ALBUTEROL SULFATE solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

A-S Medication Solutions

INN (Mezinárodní Name):

ALBUTEROL SULFATE

Složení:

ALBUTEROL 2.5 mg in 3 mL

Podání:

RESPIRATORY (INHALATION)

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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% 2 Note: This is a unit-dose vial. No dilution is required. Read complete instructions carefully before using. - Remove the vial from the foil pouch. - Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1). - Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). - Connect the nebulizer to the compressor. - Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) (or put on the face mask); and turn on the compressor. - Breathe as calmly, deeply and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minu

Přehled produktů:

Product: 50090-0516 NDC: 50090-0516-0 25 mL in a POUCH / 1 in a CARTON NDC: 50090-0516-1 25 mL in a POUCH / 5 in a CARTON

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
A-S MEDICATION SOLUTIONS
----------
ALBUTEROL SULFATE INHALATION SOLUTION, 0.083%
2.5 MG/3 ML (RDP)
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
1
(Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate)
2
1
13
21
3
2
2
4
2
2
predomi