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 abluterol sulfate); ProAir RespiClick
tablet
- 2mg
- 4mg
tablet, extended release
- 4mg
- 8mg
nebulizer solution
- 0.083%
- 0.5%
- 1.25mg/3mL
- 0.63mg/3mL
syrup
- 2mg/5mL
Bronchospasm
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: 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: 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
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
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
tablet
- 2mg
- 4mg
tablet, extended release
- 4mg
- 8mg
nebulizer solution
- 0.083%
- 0.5%
- 1.25mg/3mL
- 0.63mg/3mL
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)
- <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)
- <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
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
Hypokalemia and changes in blood glucose may occur
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)
Pregnancy & Lactation
Pregnancy category: C
Lactation: Unknown whether drug is excreted in milk; not recommended
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
Solution for Nebulization
Remove one vial from the foil pouch
Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir
Connect the nebulizer to the mouthpiece or face mask
Connect the nebulizer to the compressor
Sit in a comfortable, upright position; place the mouthpiece in your mouth or put on the face mask, and turn on the compressor
Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (about 5-15 minutes); at this point, the treatment is finished
Clean the nebulizer according to manufacturer instructions
Aerosol Metered-Dose Inhaler
For oral inhalation only
Prime the inhaler before using for the first time and in cases where the inhaler has not been used for >2 weeks by releasing 4 “test sprays” into the air, away from the face
Patient instructions for administration
- Shake well before each use
- Breathe out fully through the mouth, expelling as much air from your lungs as possible; place the mouthpiece fully into the mouth, holding the inhaler in its upright position and close the 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 as long as possible, up to 10 seconds; before breathing out, remove the inhaler from your mouth and release your finger from the canister
- If your physician has prescribed additional puffs, wait 1 minute, shake the inhaler again, and repeat steps listed above; replace the cap after use
Cleaning
- To maintain proper use of this product, it is important that the mouthpiece be washed and dried thoroughly at least once a week
- Keeping the plastic mouthpiece clean is very important to prevent medication buildup and blockage
- The inhaler may cease to deliver medication if not properly cleaned and air dried thoroughly
- If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage
Powder Metered-Dose Inhaler
For oral inhalation only
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
- If the mouthpiece needs cleaning, gently wipe with a dry cloth or tissue as needed
Extended-release oral tablets
Do not chew, crush, or mix with food
Storage
Solution for nebulization
- Store between 2-25° C (36-77° F)
- Vials should be protected 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.
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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