국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)
Boehringer Ingelheim Pharmaceuticals, Inc.
IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE ANHYDROUS 42 ug
PRESCRIPTION DRUG
New Drug Application
ATROVENT- IPRATROPIUM BROMIDE SPRAY, METERED BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. ---------- ATROVENT (IPRATROPIUM BROMIDE) NASAL SPRAY 0.06% 42 MCG/SPRAY _ATTENTION PHARMACIST: DETACH "PATIENT'S INSTRUCTIONS FOR USE" FROM PACKAGE INSERT AND_ _DISPENSE WITH THE PRODUCT._ RX ONLY PRESCRIBING INFORMATION DESCRIPTION The active ingredient in ATROVENT Nasal Spray is ipratropium bromide (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2- phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (3-endo, 8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula is: C H BrNO •H Oipratropium bromide Mol. Wt. 430.4 Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. ATROVENT Nasal Spray 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 µL) in an isotonic aqueous solution, pH- adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, sodium chloride, and purified water. Each bottle contains 165 sprays. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, based on animal studies, ® 20 30 3 2 appears to inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at the neuromuscular junctions in the lung. In humans, ipratropium bromide has anti- secretory properties and, when applied locally, inhibits secretions from the serous and seromucous glands lining the nasal mucosa. Ipratropium bromide is a quaternary amine that minimally crosses the nasal and gastrointestinal membranes and the blood-brain barrier, resulting in a re 전체 문서 읽기