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:

Proficient Rx LP

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 63187-204-25: 25 vials per carton / 25 vials per foil pouch 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 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
PROFICIENT RX LP
----------
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 the human hea