ALBUTEROL tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Virtus Pharmaceuticals LLC

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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.

Bidhaa muhtasari:

Albuterol Tablets, USP 2 mg for oral administration containing albuterol sulfate, USP equivalent to 2 mg of albuterol are supplied as follows: White, scored, round tablets debossed with N 078 on the scored side. NDC 69543-290- 10             Bottles of 100 tablets with child-resistant closure NDC 69543-290- 18             Bottles of 180 tablets with child-resistant closure Albuterol Tablets, USP 4 mg for oral administration containing albuterol sulfate, USP equivalent to 4 mg of albuterol are supplied as follows: White, scored, round tablets debossed with N 079 on the scored side. NDC 69543-291- 10             Bottles of 100 tablets with child-resistant closure NDC 69543-291- 18             Bottles of 180 tablets with child-resistant closure  Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep this and all medications out of the reach of children. For more information call Virtus at 1-888-848-3593. Distributed by: Virtus Pharmaceuticals, LLC Langhorne, PA 19047 Rev. 03/2019 LB4067-01

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

ALBUTEROL- ALBUTEROL TABLET
VIRTUS PHARMACEUTICALS LLC
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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 576.7, 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
alcohol, chloroform and ether.
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: lactose
anhydrous, magnesium stearate, pregelatinized starch, 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, 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