CETIRIZINE HYDROCHLORIDE solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Aidarex Pharmaceuticals LLC

INN (Nome Internazionale):

CETIRIZINE HYDROCHLORIDE

Composizione:

CETIRIZINE HYDROCHLORIDE 1 mg in 1 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Cetirizine hydrochloride syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Cetirizine hydrochloride syrup is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus. Cetirizine hydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine. There is no information to indicate that abuse or dependency occurs with cetirizine hydrochloride.

Dettagli prodotto:

Cetirizine hydrochloride syrup, 1 mg/1 mL, is colorless to slightly yellow with a banana-grape flavor. Each teaspoon (5 mL) contains 5 mg cetirizine hydrochloride. Cetirizine hydrochloride syrup, 1 mg/1 mL, is supplied as follows: 480 MILLILITER in a BOTTLE, GLASS (53217-163-01) Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880 Store at 20–25°C (68–77°F);  excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]; or Store refrigerated, 2–8°C (36–46°F).

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION
AIDAREX PHARMACEUTICALS 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 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 anti-serotonergic 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
Absorption
Cetirizine was rapidly absorbed with a time to maximum concentration
(T
) of approximately 1 hour
following oral administration of tablets or syrup in a