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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Life-threatening paradoxical bronchospasm may occur. Discontinue Levalbuterol Inhalation Solution, USP immediately and treat with alternative therapy. ( 5.1 ) • Need for more doses of Levalbuterol Inhalation Solution, USP than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ( 5.2 ) • Levalbuterol Inhalation Solution, USP is not a substitute for corticosteroids. ( 5.3 ) • Cardiovascular effects may occur. Consider discontinuation of Levalbuterol Inhalation Solution, USP if these effects occur. Use with caution in patients with underlying cardiovascular disorders. ( 5.4 ) • Excessive use may be fatal. Do not exceed recommended dose. ( 5.5 ) • Immediate hypersensitivity reactions may occur. Discontinue Levalbuterol Inhalation Solution, USP immediately. ( 5.6 ) • Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 ) 5.1 Paradoxical Bronchospasm Levalbuterol Inhalation Solution, USP can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, Levalbuterol Inhalation Solution, USP should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new vial. 5.2 Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Levalbuterol Inhalation Solution, USP than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. 5.3 Use of Anti-Inflammatory Agents Levalbuterol Inhalation Solution, USP is not a substitute for corticosteroids. The use of beta-adrenergic agonist alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen. 5.4 Cardiovascular Effects Levalbuterol Inhalation Solution, USP, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and symptoms. Although such effects are uncommon after administration of L...
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adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • 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 are: palpitations, chest pain, tachycardia, headache, dizziness, tremor and nervousness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 the 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 Levalbuterol Inhalation Solution, USP in adults and adolescents is derived from one 4-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in 362 patients with asthma 12 years of age and older. Adverse reactions reported in ≥ 2% of patients receiving Levalbuterol Inhalation Solution, USP or racemic albuterol and more frequently than in patients receiving placebo are listed in Table 1. Table 1: Adverse Reactions Reported in a 4-Week, Controlled Clinical Trial in Adults and Adolescents ≥ 12 Years Old Percent of Patients One treatment group, racemic albuterol 1.25 mg, with 68 subjects is omitted. Body System Preferred Term Placebo (n =75) Levalbuterol Inhalation Solution, USP 1.25 mg (n = 73) Levalbuterol Inhalation Solution, USP 0.63 mg (n = 72) Racemic albuterol 2.5 mg (n = 74) Body as a Whole Allergic reaction 1.3 0 0 2.7 Flu syndrome 0 1.4 4.2 2.7 Accidental injury 0 2.7 0 0 Pain 1.3 1.4 2.8 2.7 Back pain 0 0 0 2.7 Cardiovascular System Tachycardia 0 2.7 2.8 2.7 Migraine 0 2.7 0 0 Digestive System Dyspepsia 1.3 2.7 1.4 1.4 Musculoskeletal System Leg cramps 1.3 2.7 0 1.4 Central Nervous System Dizziness 1.3 2.7 1.4 0 Hypertonia 0 0 0 2.7 Nervousness 0 9.6 2.8 8.1 Tremor 0 6.8 0 2.7 Anxiety 0 2.7 0 0 Respiratory System Cough increased 2.7 4.1 1.4 2.7 Infection viral 9.3 12.3 6.9 12.2 Rhinitis 2.7 2.7 11.1 6.8 Sinusitis 2.7 1.4...
adverse reactions table
Table 1: Adverse Reactions Reported in a 4-Week, Controlled Clinical Trial in Adults and Adolescents ≥ 12 Years Old Percent of PatientsOne treatment group, racemic albuterol 1.25 mg, with 68 subjects is omitted. Body System Preferred Term Placebo (n =75) Levalbuterol Inhalation Solution, USP 1.25 mg (n = 73) Levalbuterol Inhalation Solution, USP 0.63 mg (n = 72) Racemic albuterol 2.5 mg (n = 74) Body as a Whole Allergic reaction 1.3 0 0 2.7 Flu syndrome 0 1.4 4.2 2.7 Accidental injury 0 2.7 0 0 Pain 1.3 1.4 2.8 2.7 Back pain 0 0 0 2.7 Cardiovascular System Tachycardia 0 2.7 2.8 2.7 Migraine 0 2.7 0 0 Digestive System Dyspepsia 1.3 2.7 1.4 1.4 Musculoskeletal System Leg cramps 1.3 2.7 0 1.4 Central Nervous System Dizziness 1.3 2.7 1.4 0 Hypertonia 0 0 0 2.7 Nervousness 0 9.6 2.8 8.1 Tremor 0 6.8 0 2.7 Anxiety 0 2.7 0 0 Respiratory System Cough increased 2.7 4.1 1.4 2.7 Infection viral 9.3 12.3 6.9 12.2 Rhinitis 2.7 2.7 11.1 6.8 Sinusitis 2.7 1.4 4.2 2.7 Turbinate edema 0 1.4 2.8 0