Levalbuterol Inhalation Solution 1.25 mg/3mL
Levalbuterol Inhalation Solution · SOLUTION · Sun Pharmaceutical Industries, Inc.
Levalbuterol Inhalation Solution is a solution containing levalbuterol inhalation solution at 1.25 mg/3mL, taken respiratory (inhalation). Manufactured by Sun Pharmaceutical Industries, Inc..
Key Facts
- Brand Name
- Levalbuterol Inhalation Solution
- Generic Name
- Levalbuterol Inhalation Solution
- NDC Code (Product)
47335-753- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 1.25 mg/3mL
- Dosage Form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA207820
- Marketing Start
- 12/01/2018
Recall History
Cipla Limited
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Levalbuterol inhalation solution 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 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 & Administration
2 DOSAGE AND ADMINISTRATION Levalbuterol inhalation solution 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 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 b…
Contraindications
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 )
Drug 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. ( 7.5 ) 7.1 Short-Acting Bronchodilators Avoid concomitant use of other short-acting sympathomimetic bronchodilators or epinephrine in patients being treated with levalbuterol inhalation solution. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. 7.2 Beta-blockers Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-adrenergic agonists such as levalbuterol inhalation solution, but may produc…
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 Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 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 in adults and adolescents is derived from one 4-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in …
Frequently Asked Questions
What is Levalbuterol Inhalation Solution used for?
Levalbuterol Inhalation Solution contains Levalbuterol Inhalation Solution. It is a solution taken respiratory (inhalation). Consult your doctor for specific uses.
Is Levalbuterol Inhalation Solution a controlled substance?
Levalbuterol Inhalation Solution is not classified as a controlled substance by the DEA.
What is the generic name for Levalbuterol Inhalation Solution?
The generic name for Levalbuterol Inhalation Solution is Levalbuterol Inhalation Solution. There are no other listed brand versions of Levalbuterol Inhalation Solution.
What is the NDC code for Levalbuterol Inhalation Solution 1.25 mg/3mL?
The NDC (National Drug Code) for Levalbuterol Inhalation Solution 1.25 mg/3mL is 47335-753, listed by Sun Pharmaceutical Industries, Inc..
Other Levalbuterol Inhalation Solution Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)