Ipratropium Bromide and Albuterol Sulfate Inhalation 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:

A-S Medication Solutions

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. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg/3 mg per 3 mL  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. Storing your Medicine Store Ipratrop

Povzetek izdelek:

Product: 50090-2567 NDC: 50090-2567-0 30 mL in a POUCH / 1 in a CARTON

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL
SULFATE SOLUTION
A-S MEDICATION SOLUTIONS
----------
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION
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.
2
1
13
21
3 2
2
4
20
30
3
2
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.
*Equivalent to 2.5 mg albuterol base
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 S