CETIRIZINE HYDROCHLORIDE solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)

Disponível em:

Breckenridge Pharmaceutical, Inc.

DCI (Denominação Comum Internacional):

Cetirizine Hydrochloride

Composição:

Cetirizine Hydrochloride 1 mg in 1 mL

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

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).

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
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
1
21
25
2
3
1
1
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
approx