Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)
Physicians Total Care, Inc.
IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE 21 ug
NASAL
PRESCRIPTION DRUG
Ipratropium bromide nasal solution 0.03% (Nasal Spray) 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% (Nasal Spray) does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. Ipratropium bromide nasal solution 0.03% (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 0.03% (Nasal Spray) is supplied as 30 ml of solution in a high density polyethylene (HDPE) bottle fitted with a metered nasal spray pump, a safety clip to prevent accidental discharge of the spray, and a plastic dust cap. It contains 31.1 g of product formulation, 345 sprays, each delivering 21 mcg (70 μL) of ipratropium per spray, or 28 days of therapy at the maximum recommended dose (two sprays per nostril three times a day). Store tightly closed at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Avoid freezing. Keep out of reach of children. Do not spray in the eyes. Patients should be reminded to read and follow the accompanying Patient's Instructions For Use, which should be dispensed with the product.
Abbreviated New Drug Application
IPRATROPIUM BROMIDE - IPRATROPIUM BROMIDE SPRAY, METERED PHYSICIANS TOTAL CARE, INC. ---------- ATTENTION PHARMACIST: DETACH “PATIENT’S INSTRUCTIONS FOR USE” FROM PACKAGE INSERT AND DISPENSE WITH PRODUCT. RX ONLY DESCRIPTION The active ingredient in Ipratropium Bromide Nasal Solution 0.03% (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 (_endo,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 0.03% (Nasal Spray) is a metered-dose, manual pump spray unit which delivers 21 mcg (70 µL) ipratropium bromide per spray on an anhydrous basis in an isotonic aqueous solution with pH-adjusted to 4.7. It also contains benzalkonium chloride, edetate disodium, sodium chloride, sodium hydroxide, hydrochloric acid, and purified water. 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. 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., Izlasiet visu dokumentu