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Albuterol Sulfate

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Overview

What is Albuterol Sulfate?

Albuterol Sulfate Inhalation Solution, 0.5% is a sterile solution that contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta-adrenergic bronchodilator (see section below). Albuterol sulfate has the chemical name α-[(Butylamino)methyl]-4-hydroxy--xylene-α, α’-diol sulfate (2:1) (salt), and the following structural formula:

Albuterol sulfate has a molecular weight of 576.71 and the molecular formula (CHNO)•HSO. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol.

The World Health Organization’s recommended name for albuterol base is salbutamol.

Albuterol sulfate inhalation solution, 0.5% is in concentrated form. Dilute the appropriate volume of the solution (see ) with sterile normal saline solution to a total volume of 3 mL and administer by nebulization.

Each mL Contains:

PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. Albuterol sulfate inhalation solution contains no sulfiting agents. It is supplied in 20 mL bottles.

Albuterol Aulfate Inhalation Solution is a clear, colorless to light yellow solution.



What does Albuterol Sulfate look like?



What are the available doses of Albuterol Sulfate?

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What should I talk to my health care provider before I take Albuterol Sulfate?

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How should I use Albuterol Sulfate?

Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.

To avoid microbial contamination, proper aseptic techniques 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.


What interacts with Albuterol Sulfate?

Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.



What are the warnings of Albuterol Sulfate?

Paradoxical Bronchospasm

 Albuterol sulfate inhalation solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol sulfate inhalation solution 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.

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers. It is therefore essential that the physician instruct the patient in the need for further evaluation if his/her asthma becomes worse.

 Cardiovascular Effects

 Albuterol sulfate inhalation solution, 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 sulfate inhalation solution 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 sulfate inhalation solution, 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 sulfate inhalation solution 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.

Immediate Hypersensitivity Reactions

 Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema.

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, eg, corticosteroids.

Microbial Contamination

It is recommended that each multi-dose bottle of albuterol be used for only one patient.


What are the precautions of Albuterol Sulfate?

General

Albuterol, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, hypertension, and cardiac arrhythmia; 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 betaadrenergic 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.

Repeated dosing with 0.15 mg/kg of albuterol inhalation solution in children aged 5 to 17 years who were initially normokalemic has been associated with an asymptomatic decline of 20% to 25% in serum potassium levels.

To avoid contaminating the multi-dose bottle of albuterol sulfate inhalation solution for inhalation, proper aseptic technique should be used when withdrawing and delivering the dose into the nebulizer.

Information for patients

The action of albuterol sulfate inhalation solution may last up to 6 hours or longer. Albuterol sulfate inhalation solution should not be used more frequently than recommended. Do not increase the dose or frequency of albuterol sulfate inhalation solution without consulting your physician. If you find that treatment with albuterol sulfate inhalation solution 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 sulfate inhalation solution, other inhaled drugs and asthma medications should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, and tremor or nervousness. If you are pregnant or nursing, contact your physician about use of albuterol sulfate inhalation solution. Effective and safe use of albuterol sulfate inhalation solution includes an understanding of the way that it should be administered.

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.

See illustrated

Drug interactions

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine 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.

 

 

 

 

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of 2.0, 10, and 50 mg/kg (approximately 2, 8, and 40 times, respectively, the maximum recommended daily inhalation dose for adults on a mg/m basis or approximately 3/5, 3, and 15 times, respectively, the maximum recommended daily inhalation dose in children on a mg/m basis). In another study this effect was blocked by the coadministration of propranolol, a nonselective beta-adrenergic antagonist. In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg (approximately 200 times the maximum recommended daily inhalation dose for adults on a mg/m basis or approximately 75 times the maximum recommended daily inhalation dose for children on a mg/m basis). In a 22-month study in the Golden hamster, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately 25 times the maximum recommended daily inhalation dose for adults on a mg/m basis or approximately 10 times the maximum recommended daily inhalation dose for children on a mg/m basis).

Albuterol sulfate was not mutagenic in the Ames test with or without metabolic activation using tester strains TA1537, TA1538, and TA98 or WP2, WP2uvrA, and WP67. No forward mutation was seen in yeast strain S9 nor any mitotic gene conversion in yeast strain JD1 with or without metabolic activation.

Fluctuation assays in TA98 and WP2, both with metabolic activation, were negative. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay at intraperitoneal doses of up to 200 mg/kg.

Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg (approximately 40 times the maximum recommended daily inhalation dose for adults on a mg/m basis).

Pregnancy

Pregnancy Category C. Albuterol has been shown to be teratogenic in mice. A study in CD-1 mice at subcutaneous (sc) doses of 0.025, 0.25, and 2.5 mg/kg (approximately 1/100, 1/10, and 1.0 times, respectively, the maximum recommended daily inhalation dose for adults on a mg/m2 basis) showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg. The drug did not induce cleft palate formation at the lowest dose, 0.025 mg/kg. Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated with 2.5 mg/kg of isoproterenol (positive control) subcutaneously (approximately 1.0 times the maximum recommended daily inhalation dose for adults on a mg/m basis).

A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol was administered orally at a 50-mg/kg dose (approximately 80 times the maximum recommended daily inhalation dose for adults on a mg/m basis).

There are no adequate and well-controlled studies in pregnant women. Albuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been rarely reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established.

Labor and delivery

Because of the potential for beta-agonist interference with uterine contractility, use of albuterol sulfate inhalation solution for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

 

Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta-agonists, including albuterol.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

The safety and effectiveness of albuterol sulfate inhalation solution have been established in children 2 years of age and older. Use of albuterol sulfate inhalation solution in these age-groups is supported by evidence from adequate and well-controlled studies of albuterol sulfate inhalation solution in adults; the likelihood that the disease course, pathophysiology, and the drug’s effect in pediatric and adult patients are substantially similar; and published reports of trials in pediatric patients 3 years of age or older.

The recommended dose for the pediatric population is based upon three published dose comparison studies of efficacy and safety in children 5 to 17 years, and on the safety profile in both adults and pediatric patients at doses equal to or higher than the recommended doses. The safety and effectiveness of albuterol sulfate inhalation solution in children below 2 years of age have not been established.


What are the side effects of Albuterol Sulfate?

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc, at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The results of clinical trials with albuterol sulfate inhalation solution in 135 patients showed the following side effects that were considered probably or possibly drug related:

No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution administration were determined in these studies.

Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventicular tachycardia, extrasystoles) have been reported after the use of albuterol sulfate inhalation solution.

Percent Incidence of Adverse Reactions
ReactionPercent IncidenceReaction n=135
Central Nervous System
Tremors 20%
Dizziness7%
Nervousness4%
Headache3%
Sleeplessness1%
Gastrointestinal
Nausea4%
Dyspepsia1%
Ear, nose and throat
Nasal congestion1%
Pharyngitis
Cardiovascular
Tachycardia1%
Hypertension1%
Respiratory
Bronchospasm8%
Cough4%
Bronchitis4%
Wheezing1%



What should I look out for while using Albuterol Sulfate?

Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.


What might happen if I take too much Albuterol Sulfate?

The expected symptoms with overdosage are those of excessive betaadrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under , 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. In isolated cases in children 2 to 12 years of age, tachycardia with rates >200 beats/min has been observed.

As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate inhalation solution. Treatment consists of discontinuation of albuterol sulfate inhalation solution 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 solution.

Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have been reported after the use of inhaled albuterol. Outbreaks of nosocomial infection (including infection with Burkholderia cepacia) have been reported with the inadvertent in-use contamination of multi-dose albuterol sulfate inhalation solution (see ). These outbreaks occurred when a single multi-dose vial was used to treat multiple patients and may have been due to improper aseptic technique.


How should I store and handle Albuterol Sulfate?

Albuterol Sulfate Inhalation Solution, 0.5% is a clear, colorless to light yellow sterile solution, and is supplied in amber glass bottles of 20 mL fill (NDC 21695-245-20) with accompanying calibrated dropper; boxes of one. PHARMACIST — DETACH HERE AND GIVE LOWER PORTION TO PATIENTAlbuterol Sulfate Inhalation Solution, 0.5% is a clear, colorless to light yellow sterile solution, and is supplied in amber glass bottles of 20 mL fill (NDC 21695-245-20) with accompanying calibrated dropper; boxes of one. PHARMACIST — DETACH HERE AND GIVE LOWER PORTION TO PATIENT


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Clinical Information

Chemical Structure

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Clinical Pharmacology

 Studies in asthmatic patients have shown that less than 20% of a single albuterol dose was absorbed following either intermittent positive-pressure breathing (IPPB) or nebulizer administration; the remaining amount was recovered from the nebulizer and apparatus and expired air. Most of the absorbed dose was recovered in the urine within 24 hours after drug administration. Following a 3-mg dose of nebulized albuterol in adults, the maximum albuterol plasma levels at 0.5 hours were 2.1 ng/mL (range, 1.4 to 3.2 ng/mL). There was a significant dose-related response in FEV (forced expiratory volume in 1 second) and peak flow rate. It has been demonstrated that following oral administration of 4 mg of albuterol, the elimination half-life was 5 to 6 hours.

Non-Clinical Toxicology
Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc, at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The results of clinical trials with albuterol sulfate inhalation solution in 135 patients showed the following side effects that were considered probably or possibly drug related:

No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution administration were determined in these studies.

Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventicular tachycardia, extrasystoles) have been reported after the use of albuterol sulfate inhalation solution.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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