PROVENTIL HFA- albuterol sulfate aerosol, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Albuterol Sulfate (UNII: 021SEF3731) (Albuterol - UNII:QF8SVZ843E)

Available from:

Rebel Distributors Corp.

INN (International Name):

Albuterol Sulfate

Composition:

Albuterol Sulfate 108 ug

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PROVENTIL® HFA 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.

Product summary:

PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with 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 42254-004-67). Rx only. Store between 15°-25°C (59°-77°F). For best results, canister should be at room temperature before use. SHAKE WELL BEFORE USING. The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product canister, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though 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. PROVENTI L ® HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant. Developed and Manufactured by 3M Health Care Limited Loughborough UK or 3M Drug Delivery Systems Northridge, CA 91324 for Schering Corporation, a subsidiary of Schering-Plough Corporation, Kenilworth, NJ 07033 USA Schering-Plough © 1996, 1998, Schering Corporation. All rights reserved. The trademarks depicted in this piece are owned by their respective companies. 673700 Rev. 02/09 Relabeled by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

New Drug Application

Summary of Product characteristics

PROVENTIL HFA- ALBUTEROL SULFATE AEROSOL, METERED
REBEL DISTRIBUTORS CORP.
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PROVENTIL® HFA
(ALBUTEROL SULFATE)
INHALATION AEROSOL
FOR ORAL INHALATION ONLY
PRESCRIBING INFORMATION
DESCRIPTION
The active component of PROVENTIL® HFA (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 (C13H21 NO3)2•H2SO4. Albuterol
sulfate is a white to off-white
crystalline solid. It is soluble in water and slightly soluble in
ethanol. PROVENTIL HFA 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
concen