ALBUTEROL SULFATE tablet ALBUTEROL SULFATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

American Health Packaging

INN (Nome Internazionale):

albuterol sulfate

Composizione:

albuterol 2 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Albuterol tablets, USP; 2 mg of albuterol as the sulfate, are white, round, scored, debossed MP 47 Unit dose packages of 30 (5 x 6) NDC 68084-949-25 Albuterol tablets, USP; 4 mg of albuterol as the sulfate, are white, round, scored, debossed MP 88 Unit dose packages of 30 (5 x 6) NDC 68084-952-25 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ALBUTEROL SULFATE- ALBUTEROL SULFATE TABLET
ALBUTEROL SULFATE- ALBUTEROL SULFATE TABLET
AMERICAN HEALTH PACKAGING
----------
ALBUTEROL TABLETS USP
8294921/0715OS
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).
2
1
13
21
3
2
2
4
2
2
2
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
inhibitio