Levalbuterol

Levalbuterol inhalation solution (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. Levalbuterol inhalation solution (concentrate) is a beta 2 -adrenergic agonist indicated for: • Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. ( 1 )

• Levalbuterol inhalation solution (concentrate) is for oral inhalation only
• Dilute with sterile normal saline before administration
• Administer by nebulization using with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor
• Do not exceed recommended dose
• For dosages less than 1.25 mg, the non-concentrate (i.e., levalbuterol inhalation solution, 3 mL) formulation must be used
• Children 6 to 11 Years Old: The recommended dosage of levalbuterol inhalation solution for patients 6 to 11 years old is 0.31 mg administered three times a day, by nebulization
• Routine dosing should not exceed 0.63 mg three times a day
• Adults and Adolescents ≥ 12 Years Old: The recommended starting dosage of levalbuterol inhalation solution for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization
• Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of levalbuterol inhalation solution may benefit from a dosage of 1.25 mg three times a day
• Patients receiving the highest dose of levalbuterol inhalation solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy
• The use of levalbuterol inhalation solution can be continued as medically indicated to help control recurring bouts of bronchospasm
• During this time, most patients gain optimal benefit from regular use of the inhalation solution. …

Levalbuterol Inhalation Solution, USP (Concentrate) 0.5 mL unit-dose vials containing 1.25 mg of levalbuterol that must be diluted before use. Levalbuterol inhalation solution (concentrate) is available in cartons of 30 individually pouched vials. Inhalation Solution Concentrate (unit-dose vial for nebulization): 1.25 mg/0.5 mL. Dilute before use. ( 3 )

• Pediatric Patients 6 Years of Age and Older The safety and efficacy of levalbuterol inhalation solution have been established
• In pediatric patients 6 years of age and older in an adequate and well-controlled clinical trial [see Adverse Reactions and Clinical Studies ]
• Pediatric Patients Less Than 6 Years of Age Levalbuterol inhalation solution is not indicated for pediatric patients less than 6 years of age. …

Clinical studies of levalbuterol inhalation solution did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Only 5 patients 65 years of age and older were treated with levalbuterol inhalation solution in a 4-week clinical study [see Clinical Pharmacology (12) and Clinical Studies (14) ] (n = 2 for 0.63 mg and n = 3 for 1.25 mg). …

• See FDA-approved patient labeling (Patient Information and Instructions for Using Levalbuterol Inhalation Solution (Concentrate))
• Patients should be given the following information: Hypersensitivity: Query patients about previously experienced hypersensitivity to levalbuterol or racemic albuterol and counsel patients to report any hypersensitivity reactions to their physician
• Frequency of Use: Inform patients not to increase the dose or use levalbuterol inhalation solution more frequently than recommended without consulting their physician. …

• Levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol
• Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see Warnings and Precautions ] . • Hypersensitivity to levalbuterol or racemic albuterol

• Other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs: May potentiate effect. ( 7.1 ) • Beta-blockers: May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. ( 7.2 ) • Diuretic: May worsen electrocardiographic changes or hypokalemia associated with diuretic may worsen. Consider monitoring potassium levels. ( 7.3 ) • Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. ( 7.4 ) • Monoamine oxidase inhibitors (MAOs) or tricyclic antidepressants: May potentiate effect of albuterol on the cardiovascular system. …

• Life-threatening paradoxical bronchospasm may occur. Discontinue levalbuterol inhalation solution immediately and treat with alternative therapy. ( 5.1 ) • Need for more doses of levalbuterol inhalation solution than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ( 5.2 ) • Levalbuterol inhalation solution is not a substitute for corticosteroids. ( 5.3 ) • Cardiovascular effects may occur. Consider discontinuation of levalbuterol inhalation solution 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. …

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. …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol inhalation solution during pregnancy. To enroll in MotherToBaby Pregnancy Studies’ Asthma & Pregnancy Study or for more information about the registry, call 1-877- 311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. …

The expected symptoms with overdosage are those of excessive beta-adrenergic receptor stimulation and/or occurrence or exaggeration of any of the symptoms listed under Adverse Reactions (6) , e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min., arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia also may occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with the abuse of levalbuterol inhalation solution. …

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