ALBUTEROL SULFATE solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Preferred Pharmaceuticals, Inc

INN (nume internaţional):

ALBUTEROL SULFATE

Compoziție:

ALBUTEROL 2.5 mg in 3 mL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
PREFERRED PHARMACEUTICALS, INC
----------
ALBUTEROL SULFATE INHALATION SOLUTION, 0.083%
2.5 MG*/3 ML
*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 576.7, and the molecular
formula is (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’s recommended name
for albuterol base is
salbutamol. Albuterol sulfate inhalation solution 0.083% requires no
dilution before administration.
Each mL 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. Albuterol sulfate inhalation solution is a clear,
colorless 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, data indicate that
10% to 50% of the beta-receptors
i