ALBUTEROL SULFATE solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Nucare Pharmaceuticals, Inc.

INN (Isem Internazzjonali):

ALBUTEROL SULFATE

Kompożizzjoni:

ALBUTEROL 2.5 mg in 3 mL

Rotta amministrattiva:

RESPIRATORY (INHALATION)

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

Unit-dose plastic vial containing sterile Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg* / 3 ml (*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate). Equivalent to 0.5 mL of albuterol sulfate inhalation solution, 0.5% diluted to 3 mL with normal saline. Supplied in cartons as listed below. NDC 66267-746-06: 6 vials per bottle PROTECT FROM LIGHT. Store vials in pouch until time of use. Store between 2° and 25° C (36° and 77° F). Rx Only Manufactured By: Nephron Pharmaceuticals Corporation Orlando, FL 32811 For Customer Service, Call 1-800-443-4313

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
NUCARE PHARMACEUTICALS, INC.
----------
ALBUTEROL SULFATE INHALATION SOLUTION, 0.083%
2.5 MG*/3 ML
*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.
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 576.7, and the molecular
formula is (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’s recommended name
for albuterol base is
salbutamol. Albuterol sulfate inhalation solution 0.083% requires no
dilution before administration.
Each mL 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. Albuterol sulfate inhalation solution is a clear,
colorless 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, data indicate that
10% to 50% of the beta-receptors
in