ATROVENT 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:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (Международно Name):

IPRATROPIUM BROMIDE

Композиция:

IPRATROPIUM BROMIDE ANHYDROUS 42 ug

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

New Drug Application

Данни за продукта

ATROVENT- IPRATROPIUM BROMIDE SPRAY, METERED
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
ATROVENT
(IPRATROPIUM BROMIDE)
NASAL SPRAY 0.06%
42 MCG/SPRAY
_ATTENTION PHARMACIST: DETACH "PATIENT'S INSTRUCTIONS FOR USE" FROM
PACKAGE INSERT AND_
_DISPENSE WITH THE PRODUCT._
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
The active ingredient in ATROVENT Nasal Spray is ipratropium bromide
(as the 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. The
structural formula is:
C
H BrNO •H Oipratropium bromide 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.
ATROVENT Nasal Spray 0.06% 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,
®
20
30
3
2
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 re