CETIRIZINE HYDROCHLORIDE syrup

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

WOCKHARDT LLC.

Designación común internacional (DCI):

CETIRIZINE HYDROCHLORIDE

Composición:

CETIRIZINE HYDROCHLORIDE 1 mg in 1 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CETIRIZINE HYDROCHLORIDE - CETIRIZINE HYDROCHLORIDE SYRUP
WOCKHARDT LLC.
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CETIRIZINE HYDROCHLORIDE SYRUP
FOR ORAL USE
RX ONLY
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 an empirical
formula of C
H ClN O •2HCl.
The molecular weight is 461.82 and the chemical structure is shown
below:
Cetirizine hydrochloride is a white, crystalline powder and is water
soluble.
Cetirizine hydrochloride syrup is a clear colorless to slightly yellow
syrup containing cetirizine
hydrochloride 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 syrup are: banana flavor;
glacial acetic acid; glycerin; grape
flavor; methylparaben; propylene glycol; propylparaben; sodium
acetate; sucrose; and water.
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
1
21
25
2
3
1
1
1
ABSORPTION
Cetirizine was rapidly absorbed with a time to maximum concentration
(T
) of approximately 1 hour
following oral administration of tablets or syrup