ALBUTEROL SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bausch & Lomb Incorporated

INN (International Name):

Albuterol Sulfate

Pharmaceutical form:

SOLUTION

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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. For children 12 years of age and under, the volume is based upon body weight. Use the dropper volume prescribed by your doctor. 2. Squeeze the solution into the nebulizer reservoir through the appropriate opening, taking care not to touch the tip of the dropper. 3. Add sterile normal saline solution, as your doctor has directed. A general guideline for the amount of saline to add is: For children us

Product summary:

Albuterol sulfate inhalation solution, 0.5% is supplied in amber glass bottles, with a calibrated dropper and with patient instructions in the following size: 20 mL bottles (NDC 59930-1647-2).

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
BAUSCH & LOMB INCORPORATED
----------
ALBUTEROL SULFATE
INHALATION SOLUTION,
0.5%*
DES CRIPTION
Albuterol Sulfate Inhalation Solution, 0.5% contains albuterol
sulfate, USP, the racemic form of
albuterol and a relatively selective beta -adrenergic bronchodilator
(see CLINICAL
PHARMACOLOGY section 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:
(C
H NO ) •H SO
Mol. Wt. 576.71
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.
Albuterol sulfate 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 beta-adrenergic agonist drugs, including
albuterol, are at least in part
attributable to stimulation through beta-adrenergic receptors of
intracellular adenyl cycla