País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)
Rebel Distributors Corp
IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE 42 ug
NASAL
PRESCRIPTION DRUG
Ipratropium bromide nasal solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide nasal solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of ipratropium bromide nasal solution 0.06% (Nasal Spray) beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established. Ipratropium bromide nasal solution 0.06% (Nasal Spray) is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray). Read complete instructions carefully before using. In order to ensure proper dosing, do not attempt to change the size of the spray opening. Ipratropium brom
Ipratropium bromide nasal solution 0.06% (Nasal Spray) is supplied in a white high density polyethylene (HDPE) bottle fitted with a metered nasal spray pump, a safety clip to prevent accidental discharge of the spray, and a clear plastic dust cap. It contains 16.6 g of product formulation, 165 sprays, each delivering 42 mcg of ipratropium bromide per spray (70 μL), or 10 days of therapy at the maximum recommended dose (two sprays per nostril four times a day). (NDC 42254-355-15)
Abbreviated New Drug Application
IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SPRAY, METERED REBEL DISTRIBUTORS CORP ---------- IPRATROPIUM BROMIDE NASAL SOLUTION 0.06% (NASAL SPRAY) ATTENTION PHARMACIST: DETACH “PATIENT’S INSTRUCTIONS FOR USE” FROM PACKAGE INSERT AND DISPENSE WITH PRODUCT. PRESCRIBING INFORMATION RX ONLY DESCRIPTION The active ingredient in Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is ipratropium bromide 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. Its structural formula is: ipratropium bromide monohydrate C H BrNO • H O 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. Ipratropium bromide nasal solution 0.06% (Nasal Spray) 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, 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 blo Leer el documento completo