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

burel pharmaceuticals, llc - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - 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/m2 basis

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

nucare pharmaceuticals,inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - 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 levalbuterol inhalation solution in pregnant wome

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

mylan pharmaceuticals inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - 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) ]. 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/m2 basis]; however,

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

sun pharmaceutical industries, inc. - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - 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 levalbuterol inhalation solution in pregnant women. there are clinical considerations with

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

northstar rxllc - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - 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 levalbuterol inhalation solution in pregnant women. there are clinical considerations with

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

bryant ranch prepack - levalbuterol tartrate (unii: ads4i3e22m) (levalbuterol - unii:edn2nbh5ss) - 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. risk summary there are no adequate and well-controlled studies of levalbuterol tartrate hfa inhalation aerosol in pregnant women.  there are clinical considerations with the use of levalbuterol tartrate hfa inhalation aerosol 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 750 times the maximum recommended human daily inhalation dose (mrhdid) of levalbuterol tartrate for adults on a mg/m2 basis]; however, racemic albuterol sulfate was teratogenic in mice (cleft palate) and rabbits (cranioschisis) 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 tartrate hfa inhalation aerosol for the treatment of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. levalbuterol tartrate hfa inhalation aerosol has not been approved for the management of preterm labor.  the benefit:risk ratio when levalbuterol tartrate 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 beta2 -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 750 times the mrhdid of levalbuterol tartrate for adults on a mg/m2 basis). in a rat developmental study, a racemic albuterol sulfate (comprising approximately 50% levalbuterol)/hfa-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 160 times the mrhdid (on a mg/m2 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 development study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 1500 times the mrhdid (on a mg/m2 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 2 times mrhdid for adults (on a mg/m2 basis at a maternal dose of 0.25 mg/kg/day) and in 10 of 108 (9.3%) fetuses at approximately 20 times mrhdid (on a mg/m2 basis at a maternal dose of 2.5 mg/kg/day).  similar effects were not observed at approximately 0.2 times mrhdid of levalbuterol tartrate for adults on a mg/m2 basis (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). 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 tartrate hfa inhalation aerosol and any potential adverse effects on the breastfed child from levalbuterol tartrate hfa inhalation aerosol or from the underlying maternal condition. pediatric patients 4 years of age and older the safety and efficacy of levalbuterol tartrate hfa inhalation aerosol have been established in pediatric patients 4 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 4 years of age levalbuterol tartrate hfa inhalation aerosol is not indicated for pediatric patients less than 4 years of age. a clinical trial in pediatric patients below the age of 4 years showed no statistical significant difference between treatment groups in the primary efficacy endpoint. there was an increased incidence of asthma-related adverse reactions reported in pediatric patients below the age of 4 years treated with levalbuterol tartrate hfa inhalation aerosol compared to placebo. levalbuterol tartrate hfa inhalation aerosol was evaluated in one 4-week, multicenter, randomized, modified-blind, placebo-controlled, parallel group trial of 196 pediatric patients ages birth to < 4 years of age with asthma or reactive airway disease (68 patients birth to < 2 years of age and 128 patients 2 to < 4 years of age). levalbuterol tartrate hfa inhalation aerosol 45 mcg (n=23), levalbuterol tartrate hfa inhalation aerosol 90 mcg (n=42), levalbuterol inhalation solution 0.31 mg (n=63), and placebo hfa (n=68) were administered three times daily. levalbuterol tartrate hfa inhalation aerosol or placebo hfa was delivered with the monaghan aerochamber max™ valved holding chamber with mask. the primary efficacy endpoint was the mean change in pediatric asthma caregiver assessment (paca) total score from baseline over the 4 week treatment period. there was no statistical difference in the change in paca total score between levalbuterol tartrate hfa inhalation aerosol and placebo. regarding safety, an increased number of treatment-emergent asthma-related adverse reactions were reported in levalbuterol tartrate hfa inhalation aerosol-treated patients. eight subjects reported asthma-related adverse reactions for levalbuterol tartrate hfa inhalation aerosol compared to 3 subjects for placebo. there was one subject that discontinued treatment due to asthma in the levalbuterol tartrate hfa inhalation aerosol group compared to zero subjects in the placebo group (table 3). other adverse reactions were consistent with those observed in the clinical trial population of patients 4 years of age and older [see adverse reactions (6.1) ]. clinical studies of levalbuterol tartrate hfa inhalation aerosol did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy. 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. instructions for use levalbuterol tartrate hfa inhalation aerosol, for oral inhalation use important information: - for oral inhalation use only - use levalbuterol tartrate hfa inhalation aerosol exactly as your doctor tells you to. - if you have any questions about the use of your inhaler, ask your doctor or pharmacist. the parts of your levalbuterol tartrate hfa inhalation aerosol inhaler (see figure 1): - levalbuterol tartrate hfa inhalation aerosol comes as a canister that fits into an actuator with a dose indicator. do not use the levalbuterol tartrate hfa inhalation aerosol actuator with a canister of medicine from any other inhaler. do not use the levalbuterol tartrate hfa inhalation aerosol canister with an actuator from any other inhaler. - do not use the levalbuterol tartrate hfa inhalation aerosol actuator with a canister of medicine from any other inhaler. - do not use the levalbuterol tartrate hfa inhalation aerosol canister with an actuator from any other inhaler. - the dose indicator display window will show you how many sprays of medicine you have left in your inhaler. a spray of medicine is released each time you press down on the center of the dose indicator. - it is important that you pay attention to the number of sprays left in your levalbuterol tartrate hfa inhalation aerosol inhaler by reading the dose indicator. you should also keep track of the number of sprays used from your inhaler. each canister of levalbuterol tartrate hfa inhalation aerosol contains enough medicine for you to spray your medicine 200 times (see figure 2a) . - the pointer will be pointing between 180 and 200 after you take 10 sprays. this means that there are 190 sprays of medicine left in the canister (see figure 2b ). - the pointer will be pointing to 180 after you take 10 more sprays. this means that there are 180 sprays of medicine left in the canister (see figure 2c ). - the dose indicator display window will continue to move after every 10 sprays. the number on the dose indicator display window will continue to change after every 20 sprays. - the dose indicator display window will change to red, as shown in the shaded area, when there are only 20 sprays of medicine left in your inhaler (see figure 2d ). you should refill your prescription or ask your doctor if you need another prescription for levalbuterol tartrate hfa inhalation aerosol. - when the number in the dose indicator display window reaches zero “0”, this means that 200 sprays of medicine have been used. throw away your levalbuterol tartrate hfa inhalation aerosol inhaler. note: do not place the canister under water to find out the amount of medicine left in the canister. preparing your levalbuterol tartrate hfa inhalation aerosol inhaler for use: - your levalbuterol tartrate hfa inhalation aerosol inhaler should be at room temperature before you use it. - shake the inhaler well before each use. priming your levalbuterol tartrate hfa inhalation aerosol inhaler: before you use levalbuterol tartrate hfa inhalation aerosol for the first time or if you have not taken your medicine for 3 days in a row, you must prime the inhaler. - look at the dose indicator on top of the inhaler. make sure that the pointer on the dose indicator is pointing to the “200” inhalation mark before you use your levalbuterol tartrate hfa inhalation aerosol inhaler for the first time. - take the cap off the mouthpiece of the actuator (see figure 3 ). check inside the mouthpiece for objects before use. - hold the inhaler in the upright position away from the face and shake the inhaler well (see figure 4) - press down fully on the center of the dose indicator to release a spray of medicine from the mouthpiece (see figure 5 ). you may hear a soft click from the dose indicator as it counts down during use. - avoid spraying in your eyes . - repeat the priming steps  3 more times (see figure 4 and figure 5 ) to finish priming the inhaler. - after priming 4 times the first time you use your levalbuterol tartrate hfa inhalation aerosol inhaler, the dose indicator should be pointing to “200” and your inhaler is now ready to use. if you do not use your levalbuterol tartrate hfa inhalation aerosol inhaler for more than 3 days, you will need to prime the inhaler again  before use . using your levalbuterol tartrate hfa inhalation aerosol inhaler: step 1: take the cap off the mouthpiece of the actuator (see figure 3 ). check inside the mouthpiece for objects. make sure the canister fits firmly in the actuator. step 2: shake the inhaler well for 5 seconds before use. step 3: hold the inhaler upright with the mouthpiece pointing towards you. before you put the mouthpiece in your mouth, breathe out through your mouth and push out as much air from your lungs as you can (see figure 6 ). step 4: put the mouthpiece in your mouth and close your lips around it. step 5: while breathing in deeply and slowly, press down on the center of the targeting rings (see figure 7 ) until a spray of medicine has been released. then stop pressing the dose indicator. step 6: when you have finished breathing in, remove the mouthpiece from your mouth. close your mouth and hold your breath for 10 seconds if possible. then breathe out gently. step 7: wait about 1 minute, then shake the inhaler well. repeat steps 3 through 6 to take your second spray of levalbuterol tartrate hfa inhalation aerosol. step 8: put the cap back on the mouthpiece right away after use. make sure the cap snaps firmly into place. cleaning your levalbuterol tartrate hfa inhalation aerosol inhaler: clean the inhaler 1 time each week. it is very important to keep the actuator clean so that medicine will not build up and block the spray from the mouthpiece (see figure 8 ). to clean the actuator: step 1: take the canister out of the actuator (see figure 9 ). do not clean the canister or let it get wet. step 2: take the cap off the mouthpiece. step 3: hold the actuator under the faucet and run warm water through it for at least 30 seconds. turn the actuator upside down and rinse the actuator again through the mouthpiece for at least 30 seconds (see figure 10 ). step 4: shake off as much water from the actuator as you can. step 5: look inside the actuator and mouthpiece to make sure any medicine build-up has been completely washed away.  medicine build-up is more likely to happen if the actuator is not allowed to air-dry completely. step 6: let the actuator air-dry overnight. do not put the canister back into the actuator if it is still wet. step 7: when the actuator is dry, put the canister back in the actuator and put the cap back on the mouthpiece.  make sure to firmly press the canister down in the actuator. note: if your actuator becomes blocked, it means that little or no medicine is coming out of the mouthpiece (see figure 11 ). repeat steps 1 through 7 above in the section “to clean the actuator ”. if you need to use your inhaler before the plastic actuator is completely dry: - shake off as much water from the actuator as you can. - put the canister back into the actuator and shake the inhaler well. - to remove most of the water from your inhaler, press down on the center of the targeting rings 2 times to release a total of 2 sprays into the air away from your face. - take your prescribed dose of medicine. - repeat steps 1 through 7 above in the section “to clean the actuator” . how should i store levalbuterol tartrate hfa inhalation aerosol? - store levalbuterol tartrate hfa inhalation aerosol at room temperature between 68°f to 77°f (20°c to 25°c). - do not use or store levalbuterol tartrate hfa inhalation aerosol inhaler near heat or open flame. temperatures above 120°f may cause the canister to burst. - do not freeze levalbuterol tartrate hfa inhalation aerosol - keep levalbuterol tartrate hfa inhalation aerosol out of direct sunlight. - do not put a hole in the levalbuterol tartrate hfa inhalation aerosol canister. - store levalbuterol tartrate hfa inhalation aerosol with the mouthpiece down. - throw away levalbuterol tartrate hfa inhalation aerosol when the dose indicator display window reaches zero “0”, showing that all 200 sprays (actuations) have been used. - do not throw levalbuterol tartrate hfa inhalation aerosol inhaler into a fire or incinerator. keep levalbuterol tartrate hfa inhalation aerosol and all medicines out of the reach of children. this patient information and instructions for use has been approved by the u.s. food and drug administration. distributed by: actavis pharma, inc. parsippany, nj 07054 usa © 2017 all rights reserved. for customer service, call 1-888-394-7377. to report adverse events, call 1-877-737-7226. for medical information, call 1-800-739-0565. revised  february 2017 10118-02

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

nucare pharmaceuticals,inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other albuterol sulfate inhalation aerosol components. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see warnings and precautions ( 5.6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. for more information, contact the mothers to baby pregnancy studies conducted by the organization of teratology information specialists at 1-877-311-8

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

proficient rx lp - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.   albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other albuterol sulfate inhalation aerosol components. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see warnings and precautions (5.6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. for more information, contact the mothers to baby pregnancy studies conducted by the organization of teratology information specialists at 1-877-311-8972 or visit http://mothertobaby.org/pre

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cipla usa inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e), ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - albuterol 2.5 mg in 3 ml - ipratropium bromide and albuterol sulfate inhalation solution is indicated for the treatment of bronchospasm associated with copd in patients requiring more than one bronchodilator. ipratropium bromide and albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.

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cardinal health - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 1.5 mg in 3 ml