CETIRIZINE HYDROCHLORIDE solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)

Disponibil de la:

Taro Pharmaceuticals U.S.A., Inc.

INN (nume internaţional):

Cetirizine Hydrochloride

Compoziție:

Cetirizine Hydrochloride 1 mg in 1 mL

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

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).

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION
TARO PHARMACEUTICALS U.S.A., INC.
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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