CETIRIZINE HYDROCHLORIDE solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Carilion Materials Management

INN (Alþjóðlegt nafn):

CETIRIZINE HYDROCHLORIDE

Samsetning:

CETIRIZINE HYDROCHLORIDE 1 mg in 1 mL

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

Product: 68151-1008 NDC: 68151-1008-2 1 mL in a PACKAGE

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION
CARILION MATERIALS MANAGEMENT
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_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.
PHARMACOKINETICS :
ABS ORPTION:
Cetirizine was rapidly absorbed with a time to maximum concentration
(Tmax) of approximately