Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
WOCKHARDT LLC.
CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 1 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Abbreviated New Drug Application
CETIRIZINE HYDROCHLORIDE - CETIRIZINE HYDROCHLORIDE SYRUP WOCKHARDT LLC. ---------- 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 Lire le document complet