Albuterol (albuterol sulfate HFA inhalation aerosol)

Generic name: Albuterol sulfate inhalation aerosol (HFA metered-dose inhaler), 108 mcg of albuterol sulfate (90 mcg of albuterol base) per actuation · Brand names: Ventolin HFA, Proventil HFA, ProAir HFA, ProAir RespiClick, AccuNeb (other forms, not covered)

Quick facts

Drug class
Albuterol is a beta2-agonist bronchodilator, a medicine that opens the airways.
Source text (exact source wording)
Albuterol sulfate inhalation aerosol, like all other beta2-adrenergic agonists, can produce clinically significant cardiovascular effects (5.4 Cardiovascular Effects). / Albuterol is in a class of medications called bronchodilators. (MedlinePlus a682145)
Rx or otc
Rx (prescription): patient information says 'Albuterol Sulfate Inhalation Aerosol is a prescription inhaled medicine'
Controlled schedule
NOT a controlled substance per label text read (no schedule statement found)
Forms and strengths
  • COVERED: Inhalation aerosol: 108 mcg of albuterol sulfate (90 mcg of albuterol base) from the mouthpiece per actuation; white plastic inhaler with a blue cap and a counter, canister containing 200 metered inhalations (Cipla label, 3 DOSAGE FORMS AND STRENGTHS)
  • NOT COVERED: tablets, 2 mg and 4 mg (Sun Pharmaceutical label, ANDA072637, Revised: 03/2023)
  • NOT COVERED: syrup, 2 mg in 5 mL (Chartwell Governmental & Specialty RX label, ANDA077788, 'Rev 12/2025')
  • NOT COVERED: combination products with ipratropium (nebulizer solution, Combivent Respimat) and with budesonide (Airsupra) seen in the DailyMed list
Generic available
Value
yes
Source
DailyMed lists ANDA albuterol HFA inhalation aerosols (Cipla ANDA219409, Lupin ANDA209954, Padagis) and NDA authorized generics (Sandoz NDA020503, Prasco)
Common use one line
A quick-relief inhaler used to treat or prevent bronchospasm (airway tightening) in people with reversible obstructive airway disease and to prevent exercise-induced bronchospasm.

What it is used for

The inhaler is used to treat or prevent bronchospasm in people aged 4 years and older who have reversible obstructive airway disease, and to prevent exercise-induced bronchospasm in people aged 4 years and older.
Source text (exact source wording)
Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. Albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. (1 INDICATIONS AND USAGE)

How it works

Albuterol attaches to beta2 receptors on the muscle around the airways. This relaxes the muscle in all airways, from the windpipe to the smallest tubes, so breathing is easier.
Source text (exact source wording)
In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared with isoproterenol. Although beta2-adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenoceptors are the predominant receptors in the heart, there are also beta2-adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta2-agonists may have cardiac effects. Activation of beta2-adrenergic receptors on airway smooth muscle leads to the activation of adenyl cyclase and to an increase in the intracellular concentration of cyclic-3′,5′-adenosine monophosphate (cyclic AMP). This increase of cyclic AMP leads to the activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. Albuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles. Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes [see Warnings and Precautions (5.4)]. (12.1 Mechanism of Action) MedlinePlus (separate source): It works by relaxing and opening air passages to the lungs to make breathing easier.

Dosage: adults

For airway tightening, the dose for adults and for children 4 years and older is 2 inhalations every 4 to 6 hours; in some patients 1 inhalation every 4 hours may be enough. More frequent use is not recommended. To prevent exercise-induced bronchospasm, take 2 inhalations 15 to 30 minutes before exercise. Prime the inhaler with 4 sprays before first use, if it has not been used for more than 2 weeks, or if it has been dropped. Wash the actuator with warm water and let it air-dry at least once a week.
Source text (exact source wording)
2.1: Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a greater number of inhalations is not recommended. 2.2: Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise. 2.3: Albuterol sulfate inhalation aerosol should be administered by the orally inhaled route only. Priming albuterol sulfate inhalation aerosol is essential to ensure appropriate albuterol content in each actuation. Prime albuterol sulfate inhalation aerosol before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime albuterol sulfate inhalation aerosol, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes. To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week. (2 DOSAGE AND ADMINISTRATION, copied verbatim; the same dosing applies to adults and to children 4 years and older)

Dosage: children

Children 4 years and older use the same dose as adults: 2 inhalations every 4 to 6 hours. Safety and effectiveness are not established in children younger than 4 years.
Source text (exact source wording)
Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. (2) The safety and effectiveness of albuterol sulfate inhalation aerosol for treatment or prevention of bronchospasm and for prevention of exercised-induced bronchospasm in pediatric patients aged 4 years and older have been established. The safety and effectiveness of albuterol sulfate inhalation aerosol in pediatric patients younger than 4 years have not been established. (8.4 Pediatric Use) Three trials have been conducted to evaluate the safety and efficacy of albuterol sulfate inhalation aerosol in subjects between birth and 4 years of age. The results of these trials did not establish the efficacy of albuterol sulfate inhalation aerosol in this age group. (6.1)

Dosage adjustments

Drug interaction caps
Other short-acting aerosol bronchodilators should not be used at the same time. Other adrenergic drugs should be used with caution.
Source text (exact source wording)
Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. (7)
Elderly
Trials did not include enough people aged 65 years and older to tell if they respond differently. For an older patient the dose should be chosen cautiously, usually at the low end of the range, because of the greater frequency of decreased liver, kidney or heart function and other conditions or medicines.
Source text (exact source wording)
Clinical trials of albuterol sulfate inhalation aerosol did not include sufficient numbers of subjects aged 65 years and older to determine whether older subjects respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (8.5 Geriatric Use)

Missed dose

The label has no missed-dose instruction. MedlinePlus says to use the missed dose as soon as you remember it and not to use a double dose to make up for a missed one.
Source text (exact source wording)
Label: NOT FOUND (albuterol HFA is used as needed or on a schedule; no missed-dose instruction in the label sections read). MedlinePlus a682145, 'What should I do if I forget a dose?' (as returned in part): use the missed dose as soon as you remember it. Do not use a double dose to make up for a missed one.

Overdose

An overdose causes signs of too much beta-adrenergic stimulation such as seizures, chest pain, high or low blood pressure, a heart rate up to 200 beats per minute, tremor and low potassium. Cardiac arrest and even death may occur. Treatment is to stop the medicine and treat symptoms. Call poison control at 1-800-222-1222.
Source text (exact source wording)
The expected signs and symptoms with overdosage of albuterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis). As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of albuterol sulfate inhalation aerosol. Treatment consists of discontinuation of albuterol sulfate inhalation aerosol 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 sulfate inhalation aerosol. (10 OVERDOSAGE) MedlinePlus a682145: In case of overdose, call the poison control helpline at 1-800-222-1222.

Storage

Store at room temperature, 68°F to 77°F (20°C to 25°C), with the mouthpiece down. Do not puncture the canister or store it near heat or flame; above 120°F it may burst. The counter starts at 200; throw the inhaler away when it reads 0.
Source text (exact source wording)
Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. Contents 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 canister into fire or incinerator. Counter: The counter starts at 200 and counts down each time a spray is released. The correct amount of medication in each actuation cannot be assured after the counter reads 0, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 0. (16, Cipla label; labeler-specific)

Boxed warning

This medicine does not have a boxed warning.
Source text (exact source wording)
NONE (no boxed warning in the Cipla label)

Contraindications

Do not use if you have ever had a hypersensitivity (allergic) reaction to any of the ingredients.
Source text (exact source wording)
Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions (5.6), Description (11)]. (4 CONTRAINDICATIONS)

Warnings and precautions

The inhaler can make breathing worse instead of better (paradoxical bronchospasm), which may be life threatening. It should be stopped right away if it happens. This often occurs with the first use of a new canister.
Heading
5.1 Paradoxical Bronchospasm
Source text (exact source wording)
Albuterol sulfate inhalation aerosol can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with albuterol sulfate inhalation aerosol, it should be discontinued immediately and alternative therapy should be instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
Asthma can get worse over hours or over days. Needing more doses than usual may mean asthma is becoming unstable and the treatment plan needs review.
Heading
5.2 Deterioration of Asthma
Source text (exact source wording)
Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of albuterol sulfate 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.
A bronchodilator alone may not control asthma in many patients; adding an anti-inflammatory medicine such as a corticosteroid should be considered early.
Heading
5.3 Use of Anti-inflammatory Agents
Source text (exact source wording)
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, to the therapeutic regimen.
It can change pulse rate or blood pressure and cause ECG changes. Use with caution in people with heart conditions, especially coronary insufficiency, irregular heart rhythms and high blood pressure.
Heading
5.4 Cardiovascular Effects
Source text (exact source wording)
Albuterol sulfate inhalation aerosol, like all other beta2-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. If such effects occur, albuterol sulfate inhalation aerosol 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 relevance of these findings is unknown. Therefore, albuterol sulfate inhalation aerosol, like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Deaths have been reported with excessive use of inhaled sympathomimetic drugs in people with asthma. Do not use more than the recommended dose.
Heading
5.5 Do Not Exceed Recommended Dose
Source text (exact source wording)
Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
Immediate allergic reactions, including anaphylaxis, can occur with hives, swelling, rash, bronchospasm and low blood pressure.
Heading
5.6 Hypersensitivity Reactions, including Anaphylaxis
Source text (exact source wording)
Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of albuterol sulfate inhalation aerosol [see Contraindications (4)].
Use with caution if you have seizures, an overactive thyroid or diabetes, or if you react unusually strongly to this type of medicine.
Heading
5.7 Coexisting Conditions
Source text (exact source wording)
Albuterol sulfate inhalation aerosol, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
It can lower blood potassium in some people, which can affect the heart. The drop is usually short-lived and usually needs no potassium supplement.
Heading
5.8 Hypokalemia
Source text (exact source wording)
Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

Pregnancy and breastfeeding

There are no randomized studies in pregnancy, and available data do not consistently show a risk of major birth defects or miscarriage. Animal studies at less than the maximum recommended human daily inhaled dose showed cleft palate in mice and delayed ossification in rabbits. Poorly or moderately controlled asthma in pregnancy raises the risk of problems, so pregnant women with asthma should be closely monitored. During labor, use should be restricted to cases where the benefits clearly outweigh the risk. There are no data on albuterol in breast milk; levels are expected to be low, and the benefits of breastfeeding should be weighed with the need for the medicine.
Source text (exact source wording)
8.1 Pregnancy: Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. Risk Summary: There are no randomized clinical studies of use of albuterol sulfate during pregnancy. Available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. There are, however, clinical considerations in pregnant women with asthma. Administration of albuterol sulfate to mice and rabbits during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than the maximum recommended human daily inhaled dose (MRHDID). In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. Labor or Delivery: Because of the potential for beta-agonist interference with uterine contractility, use of albuterol sulfate inhalation aerosol during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Albuterol sulfate inhalation aerosol has not been approved for the management of pre-term labor. Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol. 8.2 Lactation: There are no available data on the presence of albuterol or the components of albuterol sulfate inhalation aerosol in human milk, the effects on the breastfed child, or the effects on milk production. However, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, are likely to be correspondingly low. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albuterol sulfate inhalation aerosol and any potential adverse effects on the breastfed child from albuterol or from the underlying maternal condition.

Side effects

Common
The label's most common reactions (3% or more) were throat irritation, viral respiratory infections, upper respiratory inflammation, cough and musculoskeletal pain. Throat irritation was reported in 10% with albuterol compared with 7% on placebo, and viral respiratory infections in 7% compared with 4%. Section 17 lists palpitations, chest pain, rapid heart rate, tremor and nervousness as common effects.
Threshold
Label Highlights: 'Most common adverse reactions (incidence ≥3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain. (6.1)'
Source text (exact source wording)
Highlights: Most common adverse reactions (incidence ≥3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain. (6.1) Table 1 lists the incidence of all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of ≥3% in the group treated with albuterol sulfate inhalation aerosol and more frequently in the group treated with albuterol sulfate inhalation aerosol than in the HFA-134a placebo inhaler group. Table 1. Adverse Reactions with Albuterol Sulfate Inhalation Aerosol with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects. Columns: Albuterol Sulfate Inhalation Aerosol (n = 202) % | CFC 11/12-Propelled Albuterol Inhaler (n = 207) % | Placebo HFA-134a (n = 201) %. Throat irritation 10 | 6 | 7. Upper respiratory inflammation 5 | 5 | 2. Viral respiratory infections 7 | 4 | 4. Cough 5 | 4 | 2. Musculoskeletal pain 5 | 5 | 4. (6.1 Clinical Trials Experience; table cell order reconstructed from the printed row order: each row lists albuterol, CFC albuterol, placebo) Section 17 Common Adverse Effects: Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness.
Less common
Reactions in fewer than 3% of adults and adolescents included diarrhea, laryngitis, swelling of the throat, fast heartbeat and extra heartbeats. Palpitations and dizziness have also been seen. Children aged 4 to 11 years had a similar profile.
Source text (exact source wording)
Adverse reactions reported by <3% of the adult and adolescent subjects receiving albuterol sulfate inhalation aerosol and by a greater proportion of subjects receiving albuterol sulfate inhalation aerosol than receiving HFA-134a placebo inhaler and that have the potential to be related to albuterol sulfate inhalation aerosol include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles. Palpitations and dizziness have also been observed with albuterol sulfate inhalation aerosol. (6.1) Pediatric Subjects Aged 4 to 11 Years: Results from the 2-week clinical trial in pediatric subjects with asthma aged 4 to 11 years showed that this pediatric population had an adverse reaction profile similar to that of the adult and adolescent populations. (6.1) Percentages for these items are not given in the label text read.
Serious
Serious effects listed on the label are breathing that gets worse after a dose (paradoxical bronchospasm), heart problems such as faster heart rate and higher blood pressure, possible death in people with asthma who use too much, serious allergic reactions, and changes in blood sugar and potassium. Reports after approval also include irregular heart rhythms such as atrial fibrillation. Get emergency care for rash, hives, swelling of the face, mouth or tongue, or breathing problems; MedlinePlus also lists a fast, pounding or irregular heartbeat and chest pain.
Source text (exact source wording)
LABEL (5.1, 5.4, 5.5, 5.6, 5.8 above): paradoxical bronchospasm, cardiovascular effects, fatalities with excessive use, hypersensitivity reactions including anaphylaxis, hypokalemia. Postmarketing (6.2): Cases of paradoxical bronchospasm, hoarseness, arrhythmias (including atrial fibrillation, supraventricular tachycardia), and hypersensitivity reactions (including urticaria, angioedema, rash) have been reported after the use of albuterol sulfate inhalation aerosol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypokalemia, hypertension, peripheral vasodilatation, angina, tremor, central nervous system stimulation, hyperactivity, sleeplessness, headache, muscle cramps, drying or irritation of the oropharynx, and metabolic acidosis. || PATIENT INFORMATION (label): worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm); heart problems, including faster heart rate and higher blood pressure; possible death in people with asthma who use too much; serious allergic reactions (rash, hives, swelling of your face, mouth, and tongue, breathing problems): call your healthcare provider or get emergency medical care; changes in laboratory blood levels (sugar, potassium). || MEDLINEPLUS a682145 (call your doctor immediately): fast, pounding, or irregular heartbeat; chest pain; rash; hives; itching; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; increased difficulty breathing; difficulty swallowing; hoarseness.
Medwatch
You may report side effects to FDA at 1-800-FDA-1088. (Patient Information, Cipla label)

Interactions

Drugs
Do not use other short-acting aerosol bronchodilators at the same time. Use other adrenergic drugs with caution.
Name
Other short-acting sympathomimetic aerosol bronchodilators
Section
7
Source text (exact source wording)
Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
Beta-blockers can block albuterol's effect and may cause severe bronchospasm in people with asthma, so they should not normally be used in asthma.
Name
Beta-adrenergic receptor blocking agents (beta-blockers)
Section
7.1
Source text (exact source wording)
Beta-blockers not only block the pulmonary effect of beta-agonists, such as albuterol sulfate inhalation aerosol, but may also produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.
Loop or thiazide diuretics can cause ECG changes or low potassium, and albuterol can make this worse, especially above the recommended dose. Use caution together.
Name
Non-potassium-sparing diuretics
Section
7.2
Source text (exact source wording)
The ECG changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of albuterol sulfate inhalation aerosol with non–potassium-sparing diuretics.
Intravenous and oral albuterol lowered digoxin levels by 16% to 22% in healthy volunteers. The importance for inhaled use is unclear, but digoxin levels should be checked carefully.
Name
Digoxin
Section
7.3
Source text (exact source wording)
Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical relevance of these findings for patients with obstructive airway disease who are receiving inhaled albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.
Use with extreme caution with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of stopping them, because albuterol's effect on blood vessels may be stronger.
Name
Monoamine oxidase inhibitors and tricyclic antidepressants
Section
7.4
Source text (exact source wording)
Albuterol sulfate inhalation aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the vascular system may be potentiated.
Food and alcohol
Name
Food and alcohol

Patient tips

Label patient information
Do not use it until your provider has taught you to use the inhaler correctly. Use it exactly as your provider tells you and not more often than prescribed; each dose should last up to 4 hours to 6 hours. Get medical help right away if it no longer helps or your symptoms get worse. Tell your provider about heart problems, high blood pressure, seizures, thyroid problems, diabetes or low potassium. Get emergency care for rash, hives, swelling of the face, mouth or tongue, or breathing problems.
Source text (exact source wording)
What is Albuterol Sulfate Inhalation Aerosol? Albuterol Sulfate Inhalation Aerosol is a prescription inhaled medicine used in people aged 4 years and older to: treat or prevent bronchospasm in people who have reversible obstructive airway disease. prevent exercise-induced bronchospasm. It is not known if Albuterol Sulfate Inhalation Aerosol is safe and effective in children younger than 4 years of age. Do not use Albuterol Sulfate Inhalation Aerosol: if you are allergic to albuterol sulfate propionate or any of the ingredients in Albuterol Sulfate Inhalation Aerosol. Before using Albuterol Sulfate Inhalation Aerosol, tell your healthcare provider about all of your medical conditions, including if you: have heart problems. have high blood pressure. have 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 may harm your unborn baby. are breastfeeding. It is not known if the medicine in Albuterol Sulfate Inhalation Aerosol passes into your milk and if it can harm your baby. Especially tell your healthcare provider if you take: other inhaled medicines or asthma medicines; beta-blocker medicines; diuretics; digoxin; monoamine oxidase inhibitors; tricyclic antidepressants. How should I use Albuterol Sulfate Inhalation Aerosol? Do not use Albuterol Sulfate Inhalation Aerosol unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. Children should use Albuterol Sulfate Inhalation Aerosol with an adult’s help, as instructed by the child’s healthcare provider. Use Albuterol Sulfate Inhalation Aerosol exactly as your healthcare provider tells you to use it. Do not use Albuterol Sulfate Inhalation Aerosol more often than prescribed. Do not increase your dose or take extra doses of Albuterol Sulfate Inhalation Aerosol without first talking to your healthcare provider. Each dose of Albuterol Sulfate Inhalation Aerosol should last up to 4 hours to 6 hours. Get medical help right away if Albuterol Sulfate Inhalation Aerosol no longer helps your symptoms. Get medical help right away if your symptoms get worse or if you need to use your inhaler more often. Call your healthcare provider if your asthma symptoms like wheezing and trouble breathing become worse over a few hours or days. Serious side effects: worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using Albuterol Sulfate Inhalation Aerosol and call your healthcare provider or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine. heart problems, including faster heart rate and higher blood pressure. possible death in people with asthma who use too much Albuterol Sulfate Inhalation Aerosol. serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash hives swelling of your face, mouth, and tongue breathing problems changes in laboratory blood levels (sugar, potassium). (Patient Information; the common side effects and ingredients part of the leaflet was beyond the 50,000-character capture and is NOT CAPTURED VERBATIM)
Medlineplus
Use it exactly as prescribed, shake well, prime with 4 sprays, keep it clean and dry, and call your doctor if symptoms get worse. If it causes wheezing or difficulty breathing, do not use it again unless your doctor says so.
Source text (exact source wording)
Do not use more or less of it or use it more often than prescribed by your doctor. Call your doctor if your symptoms worsen. To prime the inhaler, shake it well and then press down on the canister 4 times. Shake the inhaler well. Clean your inhaler regularly. Keep the inhaler clean and dry at all times. Do not puncture the aerosol canister, and do not discard it in an incinerator or fire. Albuterol inhalation sometimes causes wheezing and difficulty breathing. Do not use albuterol inhalation again unless your doctor tells you that you should. (MedlinePlus a682145, quotes as returned in part)

Alternatives

Class source
Label: beta2-adrenergic agonist (5.4). MedlinePlus a682145: bronchodilators. openFDA and Drugs@FDA not searched.
Indication source
Label Section 1 (bronchospasm, exercise-induced bronchospasm).
Candidates
Name
levalbuterol
Note
No recommendation of one over another.

Frequently asked questions

Question
What is albuterol inhaler used for?
Answer
It is used in people aged 4 years and older to treat or prevent bronchospasm in reversible obstructive airway disease and to prevent exercise-induced bronchospasm.
Source section
1 INDICATIONS AND USAGE
Source
Cipla label, set ID fd0389e0-3713-42e0-8ef2-3bb97676fded
Question
How many puffs should I take?
Answer
For bronchospasm, 2 inhalations every 4 to 6 hours; in some patients 1 inhalation every 4 hours may be enough. To prevent exercise-induced bronchospasm, take 2 inhalations 15 to 30 minutes before exercise. More frequent use is not recommended.
Source section
2 DOSAGE AND ADMINISTRATION
Source
Cipla label
Question
Do I need to prime the inhaler?
Answer
Yes. Prime it before first use, when it has not been used for more than 2 weeks, or when it has been dropped, by releasing 4 sprays into the air away from the face, shaking well before each spray.
Source section
2 DOSAGE AND ADMINISTRATION
Source
Cipla label
Question
What are the common side effects?
Answer
In trials in people aged 12 years and older, throat irritation (10%), viral respiratory infections (7%), upper respiratory inflammation (5%), cough (5%) and musculoskeletal pain (5%) were reported at a rate of 3% or more and more often than placebo.
Source section
6.1 Clinical Trials Experience
Source
Cipla label
Question
What should I not combine with it?
Answer
Do not use other short-acting aerosol bronchodilators at the same time. Beta-blockers can block its effect and may cause severe bronchospasm in people with asthma. Use caution with loop or thiazide diuretics, and use extreme caution with MAO inhibitors or tricyclic antidepressants or within 2 weeks of stopping them. Digoxin levels should be checked.
Source section
7 DRUG INTERACTIONS
Source
Cipla label
Question
Is it safe in pregnancy or while breastfeeding?
Answer
There are no randomized studies in pregnancy and available data do not consistently show a risk of major birth defects or miscarriage. Poorly controlled asthma also carries risks in pregnancy. There are no data on albuterol in breast milk; levels are expected to be low.
Source section
8.1; 8.2
Source
Cipla label
Question
When should I call a doctor or get emergency help?
Answer
Get emergency care for signs of a serious allergic reaction such as rash, hives, swelling of the face, mouth or tongue, or breathing problems. The label also lists worsening trouble breathing, coughing and wheezing after a dose (paradoxical bronchospasm) as serious. Needing more doses than usual may mean asthma is getting worse and needs review.
Source section
5.1; 5.2; Patient Information
Source
Cipla label
Question
When should I throw the inhaler away?
Answer
The counter starts at 200 and counts down with each spray. Throw the inhaler away when the counter reads 0, because the correct amount of medicine cannot be assured after that.
Source section
16 Counter
Source
Cipla label

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug