ANTINE 10mg Tablets - (Ebastine 10mg)


Ebastine is a long-acting and selective H1-histamine receptor antagonist. After repeated administration, inhibition of peripheral receptors remain at a constant level. Ebastine is rapidly absorbed and undergoes extensive first pass metabolism following oral administration. Ebastine is almost totally converted to the pharmacologically active acid metabolite, carebastine. After a single 10 mg oral dose, peak plasma levels of carebastine occur at 2,6 to 4 hours and achieve levels of 80 to 100 ng/mL. The half-life of carebastine is between 15 and 19 hours with 66% of the medicine being excreted in the urine mainly as conjugated metabolites. Following repeated administration of 10 mg once daily, steady state is achieved in 3 to 5 days with peak plasma levels ranging from 130 to 160 ng/mL. In vitro studies with human liver microsomes show that ebastine is metabolised to carebastine predominantly via the CYP3A4 pathway. Concurrent administration of ebastine with ketoconazole or erythromycin (both CYP3A4 inhibitors) to healthy volunteers was associated with significantly increased plasma concentration and elimination half-life of ebastine and carebastine. With ketoconazole the Cmax and AUC were 15 times and 40 times respectively increased, with erythromycin the values were doubled.

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