ALBUTEROL SULFATE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

INN (International Name):

ALBUTEROL SULFATE

Composition:

ALBUTEROL 2 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease. Albuterol Sulfate Syrup is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.

Product summary:

Albuterol Sulfate Syrup, a yellow-orange liquid with an orange flavor, contains 2 mg albuterol as the sulfate per 5 mL; bottles of 4 fluid ounces, 8 fluid ounces and 16 fluid ounces.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SULFATE SYRUP
AKORN
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ALBUTEROL SULFATE SYRUP
DESCRIPTION
Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic
form of albuterol and
a relatively selective beta -adrenergic bronchodilator. Albuterol
sulfate has the chemical
name (±)α1-[(_tert_-butylamino)
methyl]-4-hydroxy-_m_-xylene-a,a'-diol sulfate (2:1) (salt),
and the following chemical structure:
Albuterol sulfate has a molecular weight of 576.7 and the molecular
formula
(C
H
NO )2 • H SO . Albuterol sulfate is a white or practically white
powder freely
soluble in water and slightly soluble in alcohol, in chloroform, and
in ether per USP
definition.
The World Health Organization recommended name for albuterol base is
salbutamol.
Each 5 mL (teaspoonful), for oral administration contains 2.4 mg of
albuterol sulfate
equivalent to 2 mg of albuterol. Albuterol Sulfate Syrup also contains
the inactive
ingredients citric acid anhydrous, FD & C Yellow No. 6, hydroxypropyl
methylcellulose,
orange flavor, purified water, saccharin, sodium benzoate, and sodium
citrate.
The pH of the syrup is 3.5 to 4.5.
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 beta2-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
2
13
21
3
2
4
2
2
are associated with relaxation of bro