IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Cardinal Health 107, LLC

INN (International namn):

IPRATROPIUM BROMIDE

Sammansättning:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 3 mL

Administreringssätt:

RESPIRATORY (INHALATION)

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

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 vials in pouch until time of use. Supplied in cartons as listed below. Available overbagged with 5 vials per bag, NDC 55154-4357-5 PROTECT FROM LIGHT. The unit-dose vial should remain stored in the protective foil pouch until time of use. Store between 2° and 25° C (36° and 77° F). Protect from light. Rx Only Manufactured by: Nephron Pharmaceuticals Corporation West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313 Distributed by: Cardinal Health Dublin, OH 43017 L4098505-10319 L4098505-20319

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
CARDINAL HEALTH 107, LLC
----------
IPRATROPIUM BROMIDE 0.5 MG AND ALBUTEROL SULFATE 3 MG* INHALATION
SOLUTION
*Equivalent to 2.5 mg albuterol base.
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’s recommended name for albuterol base is
salbutamol.
Ipratropium bromide is an anticholinergic bronchodilator chemically
described as 8-
azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-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.
Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation
Solution contains
2
1
13
21
3
2
2
4
20
30
3
2
3 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 and 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 t