ALBUTEROL SULFATE solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Nephron Pharmaceuticals Corporation

INN (Medzinárodný Name):

ALBUTEROL SULFATE

Zloženie:

ALBUTEROL 2.5 mg in 0.5 mL

Spôsob podávania:

RESPIRATORY (INHALATION)

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 12 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.

Prehľad produktov:

Albuterol Sulfate Inhalation Solution, 0.5%, is a clear, colorless to light yellow solution, and is supplied in plastic sterile unit-of-use vials of 0.5 mL each, supplied in individual foil pouches: NDC 0487-9901-30: 30 vials, each in an individual pouch. Store between 2°C and 25°C (36°F - 77°F). Rx Only Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
NEPHRON PHARMACEUTICALS CORPORATION
----------
ALBUTEROL SULFATE INHALATION SOLUTION, 0.5%
2.5MG* / 0.5 ML
*Potency expressed as albuterol
DESCRIPTION
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 chemical structure:
(C
H
NO
)
• H
SO
Mol. Wt. 576.7
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 0.5 mL of the solution to 3
mL with sterile normal saline solution prior to administration by
nebulization (see DOSAGE AND
ADMINISTRATION).
EACH 0.5 ML UNIT-OF-USE VIAL CONTAINS: ACTIVE: 2.5 mg of albuterol
(equivalent to 3 mg of
albuterol sulfate, USP) in a sterile, aqueous solution; sulfuric acid
is used to adjust the pH to between 3
and 5. Albuterol sulfate inhalation solution contains no sulfiting
agents or preservatives. It is supplied
in 0.5 mL sterile Unit-of-Use Vials.
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 leas