IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Proficient Rx LP

Pot uporabe:

RESPIRATORY (INHALATION)

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

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. 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 Orlando, FL  32811 For Customer Service, Call 1-800-443-4313 Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
PROFICIENT RX LP
----------
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 to the lu