Albuterol

Albuterol is a prescription drug indicated for the treatment of asthma symptoms in patients 4 years of age and older with reversible obstructive airway disease.

Asthma is a long-term disease of the airways and lungs. Asthma is a condition that causes breathing difficulties.

Asthma has two main components that make breathing difficult,

• Inflammation (swelling and a build-up of mucus in the airways); and
• Airway constriction (tightening of the muscles surrounding the airways)

Albuterol helps to prevent asthma symptoms, including:

• coughing
• wheezing
• shortness of breath, and
• tightness in the chest

Albuterol inhalation aerosol can be used with or without steroid treatment.

Albuterol is available under the following different brand names: Proventil HFA, Ventolin HFA, Proair HFA, ProAir RespiClick, Proventil, AccuNeb, Ventolin Injection, Ventolin Nebules PF, Ventolin Oral Liquid, Ventolin Respirator Solution, and Vospire ER.

Albuterol belongs to a category of medications called bronchodilators. Brochodilators are drugs that relax bronchial muscles (related to muscles associated with the lungs). These work by way of inhalation of medications that control asthma and asthma symptoms.

This medication is similar to Xopenex (levalbuterol HCl).

This medication is also known as Salbutamol.

Users of this medication should read the drug information leaflet that accompanies the prescription as well as every time the prescription is refilled. There may be new health information.

Adult and Pediatric Dosage Forms and Strengths

Aerosol metered-dose albuterol inhaler

• 90mcg (base)/actuation (equivalent to 108mcg albuterol sulfate)

Powder metered-dose albuterol inhaler

• 90mcg (base)/actuation (equivalent to 108mcg albuterol sulfate); ProAir RespiClick

Tablet

• 2 mg
• 4 mg

Tablet, extended release

• 4 mg
• 8 mg

Nebulizer solution

• 0.083%
• 0.5%
• 1.25mg/3mL
• 0.63mg/3mL

Syrup

• 2 mg/5 mL

Dosage Considerations – Should be Given as Follows:

Adult

Nebulizer solution: 2.5 mg two or three times/day as needed; 1.25 - 5 mg every 4-8 hours as needed for quick relief

Aerosol metered-dose inhaler: 180 mcg (2 puffs) inhaled orally every 4-6 hours; not to exceed 12 inhalations/24 hours

Powder metered-dose inhaler: 180 mcg (2 puffs) inhaled orally every 4-6 hours; not to exceed 12 inhalations/24 hours; in some patients 1 inhalation (90 mcg) every 4 hours may be sufficient

Tablet and syrup: 2-4 mg orally every 6-8 hours; not to exceed 32 mg/day

Extended release: 8 mg orally every 12 hours; in some patients 4 mg orally every 12 hours sufficient; not to exceed 32 mg/day

Pediatric

Aerosol metered-dose inhaler

• Asthmatic children younger than 4 years: Safety and efficacy not established
• Asthmatic children 4 years and older: 90-180 mcg (1-2 puffs) inhaled orally every 4-6 hours

Powder metered-dose inhaler (ProAir RespiClick)

• Children younger than 4 years: Safety and efficacy not established
• Children 4 years and older: 180 mcg (2 puffs) inhaled orally every 4-6 hours; not to exceed 12 inhalations/24 hours
• In some patients 1 inhalation (90 mcg) every 4 hours may be sufficient

Nebulizer solution

• Children younger than 2 years (off-label): 0.2-0.6 mg/kg/day divided every 4-6 hours
• Children 2-12 years and less than 15 kg: 2.5 mg/0.5mL (0.5 % solution) every 6-8 hours; not to exceed 10 mg (4 vials)/24 hours
• Children 2-12 years and greater than 15 kg: 1 vial (2.5 mg/3mL) every 6-8 hours; not to exceed 10 mg (4 vials)/24 hours
• Children older than 12 years: 2.5 mg (1 vial) every 6-8 hours as needed; not to exceed 10 mg/24 hours
• Flow rate of delivery adjusted over period of 5-15 minutes

AccuNeb

• Children younger than 2 years: Safety and efficacy not established
• Children 2-12 years 1 vial (1.25 or 0.63 mg/vial) every 6-8 hours inhaled orally via nebulizer over 5-15 min; 4 vials (5 mg)/24 hours
• Children older than 12 years: Not studied

Tablet

• Children younger than 6 years: 0.3-0.6 mg/kg/day orally divided every 8 hours; not to exceed 12 mg/day
• Children 6-12 years: 2 mg orally every 6-8 hours; may be gradually increased to 24 mg/day or more in divided doses
• Children older than 12 years: 2-4 mg orally every 6-8 hours; not to exceed 32 mg/day

Extended Release Tablet

• Children younger than 6 years: Safety and efficacy not established
• Children 6-12 years: 4 mg orally every 12 hours; not to exceed 24 mg/day
• Children older than 12 years: 8 mg orally every 12 hours; in some patients 4 mg every 12 hours sufficient

Syrup

• Children 2-6 years: 0.1 mg (0.25 mL)/kg orally every 8 hours initially, not to exceed 2 mg (5 mL) every 8 hours; if necessary, may be increased to 0.2 mg/kg orally every 8 hours, not to exceed 4 mg (10 mL) every 8 hours
• Children 6-14 years: 2 mg (5 mL) orally every 6-8 hours; may be gradually increased to 24 mg/day or more in divided doses
• Children older than 14 years: 2-4 mg orally every 6-8 hours; not to exceed 32 mg/day

Nebulizer solution: 2.5-5 mg every 20 minutes for 3 doses; follow with 2.5-10 mg every 1-4 hours as needed or 10-15 min by continuous nebulization

Metered-dose inhaler: 4-8 puffs inhaled every 20 minutes for up to 4 hours and then every 1-4 hours as needed

Adult

Aerosol or powder metered-dose inhaler: 180 mcg (2 puffs) inhaled 15-30 min before exercise

Pediatric

Aerosol metered-dose inhaler

• Children younger than 4 years: Safety and efficacy not established
• Children 4 years and older: 180 mcg (2 puffs) inhaled 15-30 min before exercise

Powder metered-dose inhaler (ProAir RespiClick)

• Children younger than 4 years: Safety and efficacy not established
• Children 4 years and older: 180 mcg (2 puffs) inhaled 15-30 min before exercise

Potential toxic dose for children younger than 6 years: 1 mg/kg

Common side effects of albuterol include:

• Tremor
• Increased blood pressure
• Nervousness in children aged 2-6 years
• Insomnia in children aged 6-12 years receiving 4-12 mg every 12 hours
• Nausea
• Fever
• Bronchospasm
• Vomiting
• Headache
• Dizziness
• Cough
• Allergic reactions
• Ear infection (otitis media)
• Nosebleed
• Increased appetite
• Urinary tract infection
• Dry mouth
• Belching or gas
• Increased sweating
• Pain
• Indigestion
• Hyperactivity
• Chills
• Enlarged lymph nodes
• Palpitations or increased heart beat
• Eye itching
• Sweating
• Conjunctivitis in children aged 2-6 years
• Difficulty speaking
• Flu syndrome
• Nervousness
• Abdominal pain

Other side effects of albuterol include:

• High blood pressure (hypertension)
• Chest pain (angina)
• Spinning sensation (vertigo)
• Central nervous system stimulation
• Insomnia
• Metabolic acidosis
• Dry or irritated throat
• Hypersensitivity
• Low blood potassium
• Increased blood glucose levels
• Prolonged QT interval and ST-segment depression
• Sleeplessness
• Fast heart rate (incidence varies with formulation)
• Hives
• Skin swelling
• Rash
• Swelling of mouth and throat (rare)

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.

Severe interactions of albuterol include:

• saquinavir

Serious interactions of albuterol include:

• amitriptyline
• amoxapine
• clomipramine
• desipramine
• dosulepin
• doxepin
• imipramine
• isocarboxazid
• linezolid
• lofepramine
• maprotiline
• mianserin
• nortriptyline
• phenelzine
• protriptyline
• tranylcypromine
• trazodone
• trimipramine

Albuterol has moderate interactions with at least 249 different drugs.

Mild Interactions of albuterol include:

• bendroflumethiazide
• bumetanide
• chlorothiazide
• chlorthalidone
• cyclopenthiazide
• digoxin
• ethacrynic acid
• eucalyptus
• furosemide
• hydrochlorothiazide
• indapamide
• methyclothiazide
• metolazone
• noni juice
• sage
• torsemide

The information presented does not contain all possible interactions from the use of this drug. Therefore, before using this product, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list of drugs with your doctor and pharmacist. Check with your doctor if you have health questions or concerns about asthma or asthma medications.

Warnings

• This medication contains albuterol. Do not take Proventil HFA, Ventolin HFA, Proair HFA, ProAir RespiClick, Proventil, AccuNeb, Ventolin Injection, Ventolin Nebules PF, Ventolin Oral Liquid, Ventolin Respirator Solution, or Vospire ER if you are allergic to albuterol or any ingredients contained in this drug
• Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Hypersensitivity to albuterol
• Severe hypersensitivity to milk proteins

Effects of Drug Abuse

• Excessive use may be fatal; do not exceed recommended dose; serious adverse effects occur when administered dose exceeds recommended dose

Short-Term Effects

• See "What Are Side Effects Associated with Using Albuterol?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Albuterol?"

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 facemask in children under 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 and Lactation

• Use albuterol with caution during pregnancy if benefits outweigh risks
• Animal studies show risk and human studies are not available or neither animal nor human studies done
• It is unknown whether albuterol is excreted in milk; use while breastfeeding is not recommended