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.

fails to respond to lower 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.

n, drying or irritation 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.

(approximately 25 times the maximum recommended daily oral dose for adults on an mg/m 2 basis). studies in pregnant rats with tritiated albuterol demonstrated that approximately 10% of the circulating maternal drug is transferred to the fetus. disposition in the fetal lungs is comparable to maternal lungs, but fetal liver disposition is 1% of the maternal liver levels. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, albuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. some of the mothers were taking multiple medications during their pregnancies. because no consistent pattern of defects can be discerned, a relationship between albuterol use and congenital anomalies has not been established.

t been established (see warnings ). 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 plasma 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. it has been shown that administration of a 4 mg albuterol extended-release tablets every 12 hours and 2 mg albuterol tablets every 6 hours for 5 days gave comparable peak albuterol levels and similar extent of absorption at steady state. 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 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. in another controlled clinical study in asthmatic patients, it has been demonstrated that the initiation of therapy with either the 4 mg albuterol extended-release tablets dosed every 12 hours or the 2 mg albuterol tablet dosed every 6 hours, achieve therapeutically comparable effects.

hat 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.

ild-resistant closure. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. please address medical inquiries to, medicalaffairs@zydususa.com or tel.: 1-877-993-8779.

e pregnant or nursing, contact your physician about use of albuterol tablets. effective and safe use of albuterol tablets includes an understanding of the way that it should be administered.