Albuterol Sulfate, Inhalation Solution, 0.5%*, Sterile, (*Potency expressed as albuterol)

DESCRIPTION

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Albuterol Sulfate Inhalation Solution, 0.5% is a sterile solution that contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta₂-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate has the chemical name α¹-[(tert—Butylamino)methyl]-4-hydroxy-m-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 (C₁₃H₂₁NO₃)₂•H₂SO₄. 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 DOSAGE AND ADMINISTRATION ) with sterile normal saline solution to a total volume of 3 mL and administer by nebulization. Each mL Contains: ACTIVE: Albuterol sulfate equivalent to 5 mg of albuterol in an aqueous solution. Sulfuric Acid may be added to adjust pH (3.0-5.0). 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.

CLINICAL PHARMACOLOGY

id: 7e97a100-9d71-4004-87ab-6267bc10bbf9
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta₂-adrenergic receptors compared with isoproterenol. While it is recognized that beta₂-adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta₂-receptors in the human heart existing in a concentration between 10% and 50%. The precise function of these receptors has not been established (see WARNINGS ). The pharmacologic effects of beta-adrenergic agonist drugs, including albuterol, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. 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. Albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol-O-methyl transferase.

INDICATIONS AND USAGE

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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.

CONTRAINDICATIONS

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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

ADVERSE REACTIONS

id: f180d181-ced5-4923-9de1-24027def7d53
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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:

OVERDOSAGE

id: 52e57e27-e69e-4011-a223-111413cbf4e1
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

The expected symptoms with overdosage are those of excessive betaadrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS , e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia may also occur. 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 WARNINGS, Microbial Contamination ). These outbreaks occurred when a single multi-dose vial was used to treat multiple patients and may have been due to improper aseptic technique.

DOSAGE AND ADMINISTRATION

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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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.

HOW SUPPLIED

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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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 54868-3407-0) with accompanying calibrated dropper; boxes of one.

Store between 2° and 25°C (
36° and 77°F). KEEP OUT OF REACH OF CHILDREN.

PHARMACIST — DETACH HERE AND GIVE LOWER PORTION TO PATIENT

Patient Instructions For Use

id: b85dc075-b0ec-4537-90c6-d1d7f0cc313c
displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3

Albuterol Sulfate Inhalation Solution, 0.5%* *Potency expressed as albuterol Note: The Albuterol Sulfate Inhalation Solution contained in the 20 mL multiple-dose bottles is concentrated and must be diluted. Read complete instructions carefully before
using. 1. Draw the appropriate volume of Albuterol SulfateInhalation Solution, 0.5% into the specially marked dropper that comes with each multidose bottle (Figure 1). For children 12 years of age and under, the volume is based upon body weight. Use the dropper volume prescribed by your doctor. Figure 1 2
. Squeeze the solution into the nebulizer reservoir through the appropriate opening, taking care not to touch the tip of the dropper (Figure 2). Figure 2 3
. Add sterile normal saline solution, as your doctor has directed. A general guideline for the amount of saline to add is: For children using 0.25 mL or 1.25 mg of albuterol sulfate inhalation solution, add 2.75 mL of sterile normal saline. For children or adults using 0.5mL or 2.5mg of albuterol sulfate inhalation solution, add 2.5 mL of sterile normal saline. 4. Gently swirl the nebulizer to mix the contents and connect it with the mouthpiece or face mask (Figure 3). Figure 3 5
. Connect the nebulizer to the compressor. 6. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 4) (or put on the face mask); and turn on the compressor. Figure 4 7. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished. 8. Clean the nebulizer (see manufacturer’s instructions). Note: Use only as directed by your physician.
More frequent administration or higher
doses are not recommended. Store Albuterol Sulfate Inhalation Solution, 0.5% between 2° and 25°C (36°- 77° F). 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. The safety and effectiveness of albuterol sulfate inhalation solution have not been determined when one or more drugs are mixed with it in a nebulizer. Check with your doctor beforemixing anymedications in your nebulizer. Call your doctor for medical advice about side effects. You may report side effects to Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088. ADDITIONAL INSTRUCTIONS: ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 741:03 9/09 MG #11208

PRINCIPAL DISPLAY PANEL

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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Albuterol Sulfate Inhalation Solution, 0.5%