ALBUTEROL SULFATE solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Akorn

INN (Algemene Internationale Benaming):

ALBUTEROL SULFATE

Samenstelling:

ALBUTEROL 5 mg in 1 mL

Toedieningsweg:

RESPIRATORY (INHALATION)

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 Sulfate Inhalation 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 d

Product samenvatting:

Albuterol Sulfate Inhalation Solution, 0.5% is a clear, colorless sterile solution, and is supplied in amber glass bottles of 20 mL fill (NDC 50383-741-20) with accompanying calibrated dropper; boxes of one. Store between 2° and 25°C (36° and 77°F). KEEP OUT OF REACH OF CHILDREN. Rx only. FOR ORAL INHALATION ONLY. Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Rev.741:04 02/17 PHARMACIST — DETACH HERE AND GIVE LOWER PORTION TO PATIENT

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
AKORN
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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 (3.5-4.2).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. Albuterol sulfate
inhalation
solution contains no sulfiting agents. It is supplied in 20 mL
bottles.
Albuterol Sulfate Inhalation Solution is a clear, colorless sterile
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 beta-adrenergic agonist drugs, includin