CETIRIZINE HYDROCHLORIDE solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

PAI Holdings, LLC dba PAI Pharma

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:

Cetirizine hydrochloride oral solution USP, 1 mg/mL is a clear, colorless to slightly yellow solution. Each teaspoon (5 mL) contains 5 mg cetirizine hydrochloride.  Cetirizine hydrochloride oral solution USP, 1 mg/mL is supplied as follows: 120 mL amber PET modern round bottle NDC 0121-0874-04 480 mL amber PET modern round bottle NDC 0121-0874-16 STORAGE: Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION
PAI HOLDINGS, LLC DBA PAI PHARMA
----------
CETIRIZINE HYDROCHLORIDE ORAL SOLUTION USP
1 MG/ML
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 clear, 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 oral solution
are: glacial acetic acid; glycerin; methylparaben; propylene glycol;
propylparaben; sodium
acetate; sucrose; and water.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
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
1
21
25
2
3
1
1
significantly occupy cerebral H receptors.
PHARMACODYNAMICS
Cetirizine hydrochloride at doses of 5 and 10 mg strongly inhibited
the wheal and flare
caused by intradermal injection of histamine in 19