ALBUTEROL- albuterol sulfate tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Mylan Pharmaceuticals Inc.

DCI (Dénomination commune internationale):

ALBUTEROL SULFATE

Composition:

ALBUTEROL 2 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

Albuterol Tablets, USP are available containing albuterol sulfate, USP 2.4 mg equivalent to albuterol 2 mg or albuterol sulfate, USP 4.8 mg equivalent to albuterol 4 mg. The 2 mg tablets are white, uncoated, round, flat-faced, scored tablets debossed with M above the score and 255 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0255-01 bottles of 100 tablets 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 0378-0572-01 bottles of 100 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. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Revised: 7/2020 ALB:R16

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ALBUTEROL- ALBUTEROL SULFATE TABLET
MYLAN PHARMACEUTICALS INC.
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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,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, 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 b