ALBUTEROL SULFATE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

ALBUTEROL SULFATE

Composition:

ALBUTEROL 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Albuterol extended-release tablets, USP are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease. Albuterol extended-release tablets are contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.

Product summary:

Albuterol Extended-release Tablets, USP are available containing 4.8 mg or 9.6 mg of albuterol sulfate, USP equivalent to 4 mg or 8 mg of albuterol, respectively. The 4 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 22 on the other side. They are available as follows: NDC 0378-4122-01 bottles of 100 tablets The 8 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and 24 on the other side. They are available as follows: NDC 0378-4124-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED MARCH 2015 ALBER:R2

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SULFATE TABLET, FILM COATED, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Albuterol extended-release tablets, USP contain albuterol sulfate, the
racemic form of albuterol and a
relatively selective beta -adrenergic bronchodilator, in an
extended-release formulation. Albuterol
sulfate has the chemical name (±) a
-[(_tert_-butyl-amino)methyl]-4-hydroxy-_m_-xylene-a, a´-diol sulfate
(2:1) (salt), and the following structural formula:
Albuterol sulfate has a molecular weight of 576.7, and the molecular
formula is (C
H NO ) •H SO .
Albuterol sulfate, USP is a white crystalline powder, soluble in water
and slightly soluble in ethanol.
The World Health Organization recommended name for albuterol base is
salbutamol.
Each tablet for oral administration contains 4 mg or 8 mg of albuterol
as 4.8 mg or 9.6 mg, respectively,
of albuterol sulfate, USP. In addition each tablet contains the
following inactive ingredients: colloidal
silicon dioxide, hypromellose, magnesium stearate, microcrystalline
cellulose, polydextrose,
polyethylene glycol, sodium lauryl sulfate, titanium dioxide,
triacetin and xanthan gum. The 8 mg tablets
also contain the following coloring agents: FD&C Blue No. 2 Aluminum
Lake and FD&C Yellow No. 6
Aluminum Lake.
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 indicates 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 on
intracellular adenyl cyclase, the enzyme
that catalyzes the conver