Albuterol

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Common Side Effects of Albuterol

You should tell your doctor if any of the following side effects of albuterol become severe or don't go away:

• Nervousness
• Shaking of a part of the body
• Headache
• Nausea
• Vomiting
• Cough
• Irritation in the throat
• Muscle, bone, or back pain

Albuterol and Weight Loss

Because albuterol has a stimulating effect, some people try to use it for weight loss. Various websites (of dubious credibility) offer instructions and discussions on how to use this medication for weight loss.

However, albuterol is not approved by the FDA for this purpose. Increasing your dose of this medicine or using it more frequently than prescribed to achieve weight loss can be dangerous and lead to life-threatening side effects.

Serious Side Effects of Albuterol

You should call your doctor immediately if you experience any of the following serious side effects:

• Chest pain
• Rash, hives, or itching
• Fast, pounding, or irregular heartbeat
• Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Difficulty swallowing
• Worsened breathing
• Hoarseness

Inhalational:

• Albuterol aerosol spray is a prescription medication used in people 4 years of age and older to:
  • treat or prevent bronchospasm (narrowing of airways) in people who have reversible obstructive airway disease (asthma)
  • prevent exercise induced bronchospasm (narrowing of airways)
• Albuterol solution for nebulization is a prescription medication used for the relief of bronchospasm (narrowing of airways) in patients 2 to 12 years of age with asthma

Oral:

• Albuterol immediate- and extended-release tablets are used for the relief of bronchospasm (narrowing of airways) in adults and children 6 years of age and older with reversible obstructive airway disease (asthma).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before you use albuterol, tell your doctor if you:

• have heart problems
• have high blood pressure (hypertension)
• have convulsions (seizures)
• have thyroid problems
• have diabetes
• have low potassium levels in your blood
• are pregnant or plan to become pregnant. It is not known if albuterol will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if albuterol passes into your breast milk. Talk to your doctor about the best way to feed your baby if you are using albuterol.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For albuterol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to albuterol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol in children 2 years of age and older.

Geriatric

No information is available on the relationship of age to the effects of albuterol in geriatric patients. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking albuterol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using albuterol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Atomoxetine
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Imipramine
• Iobenguane I 123
• Levalbuterol
• Lofepramine
• Melitracen
• Nortriptyline
• Opipramol
• Protriptyline
• Tianeptine
• Trimipramine

Using albuterol with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of albuterol. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• Heart or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Seizure disorders—Use with caution. May make these conditions worse.

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of Albuterol tablets. Treatment consists of discontinuation of Albuterol tablets together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Albuterol tablets. The oral median lethal dose of Albuterol sulfate in mice is greater than 2000 mg/kg (approximately 250 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 200 times the maximum recommended daily oral dose for children on a mg/m2 basis). In mature rats, the subcutaneous (sc) median lethal dose of Albuterol sulfate is approximately 450 mg/kg (approximately 110 times the maximum recommended daily oral dose for adults on a mg/m2 basis or, approximately 90 times the maximum recommended daily oral dose for children on a mg/m2 basis). In small young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 500 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 400 times the maximum recommended daily oral dose for children on a mg/m2 basis).

• AccuNeb
• Albuterol Sulfate
• ProAir RespiClick
• Salbutamol
• Salbutamol Sulphate
• Volmax

Bronchospasm: Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease

Exercise-induced bronchospasm: Prevention of exercise-induced bronchospasm

Inhalation: Refer to adult dosing.

Bronchospasm (treatment): Oral, regular release: 2 mg 3 to 4 times daily; maximum: 8 mg 4 times daily

Bronchospasm:

Inhalation:

Metered-dose inhaler or dry powder inhaler (90 mcg/actuation) (NAEPP 2007): Quick relief: Children and Adolescents: Refer to adult dosing.

Metered-dose inhaler (100 mcg/actuation): Airomir [Canadian product]:

Children 6 to 11 years:

Acute treatment: 1 inhalation; additional inhalations may be necessary if inadequate relief; however, patients should be advised to promptly consult health care provider or seek medical attention if no relief from acute treatment

Maintenance (in combination with corticosteroid therapy): 1 inhalation; may increase to maximum of 1 inhalation 4 times daily

Children ≥12 years and Adolescents: Refer to adult dosing.

Dry powder inhaler (200 mcg/inhalation): Ventolin Diskus [Canadian product]: Children ≥4 years and Adolescents: Refer to adult dosing.

Nebulization solution:

Manufacturer's recommendations:

Children 2 to 12 years: 0.63 to 1.25 mg 3 to 4 times daily as needed

Children ≥12 years and Adolescents: 2.5 mg 3 to 4 times daily as needed

Alternative recommendations (NAEPP 2007): Quick relief:

Children ≤4 years: 0.63 to 2.5 mg every 4 to 6 hours as needed

Children 5 to 11 years: 1.25 to 5 mg every 4 to 8 hours as needed

Children ≥12 years and Adolescents: Refer to adult dosing.

Oral: Note: Oral is not the preferred route for treatment of asthma; inhalation via nebulization or MDI is preferred (NAEPP 2007).

Regular release:

Children 2 to 6 years: 0.1 to 0.2 mg/kg/dose 3 times daily (maximum: 12 mg daily)

Children 6 to 12 years: 2 mg/dose 3 to 4 times daily (maximum: 24 mg daily)

Children >12 years and Adolescents: 2 to 4 mg/dose 3 to 4 times daily (maximum: 32 mg daily)

Extended release:

Children 6 to 12 years: 4 mg every 12 hours (maximum: 24 mg daily)

Children >12 years and Adolescents: 8 mg every 12 hours (maximum: 32 mg daily)

Exacerbation of asthma (acute, severe) (NAEPP 2007): Inhalation:

Metered-dose inhaler or dry powder inhaler (90 mcg/actuation):

Children <12 years: 4 to 8 inhalations every 20 minutes for 3 doses, then every 1 to 4 hours as needed

Children ≥12 years and Adolescents: Refer to adult dosing.

Nebulization solution:

Children <12 years: 0.15 mg/kg (minimum: 2.5 mg) every 20 minutes for 3 doses, then 0.15 to 0.3 mg/kg (maximum: 10 mg) every 1 to 4 hours as needed, or 0.5 mg/kg/hour by continuous nebulization

Children ≥12 years and Adolescents: Refer to adult dosing.

Exercise-induced bronchospasm (prevention): Inhalation:

Metered-dose inhaler or dry powder inhaler (90 mcg/actuation):

Children ≤4 years: 1 to 2 inhalations 5 minutes prior to exercise (NAEPP 2007)

Children >4 years and Adolescents: 2 inhalations 5 minutes prior to exercise (NAEPP 2007)

Metered-dose inhaler (100 mcg/actuation): Airomir [Canadian product]:

Children 6 to 11 years: 1 inhalation 30 minutes prior to exercise

Children ≥12 years and Adolescents: Refer to adult dosing.

Dry powder inhaler (200 mcg/inhalation): Ventolin Diskus [Canadian product]: Children ≥4 years and Adolescents: Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling; use with caution. No dosage adjustment required in patients on hemodialysis, peritoneal dialysis, or CRRT (Aronoff 2007).

Metered-dose inhalers (HFA aerosols): Store at 15°C to 25°C (59°F to 77°F). Do not store at temperature >120°F. Do not puncture. Do not use or store near heat or open flame.

Ventolin HFA: Discard when counter reads 000 or 12 months after removal from protective pouch, whichever comes first. Store with mouthpiece down.

Dry powder inhalers:

ProAir RespiClick: Store between 15°C and 25°C (59°F and 77°F). Avoid exposure to extreme heat, cold, or humidity. Discard 13 months after opening the foil pouch, or when the counter displays 0, whichever comes first

Ventolin Diskus [Canadian product]: Store at ≤30°C (86°F). Keep in a dry place. Protect from frost and light. Diskus is nonrefillable and should be discarded after all doses have been administered.

Infusion solution [Canadian product]: Ventolin IV: Store at 15°C to 30°C (59°F to 86°F). Protect from light. After dilution, discard unused portion after 24 hours.

Nebulization solution: Store at 2°C to 25°C (36°F to 77°F). Do not use if solution changes color or becomes cloudy. Products packaged in foil should be used within 1 week (or according to the manufacturer's recommendations) if removed from foil pouch.

Syrup: Store at 20°C to 25°C (68°F to 77°F).

Tablet: Store at 20°C to 25°C (68°F to 77°F).

Tablet, extended release: Store at 20°C to 25°C (68°F to 77°F)

Increased renin (S), increased aldosterone (S)

FEV1, peak flow, and/or other pulmonary function tests; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium, serum creatinine; asthma symptoms; arterial or capillary blood gases (if patients condition warrants)

Applies to albuterol: compounding powder, inhalation aerosol, inhalation aerosol with adapter, inhalation capsule, inhalation powder, inhalation solution, oral syrup, oral tablet, oral tablet extended release

General

The most commonly reported adverse reactions are: Taste alteration (bad, unpleasant and unusual taste), mouth and throat irritation, fine tremor (usually of the hands), nausea, sweating, restlessness, headache and dizziness. These undesirable effects may subside on continuation of treatment.[Ref]

Cardiovascular

Very common (10% or more): Peripheral vasodilation, increase in heart rate
Common (1% to 10%): Palpitations, tachycardia, pallor
Rare (0.01% to 0.1%): Myocardial ischemia, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extra systoles)
Very rare (less than 0.01%): Cardiovascular collapse, thrombopenia
Frequency not reported: Angina, hypertension, hypotension, flushing[Ref]

Nervous system

Very common (10% or more): Headache (up to 18.8%), tremor (up to 24.2%), excitement (up to 20%), nervousness (up to 15%)
Common (1% to 10%): Migraine, dizziness, shakiness, hyperkinesia, emotional lability
Uncommon (0.1% to 1%): Somnolence, dizziness, drowsiness, restlessness, irritability
Frequency not reported: Central nervous system stimulation[Ref]

Dermatologic

Common (1% to 10%): Skin/Appendage Infection (1.7%), pruritus, rash, erythema, urticaria, angioedema, sweating[Ref]

Gastrointestinal

Common (1% to 10%): Gastroenteritis, nausea, oropharyngeal pain, vomiting, increased appetite
Uncommon (0.1% to 1%): Epigastric pain, stomach ache, loss of appetite
Rare (less than 0.1%): Sore mouth
Frequency not reported: Oropharyngeal edema, throat irritation, altered taste, glossitis, tongue ulceration, gagging, drying or irritation of the oropharynx[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Rare (less than 0.1%): Nephritis
Frequency not reported: Difficulty in micturition[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction
Very rare (less than 0.01%): angioedema, urticaria, bronchospasm, hypotension and collapse[Ref]

Immunologic

Common (1% to 10%): Lymphadenopathy[Ref]

Local

Common (1% to 10%): Application site reaction (mouth and throat irritation, burning sensation of the tongue)
Frequency not reported: Slight pain or stinging (IM injection)[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscles cramps
Uncommon (0.1% to 1%): Myalgia
Very rare (less than 0.01%): Fine tremor (particularly of hands)
Frequency not reported: Myoclonus[Ref]

Other

Common (1% to 10%): Cold symptoms, flue syndrome, pain, pyrexia, hyperactivity, excitement
Uncommon (0.1% to 1%): Epistaxis, fatigue, otitis media,
Frequency not reported: Weakness[Ref]

Psychiatric

Common (1% to 10%): Tenseness
Uncommon (0.1% to 1%): Sleepiness, sleep disturbance
Rare (0.01% to 0.1%): Hallucinations
Very rare (less than 0.01%): Insomnia[Ref]

Respiratory

Common (1% to 10%): Asthma exacerbation (13%), chest pain, bronchitis, sinus headache, upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough
Very rare (less than 0.01%): Paradoxical bronchospasm, bronchospasm
Frequency not reported: Aggravated bronchospasm, asthma exacerbation, chest discomfort, pulmonary edema[Ref]

Ocular

Uncommon (0.1% to 1%): Dilated pupils, conjunctivitis[Ref]

Metabolic

Rare (less than 0.1%): Hypokalemia, hyperglycemia, increase of insulin, free fatty acids, glycerol and ketone bodies
Postmarketing reports: Metabolic acidosis, lactic acidosis[Ref]

Some side effects of albuterol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Inhalation powder: 2 inhalations (180 mcg) orally 15 to 30 minutes before exercise
Inhalation capsule: 1 inhalation (200 mcg) 15 minutes before exercise

Uses: Prevention of exercise-induced bronchospasm

Inhalation solution and oral syrup:
Safety and efficacy have not been established in patients younger than 2 years.

Inhalation powder and inhalation capsules:
Safety and efficacy have not been established in patients younger than 4 years.

Immediate and extended release oral tablet:
Safety and efficacy have not been established in patients younger than 6 years.

Intravenous infusion:
Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Albuterol helps people with asthma and certain other breathing disorders to breathe easier. While it is effective at relieving symptoms of asthma, it does not prevent asthma from getting worse.