Unimed Levocetirizine

Unimed Levocetirizine Dosage/Direction for Use

levocetirizine

Manufacturer:

FDC

Distributor:

Unimed
Full Prescribing Info
Dosage/Direction for Use
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. Adults and adolescents 12 years and above: The daily recommended dose is 5 mg (1 film-coated tablet).
Elderly: Adjustment of the dose in recommended in elderly patients with compromised renal function (see patients with renal impairment as follows).
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.
Solution: Instruction for use: Appropriate volume of oral solution should be measured with 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.
Adults and adolescents 12 years and above: The daily recommended dose is 5 mg (10 ml of solution).
Elderly: Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment as follows).
Children aged 6 to 12 years: The daily recommended dose is 5 mg (10 ml of solution).
Children aged 2 to 6 years: The daily recommended dose is 2.5 mg to be administered in 2 takes of 1.25 mg (2.5 ml of solution twice daily).
Due to the lack of data in this population, the administration of the product to infants and toddlers aged less than 2 years is not recommended.
Patients with renal impairment: The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patients creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following: (See equation.)

Click on icon to see table/diagram/image

Dosing adjustments for patients with impaired renal function: (See table.)

Click on icon to see table/diagram/image

Patients with hepatic 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 patients with renal impairment as previously mentioned).
Duration of use: Intermittent allergic rhinitis (symptoms <4days/week or during less than 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 more than 4 weeks), continuous therapy can be proposed to the patient during the period of exposure to allergens. Clinical experience with 5 mg levocetirizine as a film-coated tablet formulation is currently available for a 6-month treatment period. For chronic urticaria and chronic allergic rhinitis, up to one year, clinical experience is available for the racemate.
Mode of administration: Oral.
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