IPRATROPIUM BROMIDE solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Unit Dose Services

INN (International Name):

IPRATROPIUM BROMIDE

Sammensætning:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 2.5 mL

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION
UNIT DOSE SERVICES
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IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02% PRESCRIBING INFORMATION
RX ONLY RPIN0020
DESCRIPTION
The active ingredient, ipratropium bromide monohydrate, USP, is an
anticholinergic bronchodilator
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. +
Ipratropium Bromide Monohydrate C H BrNO •H O Mol.Wt. 430.4
Ipratropium bromide is a white crystalline substance, freely soluble
in water and lower alcohols. It is a
quaternary ammonium compound and thus exists in an ionized state in
aqueous solutions. It is relatively
insoluble in non-polar media.
Ipratropium Bromide Inhalation Solution is administered by oral
inhalation with the aid of a nebulizer. It
contains ipratropium bromide, USP 0.02% (anhydrous basis) in a
sterile, preservative-free, isotonic
saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid.
CLINICAL PHARMACOLOGY
Ipratropium bromide is an anticholinergic (parasympatholytic) agent
that, based on animal studies,
appears to inhibit vagally mediated reflexes by antagonizing the
action of acetylcholine, the transmitter
agent released from the vagus nerve.
Anticholinergics prevent the increases in intracellular concentration
of cyclic
guanosine monophosphate (cyclic GMP) that are caused by interaction of
acetylcholine with the
muscarinic receptor on bronchial smooth muscle.
The bronchodilation following inhalation of ipratropium bromide is
primarily a local, site-specific
effect, not a systemic one. Much of an administered dose is swallowed
but not absorbed, as shown by
fecal excretion studies. Following nebulization of a 2 mg dose, a mean
7% of the dose was absorbed
into the systemic circulation either from the surface of the lung or
from the gastrointestinal tract. The
half-life of elimination is about 1.6 hours after intravenous