ALBUTEROL SULFATE- 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:

Preferred Pharmaceuticals 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 16 fluid ounces (one pint) (NDC 68788-7390-4 ). 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: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA GW7147 Issued: 11/2016 8-0332ACTLNC1 Relabeled By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SULFATE SYRUP
PREFERRED PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: 00935B7F-DA25-4C72-98F0-B0B414C727B1
REFERENCE LABEL SET ID: A78ED96A-BE70-497D-BD65-CB0D797969A3
----------
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).
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 cy