XOPENEX- levalbuterol hydrochloride solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

levalbuterol hydrochloride (UNII: WDQ1526QJM) (levalbuterol - UNII:EDN2NBH5SS)

Disponibil de la:

Rebel Distributors Corp

INN (nume internaţional):

levalbuterol hydrochloride

Compoziție:

levalbuterol hydrochloride 1.25 mg in 3 mL

Calea de administrare:

RESPIRATORY (INHALATION)

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

Xopenex (levalbuterol HCl) Inhalation Solution 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 Xopenex Inhalation Solution is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Xopenex (levalbuterol HCl) Inhalation Solution, 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 21695-153-24). Store Xopenex (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. SEPRACOR Manufactured for: Sepracor Inc. Marlborough, MA 01752 USA For customer service, call 1-888-394-7377. To report adverse events, call 1-877-737-7226. For medical information, call 1-800-739-0565. February 2009 400437R07 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

XOPENEX- LEVALBUTEROL HYDROCHLORIDE SOLUTION
REBEL DISTRIBUTORS CORP
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XOPENEX (LEVALBUTEROL HCL) INHALATION SOLUTION
0.31 MG*, 0.63 MG*, 1.25 MG*
*POTENCY EXPRESSED AS LEVALBUTEROL
PRESCRIBING INFORMATION
DESCRIPTION:
Xopenex (levalbuterol HCl) Inhalation Solution 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.
Xopenex (levalbuterol HCl) Inhalation Solution 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 4.0 (3.3 to 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
terminal bronchioles. Levalb