Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Amneal Pharmaceuticals LLC
CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 5 mg in 5 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 is a clear, colorless to pale yellow solution with a grape flavor. Each teaspoonful (5 mL) contains 5 mg cetirizine hydrochloride, USP. Cetirizine hydrochloride oral solution, USP is available as: 4 fl. oz (118 mL): NDC 65162-684-86 16 fl. oz (473 mL): NDC 65162-684-90 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F); [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2020-02
Abbreviated New Drug Application
CETIRIZINE HYDROCHLORIDE- CETIRIZINE SOLUTION AMNEAL 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, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a clear, colorless to pale yellow solution containing cetirizine hydrochloride, USP 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 oral solution are: 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 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 approximately 1 hour following administration of oral sol Les hele dokumentet