Source: Health Sciences Authority (SG) Revision Year: 2018 Publisher: Manufacturer for tablets: UCB FARCHIM SA, BULLE SWITZERLAND Manufacturer for oral solution and drops: AESICA PHARMCEUTICALS S.R.L., PIANEZZA (TO) – ITALY
For relief of:
2.5 mg twice daily [5 drops twice daily or 2.5 ml of oral solution twice daily (half of a spoon twice daily)].
5 mg [10 drops, or 5 ml oral solution (1 full spoon) or half of the tablet] twice daily.
10 mg once daily [1 tablet, 20 drops, or 10 ml oral solution (2 full spoons)]. A 5 mg starting dose (half of the tablet, 10 drops, or 5 ml oral solution) may be proposed if this leads to satisfactory control of the symptoms.
The tablets need to be swallowed with a glass of liquid. The drops have to be diluted in liquid, while the solution can be swallowed as such.
Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.
Since cetirizine is mainly excreted via renal route, 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 | 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 |
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 age and body weight of the patient.
No dose adjustment is needed in patients with solely hepatic impairment.
Adjustment of the dose is recommended (see Patients with renal impairment above).
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.
Cetirizine is not effectively removed by haemodialysis.
Management should be as clinically indicated or as recommended by the national poisons centre, where available.
The expiry date is stated on the outer packaging.
Refer to the storage condition on the outer packaging.
Keep tablets in a dry place.
Tablet: Boxes containing 10, 50 and 500 film-coated tablets in blister strips.
Oral drops: Bottle containing 10 or 20 ml drops.
Oral solution: Bottle containing 75 ml solution.
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