מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Aidarex Pharmaceuticals LLC
CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 1 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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.
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).
Abbreviated New Drug Application
CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION AIDAREX PHARMACEUTICALS 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 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 קרא את המסמך השלם