Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)
NORTHSTAR RX LLC
NASAL
PRESCRIPTION DRUG
Ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Ipratropium bromide nasal solution, 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. Ipratropium bromide nasal solution, 0.03% 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, 0.03% Nasal Spray (ip" ra troe' pee um broe' mide) Rx Only Read complete instructions carefully before using. In order to ensure proper dosing, do not attempt to change the size of the spray opening. Ipratropium Bromide Nasal Solution, 0.03% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Ipratropium Bromide Nasal Solu
Ipratropium bromide nasal solution, 0.03% is supplied in a white high density polyethylene (HDPE) bottle fitted with a metered nasal spray pump, a green safety clip to prevent accidental discharge of the spray, and a clear plastic dust cap (NDC 16714-526-01). It contains 31.1g of product formulation, 345 sprays, each delivering 21 mcg (70 mcL) of ipratropium bromide per spray, or 28 days of therapy at the maximum recommended dose (two sprays per nostril three times a day). Store tightly closed at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Avoid freezing. Keep out of reach of children. Do not spray in the eyes. Address medical inquiries to Northstar Rx LLC at 1-800-206-7821 Patients should be reminded to read and follow the accompanying “Patient’s Instructions for Use”, which should be dispensed with the product. December 2021
Abbreviated New Drug Application
IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SPRAY, METERED NORTHSTAR RX LLC ---------- PRESCRIBING INFORMATION IPRATROPIUM BROMIDE NASAL SOLUTION, 0.03% NASAL SPRAY RX ONLY DESCRIPTION The active ingredient in ipratropium bromide nasal solution 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 (_endo, syn_)-, (+)-: a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula is: ipratropium bromide C H BrNO •H O monohydrate Mol. Wt. 430.4 Ipratropium bromide is a white to off-white, crystalline substance. It is freely soluble in lower alcohols and water, existing in an ionized state in aqueous solutions, and relatively insoluble in non-polar media. Ipratropium bromide nasal solution, 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg (70 mcL) ipratropium bromide per spray on an anhydrous basis in an isotonic, aqueous solution. It also contains the following inactive ingredients: benzalkonium chloride, edetate disodium, purified water and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH to 4.5 to 4.9. Each bottle contains 345 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. 20 30 3 2 In humans, ipratropium bromide has antisecretory 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 reduction of the systemic anticholinergic effects (e.g., neurologic, ophthalmic, cardiovascular, and gastroin Izlasiet visu dokumentu