ALBUTEROL SULFATE- albuterol sulfate solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Bausch & Lomb Incorporated

INN (Internationale Bezeichnung):

ALBUTEROL SULFATE

Zusammensetzung:

ALBUTEROL 5 mg in 1 mL

Verabreichungsweg:

RESPIRATORY (INHALATION)

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm. Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.

Produktbesonderheiten:

Albuterol sulfate inhalation solution, 0.5% is supplied in amber glass bottles, with a calibrated dropper and with patient instructions in the following size: 20 mL bottles - NDC 24208-347-20 Storage: Store between 2°-25°C (36°-77°F). KEEP OUT OF REACH OF CHILDREN. Revised: February 2017 9116502 (Folded) 9116602 (Flat) Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
BAUSCH & LOMB INCORPORATED
----------
ALBUTEROL SULFATE INHALATION SOLUTION, 0.5%*
*Potency expressed as albuterol
RX ONLY
FOR ORAL INHALATION ONLY
DESCRIPTION:
Albuterol Sulfate Inhalation Solution, 0.5% contains albuterol
sulfate, USP, the racemic form of
albuterol and a relatively selective beta -adrenergic bronchodilator
_(see CLINICAL PHARMACOLOGY_
section below). 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
Mol. Wt. 576.71
Albuterol sulfate is a white crystalline powder, soluble in water and
slightly soluble in ethanol.
The World Health Organization’s recommended name for albuterol base
is salbutamol.
Albuterol sulfate inhalation solution, 0.5% is in concentrated form.
Dilute the appropriate volume of the
solution _(see DOSAGE AND ADMINISTRATION)_ with sterile normal saline
solution to a total volume of
3 mL and administer by nebulization.
EACH ML CONTAINS: ACTIVE: Albuterol sulfate equivalent to 5 mg of
albuterol in an aqueous solution.
Sulfuric Acid may be added to adjust pH (3.0-5.0).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. Albuterol sulfate
inhalation solution
contains no sulfiting agents.
Albuterol sulfate inhalation solution is a clear, colorless to light
yellow solution.
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 stimu