ALBUTEROL SULFATE solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)

Beszerezhető a:

Direct_Rx

Az alkalmazás módja:

INTRABRONCHIAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm. Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components.

Termék összefoglaló:

Unit-dose plastic vial containing Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3 mL* (*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate). Equivalent to 0.5 mL albuterol (as the sulfate) 0.5% (2.5 mg albuterol) diluted to 3 mL. Supplied in cartons as listed below. carton of 25 vials. carton of 30 vials. carton of 60 vials.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
DIRECT_RX
----------
ALBUTEROL SULFATE
Albuterol Sulfate Inhalation Solution 0.083%*
(*Potency expressed as albuterol, equivalent to 3 mg albuterol
sulfate)
PRESCRIBING INFORMATION
FOR INHALATION USE ONLY-NOT FOR INJECTION.
Albuterol sulfate inhalation solution is a relatively selective
beta2-adrenergic bronchodilator (see
CLINICAL PHARMACOLOGY section below).
Albuterol sulfate, the racemic form of albuterol, has the chemical
name α1-[(tert-Butylamino)methyl]-4-
hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following
structural formula:
[Albuterol Sulfate Structural Formula]
Albuterol sulfate has a molecular weight of 576.70 and the molecular
formula (C13H21NO3)2 •
H2SO4. Albuterol sulfate is a white or practically white powder,
freely soluble in water and slightly
soluble in alcohol.
The World Health Organization recommended name for albuterol base is
salbutamol.
Albuterol sulfate inhalation solution 0.083% requires no dilution
before administration.
Each milliliter of Albuterol Sulfate Inhalation Solution 0.083%
contains 0.83 mg of albuterol (as 1 mg
of albuterol sulfate) in an isotonic, sterile, aqueous solution
containing sodium chloride; sulfuric acid is
used to adjust the pH to between 3 and 5. Albuterol Sulfate Inhalation
Solution 0.083% contains no
sulfiting agents or preservatives.
Albuterol sulfate inhalation solution is a clear, colorless to light
yellow solution.
The prime action of beta-adrenergic drugs is to stimulate adenyl
cyclase, the enzyme which catalyzes
the formation of cyclic-3’,5’-adenosine monophosphate (cyclic AMP)
from adenosine triphosphate
(ATP). The cyclic AMP thus formed mediates the cellular responses. In
vitro studies and in vivo
pharmacologic studies have demonstrated that albuterol has a
preferential effect on beta2-adrenergic
receptors compared with isoproterenol. While it is recognized that
beta2-adrenergic receptors are the
predominant receptors in bronchial smooth muscle, 10% to 50% of the
beta-receptors in the