ALBUTEROL SULFATE solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

REMEDYREPACK INC.

Stjórnsýsluleið:

RESPIRATORY (INHALATION)

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

Albuterol Sulfate Inhalation Solution, 0.083% is contained in plastic, sterile, unit dose vials of 3 mL each, supplied in foil pouches: NDC: 70518-2413-00 PACKAGING: 2 in 1 CARTON, 30 in 1 POUCH, 3 mL in 1 VIAL SINGLE DOSE, TYPE 0 Storage and Handling PROTECT FROM LIGHT. Store vials in pouch until time of use. Store between 2° and 25° C (36° and 77° F). Rx Only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
REMEDYREPACK INC.
----------
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
2
1
13
21
3
2
2
4
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-recep