Levalbuterolside effects

Use of XOPENEX HFA may be associated with the following: Paradoxical bronchospasm Cardiovascular effects Immediate hypersensitivity reactions Hypokalemia Most common adverse reactions (≥ 2% and > placebo) are accidental injury, bronchitis, dizziness, pain, pharyngitis, rhinitis, and vomiting. To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 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. Adults and Adolescents 12 Years of Age and Older Adverse reaction information concerning XOPENEX HFA in adults and adolescents is derived from two 8-week, multicenter, randomized, double-blind, active- and placebo-controlled trials in 748 adult and adolescent patients with asthma that compared XOPENEX HFA, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler. 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 2% or greater in the group treated with XOPENEX HFA and more frequently than in the HFA-134a placebo inhaler group.

Table 1: Adverse Reaction Incidence (% of Patients) in Two 8-Week Clinical Trials in Adults and Adolescents ≥ 12 Years of Age* * This table includes all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of 2% or greater in the group treated with XOPENEX HFA and more frequently than in the HFA-134a placebo inhaler group. Body System Preferred Term XOPENEX HFA 90 mcg (n=403) Racemic Albuterol HFA 180 mcg (n=179) Placebo (n=166) Respiratory System Asthma 9% 7% 6% Pharyngitis 8% 2% 2% Rhinitis 7% 2% 3% Body as a Whole Pain 4% 3% 4% Central Nervous System Dizziness 3% 1% 2% Adverse reactions reported by less than 2% and at least 2 or more of the adolescent and adult patients receiving XOPENEX HFA and by a greater proportion than receiving HFA-134a placebo inhaler include cyst, flu syndrome, viral infection, constipation, gastroenteritis, myalgia, hypertension, epistaxis, lung disorder, acne, herpes simplex, conjunctivitis, ear pain, dysmenorrhea, hematuria, and vaginal moniliasis. There were no significant laboratory abnormalities observed in these studies. Pediatric Patients 4 to 11 Years of Age Adverse reaction information concerning XOPENEX HFA in children is derived from a 4-week, randomized, double-blind trial of XOPENEX HFA, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler in 150 children aged 4 to 11 years with asthma. Table 2 lists the adverse reactions reported for XOPENEX HFA in children at a rate of 2% or greater and more frequently than for placebo.

Table 2: Adverse Reaction Incidence (% of Patients) in a 4-Week Clinical Trial in Children 4-11 Years of Age* * This table includes all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from the trial that occurred at a rate of 2% or greater in the group treated with XOPENEX HFA and more frequently than in the HFA-134a placebo inhaler group. Body System Preferred Term XOPENEX HFA 90 mcg (n=76) Racemic Albuterol HFA 180 mcg (n=39) Placebo (n=35) Digestive System Vomiting 11% 8% 6% Body as a Whole Accidental injury 9% 10% 6% Respiratory System Pharyngitis 7% 13% 6% Bronchitis 3% 0% 0% The incidence of systemic beta-adrenergic adverse reactions (e.g., tremor, nervousness) was low and comparable across all treatment groups, including placebo.

6.2 Post-marketing

Experience In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been observed in post-approval use of levalbuterol inhalation solution. 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 their seriousness, their frequency of reporting, or their likely beta-mediated mechanism: angioedema, anaphylaxis, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), asthma, chest pain, cough increased, dysphonia, dyspnea, gastrooesophageal reflux disease (GERD), metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, urticaria. In addition, XOPENEX HFA, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of the oropharynx.