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:

Rebel Distributors Corp.

INN (International Name):

ALBUTEROL SULFATE

Composition:

ALBUTEROL SULFATE 2.5 mg in 3 mL

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 any of its components.

Product summary:

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 21695-332-25 25 vials per carton NDC 21695-332-30 30 vials per carton 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 and For: Nephron Pharmaceuticals Corporation Orlando, FL 32811 For Customer Service, Call 1-800-443-4313 Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
REBEL DISTRIBUTORS CORP.
----------
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 hu