ALBUTEROL SULFATE aerosol, metered

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Par Pharmaceutical Inc.

Администрация маршрут:

RESPIRATORY (INHALATION)

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Albuterol Sulfate Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. Albuterol Sulfate Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other Albuterol Sulfate Inhalation Aerosol components. INSTRUCTIONS FOR USE Albuterol Sulfate Inhalation Aerosol with Dose Indicator Read this Instructions for Use before you start using Albuterol Sulfate Inhalation Aerosol and eachtime you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment. Your doctor should show you how your child should use Albuterol Sulfate Inhalation Aerosol. Important Information: - Albuterol Sulfate Inhalation Aerosol is for oral inhalation use only. - Take Albuterol Sulfate Inhalation A

Обзор продуктов:

Albuterol Sulfate Inhalation Aerosol is supplied as a pressurized aluminum canister, with an attached dose indicator, a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations (NDC 0254-1007-52). Rx only. Store between 15°-25°C (59°-77°F). Store the inhaler with the mouthpiece down. For best results, canister should be at room temperature before use. SHAKE WELL BEFORE USING. The yellow actuator supplied with Albuterol Sulfate Inhalation Aerosol should not be used with any other product canisters, and actuator from other products should not be used with a Albuterol Sulfate Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations and when the dose indicator display window shows zero, even though the canister is not completely empty the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used. WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children. Albuterol Sulfate Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.         Manufactured for:         Par Pharmaceutical         Chestnut Ridge, NY 10977, U.S.A.         Developed and Manufactured by:         3M Health Care Limited         Loughborough UK         or         3M Drug Delivery Systems         Northridge, CA 91324, USA

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

ALBUTEROL SULFATE- ALBUTEROL SULFATE AEROSOL, METERED
PAR PHARMACEUTICAL INC.
----------
ALBUTEROL SULFATE INHALATION AEROSOL WITH DOSE INDICATOR
FOR ORAL INHALATION ONLY
PRESCRIBING INFORMATION
DESCRIPTION
The active component of Albuterol Sulfate Inhalation Aerosol is
albuterol sulfate, USP
racemic α
[( _tert-_Butylamino)methyl]-4-hydroxy- _m_-xylene-α,α'-diol sulfate
(2:1)(salt), a
relatively selective beta
-adrenergic bronchodilator having the following chemical
structure:
Albuterol sulfate is the official generic name in the United States.
The World Health
Organization recommended name for the drug is salbutamol sulfate. The
molecular
weight of albuterol sulfate is 576.7, and the empirical formula is (C
H
NO
)
•H
SO
. Albuterol sulfate is a white to off-white crystalline solid. It is
soluble in water and
slightly soluble in ethanol. Albuterol Sulfate Inhalation Aerosol is a
pressurized metered-
dose aerosol unit for oral inhalation. It contains a microcrystalline
suspension of
albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane),
ethanol, and oleic
acid.
Each actuation delivers 120 mcg albuterol sulfate, USP from the valve
and 108 mcg
albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of
albuterol base from
the mouthpiece). Each canister provides 200 inhalations. It is
recommended to prime
the inhaler before using for the first time and in cases where the
inhaler has not been
used for more than 2 weeks by releasing four “test sprays” into
the air, away from the
face.
This product does not contain chlorofluorocarbons (CFCs) as the
propellant.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION _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 on bronchial smooth muscle, data indicate
that there is a
population of beta
-receptors in the human heart existing in a concentration b