CETIRIZINE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aventura Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Perennial Allergic Rhinitis: 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. Chronic Urticaria: 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.

Product summary:

Cetirizine Hydrochloride Oral Solution, USP is colorless to slightly yellow and available in grape flavor. Each teaspoon (5 mL) contains 5 mg cetirizine hydrochloride. Cetirizine Hydrochloride Oral Solution, USP is supplied as follows: NDC 69206-990-01 (Grape Flavor) 120 mL bottles

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION
AVENTURA PHARMACEUTICALS, LLC
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CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP
_FOR ORAL USE_
_RX ONLY_
DESCRIPTION
Cetirizine hydrochloride is an orally active and selective H
1-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 21H 25C lN 2O 3•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 syrup
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 syrup are:
CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP - GRAPE FLAVOR: calcium
acetate;
glacial acetic acid; glycerin; grape flavor; methylparaben; propylene
glycol;
propylparaben; 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 1
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 1
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 1 receptors.
PHARMACOKINETICS:
ABSORPTION: Cetirizine was rapidly absorbed with a time to maximum
concentration (T
max) of approxi