Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Aidarex Pharmaceuticals LLC
ORAL
PRESCRIPTION DRUG
Cetirizine hydrochloride oral solution 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 oral solution 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 teaspoonful (5 mL) contains 5 mg cetirizine hydrochloride. Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, is supplied as follows: 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 ORAL SOLUTION, USP _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 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 or Leggi il documento completo