Rx Item-Cetirizine 1MG-ML 120 ML Sol by Heritage Pharma USA

CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride syrup
WOCKHARDT LLC.


DESCRIPTION

Cetirizine hydrochloride is an orally active and selective H1 -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 C21 H25 ClN2 O3 �2HCl. The molecular weight is 461.82 and the chemical structure is shown below:
Structure
(click image for full-size original)


Cetirizine hydrochloride is a white, crystalline powder and is water soluble.

CLINICAL PHARMACOLOGY

Mechanism of Actions
Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H1 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 H1 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 H1 receptors.

Pharmacokinetics
Absorption

max ) of approximately 1 hour following oral administration of tablets or syrup in adults. Comparable bioavailability was found between the tablet and syrup dosage forms. When healthy volunteers were administered multiple doses of cetirizine (10 mg tablets once daily for 10 days), a mean peak plasma concentration (Cmax ) of 311 ng/mL was observed. No accumulation was observed. Cetirizine pharmacokinetics were linear for oral doses ranging from 5 to 60 mg. Food had no effect on the extent of cetirizine exposure (AUC) but Tmax was delayed by 1.7 hours and Cmax was decreased by 23% in the presence of food.
Distribution
The mean plasma protein binding of cetirizine is 93%, independent of concentration in the range of 25 to 1000 ng/mL, which includes the therapeutic plasma levels observed.

Metabolism
A mass balance study in 6 healthy male volunteers indicated that 70% of the administered radioactivity was recovered in the urine and 10% in the feces.

Rx Item-Cetirizine 1MG-ML 120 ML Sol by
Item No. RX327085, 327085, NDC No.: 23155-0292-51, 23155-292-51, 2315529251, 23155029251, 0292-51, 029251 UPC No. 3-23155-29251-0, 323155-292510, 323155292510

Rx Item-Cetirizine 1MG-ML 120 ML Sol by
Item No. RX327085, 327085, NDC No.: 23155-0292-51, 23155-292-51, 2315529251, 23155029251, 0292-51, 029251 UPC No. 3-23155-29251-0, 323155-292510, 323155292510

Rx Item-Cetirizine 1MG-ML 120 ML Sol by
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