Alatrol® Tablet : Each film coated tablet contains Cetirizine Hydrochloride BP 10 mg. Alatrol® Syrup : Each 5 ml syrup contains Cetirizine Hydrochloride BP 5 mg. Alatrol® Paediatric Drops : Each ml drops contains Cetirizine Hydrochloride BP 2.5 mg.
Alatrol® is a potent H₁ receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes which may be explained by the absence of passage through the blood brain barrier. Alatrol® inhibits the histamine mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction. Alatrol® also provides a protective effect from bronchospasm induced by inhaled histamine in asthmatics. Alatrol® absorbs very rapidly. Plasma half-life of Cetirizine is 6.7 to 10.90 hours.
Alatrol® is administered with or without food. The time of administration varies to suit individual patient needs. *Adults and Children 6 years and older:* Alatrol® Tablet : 1 tablet daily. Alatrol® Syrup : 10 ml (2 teaspoonfuls) once daily or 5 ml (1 teaspoonful) twice daily. In patients with decreased renal function (Creatinine clearance 11-31 ml/min), patients on hemodialysis (Creatinine clearance less than 7 ml/min) and in hepatically impaired patients, a dose of 1/2 tablet or 5 ml (1 teaspoonful) once daily is recommended. *Children 2-6 years:* Alatrol® Syrup : 5 ml (1 teaspoonful) once daily or 2.5 ml (1/2 teaspoonful) twice daily. *Children 6 months to less than two years:* Alatrol® Syrup : 2.5 ml (1/2 teaspoonful) once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours. Alatrol® Paediatric Drops: 1 ml, once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1 ml, every 12 hours.
Dosage in Renal and Hepatic Impairment: Dosing adjustment is necessary in patients with moderate or severe renal impairment, hepatic impairment and patients on dialysis.
No clinically significant drug interactions have been found with theophylline, azithromycin, pseudoephedrine, ketoconazole or erythromycin and with other drugs.
Pregnancy Category B: Cetirizine should be used in pregnancy only if clearly needed. Cetirizine has been reported to be excreted in human milk and thus, use of Cetirizine in lactating mother is not recommended.
Caution should be exercised when driving a car or operating a heavy machinery. Concurrent use of Cetirizine with alcohol or other CNS depressants should be avoided because additional reduction in alertness and additional impairment of CNS performance may occur.