IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

A-S Medication Solutions

Calea de administrare:

RESPIRATORY (INHALATION)

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 (IH-pruh-TROE-pee-uhm BROE-mide) and Albuterol Sulfate (al-BUE-ter-ol) Inhalation  Solution, USP 0.5 mg/3 mg *Equivalent to 2.5 mg albuterol base 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

Rezumat produs:

Product: 50090-6288 NDC: 50090-6288-0 3 mL in a VIAL / 30 in a CARTON

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE - IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
A-S MEDICATION SOLUTIONS
----------
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION, USP
0.5 MG/3 MG
*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 β2-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 molecular
formula is (C
H
NO ) •H SO . It is a white or practically white 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 molecular formula is C
H
BrNO •H O. It is a white to off-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 vial of ipratropium bromide and albuterol sulfate inhalation
solution contains 3
mg (0.1%) of albuterol sulfate USP (equivalent to 2.5 mg (0.083%) of
albuterol base) and
1
13
21
3 2
2
4
20
30
3
2
0.5 mg (0.017%) of ipratropium bromide USP in an isotonic, sterile,
aqueous solution
containing sodium chloride, hydrochloric acid to adjust to pH 4,
edetate disodium, USP
(a chelating agent) and water for injection.
Ipratropium bromide and albuterol sulfate inhalation solution is a
clear, colorless solut