Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. (UCB Pharma leaflet)
Levocetirizine is the R-enantiomer of cetirizine with an emperical formula of C21H25CLN2O3 for levocetirizine and C21H25CLN2O32HCl for Levocetirizine Hydrochloride.
With molecular weight of 461.8 and the following structural formula: (Martindale 35)
Mechanism of Action:
Levocetirizine is R-enantiomer of cetirizine, it is selective antagonist of Perpheral H1- receptors. (UCB Pharma leaflet)
Levocetirizine is rapidly and Intensively absorbed following oral administration. Peak plasma concentrations are achieved 0.9 h after dosing. Steady state is achieved after two days. The extent of absorption is dose – independent and is not altered by food, Size: 98×230 but the peak concentration is reduced and delayed. (UCB Pharma leaflet)
Levocetirizine is 90% bound to plasma proteins.
Elimination half life: 7.9+1.9 hours
The major route of excretion of Levocetirizine and metabolites is via urine, accounting for a mean of 85.4% of dose. Excretion via feces accounts for only 12.9% of the dose. (UCB Pharma leaflet)
symptomatic treatment of allergic rhinitis(including persistent allergic rhinitis) and chronic idiopathic urticaria. (UCB Pharma leaflet)
History of hypersensitivity to Levocetirizine or any of the other constituents of the formulation or to any piperazine derivatives. Patients with sever renal impairment at less than 10 m1/min creatinine clearance. (UCB Pharma Leaflet)
The use of Levocertizine is not recommended in children aged less than 6 years since the currently available film-coated tablets do not yet allow dose adaptation precaution is recommended with intake of alcohol. (UCB Pharma Leaflet)
For Levocetirizine noclinical data on emposed pregnancies are available. Caution should be enercised when prescribing to pregnant.
Women breast feeding:
Caution should be emercised when prescribing to Lactating women. (UCB Pharma Leaflet)
No interaction studies have been performed with Levocetirizine (including no studies with CYP3A4 inducers). Studies with vacemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with Pseadoephedrine, Cimetidine, ketoconazole, erytromycin, azithromycin, glipizide, diazepam). A small decrease in the clearance of cetirizine (16%) was observed in a multiple dose study with theophylline (400 mg once a day). While the disposition of theophylline was not altered by concomitant cetirizine administration. (UCB Pharma Leaflet)
Headache, somnolence, mouth dry, fatigue. In addition to the adverse reactions reported during clinical studies and listed above, very cases of the following adverse
drug reactions have been reported in past marketing emperience:
Immune system disorders: hypersensitivity including anaphylaxis.
Respiratory,thoracic, and medistinal disorders dyspnoea.
Skin and subcutaneous tissue disorders:
Angieneurotic oedema, pruritis, rash, urticaria Investigations: Weight increased. (UCB Pharma Leaflet)
Administration and dosage:
Adults and adolescents 12 years and above: the daily recommendded dose is 5 mg (1film – coated tablet)
Adjustment of dose is recommended in elderly patients with moderate to sever renal impairment.
Children aged 6 to 12 years:
The daily recommended dose is 5 mg (1 film – coated tablet)
For children aged less than 6 years no adjusted dosage is yet possible. (UCB Pharma Leaflet)
1- PDR 2007
2- Martindale 35
3 – UCB pharma leaflet