ALBUTEROL tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Mylan Institutional Inc.

INN (nume internaţional):

ALBUTEROL SULFATE

Compoziție:

ALBUTEROL 2 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

Albuterol Tablets, USP, contain albuterol sulfate equivalent to 2 mg of albuterol. The tablets containing albuterol sulfate equivalent to 2 mg of albuterol are white, scored, round tablets debossed with M255 on the scored side. They are available as follows: NDC 51079-657-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-6539 R7 6/20

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ALBUTEROL- ALBUTEROL TABLET
MYLAN INSTITUTIONAL INC.
----------
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 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 (hydrous), magnesium stearate, pregelatinized
(corn) 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
mast cells.
Albuterol has been shown in most controlled