Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
Cetirizine hydrochloride (UNII: 64O047KTOA) (cetirizine - UNII:YO7261ME24)
Padagis Israel Pharmaceuticals Ltd
Cetirizine hydrochloride
Cetirizine hydrochloride 1 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Perennial Allergic Rhinitis: Cetirizine hydrochloride 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 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 Oral Solution, USP 1 mg/mL is colorless to slightly yellow with a banana-grape flavor. Each 5 mL contains 5 mg cetirizine hydrochloride. Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL is available as follows: 120 mL amber plastic bottle (NDC 45802-626 -26) 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 PADAGIS ISRAEL PHARMACEUTICALS LTD ---------- CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP 1 MG/ML 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 oral solution, USP is a colorless to slightly yellow solution 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 solution are: banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, sodium acetate anhydrous, 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. 1 21 25 2 3 1 1 1 PHARMACOKINETICS: ABSORPTION: Cetirizine was rapidly absorbed with a time to maximum concentration (Tmax) Leggi il documento completo