IPRATROPIUM BROMIDE spray, metered

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)

Commercializzato da:

NORTHSTAR RX LLC

Via di somministrazione:

NASAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

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  

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

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