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:

Ritedose Pharmaceuticals, LLC

INN (International Name):

Levalbuterol Hydrochloride

Composition:

Levalbuterol 0.63 mg in 3 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Levalbuterol HCl Inhalation Solution is contraindicated in patients with a history of hypersensitivity to levalbuterol HCl or racemic albuterol. Levalbuterol HCl Inhalation Solution 0.63 mg2, 1.25 mg2 3 mL Unit-Dose Vials Read complete instructions carefully before using.           Figure 1           Figure 2           Figure 3           Figure 4 Note: Levalbuterol HCl Inhalation Solution should be used in a nebulizer only under the direction of a physician. More frequent administration or higher doses are not recommended without first discussing with your doctor. This solution should not be injected or administered orally. Protect from light and excessive heat. Store in the protective foil pouch at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep unopened vials in the foil pouch. Once the foi

Product summary:

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 two different strengths of levalbuterol (0.63 mg, 1.25 mg). Each strength of Levalbuterol HCl Inhalation Solution is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution, 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 76204-002-24). 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 76204-003-24). 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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

LEVALBUTEROL HYDROCHLORIDE- LEVALBUTEROL HYDROCHLORIDE SOLUTION
RITEDOSE PHARMACEUTICALS, LLC
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LEVALBUTEROL HCL INHALATION SOLUTION 0.63 MG , 1.25 MG
1
PRESCRIBING INFORMATION
DESCRIPTION
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 beta2-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 is supplied in unit-dose vials
and requires no dilution before
administration by nebulization. Each 3 mL unit-dose vial contains 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. Levalbuterol acts as a functional antagonist to
relax the airway irrespective of the
spasmogen involved, thus protectin