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Special population: Older people: Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.
Patients with moderate to severe renal impairment: There are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly excreted via renal route, 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: See equation and Table 1.
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imagePatients 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 moderate to severe renal impairment as previously mentioned).
Paediatric population: 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 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.
Method of administration: The tablets need to be swallowed with a glass of liquid.
Oral soln: Adults and Adolescents >12 years: Recommended Dose: 10 mg once daily.
Children 6-12 years: Either 5 mg twice daily or 10 mg single dose in the evening; >30 kg: 10 mg daily; ≤30 kg: 5 mg daily.
In individual cases, it maybe possible to divide the dose into 2 separate amounts (ie, 5 mg in the morning and evening).
Children 2-6 years: 2.5 mg twice daily (administered as 2.5 mL oral solution twice daily).
In the absence of pharmacokinetic and safety information for cetirizine in children <6 years with impaired renal or hepatic function, its use in this impaired patient population is not recommended.
Patients with Impaired Renal Function: The dosing intervals must be individualized according to renal function. Refer to the following and adjust the dose as indicated. To use the dose adjustment, 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:
Click on icon to see table/diagram/imageDose adjustment in patients with impaired renal function:
Normal (≥80 mL/min) and Mild (50-79 mL/min): 10 mg daily.
Moderate (30-49 mL/min): 10 mg every 2 days.
Severe (10-29 mL/min): 10 mg every 3 days.
End-Stage Renal Disease and Patients Undergoing Dialysis (<10 mL/min): Contraindicated.
Patients with Impaired Hepatic Function: In patients ≥12 years with impaired hepatic function, a dose of 5 mg once daily is recommended. Similarly, pediatric patients 6-11 years with impaired hepatic function should use the lower recommended dose.
It is advisable to take Zyrtec with a little liquid during the evening meal since the symptoms for which the product is given usually appear during the night. In patients affected by side effects, the dose may be taken as 5 mg in the morning and 5 mg in the evening.
10 mL solution = 10 mg; 5 mL solution = 5 mg; 2.5 mL solution = 2.5 mg.
