Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Albuterol Sulfate Inhalation Solution, 0.5%, is a clear, colorless to light yellow solution, and is supplied in plastic sterile unit-of-use vials of 0.5 mL each, supplied in individual foil pouches: NDC 62135-829-84: 30 foil pouches, each containing 1 vial, total 30 vials per carton. Storage and Handling Store between 2°C and 25°C (36°F - 77°F). Rx Only Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71918 Rev. 01/2024; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Albuterol Sulfate Inhalation Solution, 0.5%, 2.5mg* / 0.5 mL - 62135-829-84 - Carton - Label image description
- HOW SUPPLIED Albuterol Sulfate Inhalation Solution, 0.5%, is a clear, colorless to light yellow solution, and is supplied in plastic sterile unit-of-use vials of 0.5 mL each, supplied in individual foil pouches: NDC 62135-829-84: 30 foil pouches, each containing 1 vial, total 30 vials per carton. Storage and Handling Store between 2°C and 25°C (36°F - 77°F). Rx Only Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71918 Rev. 01/2024
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Albuterol Sulfate Inhalation Solution, 0.5%, 2.5mg* / 0.5 mL - 62135-829-84 - Carton - Label image description
Overview
Albuterol Sulfate Inhalation Solution, 0.5% contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate has the chemical name α 1-[( tert -Butylamino) methyl]-4-hydroxy- m -xylene-α,α′-diol sulfate (2:1) (salt) and the following chemical structure: (C 13 H 21 NO 3 ) 2 • H 2 SO 4 Mol. Wt. 576.7 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 0.5 mL of the solution to 3 mL with sterile normal saline solution prior to administration by nebulization (see DOSAGE AND ADMINISTRATION ). Each 0.5 mL Unit-of-Use Vial Contains: ACTIVE: 2.5 mg of albuterol (equivalent to 3 mg of albuterol sulfate, USP) in a sterile, aqueous solution; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol sulfate inhalation solution contains no sulfiting agents or preservatives. It is supplied in 0.5 mL sterile Unit-of-Use Vials. Albuterol sulfate inhalation solution is a clear, colorless to light yellow solution. image description
Indications & Usage
Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.
Dosage & Administration
The usual dosage for adults and pediatric patients 12 years of age and older is 2.5 mg of albuterol (one unit-of-use vial) administered 3 to 4 times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, dilute 0.5 mL of the 0.5% solution for inhalation to a total volume of 3 mL with sterile normal saline solution and administer by nebulization. The flow rate is regulated to suit the particular nebulizer so that albuterol sulfate inhalation solution will be delivered over approximately 5 to 15 minutes. 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. The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During treatment, most patients gain optimum benefit from regular use of the nebulizer solution. If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy. The nebulizer should be cleaned in accordance with the manufacturer’s instructions. Failure to do so could lead to bacterial contamination of the nebulizer and possible infection.
Warnings & Precautions
WARNINGS 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 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 re-evaluation 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, anaphylaxis, 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, e.g., corticosteroids.
Contraindications
Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.
Adverse Reactions
The results of clinical trials with albuterol sulfate inhalation solution in 135 patients showed the following side effects which were considered probably or possibly drug related: Percent Incidence of Adverse Reactions Reaction Percent Incidence n = 135 Central Nervous System Tremors 20 Dizziness 7 Nervousness 4 Headache 3 Sleeplessness 1 Gastrointestinal Nausea 4 Dyspepsia 1 Ear, nose and throat Nasal congestion 1 Pharyngitis <1 Cardiovascular Tachycardia 1 Hypertensions 1 Respiratory Bronchospasm 8 Cough 4 Bronchitis 4 Wheezing 1 No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution were determined in these studies. Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have been reported after the use of albuterol sulfate inhalation solution.
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