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:

Rebel Distributors Corp.

DCI (Dénomination commune internationale):

ALBUTEROL SULFATE

Composition:

ALBUTEROL 5 mg in 1 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 albuterol or any of its components. Albuterol Sulfate Inhalation Solution, 0.5%* *Potency expressed as albuterol Note: The Albuterol Sulfate Inhalation Solution contained in the 20 mL multiple-dose bottles is concentrated and must be diluted. Read complete instructions carefully before using. 1. Draw the appropriate volume of Albuterol SulfateInhalation Solution, 0.5% into the specially marked dropper that comes with each multidose bottle (Figure 1). For children 12 years of age and under, the volume is based upon body weight. Use the dropper volume prescribed by your doctor. Figure 1 2 . Squeeze the solution into the nebulizer reservoir through the appropriate opening, taking care not to touch the tip of the

Descriptif du produit:

Albuterol Sulfate Inhalation Solution, 0.5% is a clear, colorless to light yellow sterile solution, and is supplied in amber glass bottles of 20 mL fill (NDC 21695-245-20) with accompanying calibrated dropper; boxes of one. Store between 2° and 25°C ( 36° and 77°F). KEEP OUT OF REACH OF CHILDREN. PHARMACIST — DETACH HERE AND GIVE LOWER PORTION TO PATIENT

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
REBEL DISTRIBUTORS CORP.
----------
ALBUTEROL SULFATE
INHALATION SOLUTION,
0.5%*
STERILE
(*POTENCY EXPRESSED AS ALBUTEROL)
DESCRIPTION
Albuterol Sulfate Inhalation Solution, 0.5% is a sterile solution that
contains albuterol sulfate, USP, the
racemic form of albuterol and a relatively selective beta -adrenergic
bronchodilator (see CLINICAL
PHARMACOLOGYsection below). Albuterol sulfate 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 576.71 and the molecular
formula (C
H NO ) •H SO .
Albuterol sulfate is a white crystalline powder, soluble in water and
slightly soluble in ethanol.
The World Health Organization’s recommended name for albuterol base
is salbutamol.
Albuterol sulfate inhalation solution, 0.5% is in concentrated form.
Dilute the appropriate volume of the
solution (see DOSAGE AND ADMINISTRATION) with sterile normal saline
solution to a total
volume of 3 mL and administer by nebulization.
EACH ML CONTAINS: ACTIVE: Albuterol sulfate equivalent to 5 mg of
albuterol in an aqueous solution.
Sulfuric Acid may be added to adjust pH (3.0-5.0).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. Albuterol sulfate
inhalation solution
contains no sulfiting agents. It is supplied in 20 mL bottles.
Albuterol Aulfate Inhalation Solution is a clear, colorless to light
yellow solution.
CLINICAL PHARMACOLOGY
_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 there
is a population of beta -receptors in the human heart existing in a
concentration between 10% and 50%.
The precise function of these receptors has not been established (see
WARNINGS).
The pharmacologic effects of bet