ALBUTEROL SULFATE- albuterol syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

VistaPharm, Inc.

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 clear, yellow liquid with a strawberry flavor, contains 2 mg of albuterol (present as the sulfate) per 5 mL and is supplied in the following containers: Note: The unit-dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized. Dispense contents with a child resistant closure (as required) and in a tight, light-resistant container as defined in the USP/NF. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SYRUP
VISTAPHARM, INC.
----------
ALBUTEROL SULFATE SYRUP
RX ONLY
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 α - [(tert-
butylamino) methyl] - 4 hydroxy - m xylene - α,α' -diolsulfate (2:1)
(salt) and the following chemical
structure:
(C
H NO ) ·H SO M.W. 576.7
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.
Albuterol Sulfate Syrup for oral administration contains 2 mg of
albuterol as 2.4 mg of albuterol sulfate
in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the
inactive ingredients Citric Acid,
FD & C Yellow No. 6, Hypromellose, Purified Water, Sodium Benzoate,
Sodium Citrate, Sorbitol
Solution, and Strawberry Flavor. The pH of the syrup is 3.2 to 4.2.
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 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 relaxa