ALBUTEROL SULFATE solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Cardinal Health 107, LLC

Администрация маршрут:

RESPIRATORY (INHALATION)

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 12 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.

Обзор продуктов:

Albuterol Sulfate Inhalation Solution, 0.5%, is a clear, colorless to light yellow solution, and is supplied in plastic sterile unit-of-use vials of 0.5 mL each, supplied in individual foil pouches: Overbagged with 5 x 0.5 mL Sterile Unit-Of-Use Vials, each in a foil pouch, NDC 55154-4350-5 Store between 2°C and 25°C (36°F - 77°F). Rx Only Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172 Distributed By: Cardinal Health Dublin, OH 43017 L35881830319

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
CARDINAL HEALTH 107, LLC
----------
ALBUTEROL SULFATE INHALATION SOLUTION, 0.5%
2.5MG* / 0.5 ML
*Potency expressed as albuterol
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 chemical structure:
(C
H
NO
)
• H
SO
Mol. Wt. 576.7
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 0.5 mL of the
solution to 3 mL with sterile normal saline solution prior to
administration by nebulization
(see DOSAGE AND ADMINISTRATION).
EACH 0.5 ML UNIT-OF-USE VIAL CONTAINS: ACTIVE: 2.5 mg of albuterol
(equivalent to 3
mg of albuterol sulfate, USP) in a sterile, aqueous solution; sulfuric
acid is used to adjust
the pH to between 3 and 5. Albuterol sulfate inhalation solution
contains no sulfiting
agents or preservatives. It is supplied in 0.5 mL sterile Unit-of-Use
Vials.
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 a