ecg changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the dose of the beta-agonist is exceeded. although the clinical significance of these effects is unknown, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics. mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. the clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.

ial consideration of the possible need for anti-inflammatory treatment (e.g., corticosteroids). 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. cardiovascular effects albuterol sulfate, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. although such effects are uncommon for albuterol sulfate at recommended doses, if they occur, the drug may need to be discontinued. in addition, beta-agonists have been reported to produce 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 sulfate like all other 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, and oropharyngeal edema.

studied in the setting of acute attacks of bronchospasm. a 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 ml) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above. 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 which would require reassessment of therapy. the drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate inhalation solution, when mixed with other drugs in a nebulizer have not been established. the safety and efficacy of albuterol sulfate inhalation solution have been established in clinical trials when administered using the pari lc plus™ nebulizer and pari proneb™ compressor. the safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established. albuterol sulfate inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

is study. postmarketing experience: metabolic acidosis has been reported after the use of albuterol sulfate inhalation solution. because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure. to report suspected adverse events, contact actavis at 1-800-272-5525 or fda at 1-800-fda-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

ecg changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the dose of the beta-agonist is exceeded. although the clinical significance of these effects is unknown, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics. mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. the clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.

g (approximately 60 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis). a study in which pregnant rats were dosed with radiolabelled albuterol sulfate demonstrated that drug-related material was transferred from the maternal circulation to the fetus. there are no adequate and well-controlled studies of the use of albuterol sulfate in pregnant women. 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.

s, and/or electrocardiographic 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. pharmacokinetics studies in asthmatic patients have shown that less than 20% of a single albuterol dose was absorbed following either intermittent positive-pressure breathing (ippb) or nebulizer administration; the remaining amount was recovered from the nebulizer and apparatus, and expired air. most of the absorbed dose was recovered in urine collected during the 24 hours after drug administration. following oral administration of 4 mg albuterol, the elimination half-life was five to six hours. following a 3 mg dose of nebulized albuterol in adults, the mean maximum albuterol plasma level at 0.5 hours was 2.1 ng/ml (range, 1.4 to 3.2 ng/ml). the pharmacokinetics of albuterol following administration of 0.63 mg or 1.25 mg albuterol sulfate inhalation solution by nebulization have not been determined in children 2 to 12 years old. animal pharmacology/toxicology 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 plasma concentrations. in structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those found in 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. clinical trials the safety and efficacy of albuterol sulfate was evaluated in a 4-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in 349 children 6 to 12 years of age with mild-to-moderate asthma (mean baseline fev 1 60% to 70% of predicted). approximately half of the patients were also receiving inhaled corticosteroids. patients were randomized to receive albuterol sulfate 0.63 mg, albuterol sulfate 1.25 mg, or placebo three times a day administered via a pari lc plus™ nebulizer and a pari proneb™ compressor. racemic albuterol, delivered by a chlorofluorocarbon (cfc) metered dose inhaler (mdi) or nebulized, was used on an as-needed basis as the rescue medication. efficacy, as measured by the mean percent change from baseline in the area under the 6-hour curve for fev 1 , was demonstrated for both active treatment regimens (n=112 [1.25 mg group] and n=110 [0.63 mg group]) compared with placebo (n=110) on day 1 and day 28. figures 1 and 2 illustrate the mean percentage change from pre-dose fev 1 on day 1 and day 28, respectively. the mean baseline fev 1 for all patients was 1.49 l. the onset of a 15% increase in fev 1 over baseline for both doses of albuterol sulfate was seen at 30 minutes (the first post-dose assessment). the mean time to peak effect was approximately 30 to 60 minutes for both doses on day 1 and after 4 weeks of treatment. the mean duration of effect, as measured by a >15% increase from baseline in fev 1 , was approximately 2.5 hours for both doses on day 1 and approximately 2 hours for both doses after 4 weeks of treatment. in some patients, the duration of effect was as long as 6 hours. figure 1 figure 2

in the ames test or a mutation test in yeast. albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an ah 1 strain mouse micronucleus assay. reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of albuterol sulfate up to 50 mg/kg (approximately 30 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis).

ol sulfate per 3 ml in unit-dose vials and is available in the following packaging configuration. ndc 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

tibility (physical and chemical), clinical efficacy, and safety of albuterol sulfate solution, when mixed with other drugs in a nebulizer, has not been established. see illustrated patient's instructions for use .

lbuterol sulfate inhalation solution if he or she is allergic to any of its ingredients. the active ingredient is albuterol sulfate. see the end of this leaflet for a complete list of ingredients. what should i tell my child’s doctor before giving albuterol sulfate inhalation solution? tell your child’s doctor about all of your child’s medical conditions including if your child has: heart problems high blood pressure seizures a thyroid problem called hyperthyroidism diabetes tell your child’s doctor about all the medicines your child takes, including prescription and non-prescription medicines, vitamins and herbal supplements. albuterol sulfate inhalation solution and some other medicines can affect each other and may cause serious side effects. especially tell your child’s doctor if your child is taking or using: any short-acting bronchodilator medicines (sometimes called rescue inhalers) epinephrine medicines called monoamine oxidase inhibitors (maois) or tricyclic anti-depressants or has stopped taking them in the past 2 weeks. these medicines are usually used for mental problems. medicines called beta-blockers (used for heart problems and high blood pressure) certain diuretic medicines (water pills) digoxin know the medicines your child takes. keep a list of them and show it to your child’s doctor and pharmacist each time your child gets a new medicine. how should albuterol sulfate inhalation solution be given? read the patient’s instructions for use that comes with albuterol sulfate inhalation solution. ask your pharmacist for these instructions if they are not with your medicine. keep the instructions with albuterol sulfate inhalation solution because you may want to read them again. give albuterol sulfate inhalation solution exactly as prescribed for your child. do not change your child’s dose or how often it is used without talking to your child’s doctor first. albuterol sulfate inhalation solution is breathed into the lungs. albuterol sulfate inhalation solution is used with a special breathing machine called a nebulizer. do not mix other medicines with albuterol sulfate inhalation solution in the nebulizer. do not use albuterol sulfate inhalation solution that is not clear and colorless. call your child’s doctor or get emergency help right away if your child’s breathing is not helped or gets worse during treatment with albuterol sulfate inhalation solution. call your child’s doctor right away if your child needs to use albuterol sulfate inhalation solution more often than prescribed. albuterol sulfate inhalation solution has not been studied for treating acute attacks of bronchospasm (rescue use). your child may need a different medicine for rescue use. if you give your child too much albuterol sulfate inhalation solution, call your child’s doctor right away. what are the side effects with albuterol sulfate inhalation solution? albuterol sulfate inhalation solution may cause the following serious side effects: worsening of the tightening and swelling of the muscles around your child’s airways (bronchospasm). this side effect can be life threatening. call your child’s doctor or get emergency help right away if your child’s breathing is not helped or gets worse during treatment with albuterol sulfate inhalation solution. serious and life threatening allergic reactions. symptoms of a serious allergic reaction include: hives, rash swelling of your child’s face, eyelids, lips, tongue, or throat, and trouble swallowing worsening of your child’s breathing problems such as wheezing, chest tightness or shortness of breath shock (loss of blood pressure and consciousness). the most common side effects with albuterol sulfate inhalation solution include a fast or irregular heartbeat, chest pain, shakiness, or nervousness. how should albuterol aulfate inhalation solution be stored? store albuterol sulfate inhalation solution at room temperature, 20° to 25°c (68° to 77°f) in its tightly closed container. [see usp controlled room temperature] in its tightly closed container. protect vials from light before use. therefore, keep unused vials in the foil pouch or carton. once removed from the foil pouch, use vial(s) within one week. do not use albuterol sulfate inhalation solution after the expiration (exp) date printed on the vial. do not use albuterol sulfate inhalation solution that is not clear and colorless. safely, discard albuterol sulfate inhalation solution that is out-of-date or no longer needed. keep albuterol sulfate inhalation solution and all medicines out of the reach of children. general information about albuterol sulfate inhalation solution medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflets. do not use albuterol sulfate inhalation solution for a condition for which it was not prescribed. do not give albuterol sulfate inhalation solution to other people, even if they have the same symptoms your child has. it may harm them. this leaflet summarizes the most important information about albuterol sulfate inhalation solution. if you would like more information, talk with your child’s doctor. you can ask your child’s doctor or pharmacist for information about albuterol sulfate inhalation solution that is written for health professionals. you can also call actavis toll free at 1-800-272-5525. what are the ingredients in albuterol sulfate inhalation solution? active ingredient: albuterol sulfate inactive ingredients: sodium chloride and sulfuric acid manufactured by: cipla ltd. verna, goa india distributed by: actavis pharma, inc. parsippany, nj 07054 usa revised: january 2017