ALBUTEROL SULFATE syrup

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:

Teva Pharmaceuticals USA Inc

INN (nume internaţional):

ALBUTEROL SULFATE

Compoziție:

ALBUTEROL 2 mg in 5 mL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ALBUTEROL SULFATE- ALBUTEROL SULFATE SYRUP
TEVA PHARMACEUTICALS USA INC
----------
ALBUTEROL SULFATE SYRUP
0661
RX ONLY
DESCRIPTION
Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic
form of albuterol and a relatively
selective beta -adrenergic bronchodilator. Albuterol sulfate has the
chemical name α -[(_tert_-
butylamino)methyl]-4-hydroxy-_m_-xylene-α,α'-diol sulfate (2:1)
(salt) and the following chemical
structure:
(C
H NO ) •H SO M.W. 576.7
Albuterol sulfate is a white or practically white powder freely
soluble in water and slightly soluble in
alcohol, in chloroform, and in ether per USP definition.
The World Health Organization recommended name for albuterol base is
salbutamol.
Albuterol Sulfate Syrup for oral administration contains 2 mg of
albuterol as 2.4 mg of albuterol sulfate
in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the
inactive ingredients Citric Acid,
FD&C Yellow No. 6, Hypromellose, Purified Water, Sodium Benzoate,
Sodium Citrate, Sorbitol
Solution, and Strawberry Flavor. The pH of the syrup is 3.3 to 4.0.
CLINICAL PHARMACOLOGY
_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 there
is a population of beta -receptors in the human heart existing in a
concentration between 10% and 50%.
The precise function of these receptors has not been established (see
WARNINGS).
The pharmacologic effects of beta-adrenergic agonist drugs, including
albuterol, are at least in part
attributable to stimulation through beta-adrenergic receptors of
intracellular adenyl cyclase, the enzyme
that catalyzes the conversion of adenosine triphosphate (ATP) to
cyclic-3', 5'-adenosine monophosphate
(cyclic AMP). Increased cyclic AMP levels are associated with
relaxation of bronchial smooth muscle
and inhibition of release of media