Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE
Cetirizine dihydrochloride 10 mg film-coated tablets are 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:
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 | 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 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.
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 may be considered shortly after ingestion of the drug.
Cetirizine is not effectively removed by haemodialysis.
5 years.
This medicinal product does not require any special storage conditions.
The tablets are enclosed in a transparent, colorless, inert PVC blister strip thermo-sealed with a lacquered aluminium foil. These blister strips are housed in a carton box.
Boxes of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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