IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- 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:

Eon Labs, Inc.

INN (International Name):

IPRATROPIUM BROMIDE

Composition:

IPRATROPIUM BROMIDE 0.5 mg in 3 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ipratropium Bromide and Albuterol Sulfate is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator. Ipratropium Bromide and Albuterol Sulfate is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.

Product summary:

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3.0 mg 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 0185-7322-30 30 vials per carton/5 vials per foil pouch NDC 0185-7322-60 60 vials per carton/5 vials per foil pouch NDC 0185-7322-13 30 vials per carton/1 vial per foil pouch Store between 2°C and 25°C (36°F and 77°F). Protect from light. Manufactured By Dey Pharma, L.P. Napa, CA 94558 for Sandoz Inc., Princeton, NJ 08540 03-991-01 AUG 12

Authorization status:

New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL
SULFATE SOLUTION
EON LABS, INC.
----------
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3.0 mg* Inhalation
Solution
*Equivalent to 2.5 mg albuterol base
DESCRIPTION
The active components 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.
FIG URE 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.
FIG URE 3.1-2. CHEMICAL STRUCTURE OF IPRATROPIUM BROMIDE.
Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate contains
3.0 mg (0.1%) of albuterol
sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg
(0.017%) of ipratropium bromide
in an isotonic, sterile, aqueous solution containing sodium chloride,
hydrochloric acid to adjust to pH 4,
and edetate disodium, USP (a chelating agent).
Ipratropium Bromide and Albuterol Sulfate 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 deliv