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Oral drops: The daily recommended dose is 5 mg (20 drops).
Elderly: Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment as follows).
Renal impairment: The dosing intervals must be individualised according to renal function. Refer to Tables 1 and 2 and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula: See equation.
Click on icon to see table/diagram/imageIn paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There are no specific data for children with renal impairment.
Dosing adjustments for patients with impaired renal function: Film-coated tablet: See Table 1.
Click on icon to see table/diagram/imageOral drops: See Table 2.
Click on icon to see table/diagram/imageHepatic impairment: No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Renal impairment as previously mentioned).
Paediatric population: Film-coated tablet: Children aged 6 to 12 years: The daily recommended dose is 5 mg (1 film-coated tablet).
For children aged 2 to 6 years, no adjusted dosage is possible with the film-coated tablet formulation. It is recommended to use Xyzal Oral Drops.
Oral drops: Children aged 6 to 12 years: The daily recommended dose is 5 mg (20 drops).
Children aged 2 to 6 years: The daily recommended dose is 2.5 mg to be administered in 2 intakes of 1.25 mg (5 drops twice daily).
Even if some clinical data are available in children aged 6 months to 12 years (see Adverse Reactions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions), these data are not sufficient to support the administration of levocetirizine to infants and toddlers aged less than 2 years (see also Precautions).
Method of administration: Film-coated tablet: The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake.
Oral drops: The drops should be poured in a spoon or diluted in water, and taken orally.
If dilution is used, it should be considered, especially for administration to children, that the volume of water to which the drops are added, needs to be adapted according to the quantity of water the patient is able to swallow. The diluted solution should be taken immediately.
When counting the drops, the bottle should be held vertically (top down).
In case of lack of flow of drops, if the right amount of drops has not been delivered, turn the bottle over in upright position, then hold it top down again and continue counting the drops.
The drops may be taken with or without food.
Duration of use: Intermittent allergic rhinitis (symptoms experienced for less than four days a week or for less than four weeks a year) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear.
In case of persistent allergic rhinitis (symptoms experienced for more than four days a week or for more than four weeks a year), continuous therapy can be proposed to the patient during the period of exposure to allergens.
There is clinical experience with the use of levocetirizine for treatment periods of at least 6 months. In chronic urticaria and chronic allergic rhinitis, there is clinical experience of use of cetirizine (racemate) for up to one year.
