Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland
Levocetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.
The daily recommended dose is 5 mg (one film-coated tablet) once daily.
For the time being, there is no data to suggest that the dose needs to be reduced in elderly patients provided that the renal function is normal.
There are no data to document the efficacy/safety ratio in patients with renal impairment. Since levocetirizine is mainly excreted via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualised according to renal function. Refer to the following table 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:
CLcr = [140 – age(years)] x weight (kg) / 72 x serum creatinine (mg/dl)
(x 0.85 for women)
Dosing adjustments for adult patients with impaired renal function:
| Group | Creatinine clearance (ml/min) | Dosage and frequency |
|---|---|---|
| Normal | ≥80 | One tablet daily |
| Mild | 50-79 | One tablet daily |
| Moderate | 30-49 | One tablet every two days |
| Severe | <30 | One tablet every three days |
| End-stage renal disease – patients undergoing dialysis | <10 | Contraindicated |
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, his age and his body weight.
No dose adjustment is needed in patients with solely hepatic impairment.
Dose adjustment is recommended (see “Renal impairment” above).
The daily recommended dose is 5 mg (one film-coated tablet) daily. Levocetirizine is not recommended for use in children below age 6 due to insufficient data on safety and efficacy.
The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food.
Symptoms observed after an overdose of levocetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect.
Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor and urinary retention.
There is no known specific antidote to levocetirizine.
Should overdose occur, symptomatic or supportive treatment is recommended. Gastric lavage should be considered following ingestion of a short occurrence.
Levocetirizine is not effectively removed by dialysis.
3 years.
Store in the original package in order to protect from moisture.
PVC/PVDC:Al blisters or oPA/Al/PVC:Al blisters
Pack sizes:
Blisters containing 10, 14, 20, 28, 40, 50, 60, 80 or 100 tablets.
Unit dose blisters containing: 30x1 tablets.
Not all pack sizes may be marketed
No special requirements.
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