IPRATROPIUM BROMIDE solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

St Marys Medical Park Pharmacy

INN (Mezinárodní Name):

IPRATROPIUM BROMIDE

Složení:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 2.5 mL

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

IPRATROPIUM BROMIDE - IPRATROPIUM BROMIDE SOLUTION
ST MARYS MEDICAL PARK PHARMACY
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IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02%
PRESCRIBING INFORMATION
RX ONLY
RPIN0020
Ipratropium Bromide Inhalation Solution, 0.02%
Prescribing Information
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
20
30
3
2
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 t