cally 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 tablets 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 tablets, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. 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. rarely, erythema multiforme and stevens-johnson syndrome have been associated with the administration of oral albuterol sulfate in children.

ower dose. the dosage should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated if a favorable response does not occur with the 4 mg initial dosage. elderly patients and those sensitive to beta-adrenergic stimulators : an initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. if adequate bronchodilation is not obtained, dosage may be increased gradually as tolerated to as much as 8 mg three or four times a day. the total daily dose should not exceed 24 mg per day in pediatric patients from 6 to 12 years of age and 32 mg in adults and pediatric patients over 12 years of age.

ation of the oropharynx, hypertension, unusual taste, and vertigo. the reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol tablets. in selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.

ot been established. in controlled clinical trials, albuterol has been shown 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 ecg 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. preclinical intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of the plasma concentrations. in structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the whole brain. studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. the clinical significance of these findings is unknown. pharmacokinetics albuterol is rapidly and well absorbed following oral administration. in studies involving normal volunteers, the mean steady-state peak and trough plasm levels of albuterol were 6.7 and 3.8 ng/ml, respectively, following dosing with a 2 mg albuterol tablet every 6 hours and 14.8 and 8.6 ng/ml, respectively following dosing with a 4 mg albuterol tablet every 6 hours. maximum albuterol plasma levels are usually obtained between 2 and 3 hours after dosing, and the elimination half-life is 5 to 6 hours. these data indicate that albuterol administered orally is dose proportional and exhibits dose independent pharmacokinetics. in other studies, the analysis of urine samples of patients given tritiated albuterol (4 to 10 mg) orally showed that 65% to 90% of the dose was excreted over 3 days, with the majority of the dose being excreted within the first 24 hours. sixty percent of this radioactivity was shown to be the metabolite. feces collected over this period contained 4% of the administered dose. clinical trials in controlled clinical trials in patients with asthma, the onset of improvement in pulmonary function, as measured by maximum midexpiratory flow rate (mmef), was noted within 30 minutes after a dose of albuterol tablets, with peak improvement occurring between 2 and 3 hours. in controlled clinical trials in which measurements were conducted for 6 hours, significant clinical improvement in pulmonary function (defined as maintaining a 15% or more increase in forced expiratory volume in 1 second [fev 1 ] and a 20% or more increase in mmef over baseline values) was observed in 60% of patients at 4 hours and in 40% at 6 hours. in other single-dose, controlled clinical trials, clinically significant improvement was observed in at least 40% of the patients at 8 hours with the 4 mg albuterol tablet. no decrease in the effectiveness of albuterol tablets has been reported in patients who received long-term treatment with the drug in uncontrolled studies for periods up to 6 months.

71205-899-11 bottles of 1000 tablets store albuterol tablets at 20° to 25°c (68° to 77°f). [see usp for controlled room temperature.] protect from light manufactured by appco pharma llc. piscataway, new jersey 08854 distributed by: rising pharmaceuticals, inc. saddle brook, nj 07663 repackaged and relabeled by: proficient rx lp thousand oaks, ca 91320 revised: 01/2019 store albuterol tablets at 20° to 25°c (68° to 77°f). [see usp for controlled room temperature.] protect from light manufactured by appco pharma llc. piscataway, new jersey 08854 distributed by: rising pharmaceuticals, inc. saddle brook, nj 07663 repackaged and relabeled by: proficient rx lp thousand oaks, ca 91320 revised: 01/2019