ALBUTEROL SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Unit Dose Services

INN (International Name):

ALBUTEROL SULFATE

Composition:

ALBUTEROL 2.5 mg in 3 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
UNIT DOSE SERVICES
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ALBUTEROL SULFATE INHALATION SOLUTION
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.
DESCRIPTION:
Albuterol sulfate inhalation solution is a relatively selective beta
-adrenergic bronchodilator
(see CLINICAL PHARMACOLOGY section below).
Albuterol sulfate, the racemic form of albuterol, has the chemical
name α -[(_tert_-Butylamino)methyl]-4-
hydroxy-_m_-xylene-α,α'-diol sulfate (2:1) (salt), and the following
structural formula:
Albuterol sulfate has a molecular weight of 576.70 and the molecular
formula (C
H NO ) • H SO .
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.
CLINICAL PHARMACOLOGY:
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 beta -adrenergic
receptors compared with isoproterenol. While it is recognized that
beta -adrenergic receptors are the
predominant receptors in bronchial smooth muscle, 10% to 5
                                
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