ALBUTEROL SULFATE- albuterol sulfate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

ALBUTEROL SULFATE

Composition:

ALBUTEROL 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 summary:

Albuterol tablets, USP; 2 mg of albuterol as the sulfate, are white, round, scored, debossed MP 47 Albuterol tablets, USP; 4 mg of albuterol as the sulfate, are white, round, scored, debossed MP 88 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SULFATE TABLET
BRYANT RANCH PREPACK
----------
ALBUTEROL TABLETS USP
RX ONLY
DESCRIPTION
Albuterol tablets contain 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
structural formula:
Albuterol sulfate has a molecular weight of 576.71, 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 ethanol.
The World Health Organization recommended name for albuterol base is
salbutamol.
Each albuterol sulfate 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: anhydrous
lactose, magnesium stearate, pregelatinized (corn) starch, and sodium
starch glycolate.
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 mediators of immediate hypersensitivity
from cells, especially from mast