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| Drug Name |
ALBUTEROL |
| Active Ingredient(s) |
ALBUTEROL SULFATE |
Form(s) and
Strength(s) Available |
Solution; Inhalation:0.0417% | DESCRIPTION Albuterol Sulfate Inhalation Solution contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator.
Preclinical: Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations that are amounting to approximately 5.0% of the plasma concentrations. In structures outside the brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the whole brain.
Clinical Trials: In controlled clinical trials, most patients exhibited an onset of improvement in pulmonary function within 5 minutes as determined by FEV1. FEV1 measurements also showed that the maximum average improvement in pulmonary function usually occurred at approximately 1 hour following inhalation of 2.5 mg of albuterol by compressor-nebulizer and remained close to peak for 2 hours. Clinically significant improvement in pulmonary function (defined as maintenance of a 15% or more increase in FEV1 over baseline values) continued for 3 to 4 hours in most patients and in some patients continued up to 6 hours.
INDICATIONS AND 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.
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, tremor or nervousness. If you are pregnant or nursing, contact your physician about use of Albuterol Sulfate Inhalation Solution. Effective use of Albuterol Sulfate Inhalation Solution includes an understanding of the way it should be administered.
Manufacturers URL : www.nephronpharm.com
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