Rx Item-Ipratropium-Albuterol Bc 0.5 3Mg 3 Sol 60X3Ml By Nephron Gen Duoneb

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- ipratropium bromide and albuterol sulfate solution
Teva Pharmaceuticals USA Inc

DESCRIPTION

The active components in ipratropium bromide and albuterol sulfate inhalation solution are albuterol sulfate, USP and ipratropium bromide.

Albuterol sulfate, USP is a salt of racemic albuterol and a relatively selective ?2 -adrenergic bronchodilator chemically described as ?1 -[(tert-butylamino) methyl]-4-hydroxy-m-xylene-?,?'-diol sulfate (2:1) (salt). 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. It has the following structural formula:

albuterol chemical structure
(click image for full-size original)


(C13 H21 NO3 )2 �H2 SO4 M.W. 576.7

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 is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. It has the following structural formula:

Ipratropium Bromide chemical structure
(click image for full-size original)
C20 H30 BrNO3 �H2 O M.W. 430.4

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 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing disodium edetate dihydrate, hydrochloric acid, sodium chloride, and water for injection.

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 lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the nebulizer (with face mask or mouthpiece) connected to a compressor system, under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium bromide and albuterol sulfate inhalation solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).

CLINICAL PHARMACOLOGY

Ipratropium bromide and albuterol sulfate inhalation solution is a combination of the ?2 -adrenergic bronchodilator, albuterol sulfate, and the anticholinergic bronchodilator, ipratropium bromide.

Albuterol Sulfate
Mechanism of Action
The prime action of ?-adrenergic drugs is to stimulate adenyl cyclase, the enzyme that catalyzes the formation of cyclic-3?,5?-adenosine monophosphate (cAMP) from adenosine triphosphate (ATP). The cAMP thus formed mediates the cellular responses. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on ?2 -adrenergic receptors compared with isoproterenol. While it is recognized that ?2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicated that 10% to 50% of the ?-receptors in the human heart may be ?2 -receptors. The precise function of these receptors, however, is not yet established. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other ?-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients.

RX ITEM-Ipratropium-Albuterol Bc 0.5 3Mg
Item No.:RX248346/m, Item No. RX248346, 248346, NDC No.: 00487-0201-60, 00487-201-60, 0048720160, 00487020160, 0201-60, 020160 UPC No. 3-04870-20160-5, 304870-201605, 304870201605,

Ipratropium-Albuterol Bc 0.5 3Mg 3 Solut
Item No.:RX248346/m, Item No. RX248346, 248346, NDC No.: 00487-0201-60, 00487-201-60, 0048720160, 00487020160, 0201-60, 020160 UPC No. 3-04870-20160-5, 304870-201605, 304870201605,

IPRATROPIUM/ALBUTEROL SUL
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