CETIRIZINE HYDROCHLORIDE solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)

Fáanlegur frá:

Nostrum Laboratories, Inc.

INN (Alþjóðlegt nafn):

CETIRIZINE HYDROCHLORIDE

Samsetning:

CETIRIZINE HYDROCHLORIDE 1 mg in 1 mL

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION
NOSTRUM LABORATORIES, INC.
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DESCRIPTION
Cetirizine hydrochloride is an orally active and selective H -receptor
antagonist. The chemical name is
(±) - [2- [4- [ (4-chlorophenyl)phenylmethyl] -1- piperazinyl]
ethoxy]acetic acid, dihydrochloride.
Cetirizine hydrochloride is a racemic compound with a molecular
formula of C
H ClN O •2HCl.
The molecular weight is 461.82 and the chemical structure is shown
below:
Cetirizine hydrochloride, USP is a white, crystalline powder and is
water soluble.
Cetirizine hydrochloride oral solution, USP is a colorless to slightly
yellow oral solution containing
cetirizine hydrochloride, USP at a concentration of 1 mg/mL (5 mg/5
mL) for oral administration. The
pH is between 4 and 5. The inactive ingredients of the oral solution
are: artificial grape flavor, glacial
acetic acid, glycerin, methylparaben, purified water, propylene
glycol, propylparaben, sodium acetate,
and sucrose.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTIONS
Cetirizine, a human metabolite of hydroxyzine, is an antihistamine;
its principal effects are mediated via
selective inhibition of peripheral H receptors. The antihistaminic
activity of cetirizine has been clearly
documented in a variety of animal and human models. _In vivo_ and _ex
vivo_ animal models have shown
negligible anticholinergic and antiserotonergic activity. In clinical
studies, however, dry mouth was
more common with cetirizine than with placebo. _In vitro_ receptor
binding studies have shown no
measurable affinity for other than H receptors. Autoradiographic
studies with radiolabeled cetirizine
in the rat have shown negligible penetration into the brain. _Ex vivo_
experiments in the mouse have shown
that systemically administered cetirizine does not significantly
occupy cerebral H receptors.
PHARMACOKINETICS
ABS ORPTION
Cetirizine was rapidly absorbed with a time to maximum concentration
(T
of approximately 1 hour
following oral administration of tablets or oral solution in adults.
C