Albuterol aer hfa dosage full#
Albuterol aer hfa dosage trial#

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% in the group treated with VENTOLIN HFA and more frequently in the group treated with VENTOLIN HFA than in the HFA-134a placebo inhaler group. Overall, the incidence and nature of the adverse reactions reported for VENTOLIN HFA and a CFC 11/12-propelled albuterol inhaler were comparable.

The two 12-week, randomized, double-blind trials in 610 adult and adolescent subjects with asthma that compared VENTOLIN HFA, a CFC 11/12-propelled albuterol inhaler, and an HFA-134a placebo inhaler. The population was 21 female, 25 male and 25 white, 17 black, 3 Hispanic, 1 other.Īdult and Adolescent Subjects Aged 12 Years and Older

Albuterol aer hfa dosage trial#

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 VENTOLIN HFA 2 inhalations 4 times daily for 2 weeks’ duration. The adult/adolescent population was 92 female, 110 male and 163 white, 19 black, 18 Hispanic, 2 other. 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 VENTOLIN HFA 2 inhalations 4 times daily for 12 weeks’ duration.

The safety data described below reflects exposure to VENTOLIN HFA in 248 subjects treated with VENTOLIN HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration.

Albuterol aer hfa dosage full#

FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 1.1 Bronchospasm 1.2 Exercise-Induced Bronchospasm 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage for Bronchospasm (Acute Episodes or Symptoms Associated with Bronchospasm) 2.2 Recommended Dosage for Prevention of Exercise-Induced Bronchospasm 2.3 Administration Information 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Paradoxical Bronchospasm 5.2 Deterioration of Asthma 5.3 Use of Anti-inflammatory Agents 5.4 Cardiovascular Effects 5.5 Do Not Exceed Recommended Dose 5.6 Hypersensitivity Reactions, including Anaphylaxis 5.7 Coexisting Conditions 5.8 Hypokalemia 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Beta-Adrenergic Receptor Blocking Agents 7.2 Non–Potassium-Sparing Diuretics 7.3 Digoxin 7.4 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Bronchospasm Associated with Asthma 14.2 Exercise-Induced Bronchospasm 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.īecause 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.