albuterol- Albuterol aerosol, spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Warrick Pharmaceuticals Corporation

INN (International Name):

Albuterol

Pharmaceutical form:

AEROSOL, SPRAY

Composition:

90 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Albuterol Inhalation Aerosol is indicated in patients 12 years of age and older, for the prevention and relief of bronchospasm in patients with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm. Albuterol Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.

Product summary:

Albuterol Inhalation Aerosol, 17.0 g canister contains 200 metered inhalations, box of one (NDC 59930-1560-1). Each actuation delivers 100 mcg of albuterol from the valve and 90 mcg of albuterol from the mouthpiece. Each canister is supplied with a white plastic actuator with white dust cap, and Patient's Instructions. Albuterol Inhalation Aerosol REFILL canister, 17.0 g, contains 200 metered inhalations, with Patient's Instructions; box of one (NDC 59930-1560-2). The correct amount of medication in each inhalation cannot be assured after 200 actuations from the 17.0 g canister or 80 actuations from the 6.8 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Failure to use the product within this temperature range may result in improper dosing. For optimal results, the canister should be at room temperature before use. Shake well before using. Albuterol Inhalation Aerosol canister should be used only with the actuator provided. The white actuator should not be used with other aerosol medication canisters. Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs). A notice similar to the above WARNING has been placed in the "Patient's Instructions for Use" portion of this package insert under the Environmental Protection Agency's (EPA's) regulations. 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, SPRAY
WARRICK PHARMACEUTICALS CORPORATION
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ALBUTEROL, USP INHALATION AEROSOL
BRONCHODILATOR AEROSOL
FOR ORAL INHALATION ONLY
DESCRIPTION
The active component of Albuterol Inhalation Aerosol is albuterol, USP
racemic α -[(_tert_-
butylamino)methyl]-4-hydroxy-_m_-xylene-α,α'-diol), a relatively
selective beta -adrenergic
bronchodilator, having the chemical structure:
The molecular weight of albuterol is 239.3, and the empirical 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. The World Health Organization recommended name for
albuterol base is salbutamol.
Albuterol Inhalation Aerosol is a pressurized metered-dose aerosol
unit for oral inhalation. It contains a
microcrystalline suspension of albuterol in propellants
(trichloromonofluoromethane and
dichlorodifluoromethane) with oleic acid. Each actuation delivers 100
mcg albuterol, USP from the
valve and 90 mcg of albuterol, USP from the mouthpiece. Each 17.0 g
canister provides 200 oral
inhalations. Each 6.8 g canister provides 80 oral inhalations.
Albuterol Inhalation Aerosol should be primed by actuating into air,
away from the eyes and face, four
times before using for the first time and two times when the aerosol
has not been used for a period of at
least four days.
CLINICAL PHARMACOLOGY
The primary action of beta-adrenergic drugs, including albuterol, is
to stimulate adenyl cyclase, the
enzyme which catalyzes the formation of cyclic-3',5'-adenosine
monophosphate (cyclic AMP) from
adenosine triphosphate (ATP) in beta-adrenergic cells. The cyclic AMP
thus formed mediates the
cellular responses. Increased cyclic AMP levels are associated with
relaxation of bronchial smooth
muscle and inhibition of release of mediators of immediate
hypersensitivity from cells, especially from
mast cells.
_In vitro_ studies and _in vivo_ pharmacologic studies have
demonstrated that albuterol has a preferential
effect on beta -adrene