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

physicians total care, inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol sulfate 108 ug - ventolin hfa is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ventolin hfa is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. ventolin hfa is contraindicated in patients with a history of hypersensitivity to albuterol or any other components of ventolin hfa. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies of ventolin hfa or albuterol sulfate in pregnant women. 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. no consistent pattern of defects can be discerned, and a relatio

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

stat rx usa llc - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol sulfate 108 ug - ventolin hfa is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ventolin hfa is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. ventolin hfa is contraindicated in patients with a history of hypersensitivity to albuterol or any other components of ventolin hfa. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. teratogenic effects pregnancy category c. there are no adequate and well-controlled studies of ventolin hfa or albuterol sulfate in pregnant women. 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. no consistent pattern of defects can be discerned, and a relations

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

proficient rx lp - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - ventolin® hfa is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ventolin hfa is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. ventolin hfa is contraindicated in patients with a history of hypersensitivity to albuterol or any other components of ventolin hfa. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies of ventolin hfa or albuterol sulfate in pregnant women. 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. no consistent pattern of defects can be discerned, and a relat

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

h.j. harkins company, inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol sulfate 108 ug - ventolin hfa is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ventolin hfa is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. ventolin hfa is contraindicated in patients with a history of hypersensitivity to albuterol or any other components of ventolin hfa. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies of ventolin hfa or albuterol sulfate in pregnant women. 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. no consistent pattern of defects can be discerned, and a relatio

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

lake erie medical dba quality care products llc - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol sulfate 108 ug - ventolin® hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease. ventolin hfa is indicated for the prevention of exercise-induced bronchospasm in patients aged 4 years and older. ventolin hfa is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see warnings and precautions (5.6), description (11)] . teratogenic effects: pregnancy category c. there are no adequate and well-controlled trials with ventolin hfa or albuterol sulfate in pregnant women. 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. no consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established. animal reprod

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

glaxosmithkline llc - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - ventolin hfa is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ventolin hfa is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ventolin hfa is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see warnings and precautions (5.6), description (11)] . 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 mothertobaby pregnancy studies conducted by the organization of teratology information specialists at 1‑877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. risk summary there are no randomized clinical studies of use of albuterol sulfate during pregnancy. available data from epidemiological studies and postmarketing case reports of pregnancy ou

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

preferred pharmaceuticals, inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - ventolin hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease. ventolin hfa is indicated for the prevention of exercise-induced bronchospasm in patients aged 4 years and older. ventolin hfa is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see warnings and precautions (5.6), description (11)] . teratogenic effects pregnancy category c. there are no adequate and well-controlled trials with ventolin hfa or albuterol sulfate in pregnant women. 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. no consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established. animal reproducti

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

nucare pharmaceuticals,inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - ventolin ® hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease. ventolin hfa is indicated for the prevention of exercise-induced bronchospasm in patients aged 4 years and older. ventolin hfa is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see warnings and precautions (5.6), description (11)] . teratogenic effects: pregnancy category c. there are no adequate and well-controlled trials with ventolin hfa or albuterol sulfate in pregnant women. 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. no consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not bee

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

remedyrepack inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - ventolin hfa is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ventolin hfa is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ventolin hfa is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see warnings and precautions ( 5.6), description ( 11)] . 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 mothertobaby pregnancy studies conducted by the organization of teratology information specialists at 1‑877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. risk summary there are no randomized clinical studies of use of albuterol sulfate during pregnancy. available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. there are, however, clinical considerations in pregnant women with asthma. (see clinical considerations.) administration of ventolin hfa to mice and rabbits during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than the maximum recommended human daily inhaled dose (mrhdid). (see data.) the estimated background risk of major birth defects and miscarriage for the indicated population(s) is 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 embryofetal risk: in women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. labor or delivery: because of the potential for beta-agonist interference with uterine contractility, use of ventolin hfa during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. ventolin hfa has not been approved for the management of pre-term labor. serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta 2 -agonists, including albuterol. data human data: while available studies cannot definitively establish the absence of risk, published data from epidemiological studies and case reports have not consistently demonstrated an association with use of ventolin hfa during pregnancy and major birth defects, specific birth defects, or miscarriage. the available studies have methodologic limitations, including inconsistent comparator groups, definitions of outcomes, and assessment of disease impact. animal data: in a study in pregnant mice, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure less than the mrhdid for adults (on a mg/m 2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the mrhdid (on a mg/m 2 basis at a maternal dose of 2.5 mg/kg). cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol, another beta 2 -agonist. in a study in pregnant rabbits, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the mrhdid (on a mg/m 2 basis at a maternal dose of 50 mg/kg). in a study in pregnant rabbits, an albuterol/hfa-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the mrhdid on a mg/m 2 basis. a study in which pregnant rats were dosed with radiolabeled 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 albuterol or the components of ventolin hfa in human milk, the effects on the breastfed child, or the effects on milk production. however, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, are likely to be correspondingly low [see clinical pharmacology (12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ventolin hfa and any potential adverse effects on the breastfed child from ventolin hfa or from the underlying maternal condition. the safety and effectiveness of ventolin hfa for treatment or prevention of bronchospasm and for prevention of exercised-induced bronchospasm in pediatric patients aged 4 years and older have been established. use of ventolin hfa for this indication is supported by evidence from adequate and well-controlled studies of two 12-week clinical trials in subjects aged 12 years and older with asthma and one 2-week clinical trial in subjects aged 4 to 11 years with asthma [see adverse reactions (6.1), clinical studies (14.1)]. the safety and effectiveness of ventolin hfa in pediatric patients younger than 4 years have not been established. three trials have been conducted to evaluate the safety and efficacy of ventolin hfa in subjects younger than 4 years and the findings are described below. two 4-week randomized, double-blind, placebo-controlled trials were conducted in 163 pediatric subjects aged from birth to 48 months with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea, or chest tightness). ventolin hfa or placebo hfa was delivered with either an aerochamber plus valved holding chamber or an optichamber valved holding chamber with mask 3 times daily. in one trial, ventolin hfa 90 mcg (n = 26), ventolin hfa 180 mcg (n = 25), and placebo hfa (n = 26) were administered to children aged between 24 and 48 months. in the second trial, ventolin hfa 90 mcg (n = 29), ventolin hfa 180 mcg (n = 29), and placebo hfa (n = 28) were administered to children aged between birth and 24 months. over the 4-week treatment period, there were no treatment differences in asthma symptom scores between the groups receiving ventolin hfa 90 mcg, ventolin hfa 180 mcg, and placebo in either trial. in a third trial, ventolin hfa was evaluated in 87 pediatric subjects younger than 24 months for the treatment of acute wheezing. ventolin hfa was delivered with an aerochamber plus valved holding chamber in this trial. there were no significant differences in asthma symptom scores and mean change from baseline in an asthma symptom score between ventolin hfa 180 mcg and ventolin hfa 360 mcg. in vitro dose characterization studies were performed to evaluate the delivery of ventolin hfa via holding chambers with attached masks. the studies were conducted with 2 different holding chambers with masks (small and medium size). the in vitro study data when simulating patient breathing suggest that the dose of ventolin hfa presented for inhalation via a valved holding chamber with mask will be comparable to the dose delivered in adults without a spacer and mask per kilogram of body weight (table 2). however, clinical trials in children younger than 4 years described above suggest that either the optimal dose of ventolin hfa has not been defined in this age group or ventolin hfa is not effective in this age group. the safety and effectiveness of ventolin hfa administered with or without a spacer device in children younger than 4 years have not been demonstrated. age mask flow rate (l/min) holding time (seconds) mean medication delivery through aerochamber plus (mcg/actuation) body weight 50 th percentile (kg) a medication delivered per actuation (mcg/kg) b 6 to 12 months small 4.9 18.2 7.5-9.9 1.8-2.4 2 19.8 2.0-2.6 5 13.8 1.4-1.8 10 15.4 1.6-2.1 2 to 5 years small 8.0 17.8 12.3-18.0 1.0-1.4 2 16.0 0.9-1.3 5 16.3 0.9-1.3 10 18.3 1.0-1.5 2 to 5 years medium 8.0 21.1 12.3-18.0 1.2-1.7 2 15.3 0.8-1.2 5 18.3 1.0-1.5 10 18.2 1.0-1.5 >5 years medium 12.0 26.8 18.0 1.5 2 20.9 1.2 5 19.6 1.1 10 20.3 1.1 clinical trials of ventolin hfa did not include sufficient numbers of subjects aged 65 years and older to determine whether older subjects respond differently than 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 disease or other drug therapy.

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

remedyrepack inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - ventolin hfa is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ventolin hfa is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ventolin hfa is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see warnings and precautions ( 5.6), description ( 11)] . 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 mothertobaby pregnancy studies conducted by the organization of teratology information specialists at 1‑877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. risk summary there are no randomized clinical studies of use of albuterol sulfate during pregnancy. available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. there are, however, clinical considerations in pregnant women with asthma. (see clinical considerations.) administration of ventolin hfa to mice and rabbits during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than the maximum recommended human daily inhaled dose (mrhdid). (see data.) the estimated background risk of major birth defects and miscarriage for the indicated population(s) is 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 embryofetal risk: in women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. labor or delivery: because of the potential for beta-agonist interference with uterine contractility, use of ventolin hfa during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. ventolin hfa has not been approved for the management of pre-term labor. serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta 2 -agonists, including albuterol. data human data: while available studies cannot definitively establish the absence of risk, published data from epidemiological studies and case reports have not consistently demonstrated an association with use of ventolin hfa during pregnancy and major birth defects, specific birth defects, or miscarriage. the available studies have methodologic limitations, including inconsistent comparator groups, definitions of outcomes, and assessment of disease impact. animal data: in a study in pregnant mice, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure less than the mrhdid for adults (on a mg/m 2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the mrhdid (on a mg/m 2 basis at a maternal dose of 2.5 mg/kg). cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol, another beta 2 -agonist. in a study in pregnant rabbits, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the mrhdid (on a mg/m 2 basis at a maternal dose of 50 mg/kg). in a study in pregnant rabbits, an albuterol/hfa-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the mrhdid on a mg/m 2 basis. a study in which pregnant rats were dosed with radiolabeled 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 albuterol or the components of ventolin hfa in human milk, the effects on the breastfed child, or the effects on milk production. however, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, are likely to be correspondingly low [see clinical pharmacology (12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ventolin hfa and any potential adverse effects on the breastfed child from ventolin hfa or from the underlying maternal condition. the safety and effectiveness of ventolin hfa for treatment or prevention of bronchospasm and for prevention of exercised-induced bronchospasm in pediatric patients aged 4 years and older have been established. use of ventolin hfa for this indication is supported by evidence from adequate and well-controlled studies of two 12-week clinical trials in subjects aged 12 years and older with asthma and one 2-week clinical trial in subjects aged 4 to 11 years with asthma [see adverse reactions (6.1), clinical studies (14.1)]. the safety and effectiveness of ventolin hfa in pediatric patients younger than 4 years have not been established. three trials have been conducted to evaluate the safety and efficacy of ventolin hfa in subjects younger than 4 years and the findings are described below. two 4-week randomized, double-blind, placebo-controlled trials were conducted in 163 pediatric subjects aged from birth to 48 months with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea, or chest tightness). ventolin hfa or placebo hfa was delivered with either an aerochamber plus valved holding chamber or an optichamber valved holding chamber with mask 3 times daily. in one trial, ventolin hfa 90 mcg (n = 26), ventolin hfa 180 mcg (n = 25), and placebo hfa (n = 26) were administered to children aged between 24 and 48 months. in the second trial, ventolin hfa 90 mcg (n = 29), ventolin hfa 180 mcg (n = 29), and placebo hfa (n = 28) were administered to children aged between birth and 24 months. over the 4-week treatment period, there were no treatment differences in asthma symptom scores between the groups receiving ventolin hfa 90 mcg, ventolin hfa 180 mcg, and placebo in either trial. in a third trial, ventolin hfa was evaluated in 87 pediatric subjects younger than 24 months for the treatment of acute wheezing. ventolin hfa was delivered with an aerochamber plus valved holding chamber in this trial. there were no significant differences in asthma symptom scores and mean change from baseline in an asthma symptom score between ventolin hfa 180 mcg and ventolin hfa 360 mcg. in vitro dose characterization studies were performed to evaluate the delivery of ventolin hfa via holding chambers with attached masks. the studies were conducted with 2 different holding chambers with masks (small and medium size). the in vitro study data when simulating patient breathing suggest that the dose of ventolin hfa presented for inhalation via a valved holding chamber with mask will be comparable to the dose delivered in adults without a spacer and mask per kilogram of body weight (table 2). however, clinical trials in children younger than 4 years described above suggest that either the optimal dose of ventolin hfa has not been defined in this age group or ventolin hfa is not effective in this age group. the safety and effectiveness of ventolin hfa administered with or without a spacer device in children younger than 4 years have not been demonstrated. age mask flow rate (l/min) holding time (seconds) mean medication delivery through aerochamber plus (mcg/actuation) body weight 50 th percentile (kg) a medication delivered per actuation (mcg/kg) b 6 to 12 months small 4.9 18.2 7.5-9.9 1.8-2.4 2 19.8 2.0-2.6 5 13.8 1.4-1.8 10 15.4 1.6-2.1 2 to 5 years small 8.0 17.8 12.3-18.0 1.0-1.4 2 16.0 0.9-1.3 5 16.3 0.9-1.3 10 18.3 1.0-1.5 2 to 5 years medium 8.0 21.1 12.3-18.0 1.2-1.7 2 15.3 0.8-1.2 5 18.3 1.0-1.5 10 18.2 1.0-1.5 >5 years medium 12.0 26.8 18.0 1.5 2 20.9 1.2 5 19.6 1.1 10 20.3 1.1 clinical trials of ventolin hfa did not include sufficient numbers of subjects aged 65 years and older to determine whether older subjects respond differently than 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 disease or other drug therapy.