Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Rowex Ltd, Bantry, Co. Cork, Ireland
Cetrine is indicated in adults and paediatric patients 6 years and above:
5mg twice daily (a half a tablet twice daily).
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 individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use the 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 | 10mg once daily |
| Mild | 50 – 79 | 10mg once daily |
| Moderate | 30 – 49 | 5mg once daily |
| Severe | <30 | 5 mg once every 2 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 and the body weight.
No dose adjustment is needed in patients with solely hepatic impairment.
Dose adjustment is recommended (see Patients with moderate to severe renal impairment above).
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 treatment is recommended. Gastric lavage should be considered following ingestion of the medicinal product.
Cetirizine is not effectively removed by haemodialysis.
3 years.
Do not store above 25°C.
Cetrine 10 mg tablets are packed into PVC/Al strips and inserted into a carton.
Cetrine 10 mg tablets are available in packs of 30 tablets.
Not all pack sizes may be marketed.
Not applicable.
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