CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Caraco Pharmaceutical Laboratories, Ltd.

INN (International Name):

CETIRIZINE HYDROCHLORIDE

Composition:

CETIRIZINE HYDROCHLORIDE 1 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cetirizine hydrochloride syrup 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. Cetirizine hydrochloride syrup is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus. Cetirizine hydrochloride syrup 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 syrup is colorless to slightly yellow with a grape flavor. Each teaspoon (5 mL) contains 5 mg cetirizine hydrochloride. Cetirizine hydrochloride syrup is supplied as follows: NDC 57664-181-31               4 fl. oz. (120 mL) amber glass bottles NDC 57664-181-34               16 fl. oz. (473 mL) amber glass bottles STORAGE: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]; or store refrigerated, 2- 8°C (36-46°F). Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, Michigan 48202 Manufactured by: SUN Pharmaceutical Industries, Inc. Bryan, Ohio 43506 6007T01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE - CETIRIZINE HYDROCHLORIDE SYRUP
CARACO PHARMACEUTICAL LABORATORIES, LTD.
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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 molecular
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, crystalline powder and is water
soluble.
Cetirizine hydrochloride syrup 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: artificial grape
flavor, glacial acetic acid, glycerin,
methylparaben, purified water, propylene glycol, propylparaben, sodium
acetate, and sucrose.
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 oral administration of tablets or syrup in adults.
Comparable bioavailability was fo