CETIRIZINE HYDROCHLORIDE ORAL SOLUTION solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Torrent Pharma, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Perennial Allergic Rhinitis: Cetirizine Hydrochloride Oral Solution, USP 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 Oral Solution, USP 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 Oral Solution, USP 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.

Product summary:

Cetirizine Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/mL) is a colorless to slightly yellow oral solution supplied in bottles of 120 mL. Bottles of 120 mL NDC 13668-029-07 Cetirizine Hydrochloride Oral Solution, USP 5 mg/5 mL (1 mg/mL) is a colorless to slightly yellow oral solution supplied in bottles of 480 mL. Bottles of 480 mL NDC 13668-029-11

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE ORAL SOLUTION- CETIRIZINE HYDROCHLORIDE ORAL
SOLUTION SOLUTION
TORRENT PHARMA, INC.
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CETIRIZINE HYDROCHLORIDE ORAL SOLUTION
CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP
For Oral Use
Rx Only
DESCRIPTION
Cetirizine hydrochloride is an orally active and selective H1-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 C21H25ClN2O3 •2HCl. The molecular weight is
461.82 and the
chemical structure is shown below:
Cetirizine dihydrochloride is a white or almost white powder and is
freely soluble in water,
practically insoluble in acetone and in methylene chloride. Cetirizine
Hydrochloride Oral
Solution, USP 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: glacial acetic
acid, grape flavor, glycerin, methylparaben, propylene glycol,
propylparaben, sodium
acetate, sucrose and purified 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 H1
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 H1 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 H1 receptors.
PHARMACOKINETIC