ALBUTEROL- albuterol sulfate tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

PD-Rx Pharmaceuticals, Inc.

INN (Algemene Internationale Benaming):

ALBUTEROL SULFATE

Samenstelling:

ALBUTEROL 4 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease. Albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of its components.

Product samenvatting:

Albuterol Tablets, USP are available containing albuterol sulfate, USP 4.8 mg equivalent to albuterol 4 mg. The 4 mg tablets are white, uncoated, round, flat-faced, scored tablets debossed with M above the score and 572 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 55289-045-30 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ALBUTEROL- ALBUTEROL SULFATE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
DESCRIPTION
Albuterol tablets contain albuterol sulfate 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,αʹ-diol
sulfate (2:1) (salt) and the
following structural formula:
Albuterol sulfate has a molecular weight of 576.71, and the molecular
formula is (C
H
NO
)
•H
SO
. Albuterol sulfate, USP is a white or practically white powder,
freely
soluble in water and slightly soluble in ethanol.
The World Health Organization recommended name for albuterol base is
salbutamol.
Each albuterol tablet for oral administration contains 2 or 4 mg of
albuterol as 2.4 or 4.8
mg of albuterol sulfate, respectively. Each tablet also contains the
following inactive
ingredients: lactose monohydrate, magnesium stearate, pregelatinized
starch (corn) and
sodium lauryl sulfate.
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 tablets,
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 mediators of immediate hypersensitivity from
cells, especially from
mast cells.
Albuterol tablets have