البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Heritage Pharmaceuticals Inc.
CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 1 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Perennial Allergic Rhinitis : Cetirizine Hydrochloride Oral Solution, USP 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. Chronic Urticaria: Cetirizine Hydrochloride Oral Solution, USP 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 Oral Solution, USP 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 Oral Solution, USP 5 mg/5 mL (1 mg/mL) is a colorless to slightly yellow syrup supplied in bottles of 120 mL. Bottles of 120 ml NDC 23155-292-51 Cetirizine Hydrochloride Oral Solution, USP 5 mg/5 mL (1 mg/mL) is a colorless to slightly yellow syrup supplied in bottles of 480 ml. Bottles of 480 ml NDC 23155-292-52 Store at 20° to 25°C (68° to 77°F) F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Rx only Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Issued: 11/2016
Abbreviated New Drug Application
CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION HERITAGE PHARMACEUTICALS INC. ---------- CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP 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 or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Cetirizine Hydrochloride Oral Solution, USP 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: glacial acetic acid, grape flavor, glycerin, methylparaben, propylene glycol, propylparaben, sodium acetate, sucrose and purified water. CLINICAL PHARMACOLOGY _MECHANISM OF ACTION_ 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_ Absorption: Cetirizine was rapidly absorbed with a time to maximum concentration (T ) of approximate اقرأ الوثيقة كاملة