Prixlae

Prixlae

cetirizine

Manufacturer:

Shou Chan

Distributor:

New Smart Formulae
Full Prescribing Info
Contents
Cetirizine dihydrochloride.
Description
Each film-coated tablet contains Cetirizine dihydrochloride 10 mg. Each syrup contains Cetirizine dihydrochloride 1 mg/mL.
Action
Pharmacology: Pharmacodynamics: Cetirizine is a long-acting antihistamine. The drug has been characterized as a selective peripheral H1-receptor antagonist. Cetirizine is a human metabolite of hydroxyzine. Cetirizine does not possess appreciable anticholinergic or antiserotonergic effects, although the incidence of dry mouth in clinical trials was higher in patients receiving cetirizine than in those receiving placebo. In vitro receptor binding studies have no measurable affinity for other than H1 receptors. Autoradiographic studies with radiolabelled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systematically administered cetirizine does not significantly occupy cerebral H1 receptors.
Indications/Uses
It is used for the symptomatic relief of allergic conditions including seasonal rhinitis catarrh, allergic rhinitis, urticaria and allergic pruritus.
Dosage/Direction for Use
FC tab Childn 2-6 year and Over: 10 mg daily.
Syr Adult & childn ≥12 year: 10 mL once daily. 6-12 year: 10 mL once daily or 5 mL twice daily. 2-6 year: 5 mL once daily.
Contraindications
Cetirizine is contraindicated in patients who are hypersensitive to the drug or any ingredient in the formulation.
Special Precautions
Because somnolence has been reported in some individuals in clinical studies, patients should be warned that the drug may impair their ability to perform hazardous activities requiring mental alertness or physical coordination (e.g. operating machinery, driving a motor vehicle). In addition, patients should be warned that additive CNS depression may occur when cetirizine is administered concomitantly with other CNS depressants, including alcohol.
Adverse Reactions
Most adverse reactions reported during therapy with cetirizine were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving cetirizine 10 mg was not significantly different from placebo. The most common adverse reactions in patients aged 12 years and older that occurred more frequently on cetirizine than placebo was somnolence. Fatigue, dry mouth, pharyngitis, dizziness, headache and nausea also appeared to be treatment-related adverse reactions.
Drug Interactions
No interactions were observed in pharmacokinetic interaction studies when cetirizine was used concomitantly with pseudoephedrine or antipyrine.
Storage
Store below 30°C.
ATC Classification
R06AE07 - cetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Presentation/Packing
FC tab 10 mg x 100's. Syr 1 mg/mL x 60 mL.
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