Zertin

Cetirizine dihydrochloride.

Each tablet contains: Cetirizine Dihydrochloride 10 mg.

Pharmacology: Cetirizine, a human metabolite of hydroxyzine, is a potent antihistamine with a low potential for drowsiness at normal therapeutic doses. Its principal effects are mediated via selective inhibition of peripheral H1 receptors. In experimental animals, cetirizine has been shown to be an anti-H1 agent without any significant anticholinergic or antiserotonin effects. At pharmacological active doses, cetirizine does not induce sedation and behavioural changes due to the fact that it does not cross the blood-brain barrier.
Cetirizine inhibits certain effects produced by exogenous and endogenous histamine. 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 and also reduces the migration of inflammatory cells, eg eosinophils and the release of mediators associated with the "late" cutaneous allergic response.
Cetirizine reduces bronchial hyper-reactivity to histamine in the asthmatic patient and the allergic reaction induced by specific allergens. These effects are obtained without any central effects being demonstrated.
Cetirizine is rapidly and almost completely absorbed following oral administration. Absorption is very consistent from one subject to the next. Peak plasma concentrations are generally obtained within 1 hour under fasting conditions. The extent of absorption is not reduced by food; however, the rate of absorption is reduced and the peak levels are expected about 3 hours after dosing. After repeated oral administration, the daily urinary excretion of unchanged cetirizine is about 65% of the dose. The absorption and the elimination of cetirizine are independent of the dose. Its renal clearance is 30ml/min. The plasma half-life of cetirizine is approximately 9 hours. This value is increased in patients with reduced renal function. Cetirizine is strongly bound to human plasma proteins (93%).

Adults and children of 3 years or above: Symptomatic treatment of seasonal rhinitis, perennial allergic rhinitis and urticaria of allergic origin.

Adults: 10 mg once daily.
Children ≥6 years: 10 mg daily, either 5 mg twice daily or 10 mg once daily.
Children 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. The dose may be taken as 5 mg in the morning and 5 mg in the evening in patient affected by side effects.

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.

Contraindicated in patients with known hypersensitivity of any of the ingredients of Zertin Tablet. Cetirizine is contraindicated during lactation.

Cetirizine does not potentiate the effect of alcohol (at a blood level of 0.8 g/L). However, care should be taken
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.
Use in pregnancy and lactation: 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 breastfeeding.
Use in pediatric patients: The safety and effectiveness of cetirizine in pediatric patients under the age of 2 years have not yet been established.

Cetirizine is contraindicated during lactation.
Use in pregnancy and lactation: 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 breastfeeding.

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. As with other antihistamines it is advisable to avoid excessive alcohol consumption. If sedatives are also being taken, cetirizine should be used with caution.

Store in a dry place below 30°C.
Protect from light.

Antihistamines & Antiallergics

R06AE07 - cetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.

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