IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL), ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)

Disponible desde:

REMEDYREPACK INC.

Vía de administración:

RESPIRATORY (INHALATION)

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg / 3 mg per 3 mL Patient's Instructions for Use Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication as you may want to read them again. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should only be used under the direction of a physician. Your physician and pharmacist have more information about Ipratropium Bromide and Albuterol Sulfate Inhalation Solution and the condition for which it has been prescribed. Contact them if you have additional questions. Stori

Resumen del producto:

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a 3-mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store in pouch until time of use. Supplied in cartons as listed below. NDC: 70518-3347-00 PACKAGING: 2 in 1 CARTON, 30 in 1 POUCH, 3 mL in 1 VIAL TYPE 0 Store between 2°C and 25°C (36°F and 77°F). Protect from light. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
REMEDYREPACK INC.
----------
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION 0.5 MG /
3 MG
PER 3 ML<BR><BR>RX ONLY
DESCRIPTION
The active components in Ipratropium Bromide and Albuterol Sulfate
Inhalation Solution
are albuterol sulfate and ipratropium bromide.
Albuterol sulfate, is a salt of racemic albuterol and a relatively
selective β
-adrenergic
bronchodilator chemically described as α
-[( _tert_-butylamino)methyl]-4-hydroxy- _m_-xylene-α, α'-diol
sulfate (2:1) (salt). It has a
molecular weight of 576.7 and the empirical formula is (C
H
NO
)
•H
SO
. It is a
white crystalline powder, soluble in water and slightly soluble in
ethanol. The World
Health Organization recommended name for albuterol base is salbutamol.
Figure 3.1-1. Chemical structure of albuterol sulfate.
Ipratropium bromide is an anticholinergic bronchodilator chemically
described as 8-
azoniabicyclo [3.2.1]-octane,
3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-
methylethyl)-, bromide, monohydrate ( _endo, syn_)-, (±)-; a
synthetic quaternary
ammonium compound, chemically related to atropine. It has a molecular
weight of 430.4
and the empirical formula is C
H
BrNO
•H
O. It is a white crystalline substance,
freely soluble in water and lower alcohols, and insoluble in
lipophilic solvents such as
ether, chloroform, and fluorocarbons.
2
1
13
21
3
2
2
4
20
30
3
2
Figure 3.1-2. Chemical structure of ipratropium bromide.
Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium
bromide (0.017%) and 3
mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in
an isotonic, sterile,
aqueous solution containing sodium chloride and 1 N hydrochloric acid
to adjust to pH 4
*Equivalent to 2.5 mg albuterol base
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a
clear, colorless
solution. It does not require dilution prior to administration by
nebulization. For
Ipratropium Bromide and Albuterol Sulfa