Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)
REMEDYREPACK INC.
IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 3 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION REMEDYREPACK INC. ---------- 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 Sulfa Przeczytaj cały dokument