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:

Chartwell RX, 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 fruity or grape flavor. Each teaspoon (5 mL) contains 5 mg cetirizine hydrochloride. Cetirizine Hydrochloride Oral Solution, USP is supplied as follows: NDC 62135-058-41 (Fruity Flavor) 120 mL bottles NDC 62135-058-47 (Fruity Flavor) 473 mL bottles NDC 62135-057-41 (Grape Flavor) 120 mL bottles NDC 62135-057-47 (Grape Flavor) 473 mL bottles STORAGE: 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]. Manufactured by: Chartwell Pharmaceuticals Carmel, LLC. Carmel, NY 10512 Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Rev. 06/2022 L70915

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE ORAL SOLUTION- CETIRIZINE HYDROCHLORIDE ORAL
SOLUTION SOLUTION
CHARTWELL RX, LLC
----------
CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP
_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
C N
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 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 - FRUITY FLAVOR: calcium
acetate; fruity
flavor; glacial acetic acid; glycerin; methylparaben; propylene
glycol; propylparaben; and
water.
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
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
1
21
25
l
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