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:

Physicians Total Care, 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 yellow-orange liquid with an orange flavor, contains 2 mg albuterol as the sulfate per 5 mL; bottles of 16 fluid ounces  (NDC 54868-2887-0). Store between 2° and 30°C (36° and 86°F). Dispense in a tight, light-resistant container. Manufactured by: HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Rev. 740:03 4/09 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma        74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL SULFATE - ALBUTEROL SULFATE SYRUP
PHYSICIANS TOTAL CARE, INC.
----------
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 (±)α -[(_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 576.70 and the molecular
formula (C
H NO ) o 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 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 o