ALBUTEROL SULFATE ER tablet extended release

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:

DAVA Pharmaceuticals, Inc.

INN (nume internaţional):

ALBUTEROL SULFATE

Compoziție:

ALBUTEROL 4 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ALBUTEROL SULFATE ER- ALBUTEROL SULFATE TABLET, EXTENDED RELEASE
DAVA PHARMACEUTICALS, INC.
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ALBUTEROL SULFATE
EXTENDED-RELEASE TABLETS
DESCRIPTION:
Albuterol extended-release tablets contain albuterol sulfate, the
racemic form of albuterol and a
relatively selective beta -adrenergic bronchodilator, in an
extended-release formulation. Albuterol
sulfate 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 crystalline powder, soluble in water and
slightly soluble in ethanol.
The World Health Organization recommended name for albuterol base is
salbutamol.
Each tablet for oral administration contains 4 mg or 8 mg of albuterol
as 4.8 mg or 9.6 mg, respectively,
of albuterol sulfate in a cellulosic material that serves as a
diffusion-release membrane. In addition each
tablet contains the following inactive ingredients: Calcium sulfate,
carnauba wax, ethylcellulose, ferric
oxide black, hypromellose, ink-thinner XI, lactose monohydrate,
magnesium stearate, polyethylene
glycol, propylene glycol, shellac, stearic acid, titanium dioxide,
triacetin, D&C Yellow #10, (4 mg
only) and FD&C Blue #1 (4 mg only).
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 indicates 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 on
intrace