Albuterol Sulate HFA
Generic: ALBUTEROL SULFATE
Basic Information
Manufacturer
NuCare Pharmaceuticals,Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
RESPIRATORY (INHALATION)
FDA Set ID
825975b1-a4a9-78ca-e053-2a91aa0a3948
Indications & Usage
1 INDICATIONS AND USAGE Albuterol Sulfate HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease.
( 1.1 ) Prevention of exercise-induced bronchospasm in patients aged 4 years and older.
(1.2) 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA is indicated for the prevention of exercise-induced bronchospasm in patients aged 4 years and older.
( 1.1 ) Prevention of exercise-induced bronchospasm in patients aged 4 years and older.
(1.2) 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA is indicated for the prevention of exercise-induced bronchospasm in patients aged 4 years and older.
Adverse Reactions
6 ADVERSE REACTIONS Use of Albuterol Sulfate HFA may be associated with the following: Paradoxical bronchospasm [see Warnings and Precautions (5.1)] Cardiovascular effects [see Warnings and Precautions (5.4)] Immediate hypersensitivity reactions [see Warnings and Precautions (5.6)] Hypokalemia [see Warnings and Precautions (5.8)] Most common adverse reactions (incidence greater than or equal to 3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described below reflects exposure to albuterol sulfate HFA in 248 subjects treated with albuterol sulfate HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration.
The data from adults and adolescents is based upon 2 clinical trials in which 202 subjects with asthma aged 12 years and older were treated with albuterol sulfate HFA 2 inhalations 4 times daily for 12 weeks’ duration.
The adult/adolescent population was 92 female, 110 male and 163 white, 19 black, 18 Hispanic, 2 other.
The data from pediatric subjects are based upon 1 clinical trial in which 46 subjects with asthma aged 4 to 11 years were treated with albuterol sulfate HFA 2 inhalations 4 times daily for 2 weeks’ duration.
The population was 21 female, 25 male and 25 white, 17 black, 3 Hispanic, 1 other.
Adult and Adolescent Subjects Aged 12 Years and Older: The two 12-week, randomized, double-blind trials in 610 adult and adolescent subjects with asthma that compared albuterol sulfate HFA, a CFC 11/12-propelled albuterol inhaler, and an HFA-134a placebo inhaler.
Overall, the incidence and nature of the adverse reactions reported for albuterol sulfate HFA and a CFC 11/12-propelled albuterol inhaler were comparable.
Table 1 lists the incidence of all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of 3% or greater in the group treated with albuterol sulfate HFA and more frequently in the group treated with albuterol sulfate HFA than in the HFA-134a placebo inhaler group.
Table 1.
Adverse Reactions with Albuterol Sulfate HFA with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects Adverse Reaction Percent of Subjects Albuterol Sulfate HFA (n = 202) % CFC 11/12-Propelled Albuterol Inhaler (n = 207) % Placebo HFA-134a (n = 201) % Ear, nose, and throat Throat irritation 10 6 7 Upper respiratory inflammation 5 5 2 Lower respiratory Viral respiratory infections 7 4 4 Cough 5 2 2 Musculoskeletal Musculoskeletal pain 5 5 4 Adverse reactions reported by less than 3% of the adult and adolescent subjects receiving albuterol sulfate HFA and by a greater proportion of subjects receiving albuterol sulfate HFA than receiving HFA-134a placebo inhaler and that have the potential to be related to albuterol sulfate HFA include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles.
Palpitations and dizziness have also been observed with albuterol sulfate HFA.
Pediatric Subjects Aged 4 to 11 Years: Results from the 2-week clinical trial in pediatric subjects with asthma aged 4 to 11 years showed that this pediatric population had an adverse reaction profile similar to that of the adult and adolescent populations.
Three trials have been conducted to evaluate the safety and efficacy of albuterol sulfate HFA in subjects between birth and 4 years of age.
The results of these trials did not establish the efficacy of albuterol sulfate HFA in this age-group [see Use in Specific Populations (8.4)] .
Since the efficacy of albuterol sulfate HFA has not been demonstrated in children between birth and 48 months of age, the safety of albuterol sulfate HFA in this age-group cannot be established.
However, the safety profile observed in the pediatric population younger than 4 years was comparable to that observed in the older pediatric subjects and in adults and adolescents.
Where adverse reaction incidence rates were greater in subjects younger than 4 years compared with older subjects, the higher incidence rates were noted in all treatment arms, including placebo.
These adverse reactions included upper respiratory tract infection, nasopharyngitis, pyrexia, and tachycardia.
6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of albuterol sulfate.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to albuterol or a combination of these factors.
Cases of paradoxical bronchospasm, hoarseness, arrhythmias (including atrial fibrillation, supraventricular tachycardia), and hypersensitivity reactions (including urticaria, angioedema, rash) have been reported after the use of albuterol sulfate HFA.
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypokalemia, hypertension, peripheral vasodilatation, angina, tremor, central nervous system stimulation, hyperactivity, sleeplessness, headache, muscle cramps, drying or irritation of the oropharynx, and metabolic acidosis.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described below reflects exposure to albuterol sulfate HFA in 248 subjects treated with albuterol sulfate HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration.
The data from adults and adolescents is based upon 2 clinical trials in which 202 subjects with asthma aged 12 years and older were treated with albuterol sulfate HFA 2 inhalations 4 times daily for 12 weeks’ duration.
The adult/adolescent population was 92 female, 110 male and 163 white, 19 black, 18 Hispanic, 2 other.
The data from pediatric subjects are based upon 1 clinical trial in which 46 subjects with asthma aged 4 to 11 years were treated with albuterol sulfate HFA 2 inhalations 4 times daily for 2 weeks’ duration.
The population was 21 female, 25 male and 25 white, 17 black, 3 Hispanic, 1 other.
Adult and Adolescent Subjects Aged 12 Years and Older: The two 12-week, randomized, double-blind trials in 610 adult and adolescent subjects with asthma that compared albuterol sulfate HFA, a CFC 11/12-propelled albuterol inhaler, and an HFA-134a placebo inhaler.
Overall, the incidence and nature of the adverse reactions reported for albuterol sulfate HFA and a CFC 11/12-propelled albuterol inhaler were comparable.
Table 1 lists the incidence of all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of 3% or greater in the group treated with albuterol sulfate HFA and more frequently in the group treated with albuterol sulfate HFA than in the HFA-134a placebo inhaler group.
Table 1.
Adverse Reactions with Albuterol Sulfate HFA with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects Adverse Reaction Percent of Subjects Albuterol Sulfate HFA (n = 202) % CFC 11/12-Propelled Albuterol Inhaler (n = 207) % Placebo HFA-134a (n = 201) % Ear, nose, and throat Throat irritation 10 6 7 Upper respiratory inflammation 5 5 2 Lower respiratory Viral respiratory infections 7 4 4 Cough 5 2 2 Musculoskeletal Musculoskeletal pain 5 5 4 Adverse reactions reported by less than 3% of the adult and adolescent subjects receiving albuterol sulfate HFA and by a greater proportion of subjects receiving albuterol sulfate HFA than receiving HFA-134a placebo inhaler and that have the potential to be related to albuterol sulfate HFA include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles.
Palpitations and dizziness have also been observed with albuterol sulfate HFA.
Pediatric Subjects Aged 4 to 11 Years: Results from the 2-week clinical trial in pediatric subjects with asthma aged 4 to 11 years showed that this pediatric population had an adverse reaction profile similar to that of the adult and adolescent populations.
Three trials have been conducted to evaluate the safety and efficacy of albuterol sulfate HFA in subjects between birth and 4 years of age.
The results of these trials did not establish the efficacy of albuterol sulfate HFA in this age-group [see Use in Specific Populations (8.4)] .
Since the efficacy of albuterol sulfate HFA has not been demonstrated in children between birth and 48 months of age, the safety of albuterol sulfate HFA in this age-group cannot be established.
However, the safety profile observed in the pediatric population younger than 4 years was comparable to that observed in the older pediatric subjects and in adults and adolescents.
Where adverse reaction incidence rates were greater in subjects younger than 4 years compared with older subjects, the higher incidence rates were noted in all treatment arms, including placebo.
These adverse reactions included upper respiratory tract infection, nasopharyngitis, pyrexia, and tachycardia.
6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of albuterol sulfate.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to albuterol or a combination of these factors.
Cases of paradoxical bronchospasm, hoarseness, arrhythmias (including atrial fibrillation, supraventricular tachycardia), and hypersensitivity reactions (including urticaria, angioedema, rash) have been reported after the use of albuterol sulfate HFA.
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypokalemia, hypertension, peripheral vasodilatation, angina, tremor, central nervous system stimulation, hyperactivity, sleeplessness, headache, muscle cramps, drying or irritation of the oropharynx, and metabolic acidosis.