IPRATROPIUM BROMIDE spray, metered

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NORTHSTAR RX LLC

Administreringsrute:

NASAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ipratropium bromide nasal solution, 0.06% 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% 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% 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% 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 (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 So

Produkt oppsummering:

Ipratropium Bromide Nasal Solution, 0.06% 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 16714-527-01). It contains 16.6 g of product formulation, 165 sprays, each delivering 42 mcg of ipratropium bromide per spray (70 mcL), or 10 days of therapy at the maximum recommended dose (two sprays per nostril four times a day). Store tightly closed at 20° to 25°C (68° to 77°F) [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

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SPRAY, METERED
NORTHSTAR RX LLC
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IPRATROPIUM BROMIDE NASAL SOLUTION, 0.06%NASAL SPRAY RX ONLY
_ATTENTION PHARMACIST: DETACH "PATIENT'S INSTRUCTIONS FOR USE" FROM_
_PACKAGE INSERT AND DISPENSE WITH THE PRODUCT._
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. Its structural formula is:
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, 0.06% is a metered-dose, manual
pump spray unit
which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per
spray (70 mcL)
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 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 blood-brain barrier, resulting in a
reduction of the
systemic anticholinergic effects (e.g., neurologic, ophthalmic,
cardiovasc