ALBUTEROL SULFATE- albuterol sulfate solution
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Albuterol sulfate inhalation solution is relatively selective beta2 -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name ?1 -[(tert -Butylamino)methyl]-4-hydroxy-m -xylene-?,??-diol sulfate (2:1) (salt)
Albuterol sulfate has molecular weight of 576.7, and the molecular formula is (C13 H21 NO3 )2 ?H2 SO4 Albuterol sulfate is white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization?s recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution 0.083% requires no dilution before administration.
Each mL of albuterol sulfate inhalation solution (0.083%) contains 0.83 mg of albuterol (as mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between and 5. Albuterol sulfate inhalation solution (0.083%) contains no sulfiting agents. Albuterol sulfate inhalation solution is clear, colorless solution.
Albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not substrate for the cellular uptake processes for catecholamines nor for catechol-O -methyl transferase.
INDICATIONS AND USAGE
Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.
Albuterol sulfate inhalation solution is contraindicated in patients with history of hypersensitivity to any of its components.
As with other inhaled beta-adrenergic agonists, albuterol sulfate inhalation solution can produce paradoxical bronchospasm, which can be life threatening. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.
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. In individual patients, any beta2 -adrenergic agonist, including albuterol solution for inhalation, may have clinically significant cardiac effect.
Immediate hypersensitivity reactions may occur after administration of albuterol as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema.
info. for Patients
The action of albuterol sulfate inhalation solution may last up to six hours, and therefore it should not be used more frequently than recommended. Do not increase the dose or frequency of medication without medical consultation. If symptoms get worse, medical consultation should be sought promptly. While taking albuterol sulfate inhalation solution, other anti-asthma medicines should not be used unless prescribed.