IPRATROPIUM BROMIDE spray, metered

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Rebel Distributors Corp

INN (Международно Name):

IPRATROPIUM BROMIDE

Композиция:

IPRATROPIUM BROMIDE 42 ug

Начин на приложение:

NASAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

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)

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SPRAY, METERED
REBEL DISTRIBUTORS CORP
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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