ALBUTEROL- albuterol aerosol, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Albuterol (UNII: QF8SVZ843E) (Albuterol - UNII:QF8SVZ843E)

Available from:

Armstrong Pharmaceuticals, Inc.

INN (International Name):

Albuterol

Pharmaceutical form:

AEROSOL, METERED

Composition:

90 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Albuterol Inhalation Aerosol is indicated for the prevention and relief of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, and for the prevention of exercise induced bronchospasm in patients 4 years of age and older. Albuterol Inhalation Aerosol can be used with or without concomitant steroid therapy. Albuterol Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components. Before using your Albuterol Inhalation Aerosol, read complete instructions carefully. Children should use Albuterol Inhalation Aerosol under adult supervision, as instructed by the patient's doctor. The blue adapter supplied with Albuterol Inhalation Aerosol should not be used with any other product canisters, and adapters from other products should not be used with an Albuterol Inhalation Aerosol canister. The refill canister is to be used only with the blue Albuterol Inhalation Aerosol adapter ID#720. DOSAGE Use only as directed by y

Product summary:

Albuterol Inhalation Aerosol is supplied in 17 g canisters containing 200 metered inhalations (NDC 17270-721-01) in boxes of one. Each actuation delivers 100 mcg of albuterol from the valve and 90 mcg of albuterol from the mouthpiece. Each canister is supplied with a blue oral adapter and patient's instructions. Also available, Albuterol Inhalation Aerosol Refill with patient's instructions (NDC 17270-721-02). The blue adapter supplied with Albuterol Inhalation Aerosol should not be used with any other product canisters, and the adapters from other products should not be used with an Albuterol 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. Store between 15°–30°C (59°–86°F). As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold; for best results, the canister should be at room temperature before use. Shake well before using. Note: The indented statement below is required by the Federal government Clean Air Act for all products containing chlorofluorocarbons (CFC's). A notice similar to the above warning has been placed in the patient instruction leaflet of this package insert pursuant to the regulations of the U.S. Environmental Protection Agency (EPA). The patient's warning states that the patient should consult his or her physician if there are questions about alternatives.

Summary of Product characteristics

ALBUTEROL- ALBUTEROL AEROSOL, METERED
ARMSTRONG PHARMACEUTICALS, INC.
----------
ALBUTEROL
INHALATION AEROSOL
BRONCHODILATOR AEROSOL
FOR ORAL INHALATION ONLY
RX ONLY
DESCRIPTION
The active component of Albuterol Inhalation Aerosol is albuterol (α
-[(tert-butylamino)methyl]-4-
hydroxy-_m_-xylene-α,α'-diol), a relatively selective beta
-adrenergic bronchodilator, having the
following structural formula:
Albuterol is the official generic name in the United States. The World
Health Organization
recommended name for the drug is salbutamol. The molecular weight of
albuterol is 239.2, and the
molecular formula is C
H NO . Albuterol is a white to off-white crystalline solid. It is
soluble in
ethanol, sparingly soluble in water, and very soluble in chloroform.
Albuterol Inhalation Aerosol is a pressurized metered-dose aerosol
unit for oral inhalation. It contains a
microcrystalline (95% ≤ 10 µm) suspension of albuterol in
propellants (trichloromonofluoromethane
and dichlorodifluoromethane) with oleic acid. Each actuation delivers
100 mcg of albuterol from the
valve and 90 mcg of albuterol from the mouthpiece. Each canister
provides 200 inhalations.
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.
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 relaxat