ALBUTEROL SULFATE solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Sandoz Inc.

DCI (Dénomination commune internationale):

ALBUTEROL SULFATE

Composition:

ALBUTEROL 2.5 mg in 3 mL

Mode d'administration:

RESPIRATORY (INHALATION)

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

Unit-dose plastic vial containing Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3 mL 2. 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 0781-7155-86 carton of 25 vials. NDC 0781-7155-64 carton of 30 vials. NDC 0781-7155-29 carton of 60 vials. PROTECT FROM LIGHT. Store in pouch until time of use. Store between 2° and 25° C (36° and 77° F).

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
SANDOZ 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, however, is