Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E), IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)
REMEDYREPACK INC.
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
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.
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: 70518-2627-00 PACKAGING: 12 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
Abbreviated New Drug Application
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION REMEDYREPACK INC. ---------- 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 Les hele dokumentet