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preferred pharmaceuticals, inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.63 mg in 3 ml - levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. risk summary there are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women. there are clinical considerations with the use of levalbuterol inhalation solution in pregnant women [see clinical considerations]. following oral administration of levelbuterol hcl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 108 times the maximum recommended human daily inhalation dose (mrhdid) of levalbuterol hcl for adults on a mg/m2 basis]; however, racemic a

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mylan pharmaceuticals inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 1.25 mg in 3 ml - levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6)] . there are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women. because animal reproduction studies are not always predictive of human response, levalbuterol inhalation solution 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 newborns of women treated with racemic albuterol which contains the levalbuterol isomer

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ritedose pharmaceuticals, llc - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.63 mg in 3 ml - levalbuterol hcl inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol hcl inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol hcl or racemic albuterol. levalbuterol hcl inhalation solution 0.63 mg2, 1.25 mg2 3 ml unit-dose vials read complete instructions carefully before using.           figure 1           figure 2           figure 3           figure 4 note: levalbuterol hcl inhalation solution should be used in a nebulizer only under the direction of a physician. more frequent administration or higher doses are not recommended without first discussing with your doctor. this solution should not be injected or administered orally. protect from light and excessive heat. store in the protective foil pouch at 20-25°c (68-77°f) [see usp controlled room temperature]. keep unopened vials in the foil pouch. once the foi

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remedyrepack inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 1.25 mg in 3 ml - levalbuterol hcl inhalation solution, usp is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol hcl inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol hcl or racemic albuterol.

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preferred pharmaceuticals inc. - levalbuterol tartrate (unii: ads4i3e22m) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 45 ug - levalbuterol tartrate hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease. levalbuterol tartrate hfa inhalation aerosol is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of levalbuterol tartrate hfa inhalation aerosol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies of levalbuterol tartrate hfa inhalation aerosol in pregnant women. because animal reproduction studies are not always predictive of human response, levalbuterol tartrate hfa inhalation aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. rare instances of congenital anomalies, including cleft palate and limb defects, were reported in

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ritedose pharmaceuticals, llc - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.31 mg in 3 ml - levalbuterol inhalation solution, usp is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution, usp is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. risk summary there are no adequate and well-controlled studies of levalbuterol inhalation solution, usp in pregnant women. there are clinical considerations with the use of levalbuterol inhalation solution, usp in pregnant women [see clinical considerations] . following oral administration of levalbuterol hcl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 108 times the maximum recommended human daily inhalation dose (mrhdid) of levalbuterol hcl for adults on a mg/m 2 basis]; however, racemic albuterol sulfate was teratogenic in mice (cleft palate) and rabbits (cramioschisis) at doses slightly higher than the human therapeutic range ( see data ). the estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk in women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control. labor or delivery because of the potential for beta-adrenergic agonists to interfere with uterine contractility, the use of levalbuterol inhalation solution, usp for the treatment of bronchospasm during labor should be restricted to those patients for whom the benefits clearly outweigh the risk. levalbuterol inhalation solution, usp has not been approved for the management of preterm labor. the benefit-risk ratio when levalbuterol inhalation solution, usp is administered for tocolysis has not been established. serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta 2 -agonists, including racemic albuterol. data animal data the oral administration of levalbuterol hcl to pregnant new zealand white rabbits during the period of organogenesis found no evidence of teratogenicity at doses up to 25 mg/kg/day (approximately 108 times the mrhdid of levalbuterol hcl for adults on a mg/m 2 basis). in a rat developmental study, racemic albuterol sulfate administered by inhalation did not produce any teratogenic effects at exposures approximately 63 times the mrhdid (on a mg/m 2 basis at a maternal dose of 10.5 mg/kg). however, other developmental studies with the racemic albuterol sulfate, did result in teratogenic effects in mice and rabbits at doses slightly higher than the human therapeutic range. in a rabbit developmental study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 215 times the mrhdid for adults (on a mg/m 2 basis at a maternal dose of 50 mg/kg). in a mouse developmental study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure approximately 0.3 times the mrhdid for adults (on a mg/m 2 basis at a maternal dose of 0.25 mg/kg/day) and in 10 of 108 (9.3%) fetuses at approximately 3 times the mrhdid (on a mg/m 2 basis at a maternal dose of 2.5 mg/kg/day). similar effects were not observed at approximately 0.03 times the mrhdid for adults on a mg/m 2 basis at a maternal dose of 0.025 mg/kg/day (i.e., less than the therapeutic dose). cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control). non-teratogenic effects: a study in which pregnant rats were dosed with radiolabeled racemic albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus. risk summary there are no available data on the presence of levalbuterol in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for levalbuterol inhalation solution, usp and any potential adverse effects on the breastfed child from levalbuterol inhalation solution, usp or from the underlying maternal condition. pediatric patients 6 years of age and older the safety and efficacy of levalbuterol inhalation solution, usp have been established in pediatric patients 6 years of age and older in an adequate and well-controlled clinical trial [see adverse reactions (6) and clinical studies (14) ]. pediatric patients less than 6 years of age levalbuterol inhalation solution, usp is not indicated for pediatric patients less than 6 years of age. clinical trials with levalbuterol inhalation solution, usp in this age group failed to meet the primary efficacy endpoint and demonstrated an increased number of asthma related adverse reactions following chronic levalbuterol inhalation solution, usp treatment. levalbuterol inhalation solution, usp was studied in 379 pediatric patients less than 6 years of age with asthma or reactive airway disease - (291 patients 2 to 5 years of age, and 88 patients from birth to less than 2 years of age). efficacy and safety data for levalbuterol inhalation solution, usp in this age group are primarily available from one 3-week, multicenter, randomized, double-blind, active and placebo-controlled study (study 1) in 211 pediatric patients between the ages of 2 and 5 years, of whom 119 received levalbuterol inhalation solution, usp. over the 3 week treatment period, there were no significant treatment differences in the pediatric asthma questionnaire (paq) total score between groups receiving levalbuterol inhalation solution, usp 0.31 mg, levalbuterol inhalation solution, usp 0.63 mg, racemic albuterol, and placebo. additional safety data following chronic dosing is available from a 4-week, multicenter, randomized, modified-blind, placebo-controlled study (study 2) of 196 patients between the ages of birth and 3 years, of whom 63 received open-label levalbuterol inhalation solution, usp. in these two studies, treatment-emergent asthma exacerbations or asthma-related adverse reactions and treatment discontinuations due to asthma occurred at a higher frequency in levalbuterol inhalation-treated subjects compared to control (table 5). other adverse reactions were consistent with those observed in the clinical trial population of patients 6 years of age and older [see adverse reactions (6.1) ]. * asthma exacerbation defined as worsening of asthma symptoms or pulmonary function that required any of the following: emergency department visit, hospitalization, therapeutic intervention with oral or parenteral steroids, unscheduled clinic visit to treat acute asthma symptoms ** includes the following preferred terms (whether considered by the investigator to be related or unrelated to drug): asthma, cough, hypoxia, status asthmaticus, tachypnea. clinical studies of levalbuterol inhalation solution, usp did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. only 5 patients 65 years of age and older were treated with levalbuterol inhalation solution, usp in a 4-week clinical study [see clinical pharmacology (12) and clinical studies (14) ] (n = 2 for 0.63 mg and n = 3 for 1.25 mg). in these patients, bronchodilation was observed after the first dose on day 1 and after 4 weeks of treatment. in general, patients 65 years of age and older should be started at a dose of 0.63 mg of levalbuterol inhalation solution, usp. if clinically warranted due to insufficient bronchodilator response, the dose of levalbuterol inhalation solution, usp may be increased in elderly patients as tolerated, in conjunction with frequent clinical and laboratory monitoring, to the maximum recommended daily dose [see dosage and administration (2) ]. albuterol is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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teva pharmaceuticals usa, inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 1.25 mg in 0.5 ml - levalbuterol inhalation solution (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. risk summary there are no adequate and well-controlled studies of levalbuterol inhalation solution concentrate in pregnant women. there are clinical considerations with the use of levalbuterol inhalation solution concentrate in pregnant women [see clinical considerations]. following oral administration of levalbuterol hcl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 108 times the maximum recommended human daily inhalation dose (mrhdid) of levalbuterol hcl for adults

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.31 mg in 3 ml - levalbuterol inhalation solution, usp is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution, usp is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies of levalbuterol inhalation solution, usp in pregnant women. because animal reproduction studies are not always predictive of human response, levalbuterol inhalation solution, usp 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 newborns

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.31 mg in 3 ml - levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol inhalation solution, during pregnancy. to enroll in mothertobaby pregnancy studies’ asthma & pregnancy study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. risk summary there are no adequate and well-controlled studies of levalbu

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 1.25 mg in 0.5 ml - levalbuterol inhalation solution (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol inhalation solution during pregnancy. to enroll in mothertobaby pregnancy studies’ asthma & pregnancy study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. risk summary there are no adequate and well-controlled studies of levalbuterol inhalation solutio