IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

IPRATROPIUM BROMIDE

Composition:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 3 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 0378-9671-93 30 vials per carton / 1 vial per foil pouch NDC 0378-9671-58 30 vials per carton / 5 vials per foil pouch NDC 0378-9671-30 30 vials per carton / 30 vials per foil pouch NDC 0378-9671-91 60 vials per carton / 5 vials per foil pouch NDC 0378-9671-60 60 vials per carton / 30 vials per foil pouch Store between 2°C and 25°C (36°F and 77°F). Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL
SULFATE SOLUTION
MYLAN PHARMACEUTICALS 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
sulfate (0.083%) in an isotonic, sterile, aqueous solution containing
sodium chloride and 1 N
hydrochloric acid to adjust to pH 4.
1
13
21
3
2
2
4
20
30
3
2
1
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