CETIRIZINE HYDROCHLORIDE solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

Cetirizine hydrochloride (UNII: 64O047KTOA) (cetirizine - UNII:YO7261ME24)

Предлага се от:

Padagis Israel Pharmaceuticals Ltd

INN (Международно Name):

Cetirizine hydrochloride

Композиция:

Cetirizine hydrochloride 1 mg in 1 mL

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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.

Каталог на резюме:

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).

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

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)