CETIRIZINE HYDROCHLORIDE- cetirizine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

CETIRIZINE HYDROCHLORIDE

Composition:

CETIRIZINE HYDROCHLORIDE 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Cetirizine hydrochloride oral solution, USP is a clear, colorless to pale yellow solution with a grape flavor. Each teaspoonful (5 mL) contains 5 mg cetirizine hydrochloride, USP. Cetirizine hydrochloride oral solution, USP is available as: 4 fl. oz (118 mL): NDC 65162-684-86 16 fl. oz (473 mL): NDC 65162-684-90 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F); [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2020-02

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE- CETIRIZINE SOLUTION
AMNEAL 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 -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, USP is a white, crystalline powder and is
water soluble. Cetirizine
hydrochloride oral solution, USP is a clear, colorless to pale yellow
solution containing
cetirizine hydrochloride, USP 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, grape flavor, methylparaben,
propylene glycol,
propylparaben, sodium acetate, 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
ABSORPTION: Cetirizine was rapidly absorbed with a time to maximum
concentration
(T
) of approximately 1 hour following administration of oral sol