ALBUTEROL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 summary:

Albuterol Tablets, USP 2 mg are white to off-white, uncoated, circular, flat face bevel edged tablets debossed “S” above and “2” below the score on one side and plain on other side. They are available as follows:                  Bottles of 100               NDC 59651-333-01                  Bottles of 500               NDC 59651-333-05 Albuterol Tablets, USP 4 mg are white to off-white, uncoated, circular, flat face bevel edged tablets debossed “S” above and “4” below the score on one side and plain on other side. They are available as follows:                  Bottles of 100               NDC 59651-334-01                  Bottles of 500               NDC 59651-334-05 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 using a child-resistant closure. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 12/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL - ALBUTEROL TABLET
AUROBINDO PHARMA LIMITED
----------
ALBUTEROL TABLETS, USP
RX ONLY
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 576.70, and the molecular
formula
is (C
H
NO ) •H SO . Albuterol sulfate is a white or practically white
powder, freely
soluble in water, slightly soluble in alcohol, in ether and
practically insoluble in
chloroform.
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: lactose monohydrate, magnesium
stearate, pregelatinized
starch (maize) 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
2
1
13
21
3 2
2
4
2
2
2
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