Levalbuterol Inhalation 0.63mg/3ml
Generic Name: levalbuterol inhalation 0.63mg/3ml
Brand Names:
Levalbuterol Inhalation
11 DESCRIPTION Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2 -adrenergic receptor agonist [see Clinical Pharmacology ( 12 )].
Overview
11 DESCRIPTION Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2 -adrenergic receptor agonist [see Clinical Pharmacology ( 12 )].
Uses
1 INDICATIONS AND USAGE Levalbuterol Inhalation Solution, USP 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, USP 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 )
Dosage
2 DOSAGE AND ADMINISTRATION Levalbuterol Inhalation Solution, USP is for oral inhalation only. 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. Children 6-11 years old: The recommended dosage of Levalbuterol Inhalation Solution, USP for patients 6-11 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, USP for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.
Side Effects
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 Cipla Ltd., India at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Interactions
7 DRUG INTERACTIONS 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.
Warnings
5 WARNINGS AND PRECAUTIONS 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. ( 5.5 ) Immediate hypersensitivity reactions may occur. Discontinue Levalbuterol Inhalation Solution immediately. 4 CONTRAINDICATIONS 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 ( 5.6 ) ]. Hypersensitivity to levalbuterol or racemic albuterol. ( 4 )
Pregnancy
8.1 Pregnancy Teratogenic Effects: Pregnancy Category C . There are no adequate and well-controlled studies of Levalbuterol Inhalation Solution in pregnant women. Because animal reproduction studies are not always predictive of human response, Levalbuterol Inhalation Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Levalbuterol Inhalation Solution, USP is supplied in 3 mL unit-dose, low-density polyethylene (LDPE) vials as a clear, colorless, sterile, preservative-free, aqueous solution, in three different strengths of levalbuterol (0.31 mg,0.63 mg, 1.25 mg).
Frequently Asked Questions
What is Levalbuterol Inhalation 0.63mg/3ml used for?▼
1 INDICATIONS AND USAGE Levalbuterol Inhalation Solution, USP 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, USP 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 )
What are the side effects of Levalbuterol Inhalation 0.63mg/3ml?▼
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 Cipla Ltd., India at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Levalbuterol Inhalation 0.63mg/3ml during pregnancy?▼
8.1 Pregnancy Teratogenic Effects: Pregnancy Category C . There are no adequate and well-controlled studies of Levalbuterol Inhalation Solution in pregnant women. Because animal reproduction studies are not always predictive of human response, Levalbuterol Inhalation Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
What are the important warnings for Levalbuterol Inhalation 0.63mg/3ml?▼
5 WARNINGS AND PRECAUTIONS 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. ( 5.5 ) Immediate hypersensitivity reactions may occur. Discontinue Levalbuterol Inhalation Solution immediately. 4 CONTRAINDICATIONS 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 ( 5.6 ) ]. Hypersensitivity to levalbuterol or racemic albuterol. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.