Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL), ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Eon Labs, Inc.
IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE 0.5 mg in 3 mL
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
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.
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 0185-7322-30 30 vials per carton/5 vials per foil pouch NDC 0185-7322-60 60 vials per carton/5 vials per foil pouch NDC 0185-7322-13 30 vials per carton/1 vial per foil pouch Store between 2°C and 25°C (36°F and 77°F). Protect from light. Manufactured By Dey Pharma, L.P. Napa, CA 94558 for Sandoz Inc., Princeton, NJ 08540 03-991-01 AUG 12
New Drug Application
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION EON LABS, INC. ---------- Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3.0 mg* Inhalation Solution *Equivalent to 2.5 mg albuterol base 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. FIG URE 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. FIG URE 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 deliv Läs hela dokumentet