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Adults and Adolescents ≥12 years: 5 mg once daily (1 film-coated tablet or 10 mL of solution or 20 drops).
Children 6-12 years: 5 mg once daily (1 film-coated tablet or 10 mL of solution or 20 drops). No adjusted dosage is possible with the film-coated tablet. It is recommended to use a pediatric formulation of levocetirizine (see Precautions).
Children 2-6 years: 2.5 mg to be administered in 2 intakes of 1.25 mg (2.5 mL of solution or 5 drops twice daily).
Elderly with Renal Impairment: 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 individualized according to renal function. Refer to the table as follows and adjust the dose as indicated. To use the dosing table, an estimate of the patient's CrCl in mL/min is needed. (See table.) The CrCl (mL/min) may be estimated from serum creatinine (mg/dL) determination using the following formula:
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageIn pediatric 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.
Hepatic Impairment: No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic and renal impairment, adjustment of the dose is recommended (see Renal Impairment as previously mentioned).
Duration of Use: Intermittent allergic rhinitis (symptoms <4 days/week or during <4 weeks) 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 >4 days/week and during >4 weeks), continuous therapy can be proposed to the patient during the period of exposure to allergens.
Clinical experience with levocetirizine 5 mg as a film-coated tablet formulation is currently available for a 6-month treatment period. For chronic urticaria and chronic allergic rhinitis, up to 1 year clinical experience is available for the racemate.
Administration: Film-Coated Tablet: Xyzal 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 Solution: The appropriate volume of oral solution should be measured with the oral syringe and poured in a spoon or in a glass of water. The oral solution must be taken orally immediately after dilution and may be taken with or without food.
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.
