LEVALBUTEROL HYDROCHLORIDE- levalbuterol hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVALBUTEROL HYDROCHLORIDE (UNII: WDQ1526QJM) (LEVALBUTEROL - UNII:EDN2NBH5SS)

Available from:

REMEDYREPACK INC.

INN (International Name):

LEVALBUTEROL HYDROCHLORIDE

Composition:

LEVALBUTEROL 1.25 mg in 3 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levalbuterol HCl 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 HCl Inhalation Solution is contraindicated in patients with a history of hypersensitivity to levalbuterol HCl or racemic albuterol.

Product summary:

Levalbuterol HCl 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 HCl Inhalation Solution, USP is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution, USP 0.31 mg (foil pouch label color green ) contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 0591-2736-23). Levalbuterol HCl Inhalation Solution , USP 0.63 mg (foil pouch label color yellow ) contains 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 0591-2737-23). Levalbuterol HCl Inhalation Solution , USP 1.25 mg (foil pouch label color red) contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 0591-2738-23). Store Levalbuterol HCl Inhalation Solution in the protective foil pouch at 20-25°C (68-77°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 1 week. Discard any vial if the solution is not colorless. Distributed by:  Actavis Pharma Inc., Parsippany, NJ 07054                                                        Revised: October 2013                                                                                                                                                                   ACTX024-642R00 To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov.medwatch.                                                221394

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVALBUTEROL HYDROCHLORIDE- LEVALBUTEROL HYDROCHLORIDE SOLUTION
REMEDYREPACK INC.
----------
LEVALBUTEROL HCL
INHALATION SOLUTION, USP
0.31 MG*, 0.63 MG*, 1.25 MG*
*POTENCY EXPRESSED AS LEVALBUTEROL
ACTX024-642R00 221394
PRESCRIBING INFORMATION
DESCRIPTION:
Levalbuterol HCl 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
-adrenergic receptor agonist (see CLINICAL
PHARMACOLOGY). The chemical name for levalbuterol HCl is (R)-α
-[[(1,1-
dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol
hydrochloride, and its established
chemical structure is as follows:
The molecular weight of levalbuterol HCl is 275.8, and its empirical
formula is C
H
NO
•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 HCl is the USAN modified name for (R)-albuterol HCl in
the United States.
Levalbuterol HCl Inhalation Solution, USP is supplied in unit-dose
vials and requires no dilution before
administration by nebulization. Each 3 mL unit-dose vial contains 0.31
mg of levalbuterol (as 0.36 mg of
levalbuterol HCl) or 0.63 mg of levalbuterol (as 0.73 mg of
levalbuterol HCl) or 1.25 mg of
levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to
adjust tonicity, and sulfuric acid to
adjust the pH to between 3.3 and 4.5.
CLINICAL PHARMACOLOGY:
Activation of beta
-adrenergic receptors on airway smooth muscle leads to the activation
of
adenylcyclase and to an increase in the intracellular concentration of
cyclic-3´, 5´-adenosine
monophosphate (cyclic AMP). This increase in cyclic AMP leads to the
activation of protein kinase A,
which inhibits the phosphorylation of myosin and lowers intracellular
ionic calcium concentrations,
resulting in relaxation. Levalbuterol relaxes the smooth muscles of
all airways, from the trachea to the
termi