Each film coated tablet contains Cetirizine dihydrochloride 10 mg.
Pharmacology: Pharmacodynamics: In experimental animals, cetirizine has been shown to be an anti-H1 agent devoid of any significant anticholinergic or antiserotonin effects. At pharmacologically active doses, it induces neither sedation nor behavioral changes. This may be explained by the fact that cetirizine does not cross the blood-brain barrier.
It was shown in human pharmacology studies that cetirizine will inhibit certain effects produced by exogenous histamine. This activity appears rapidly. Cetirizine also inhibits the effects produced by endogenous histamine released in vivo by an agent.
It inhibits the cutaneous reaction induced by VIP (Vasoactive Intestinal Polypeptide) and substance P, neuropeptides which are believed to take part in the allergic reaction.
Cetirizine inhibits the histamine-mediated "early" phase of the cutaneous allergic reaction. It also significantly reduces the migration of inflammatory cell such as eosinophils and the release of mediators associated with the "late" cutaneous allergic response.
Cetirizine markedly reduces bronchial hyperreactivity to histamine in the asthmatic patient. It also reduces the allergic reaction induced by specific allergens. These effects are obtained without any central effects being demonstrated either by psychometric tests or by a quantified EEG.
Peak blood levels are reached within one hour after oral administration of cetirizine. The plasma half-life is approximately 10 hours in adults, 6 hours in children aged 6 to 12 years, and 5 hours in children aged 2 to 6 years. These data are consistent with the urinary excretion half-life to the drug. The cumulative urinary excretion represents about two thirds of the dose given in both adults and children. Consequently, the apparent plasma clearance in children is higher than that measured in adults.
Pharmacokinetics: Absorption is very consistent from on subject to the next.
Plasma levels are linearly related to the dose given.
Cetirizine is strongly bound to plasma proteins.
Symptomatic treatment of seasonal rhinitis and conjunctivitis, perennial allergic rhinitis as well as pruritus and urticaria of allergic origin and insect bites.
Adults and Children 6 years of age and over: 1 tablet (10 mg) once daily.
Children 2 to 6 years: 1/2 tablet (5 mg) once daily.
It is advisable to take the drug with a little liquid during the evening meal since the symptoms for which the product is given usually appear during the night. In patients affected by side-effects, the dose may be taken as divided doses in the morning and in the evening.
Drowsiness can be a symptom of overdosage occurring from administration of 50 mg as a single dose to dated, there is no specific antidote. In the case of massive overdosage gastric lavage should be performed as soon as possible. Apart from the usual supportive measures, all vital parameters have to be monitored regularly.
Hypersensitivity to an ingredient of the product.
Teratology studies in animals have not demonstrated any special adverse effects. As a precaution, however, cetirizine should not be administered to pregnant women during the first three months of pregnancy, nor should women who are breastfeeding take the drug.
There have been occasional reports of mild and transient subjective side-effects, such as headache, dizziness, drowsiness, agitation, dry mouth and gastro-intestinal discomfort. In objective tests of psychomotor function, the incidence of sedation with cetirizine was similar to that of placebo.
Very occasionally symptoms of hypersensitivity have been reported.
Store at room temperature (23-32°C).
R06AE07 - cetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Tab 10 mg x 10 x 10's, 50 x 10's.