Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Taro Pharmaceuticals U.S.A., Inc.
Cetirizine Hydrochloride
Cetirizine Hydrochloride 1 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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. 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, 5 mg/5 mL (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 is supplied as follows: 120 mL plastic bottles NDC 51672-4070-8 Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]; or Store refrigerated, 2° to 8°C (36° to 46°F).
Abbreviated New Drug Application
CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION TARO PHARMACEUTICALS U.S.A., INC. ---------- CETIRIZINE HYDROCHLORIDE ORAL SOLUTION USP, 5 MG/5 ML (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 is a colorless to slightly yellow oral 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 oral solution are: artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose. 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 1 21 25 2 3 1 1 shown that systemically administered cetirizine does not significantly occupy cerebral H receptors. PHARMACOKINETICS Absorption Cetirizine was rapidly absor Les hele dokumentet