Source: Υπουργείο Υγείας (CY) Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Cetirizine is indicated in adults and paediatric patients 6 years and above:
10 mg once daily (1 tablet).
Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.
There are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly excreted via renal route (see section 5.2), in cases no alternative treatment can be used, 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 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:
Dosing adjustments for adult patients with impaired renal function:
| Group | Creatinine clearance (mL/min) | Dosage and frequency |
|---|---|---|
| Normal | ≥80 | 10 mg once daily |
| Mild | 50-79 | 10 mg once daily |
| Moderate | 30-49 | 5 mg once daily |
| Severe | <30 | 5 mg once every 2 days |
| End-stage renal disease – Patients undergoing dialysis | <10 | Contraindicated |
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 moderate to severe renal impairment above).
The tablet formulation should not be used in children under 6 years of age as it does not allow the necessary dose adjustments.
Children aged from 6 to 12 years: 5 mg twice daily (a half tablet twice daily).
Adolescents above 12 years: 10 mg once daily (1 tablet)
In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance, age and body weight of the patient.
Oral administration.
The tablets need to be swallowed with a glass of liquid.
Symptoms observed after an overdose of cetirizine 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 cetirizine.
Should overdose occur, symptomatic or supportive measures are recommended. Gastric lavage should be considered following ingestion of the drug.
Cetirizine is not effectively removed by haemodialysis.
5 years.
Store below 25°C. Protect from light and moisture.
PVC/Aluminium blisters Pack-sizes of 10, 30, 100 and 1000 film-coated tablets.
PP containers with PE closure. Pack-size of 1000 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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