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Black Box Warning
WARNINGS
See full prescribing information for complete Boxed Warning.
The action of Albuterol Inhalation Aerosol may last up to 6 hours or longer. Albuterol Inhalation Aerosol should not be used more frequently than recommended. Do not increase the dose or frequency of Albuterol Inhalation Aerosol without consulting your doctor. If you find that treatment with Albuterol Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While you are using Albuterol Inhalation Aerosol, other inhaled drugs and asthma medicines should be used only as directed by your doctor.
Overview
Albuterol is a Beta-2 Adrenergic Agonist that is FDA approved for the prophylaxis of for the prevention and relief of bronchospasm in patients (12 years of age and older) with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Tachyarrhythmia, Hypokalemia, Nausea, Pharyngitis, Throat irritation, Feeling nervous, Headache, Tremor, Cough, Rhinitis, Upper respiratory infection, Viral lower respiratory infection.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Acute Episodes of Bronchospasm
Dosing information (Aerosol,Inhalant)
Usual dosage: two inhalations repeated every four to six hours
In some patients, one inhalation every four hours may be sufficient. More frequent administration or a larger number of inhalations are not recommended.
It is recommended to "test spray" Albuterol Inhalation Aerosol into the air before using for the first time and in cases where the aerosol has not been used for a prolonged period of time.
The use of Albuterol Inhalation Aerosol can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhaler. Safe usage for periods extending over several years has been documented.
If a previously effective dosage regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Exercise-Induced Bronchospasm Prevention
Usual dosage for adults and pediatric patients 4 years and older is two inhalations 15 minutes before exercise.
For treatment, see above.
Dosing information (Tablet)
Usual starting dosage: 2 or 4 mg PO tid or aid
Dosage Adjustment
A dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4 mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators
An initial dosage: 2 mg PO tid or qid. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults.
Dosing information (Syrup)
Usual starting dosage: 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.
Dosage Adjustment
A dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
Dosing information (Solution)
Usual dosage for adults: 2.5 mg three to four times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, dilute 0.5 mL of the 0.5% inhalation solution with 2.5 mL of sterile normal saline solution. The flow rate is regulated to suit the particular nebulizer so that albuterol sulfate inhalation solution will be delivered over approximately 5 to 15 minutes.
The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
Drug compatibility (physical and chemical), efficacy, and safety of albuterol sulfate inhalation solution when mixed with other drugs in a nebulizer have not been established.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Albuterol in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Albuterol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Bronchospasm
Dosing information (Tablet)
Usual starting dosage: 2 or 4 mg PO tid or aid
Dosage Adjustment
Children Over 12 Years of Age
For adults and children 12 years and older, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4 mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Dosing information (Syrup)
The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.
The usual starting dosage for children over 6 years to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.
Dosing in children 2 to 5 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.
Dosage Adjustment
For adults and children over 14 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
For children over 6 years to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
For children from 2 to 5 years of age who do not respond satisfactorily to the initial starting dosage, the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day.
Dosing information (Solution)
The usual dosage for children 12 years of age and older : 2.5 mg three to four times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, dilute 0.5 mL of the 0.5% inhalation solution with 2.5 mL of sterile normal saline solution. The flow rate is regulated to suit the particular nebulizer so that albuterol sulfate inhalation solution will be delivered over approximately 5 to 15 minutes.
The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
Drug compatibility (physical and chemical), efficacy, and safety of albuterol sulfate inhalation solution when mixed with other drugs in a nebulizer have not been established.
For children 2 to 12 years of age, initial dosing should be based upon body weight (0.1 to 0.15 mg/kg per dose), with subsequent dosing titrated to achieve the desired clinical response. Dosing should not exceed 2.5 mg three to four times daily by nebulization. The following table outlines approximate dosing according to body weight.
This image is provided by the National Library of Medicine.
The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total volume of 3 mL prior to administration via nebulization.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Albuterol in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Albuterol in pediatric patients.
Contraindications
Albuterol is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.
Warnings
WARNINGS
See full prescribing information for complete Boxed Warning.
The action of Albuterol Inhalation Aerosol may last up to 6 hours or longer. Albuterol Inhalation Aerosol should not be used more frequently than recommended. Do not increase the dose or frequency of Albuterol Inhalation Aerosol without consulting your doctor. If you find that treatment with Albuterol Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While you are using Albuterol Inhalation Aerosol, other inhaled drugs and asthma medicines should be used only as directed by your doctor.
Paradoxical Bronchospasm
Albuterol can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Albuterol Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.
Cardiovascular Effects
Albuterol, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Albuterol Inhalation Aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, albuterol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Deterioration of Asthma
Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Albuterol Inhalation Aerosol than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Use of Anti-Inflammatory Agents
The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.
Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur after administration of Albuterol Inhalation Aerosol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
The contents of Albuterol Inhalation Aerosol are under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Avoid spraying in eyes. Keep out of reach of children.
Microbial Contamination (only in solution): To avoid microbial contamination, proper aseptic technique should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the solution changes color or becomes cloudy, it should not be used.
PRECAUTIONS
=General
Albuterol, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.
Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists, albuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.
Although there have been no reports concerning the use of Albuterol Inhalation Aerosol during labor and delivery, it has been reported that high doses of albuterol administered intravenously inhibit uterine contractions. Although this effect is extremely unlikely as a consequence of aerosol use, it should be kept in mind.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Albuterol Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Albuterol Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Albuterol Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Albuterol in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Albuterol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Albuterol during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Albuterol in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Albuterol in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Albuterol in geriatric settings.
Gender
There is no FDA guidance on the use of Albuterol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Albuterol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Albuterol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Albuterol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Albuterol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Albuterol in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Albuterol Administration in the drug label.
Monitoring
There is limited information regarding Albuterol Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Albuterol and IV administrations.
Overdosage
There is limited information regarding Albuterol overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Albuterol Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Albuterol Mechanism of Action in the drug label.
Structure
There is limited information regarding Albuterol Structure in the drug label.
Pharmacodynamics
There is limited information regarding Albuterol Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Albuterol Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Albuterol Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Albuterol Clinical Studies in the drug label.
How Supplied
There is limited information regarding Albuterol How Supplied in the drug label.
Storage
There is limited information regarding Albuterol Storage in the drug label.
Images
Drug Images
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