CETIRIZINE HYDROCHLORIDE- 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:

Heritage Pharmaceuticals Inc.

INN (International Name):

CETIRIZINE HYDROCHLORIDE

Composition:

CETIRIZINE HYDROCHLORIDE 1 mg in 1 mL

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 (1 mg/mL)  is a colorless to slightly yellow syrup supplied in bottles of 120 mL. Bottles of 120 ml NDC 23155-292-51 Cetirizine Hydrochloride Oral Solution, USP 5 mg/5 mL (1 mg/mL) is a colorless to slightly yellow syrup supplied in bottles of 480 ml. Bottles of 480 ml NDC 23155-292-52 Store at 20° to 25°C (68° to 77°F) F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Rx only Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Issued: 11/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE SOLUTION
HERITAGE PHARMACEUTICALS INC.
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CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP
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 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 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:
glacial acetic acid, grape flavor, glycerin, methylparaben, propylene
glycol, propylparaben, sodium
acetate, sucrose and purified 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 significantly
occupy cerebral H
receptors.
_PHARMACOKINETICS_
Absorption: Cetirizine was rapidly absorbed with a time to maximum
concentration (T
) of
approximate