Drug Catalog - Product Detail
LEVALBUTEROL HCL INHALATION SOLUTION SOL 1.25MG/3ML 24X3ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-9682-44 | MYLAN | 3 | 1.25MG/3ML | NEBULIZER SOLUTION |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
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 hydrochloride is a relatively selective beta 2 -adrenergic receptor agonist [see Clinical Pharmacology (12) ] . The chemical name for levalbuterol hydrochloride is (R)-α 1 -[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows: The molecular weight of levalbuterol hydrochloride is 275.8, and its molecular formula is C 13 H 21 NO 3 •HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol hydrochloride is the USAN modified name for (R)-albuterol hydrochloride in the United States. Levalbuterol inhalation solution is supplied in sterile unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol hydrochloride) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol hydrochloride) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol hydrochloride), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5). Levalbuterol Structural Formula
How Supplied
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). Each strength of levalbuterol inhalation solution is available in a shelf-carton containing two foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol Inhalation Solution USP, 0.31 mg ( foil pouch label color green ) contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol hydrochloride) and is available in cartons of 24 unit-dose LDPE vials (NDC 0378-9680-44). Levalbuterol Inhalation Solution USP, 0.63 mg ( foil pouch label color yellow ) contains 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol hydrochloride) and is available in cartons of 24 unit-dose LDPE vials (NDC 0378-9681-44). Levalbuterol Inhalation Solution USP, 1.25 mg ( foil pouch label color red ) contains 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol hydrochloride) and is available in cartons of 24 unit-dose LDPE vials (NDC 0378-9682-44). Store levalbuterol inhalation solution in the protective foil pouch at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within one week. Discard any vial if the solution is not colorless.
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 and 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 3 times a day, by nebulization. Routine dosing should not exceed 0.63 mg 3 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 3 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 3 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. If a previously effective dosage regimen fails to provide the usual response this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. The drug compatibility (physical and chemical), efficacy, and safety of levalbuterol inhalation solution when mixed with other drugs in a nebulizer have not been established. The safety and efficacy of levalbuterol inhalation solution have been established in clinical trials when administered using the PARI LC Jet™ and PARI LC Plus™ nebulizers, and the PARI Master ® Dura-Neb ® 2000 and Dura-Neb ® 3000 compressors. The safety and efficacy of levalbuterol inhalation solution when administered using other nebulizer systems have not been established. • FOR ORAL INHALATION ONLY ( 2 ) • Children 6 to 11 Years Old: 0.31 mg administered 3 times a day, by nebulization. Routine dosing should not exceed 0.63 mg 3 times a day. ( 2 ) • Adults and Adolescents ≥ 12 Years Old: 0.63 mg administered 3 times a day, every 6 to 8 hours, by nebulization. The maximum recommended dose is 1.25 mg 3 times a day. ( 2 ) • For use with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. ( 2 )