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:

Actavis Pharma, 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. Safety and effectiveness in children below 2 years of age have not been established.

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 in bottles of 4 fluid ounces (NDC 0472-0825-04) and 16 fluid ounces (one pint) (NDC 0472-0825-16). Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Cosette Pharmaceuticals, Inc. Lincolnton, NC 28092 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA VC7466 Revised: 11/2020 8-0332ACTLNC2

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SULFATE SYRUP
ACTAVIS PHARMA, INC.
REFERENCE LABEL SET ID: A78ED96A-BE70-497D-BD65-CB0D797969A3
REFERENCE LABEL SET ID: 00935B7F-DA25-4C72-98F0-B0B414C727B1
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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'-diol
sulfate (2:1) (salt) and
the following structural formula:
(C
H
NO
) •H
SO
M.W. 576.7
Albuterol sulfate is a white crystalline powder, soluble in water and
slightly soluble in
ethanol.
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 #6, flavor enhancer,
hypromellose,
propylene glycol, purified water, sodium benzoate, sodium citrate,
strawberry flavor.
Sodium hydroxide may be added to adjust pH.
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).
2
1
13
21
3
2
4
2
2
2
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).