ALBUTEROL SULFATE 90 ug Inhalant
Other active recalls for Albuterol Sulfate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the beta2-Adrenergic Agonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Albuterol quickly relaxes the muscles around your airways, opening them up so you can breathe more easily. Think of it as a fast-acting rescue medicine — you use it when you feel y...
- What exactly does albuterol do, and when should I use it?
- That depends on which inhaler you have. If you have a standard HFA inhaler (like Ventolin HFA or Albuterol Sulfate HFA), shake it well before every puff and prime it with a few tes...
- The most common side effects are pretty mild — a scratchy throat, cough, or upper respiratory irritation, and sometimes a slightly faster heartbeat, shakiness, or headache. Those u...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Albuterol Sulfate — tap one for details:
Albuterol Sulfate may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII DH9E53K1Y8
A synthetic fluorinated hydrocarbon used primarily as a propellant or aerosol dispersant in pressurized inhaler formulations to help deliver medication to the lungs.
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UNII 2UMI9U37CP
Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.126 | — |
| Medicaid paysCMS SDUD · 12 mo | $2.66 | — |
| Medicare drug plans payPart D · Q2 2026 | $2.19 | — |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Albuterol Sulfate HFA 90 ug 00093-3174-31 | Teva | 1 inhaler | $1.553 | AB2 | Availability likely | save 27% |
| Albuterol Sulfate 90 ug 17270-0740-00 | Armstrong | 1 inhaler | $1.553 | AB2 | Availability likely | save 27% |
| albuterol sulfate 90 ug 45802-0088-01 | Padagis | 1 inhaler | $1.553 | AB2 | Availability likely | save 27% |
| Albuterol sulfate 90 ug 68180-0963-01 | Lupin | 1 canister | $1.553 | AB2 | Availability likely | save 27% |
| Albuterol Sulfate HFA 90 ug 66993-0019-68 | Prasco | 1 inhaler | $1.819 | AB3 | Availability likely | save 14% |
| Albuterol 90 ug 69097-0021-60 | Cipla | 1 inhaler | $1.819 | AB3 | Availability likely | save 14% |
| Albuterol Sulfate 90 ug 00054-0742-87 | Hikma | 1 canister | $2.126 | AB1 | Availability likely | — |
| Albuterol Sulfate 108 ug 00781-7296-85 | Sandoz | 1 canister | $2.126 | AB1 | Availability likely | — |
| Albuterol Sulfate 90 ug 60687-0662-91 | American | 1 canister | $2.126 | AB1 | Availability likely | — |
| Albuterol Sulfate 90 ug 69097-0142-60 | Cipla | 1 canister | $2.126 | AB1 | Availability likely | — |
| Albuterol Sulfate 90 ugthis 76282-0679-42 | Exelan | 1 canister | $2.126 | AB1 | Availability likely | — |
| Ventolin Hfa 90 ug 00173-0682-20 | GlaxoSmithKline | 1 inhaler | $3.035 | AB3 | Availability likely | +43% |
| ProAir Digihaler 90 ug 59310-0117-20 | Teva | 1 inhaler | $86.326 | — | FDA listed | +3961% |
| Albuterol Sulfate 90 ug 50090-5179-00 | A-S | 1 canister | — | AB1 | FDA listed | — |
| Albuterol Sulfate 90 ug 50090-5735-01 | A-S | 96 canisters | — | AB1 | FDA listed | — |
| Albuterol Sulfate 108 ug 68788-7996-02 | Preferred | 1 canister | — | AB1 | FDA listed | — |
| Albuterol Sulfate 90 ug 68788-8787-02 | Preferred | 1 canister | — | AB1 | FDA listed | — |
| Albuterol Sulfate 90 ug 68788-8874-02 | Preferred | 1 canister | — | AB1 | FDA listed | — |
| Albuterol Sulfate 108 ug 70518-4528-00 | REMEDYREPACK | 1 canister | — | AB1 | FDA listed | — |
| Albuterol Sulfate 90 ug 76420-0531-01 | Asclemed | 200 aerosols | — | AB1 | FDA listed | — |
| Albuterol Sulfate 108 ug 82804-0036-67 | Proficient | 1 canister | — | AB1 | FDA listed | — |
| Albuterol Sulfate 90 ug 82804-0189-67 | Proficient | 1 canister | — | AB1 | FDA listed | — |
| Albuterol Sulfate 90 ug 85766-0020-90 | Sportpharm | 1 canister | — | AB1 | FDA listed | — |
| albuterol sulfate HFA 90 ug 50090-4137-00 | A-S | 1 inhaler | — | AB3 | FDA listed | — |
| Albuterol Sulfate 90 ug 51662-1513-01 | HF | 1 inhaler | — | AB2 | FDA listed | — |
| Ventolin Hfa 90 ug 63187-0026-08 | Proficient | 60 aerosols | — | AB3 | FDA listed | — |
| Albuterol Sulfate HFA 90 ug 71205-0211-85 | Proficient | 1 inhaler | — | AB2 | FDA listed | — |
| albuterol sulfate 90 ug 71205-0441-85 | Proficient | 1 inhaler | — | AB2 | FDA listed | — |
| Albuterol sulfate 90 ug 71205-0732-85 | Proficient | 1 canister | — | AB2 | FDA listed | — |
| Albuterol Sulfate HFA 90 ug 76420-0088-01 | Asclemed | 1 inhaler | — | AB2 | FDA listed | — |
| Albuterol sulfate 90 ug 85766-0062-90 | Sportpharm | 1 canister | — | AB2 | FDA listed | — |
| Albuterol Sulfate 90 ug 68071-3902-02 | NuCare | 1 inhaler | — | AB2 | FDA listed | — |
| Ventolin Hfa 90 ug 50090-1158-00 | A-S | 1 inhaler | — | AB3 | FDA listed | — |
| Albuterol Sulfate 90 ug 51662-1267-01 | HF | 1 inhaler | — | AB3 | FDA listed | — |
| Ventolin Hfa 90 ug 68071-1890-06 | NuCare | 60 aerosols | — | AB3 | FDA listed | — |
| Albuterol Sulfate HFA 90 ug 68071-4940-02 | NuCare | 200 aerosols | — | AB2 | FDA listed | — |
| Ventolin Hfa 90 ug 70518-1081-00 | REMEDYREPACK | 200 aerosols | — | AB3 | FDA listed | — |
| Ventolin Hfa 90 ug 70518-1237-00 | REMEDYREPACK | 1 inhaler | — | AB3 | FDA listed | — |
| albuterol sulfate 90 ug 85766-0055-90 | Sportpharm | 1 inhaler | — | AB2 | FDA listed | — |
| Albuterol sulfate 90 ug 50090-5231-00 | A-S | 1 canister | — | AB2 | FDA listed | — |
| Albuterol Sulfate 90 ug 68788-4041-02 | Preferred | 1 inhaler | — | AB2 | FDA listed | — |
| Albuterol Sulfate HFA 90 ug 80425-0359-01 | Advanced | 1 inhaler | — | AB3 | FDA listed | — |
| Albuterol Sulfate 90 ug 70518-4496-00 | REMEDYREPACK | 1 inhaler | — | AB2 | FDA listed | — |
| Ventolin Hfa 90 ug 50090-1159-00 | A-S | 1 inhaler | — | AB3 | FDA listed | — |
| Albuterol Sulfate 90 ug 80425-0266-01 | Advanced | 1 canister | — | AB2 | FDA listed | — |
| Ventolin Hfa 90 ug 68071-1670-02 | NuCare | 200 aerosols | — | AB3 | FDA listed | — |
| Albuterol Sulate HFA 90 ug 70518-2072-00 | REMEDYREPACK | 1 inhaler | — | AB3 | FDA listed | — |
| Albuterol sulfate 90 ug 68788-8878-02 | Preferred | 1 canister | — | AB2 | FDA listed | — |
| Albuterol sulfate 90 ug 70518-3541-00 | REMEDYREPACK | 1 canister | — | AB2 | FDA listed | — |
| Albuterol sulfate 90 ug 76420-0350-90 | Asclemed | 1 canister | — | AB2 | FDA listed | — |
| Albuterol sulfate 90 ug 68071-2300-02 | NuCare | 1 canister | — | AB2 | FDA listed | — |
| Albuterol Sulate HFA 90 ug 68071-4777-02 | NuCare | 200 aerosols | — | AB3 | FDA listed | — |
| Albuterol Sulfate 90 ug 85534-0039-00 | HAWAII | 1 canister | — | AB1 | FDA listed | — |
| Albuterol Sulfate 90 ug 68071-5312-06 | NuCare | 1 canister | — | AB1 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 76282-0679-42 You're viewing this | 1 CANISTER in 1 CARTON (76282-679-42) / 200 INHALANT in 1 CANISTER | 2021-10-04 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.
Each actuation of Albuterol sulfate inhalation aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four "test sprays" into the air, away from the face. Albuterol sulfate inhalation aerosol contains 200 inhalations per canister.
The canister has an attached dose indicator, which indicates how many inhalations remain. The dose indicator display will move after every tenth actuation. When nearing the end of the usable inhalations, the background behind the number in the dose indicator display window changes to red at 20 actuations or lower.
Albuterol sulfate inhalation aerosol should be discarded when the dose indicator display window shows zero. Exercise Induced Bronchospasm Prevention: The usual dosage for adults and children 4 years of age and older is two inhalations 15 to 30 minutes before exercise. To maintain proper use of this product, it is important that the mouthpiece be washed and dried thoroughly at least once a week.
The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly (see PRECAUTIONS, Information for Patients section). Keeping the plastic mouthpiece clean is very important to prevent medication buildup and blockage. The inhaler may cease to deliver medication if not properly cleaned and air dried thoroughly.
If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If a previously effective dose 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.
⛔ Contraindications ▾
CONTRAINDICATIONS Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other Albuterol sulfate inhalation aerosol components.
⚠️ Warnings ▾
WARNINGS 1. Paradoxical Bronchospasm: Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, Albuterol sulfate 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. 2. 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 sulfate inhalation aerosol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. 3. 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, to the therapeutic regimen. 4. Cardiovascular Effects: Albuterol sulfate inhalation aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms.
Although such effects are uncommon after administration of Albuterol sulfate inhalation aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce 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 sulfate inhalation aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. 5. Do Not Exceed Recommended Dose: 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. 6. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reaction information concerning Albuterol sulfate inhalation aerosol is derived from a 12‑week, double-blind, double-dummy study which compared Albuterol sulfate inhalation aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler in 565 asthmatic patients. The following table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the Albuterol sulfate inhalation aerosol treatment group and more frequently in the Albuterol sulfate inhalation aerosol treatment group than in the placebo group.
Overall, the incidence and nature of the adverse reactions reported for Albuterol sulfate inhalation aerosol and a CFC 11/12 propelled albuterol inhaler were comparable. Adverse Experience Incidences (% of patients) in a Large 12-week Clinical Trial * * This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the Albuterol sulfate inhalation aerosol group and more frequently in the Albuterol sulfate inhalation aerosol group than in the HFA-134a placebo inhaler group.
Body System/ Adverse Event (Preferred Term) Albuterol Sulfate Inhalation Aerosol (N=193) CFC 11/12 Propelled Albuterol Inhaler (N=186) HFA-134a Placebo Inhaler (N=186) Application Site Disorders Inhalation Site Sensation 6 9 2 Inhalation Taste Sensation 4 3 3 Body as a Whole Allergic Reaction/Symptoms 6 4 <1 Back Pain 4 2 3 Fever 6 2 5 Central and Peripheral Nervous System Tremor 7 8 2 Gastrointestinal System Nausea 10 9 5 Vomiting 7 2 3 Heart Rate and Rhythm Disorder Tachycardia 7 2 <1 Psychiatric Disorders Nervousness 7 9 3 Respiratory System Disorders Respiratory Disorder (unspecified) 6 4 5 Rhinitis 16 22 14 Upper Resp Tract Infection 21 20 18 Urinary System Disorder Urinary Tract Infection 3 4 2 Adverse events reported by less than 3% of the patients receiving Albuterol sulfate inhalation aerosol, and by a greater proportion of Albuterol sulfate inhalation aerosol patients than placebo patients, which have the potential to be related to Albuterol sulfate inhalation aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesia, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash.
Palpitation and dizziness have also been observed with Albuterol sulfate inhalation aerosol. Adverse events reported in a 4-week pediatric clinical trial comparing Albuterol sulfate inhalation aerosol and a CFC 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials. In small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related.
Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, metabolic acidosis, and drying or irritation of the oropharynx. To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
🔄 Drug Interactions ▾
Drug Interactions 1. Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Albuterol sulfate inhalation aerosol, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta‑blockers.
However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution. 2.
Diuretics: The ECG changes and/or hypokalemia which may result from the administration of nonpotassium-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 beta-agonists with nonpotassium-sparing diuretics. 3.
Albuterol-Digoxin: Mean decreases of 16% and 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 significance of these findings for patients with obstructive airway disease who are receiving 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.
4. Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: 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 cardiovascular system may be potentiated.
🆘 Overdosage ▾
OVERDOSAGE 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 per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of Albuterol sulfate inhalation aerosol.
Treatment consists of discontinuation of Albuterol sulfate inhalation aerosol together with appropriate symptomatic therapy. The judicious use of a cardio selective 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.
The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3000 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 1400 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis).
In young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 6400 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). The inhalation median lethal dose has not been determined in animals.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol. While it is recognized that beta 2 -adrenergic receptors are the predominant receptors on bronchial smooth muscle, data indicate that there is a population of beta 2 -receptors in the human heart existing in a concentration between 10% and 50% of cardiac beta-adrenergic receptors. The precise function of these receptors has not been established.
(See WARNINGS, Cardiovascular Effects section.) Activation of beta 2 -adrenergic receptors on airway smooth muscle leads to the activation of adenylcyclase 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 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. Preclinical Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of the plasma concentrations. In structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the whole brain.
Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta 2 -agonist and methylxanthines were administered concurrently. The clinical significance of these findings is unknown. Propellant HFA-134a is devoid of pharmacological activity except at very high doses in animals (380‑1300 times the maximum human exposure based on comparisons of AUC values), primarily producing ataxia, tremors, dyspnea, or salivation.
These are similar to effects produced by the structurally related chlorofluorocarbons (CFCs), which have been used extensively in metered dose inhalers. In animals and humans, propellant HFA-134a was found to be rapidly absorbed and rapidly eliminated, with an elimination half-life of 3 to 27 minutes in animals and 5 to 7 minutes in humans. Time to maximum plasma concentration (T max ) and mean residence time are both extremely short, leading to a transient appearance of HFA-134a in the blood with no evidence of accumulation.
Pharmacokinetics In a single-dose bioavailability study which enrolled six healthy, male volunteers, transient low albuterol levels (close to the lower limit of quantitation) were observed after administration of two puffs from both Albuterol sulfate inhalation aerosol and a CFC 11/12 propelled albuterol inhaler. No formal pharmacokinetic analyses were possible for either treatment, but systemic albuterol levels appeared similar. Clinical Trials In a 12-week, randomized, double-blind, double-dummy, active- and placebo-controlled trial, 565 patients with asthma were evaluated for the bronchodilator eff…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Albuterol sulfate inhalation aerosol is supplied as a pressurized aluminum canister with an attached dose indicator, a white plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations (NDC 76282-679-42).
Rx only. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Store the inhaler with the mouthpiece down. For best results, canister should be at room temperature before use.
SHAKE WELL BEFORE USING. The white actuator supplied with Albuterol sulfate inhalation aerosol should not be used with any other product canisters, and actuator from other products should not be used with an Albuterol sulfate inhalation aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations and when the dose indicator display window shows zero , even though the canister is not completely empty.
The canister should be discarded when the labeled number of actuations have been used. WARNING: Avoid spraying in eyes. Contents under pressure.
Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.
Albuterol sulfate inhalation aerosol does not contain chlorofluorocarbons (CFCs) as the propellant. Manufactured for: Exelan Pharmaceuticals Inc. Boca Raton, FL 33432 Disclaimer: Other brands listed are the registered trademarks of their respective owners.
Issued: 11/2021
📋 Description ▾
DESCRIPTION The active component of Albuterol sulfate inhalation aerosol is albuterol sulfate, USP racemic α 1 [( tert- Butylamino)methyl]-4-hydroxy- m -xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta 2 -adrenergic bronchodilator having the following chemical structure: Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 .
Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate inhalation aerosol is a pressurized metered-dose aerosol unit for oral inhalation.
It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid. Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations.
It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four "test sprays" into the air, away from the face. This product does not contain chlorofluorocarbons (CFCs) as the propellant. Image