IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Ipratropium Bromide (UNII: J697UZ2A9J) (Ipratropium - UNII:GR88G0I6UL), Albuterol Sulfate (UNII: 021SEF3731) (Albuterol - UNII:QF8SVZ843E)

Mevcut itibaren:

Sandoz Inc.

INN (International Adı):

Ipratropium Bromide

Kompozisyon:

Ipratropium Bromide Anhydrous 0.5 mg in 3 mL

Uygulama yolu:

RESPIRATORY (INHALATION)

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

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 0781-7146-64 30 vials per carton / 5 vials per foil pouch NDC 0781-7146-87 30 vials per carton / 30 vials per foil pouch NDC 0781-7146-29 60 vials per carton / 5 vials per foil pouch NDC 0781-7146-63 60 vials per carton / 30 vials per foil pouch Store between 2°C and 25°C (36°F and 77°F). Protect from light.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL
SULFATE SOLUTION
SANDOZ INC.
----------
IPRATROPIUM BROMIDE
AND ALBUTEROL SULFATE
INHALATION SOLUTION
0.5 MG/3 MG PER 3 ML
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.
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 albuterol
2
1
13
21
3 2
2
4
20
30
3
2
1
sulfate (0.083%) in an isotonic, sterile, aqueous solution containing
sodium chloride and 1 N
hydrochloric acid to adjust to pH 4.
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 Sulfate
Inhalation Solution, like all other nebulized treatments, the amount
delivered to the lungs will depend