Overview
DESCRIPTION Cetirizine hydrochloride, USP 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 a molecular formula of C 21 H 25 ClN 2 O 3 •2HCl. The molecular weight is 461.
Mechanism of Action
CLINICAL PHARMACOLOGY 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.
Indications
- INDICATIONS AND USAGE 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...
Common Doses
- 2.5 mg
- 5 mg
Dosage
DOSAGE AND ADMINISTRATION Cetirizine hydrochloride oral solution, USP can be taken without regard to food consumption. Children 2 to 5 Years for Chronic Urticaria: The recommended initial dose of cetirizine hydrochloride oral solution, USP in children aged 2 to 5 years is 2.5 mg (½ teaspoonful) oral solution once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful oral solution once a day or one ½ teaspoonful oral solution given every 12 hours. Children 6 months to
Contraindications
- CONTRAINDICATIONS Cetirizine hydrochloride oral solution, USP is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.
Side Effects
- ADVERSE REACTIONS Pediatric studies were conducted with cetirizine hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with cetirizine hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks. Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received cetirizine, the majority of whom received single daily doses of 5 mg.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.