IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

REMEDYREPACK INC.

Njia ya uendeshaji:

RESPIRATORY (INHALATION)

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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.

Bidhaa muhtasari:

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is supplied as a 3-mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Each 3-mL vial contains 3 mg albuterol sulfate (0.083%)* and 0.5 mg ipratropium bromide (0.017%). Store in pouch until time of use. Supplied in cartons as listed below. *Equivalent to 2.5 mg albuterol base NDC: 70518-2351-00 PACKAGING: 6 in 1 CARTON, 5 in 1 POUCH, 3 mL in 1 VIAL TYPE 0 Store at 20°C to 25° C (68°F to 77° F) [See USP Controlled Room Temperature]. Protect from light. Unit-dose vials should remain stored in the protective foil pouch at all times. Once removed from the foil pouch, the individual vials should be used within one week. Discard if the solution is not colorless. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
REMEDYREPACK INC.
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IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION, USP
DESCRIPTION
The active components in Ipratropium Bromide and Albuterol Sulfate
Inhalation Solution,
USP are albuterol sulfate and ipratropium bromide.
Albuterol sulfate, is a salt of racemic albuterol and a relatively
selective β
-adrenergic
bronchodilator chemically described as
α1-[(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
13
21
3
2
2
4
20
30
3
2
Figure 3. 1-2. Chemical structure of ipratropium bromide.
Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation
Solution, USP
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 Inhalation Solution USP is a
clear, colorless
solution. It does not require dilution prior to administration by
nebulization. For
Ipratropium Br