Classes
DEA Class; Rx
Common Brand Names; Proventil HFA, Ventolin HFA, Proair HFA, ProAir RespiClick, Proventil, AccuNeb, Ventolin Injection, Ventolin Nebules PF, Ventolin Oral Liquid, Ventolin Respirator Solution, ProAir Digihaler
- Beta2 Agonists
Description
Short-acting beta-2 agonist (SABA); primarily used as a nebulizer solution or oral inhaler
Used for the relief of acute bronchospasm and episodic wheezing in patients with asthma or exercise-induced bronchospasm; used as reliever-therapy for COPD in adults
Inhaled albuterol is preferred for all uses vs. oral albuterol due to side-effect profile
Indications
Indicated for treatment or prevention of bronchospasm in patients with reversible obstructive airway disease
Acute or Severe Bronchospasm
Indicated for prevention of exercise-induced bronchospasm
Prevention of paralysis caused by spinal cord injury
Contraindications
Hypersensitivity to donepezil or to piperidine derivatives
Adverse Effects
- Tremor (20%)
- Nervousness in children aged 2-6 years (20%)
- Insomnia in children aged 6-12 years receiving 4-12 mg q12hr (11%)
- 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
Warnings
Risk of GI bleed, especially in patients with history of gastric ulcer or those on NSAIDs
Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia
Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block
Can cause vomiting (higher risk with dose of 23 mg/day)
May cause anorexia and/or weight loss (dose dependent)
Cholinomimetics may cause bladder outflow obstructions
Cholinomimetics are believed to have some potential to cause generalized convulsions
Cholinesterase inhibitors should be prescribed with care with history of asthma or obstructive pulmonary disease
Use with caution in patients with history of seizure disorders, urinary tract obstruction, peptic ulcer disease, cardiac conduction abnormalities, or respiratory disease including COPD or asthma
Pregnancy and Lactation
There are no randomized clinical studies of use during pregnancy
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
Maximum Dosage
Adults
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 (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
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
Pediatric
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
How supplied
Albuterol sulfate
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