IPRATROPIUM BROMIDE spray, metered

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Physicians Total Care, Inc.

INN (International Name):

IPRATROPIUM BROMIDE

Sammensætning:

IPRATROPIUM BROMIDE 21 ug

Indgivelsesvej:

NASAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

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.,