Cetirizine dihydrochloride.
Pharmacotherapeutic group: Antihistamine (H1-Receptor).
Pharmacology: In animals, Cetihis has been shown to be an anti-H1 agent devoid of any significant anticholinergic or antiserotonin effects. At active doses, it does not induce sedation or behavioral changes.
Cetihis will inhibit certain effects produced by exogenous histamine. Cetihis also inhibits the effects produced by endogenous histamine released in vivo. It inhibits the cutaneous reaction induced by Vasoactive Intestinal Polypeptide and substance P. neuropeptides.
Cetihis inhibits the histamine-induced "early" phase of the allergic reaction. It also significantly reduces the migration of inflammatory cells e.g., eosinophils and the release of mediators associated with the "'late" allergic response.
Cetihis reduces bronchial hyper reactivity to histamine in the asthmatic patient. It also reduces the allergic reaction induced by specific allergens. These effects are obtained without any central effects.
Pharmacokinetics: Peak blood levels reached between 30 and 60 minutes after administration of 10 mg Cetihis. It is strongly bound to plasma proteins.
Adults and children > 3 years: Symptomatic treatment of seasonal rhinitis, perennial allergic rhinitis and urticaria of allergic origin.
Oral.
Adult: 10 mg once daily.
Children: > 6 years: 10 mg daily, either 5 mg twice daily or 10 mg once daily;
3-6 years: 5 mg daily, either 2.5 mg twice daily or 5 mg once daily.
Patients with Renal Insufficiency: Dosage should be reduced to 1/2 the daily dose.
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 5 mg in the morning and 5 mg in the evening.
Oral solution: 10 mL solution = 10 mg or 5 mL solution = 5 mg or 2.5 mL solution = 2.5 mg.
Drowsiness can be a symptom of overdosage, occurring from administration of 50 mg of Cetirizine as a single dose.
In children, agitation can occur.
To date there is no specific antidote. In case of massive overdosage, gastric lavage should be performed together with the usual supportive measures. Routine observation should also be carried out regularly.
Patients with a history of hypersensitivity to any of Cetihis constituents.
Children (2 to 6 years) with renal or hepatic disease.
Activities Requiring Mental Alertness: In clinical trials the occurrence of somnolence has been reported in some patients taking Cetirizine: due caution should therefore be exercised when driving a car or operating potentially dangerous machinery.
No adverse effects have been reported from animal studies. As with other drugs, the use of Cetirizine in pregnancy should be avoided, especially during the first trimester. Cetirizine has been reported to be excreted in human breast milk.
Thus, it is contraindicated in women who are breast feeding.
There have been occasional reports of mild and transient side effects such as headache, dizziness, drowsiness, agitation, dry mouth, gastrointestinal discomfort and hypersensitivity.
To date, there are no known interactions with other drugs. Nevertheless, Cetihis should be used with caution if sedatives are also being taken.
Store at temperature of not more than 30°C.
R06AE07 - cetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Cetihis syr 5 mg/5 mL
60 mL x 1's
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