IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Physicians Total Care, Inc.

INN (Algemene Internationale Benaming):

IPRATROPIUM BROMIDE

Samenstelling:

IPRATROPIUM BROMIDE 0.5 mg

Toedieningsweg:

RESPIRATORY (INHALATION)

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

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 54868-5974-0    30 vials per carton/5 vials per foil pouch Store between 2°C and 25°C (36°F and 77°F). Protect from light. Manufactured By Dey, L.P. Napa, CA 94558 for Sandoz Inc., Princeton, NJ 08540 03-738-02 Feb. 09 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK      74146

Autorisatie-status:

New Drug Application

Productkenmerken

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE - IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
PHYSICIANS TOTAL CARE, INC.
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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.
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.
Figure 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 delivered to
the lungs will depend on patient
factors, the jet nebulizer utilized, and compressor performan