IPRATROPIUM BROMIDE spray, metered

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Physicians Total Care, Inc.

Administreringsrute:

NASAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ipratropium bromide nasal solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold 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.

Produkt oppsummering:

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).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

IPRATROPIUM BROMIDE - IPRATROPIUM BROMIDE SPRAY, METERED
PHYSICIANS TOTAL CARE, INC.
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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
(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. 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% (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 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 165
sprays.
CLINICAL PHARMACOLOGY
Mechanism of Action
Ipratropium bromide is an anticholinergic agent that inhibits
vagally-mediated reflexes by antagonizing
the action of acetylcholine at the cholinergic receptor. 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 membrane and the blood-brain barrier,
resulting in a reduction of the systemic
anticholinergic effects (e.g., neurologic, ophthalmic, cardiovascular,
and gastrointestinal effects) that
are seen with tertiary anticholinergic amines.
Pharmacokinetics
Absorption: Ipratropium bromide is poorly absorbed into the systemic
circulation following oral
administration (2-3%). Less tha