ALBUTEROL SULFATE syrup

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

QUAGEN PHARMACEUTICALS LLC

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Albuterol Sulfate Syrup, 2 mg/5 mL, a clear, yellow liquid with a strawberry flavor, contains 2 mg of albuterol (present as the sulfate) per 5 mL in bottles of 16 fluid ounces (one pint) (NDC 70752-102-12). 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, with a child-resistant closure (as required).

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ALBUTEROL SULFATE- ALBUTEROL SULFATE SYRUP
QUAGEN PHARMACEUTICALS LLC
----------
ALBUTEROL SULFATE SYRUP, 2 MG/5 ML
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 chemical structure:
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 3.5 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
2
1
2
2
2
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 of bronchial smooth muscle and
inhibition of release of
mediators of immediate