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Albuterol

    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

    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

    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

    Hypersensitivity to donepezil or to piperidine derivatives

    • 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

    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

    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

    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

    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