ALBUTEROL SULFATE solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Mylan Pharmaceuticals Inc.

INN (International namn):

Albuterol Sulfate

Sammansättning:

Albuterol 2.5 mg in 3 mL

Administreringssätt:

RESPIRATORY (INHALATION)

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 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 any of its components. Albuterol Sulfate Inhalation Solution 0.083% 3 Note: This is a unit-dose vial. No dilution is required. Read complete instructions carefully before using. Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended . Store Albuterol Sulfate Inhalation Solution 0.083%3 between 2° and 25° C (36° and 77° F). Store in pouch until time of use. ADDITIONAL INSTRUCTIONS: ___________________________________________ ________________________________________________________________________ ________________________________________________________________________ Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Manufactured by:

Produktsammanfattning:

Unit-dose plastic vial containing Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3 mL2. Equivalent to 0.5 mL albuterol (as the sulfate) 0.5% (2.5 mg albuterol) diluted to 3 mL. Supplied in cartons as listed below. NDC 0378-8270-52         25 vials per carton / 25 vials per foil pouch NDC 0378-8270-93         30 vials per carton / 30 vials per foil pouch NDC 0378-8270-91         60 vials per carton / 30 vials per foil pouch NDC 0378-8270-55         30 vials per carton / 1 vial per foil pouch PROTECT FROM LIGHT. Store in pouch until time of use. Store between 2° and 25° C (36° and 77° F).

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
MYLAN PHARMACEUTICALS INC.
----------
Albuterol Sulfate Inhalation Solution 0.083%
1
PRESCRIBING INFORMATION
FOR INHALATION USE ONLY-NOT FOR INJECTION.
DESCRIPTION
Albuterol sulfate inhalation solution is a relatively selective beta
-adrenergic bronchodilator (see
CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic
form of albuterol, has
the chemical name α
-[(_tert_-Butylamino)methyl]-4-hydroxy-_m_-xylene-α,α'-diol sulfate
(2:1) (salt), and
the following structural formula:
Albuterol sulfate has a molecular weight of 576.70, and the molecular
formula (C
H NO ) • H SO .
Albuterol sulfate is a white or practically white powder, freely
soluble in water and slightly soluble in
alcohol.
The World Health Organization recommended name for albuterol base is
salbutamol.
Albuterol sulfate inhalation solution 0.083% requires no dilution
before administration.
Each milliliter of Albuterol Sulfate Inhalation Solution 0.083%
contains 0.83 mg of albuterol (as 1 mg
of albuterol sulfate) in an isotonic, sterile, aqueous solution
containing sodium chloride; sulfuric acid is
used to adjust the pH to between 3 and 5. Albuterol Sulfate Inhalation
Solution 0.083% contains no
sulfiting agents or preservatives.
Albuterol sulfate inhalation solution is a clear, colorless to light
yellow solution.
CLINICAL PHARMACOLOGY
The prime action of beta-adrenergic drugs is to stimulate adenyl
cyclase, the enzyme which catalyzes
the formation of cyclic-3',5'-adenosine monophosphate (cyclic AMP)
from adenosine triphosphate
(ATP). The cyclic AMP thus formed mediates the cellular responses. _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, 10% to 50% of the
beta-receptors in the human heart
may be beta -receptors. The precise function of these receptors