ASMOCET-L Tablet

For

- The relief or nasal and ocular symptoms of seasonal and perennial allergic rhinitis;

- The relief of symptoms of chronic idiopathic urticaria.

Dosage and administration

Must be taken orally, swallowed whole with liquid and may be taken with or without food.

Adults and adolescents 12 years and above

5mg once daily.

Children aged 6-12 years

5mg once daily.

Levocetirizine is not recommended for use in children below age 6 due to insufficient data on safety and efficacy.

Elderly

For the time being, there is no data to suggest that the dose needs to be reduced in elderly patients provided that the renal function is normal.

- Hypersensitivity to levocetirizine to any of the excipients, to hydroxyzine or to any piperazine derivatives,

- Patients with severe renal impairment at less than 10mL/min creatinine clearance

- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take levocetirizine film-coated tablets.

- No interaction studies have been performed with levocetirizine (including no studies with CYP3A4 inducers); studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam). A small decrease in the clearance of cetirizine (16%) was observed in a multiple dose study with theophylline (400mg once a day); while the disposition of theophylline was not altered by concomitant cetirizine administration.

- The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased.

- In sensitive patients the simultaneous administration of cetirizine or levocetirizine and alcohol or other CNS is risk to the suckling child.

Levocetirizine, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors.

It is antihistamine for systemic use, piperazine derivative.

Levocetirizine inhibits eotaxin-induced eosinophil trans endothelial migration through both dermal and lung cells.