instructions
Aerosol metered-dose inhaler
- Prime inhaler (before first-time use or when inhaler has not been used for >2 weeks): Release 4 test sprays into the air, away from the face
- Shake well before each use
- Breathe out fully through the mouth; place mouthpiece fully into mouth, holding inhaler in its upright position and close lips around it
- While breathing in deeply and slowly through the mouth, fully depress the top of the metal canister with your index finger
- Hold your breath for ≤10 sec; before breathing out
- For additional puffs, wait 1 minute, shake inhaler again, and repeat steps listed above; replace cap after use
- Cleaning: To maintain proper use of this product, wash and dry mouthpiece thoroughly ≥1/week
Powder metered-dose inhaler
- Does NOT require priming
- Do not use with a spacer or volume holding chamber
- Cleaning
- Keep clean and dry at all times
- Never wash or put any part of inhaler in water
- Routine maintenance not required
Oral Administration
Extended-release tablets: Do not chew, crush, or mix with food
Storage
Nebulizer solution
- Store between 2-25°C (36-77°F)
- Protect from light before use, therefore, keep unused vials in the foil pouch
Aerosol metered-dose inhaler
- Store at room temperature (15-25°C [59-77°F])
Powder metered-dose inhaler
- Store at room temperature (15-25°C [59-77°F])
- Avoid exposure to extreme heat, cold, or humidity
- Discard 13 months after opening the foil pouch, when the dose counter displays zero, or after the expiration date on the product, whichever comes first
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
