- Approval Id
- dc75488da9e454b6
- Drug Name
- XYZAL FILM-COATED TABLET 5 MG
- Product Name
- XYZAL FILM-COATED TABLET 5 MG
- Approval Number
- SIN16028P
- Approval Date
- 2020-10-14
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- POSOLOGY AND METHOD OF ADMINISTRATION
**Film-coated tablet**: it must be taken orally, swallowed whole with liquid and may be taken with or without food.
Duration of use:
Intermittent allergic rhinitis (symptoms <4 days/week or for less than 4 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 >4 days/week or for more than 4 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. For chronic urticaria and chronic allergic rhinitis, there is clinical experience of use of cetirizine (racemate) for up to one year.
Route of Administration:
For oral use.
Adults and adolescents 12 years and above:
The recommended dose is 5 mg once daily (1 film-coated tablet).
Elderly:
Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment _(see Patients with renal impairment below)_.
Children aged 6 to 12 years:
The recommended dose is 5 mg once daily (1 film-coated tablet).
Adult patients with renal impairment:
The dosing intervals must be individualised according to renal function (eGFR – estimated Glomerular Filtration Rate). Refer to the following table and adjust the dose as indicated.
In 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.
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 above)_.
- Route Of Administration
- ORAL
- Indication Info
- THERAPEUTIC INDICATIONS
Levocetirizine is indicated for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria.
- Contraindications
- CONTRAINDICATIONS
Hypersensitivity to levocetirizine, to cetirizine, to hydroxyzine, to any piperazine derivatives, or to any of the excipients.
Patients with end stage renal disease with estimated Glomerular Filtration Rate (eGFR) below 15 ml/min (requiring dialysis treatment).
Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take the tablet formulation.
- Atc Code
- R06A E09
- Atc Item Name
- xr 06 a e 09
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/cac9b4e7bceb9ea7/glaxosmithkline-pte-ltd
