XOPENEX- levalbuterol hydrochloride solution, concentrate XOPENEX- levalbuterol hydrochloride solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Physicians Total Care, Inc.

INN (Kansainvälinen yleisnimi):

LEVALBUTEROL HYDROCHLORIDE

Koostumus:

LEVALBUTEROL HYDROCHLORIDE 1.25 mg in 0.5 mL

Antoreitti:

RESPIRATORY (INHALATION)

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT --------------------------------------------------------------------------------------------------------------- Xopenex ® (levalbuterol HCl) Inhalation Solution Concentrate; 1.25 mg*; 0.5 mL Unit-Dose Vials *Potency expressed as levalbuterol Read complete instructions carefully before using. Open the foil pouch by tearing on the serrated edge along the seam of the pouch. Remove one unit-dose vial for immediate use. Keep the rest of the unused unit-dose vials in the foil pouch to protect them from light. 2. Carefully twist open the top of the unit-dose vial (Figure 1 ) and sque

Tuoteyhteenveto:

Xopenex (levalbuterol HCl) Inhalation Solution Concentrate (foil pouch label color red) is supplied in 0.5 mL unit-dose, low-density polyethylene (LDPE) vials, and is a clear, colorless, sterile, preservative-free, aqueous solution. Each vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl) and is available in cartons of 30 (NDC 54868-6021-0 ) individually pouched vials. Xopenex (levalbuterol HCl) Inhalation Solution is also available in 3 mL vials in three different strengths of levalbuterol: 0.63 mg (NDC 54868-4409-0 ), and 1.25 mg (NDC 54868-5459-0 ).

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

XOPENEX - LEVALBUTEROL HYDROCHLORIDE SOLUTION, CONCENTRATE
XOPENEX - LEVALBUTEROL HYDROCHLORIDE SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
*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 Concentrate supplied in
0.5 mL unit-dose vials should
be diluted with sterile normal saline before administration by
nebulization. Each 0.5 mL unit-dose vial
contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl),
sodium chloride to adjust tonicity,
and hydrochloric 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. Levalbuterol acts as a functional antagonist to
relax the airway irrespective of the
spasmogen