Albuterol Sulfate

DOSAGE AND ADMINISTRATION

5 mg of albuterol (one vial) administered three to four times daily by nebulization. 083%. More frequent administration or higher doses are not recommended. 083% inhalation solution) by nebulization. The flow rate is regulated to suit the particular nebulizer so that albuterol inhalation solution will be delivered over approximately 5 to 15 minutes.

The use of albuterol inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation 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 that would require reassessment of therapy.

ADVERSE REACTIONS

The results of clinical trials with albuterol inhalation solution in 135 patients showed the following side effects which were considered probably or possibly drug related: Central Nervous System: tremors (20%), dizziness (7%), nervousness (4%), headache (3%), insomnia (1%).

Gastrointestinal: nausea (4%), dyspepsia (1%). Ear, Nose and Throat: pharyngitis (<1%), nasal congestion (1%). Cardiovascular: tachycardia (1%), hypertension (1%). Respiratory: bronchospasm (8%), cough (4%), bronchitis (4%), wheezing (1%).

No clinically relevant laboratory abnormalities related to albuterol inhalation solution administration were determined in these studies. In comparing the adverse reactions reported for patients treated with albuterol inhalation solution with those of patients treated with isoproterenol during clinical trials of three months, the following moderate to severe reactions, as judged by the investigators, were reported.

This table does not include mild reactions. 5% 0% *The finding of no arrhythmias and no palpitations after albuterol administration in the clinical study should not be interpreted as indicating that these adverse effects cannot occur after the administration of inhaled albuterol.

+In most cases of bronchospasm, this term was generally used to describe exacerbations in the underlying pulmonary disease. Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, arrhythmias (including atrial fibrillations, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol inhalation solution.

WARNINGS

As with other inhaled beta-adrenergic agonists, albuterol 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 beta 2 -adrenergic agonist, including albuterol solution for inhalation, may have a 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.

CONTRAINDICATIONS

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