ALBUTEROL- albuterol sulfate tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Dash Pharmaceutical LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

Albuterol Tablets, USP contain albuterol sulfate equivalent to 2 mg or 4 mg of albuterol. The tablets containing albuterol sulfate equivalent to 2 mg of albuterol are white to off white color round shaped flat beveled edge tablets scored on one side and debossed with 'D126' on other side. They are available as follows: Bottles of 100 tablets with child resistant closure, NDC 69339-126-01 The tablets containing albuterol sulfate equivalent to 4 mg of albuterol are white to off white color round shaped flat beveled edge tablets scored on one side and debossed with 'D127' on other side. They are available as follows: Bottle of 100 tablets with child resistant closure, NDC 69339-127-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Aizant Drug Research Solutions Pvt Ltd Hyderabad, Telangana-500 100, India. Manufactured for: DASH Pharmaceutical LLC Upper Saddle River, NJ 07458 USA Revised: March 2019

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ALBUTEROL- ALBUTEROL SULFATE TABLET
DASH PHARMACEUTICAL LLC
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DESCRIPTION
Albuterol tablets contain albuterol sulfate USP, the racemic form of
albuterol and a relatively selective
beta2-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 USP is a white or almost white crystalline powder,
freely soluble in water,
practically insoluble or very slightly soluble in methylene chloride
and alcohol, slightly soluble in
chloroform and ether.
The World Health Organization recommended name for albuterol base is
salbutamol.
Each albuterol tablet for oral administration contains 2 mg or 4 mg of
albuterol as 2.4 mg or 4.8 mg of
albuterol sulfate USP, respectively. Each tablet also contains the
following inactive ingredients:
anhydrous lactose, hypromellose, magnesium stearate 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