Source: Health Products Regulatory Authority (ZA) Publisher: Abex Pharmaceutica (Pty) Ltd, Suite C, Rubenstein Ridge, 617 Rubenstein Drive, Moreleta Park, 0181, South Africa
CETAWAY SOLUTION is indicated for the relief of symptoms associated with the following allergic conditions:
The daily recommended dose is 5 mg (10 ml) once daily.
Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment below).
The dosing interval 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 (μmol/l) using the following formula:
CLcr = (140 – age) x body weight (kg) (x 0,85 for women) / serum creatinine (μmol/l)
Dosing Adjustments for Patients with Impaired Renal Function:
| Group | Creatinine clearance (ml/min) | Dosage and frequency |
|---|---|---|
| Normal | ≥80 | 5 mg once daily |
| Mild | 50-79 | 5 mg once daily |
| Moderate | 30-49 | 5 mg once every 2 days |
| Severe | <30 | 5 mg once every 3 days |
| End-stage renal disease - Patients undergoing dialysis | <10 | Contraindicated |
The dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his/her body weight. There are no specific data for children with renal 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 renal impairment above).
Children aged less than 2 years:
The administration of CETAWAY SOLUTION to infants and toddlers aged less than 2 years is not recommended (see section 4.4).
Children aged 2 to 6 years:
The daily recommended dose is 2,5 mg to be administered in 2 intakes of 1,25 mg (2,5 ml of solution twice daily).
Children aged 6 to 12 years:
The daily recommended dose is 5 mg (10 ml) once daily.
Intermittent allergic rhinitis (symptoms <4 days/week or during less than 4 weeks) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear. In case of persistent allergic rhinitis (symptoms >4 days/week or during more than 4 weeks), continuous therapy can be proposed to the patient during the period of exposure to allergens. Clinical experience with CETAWAY SOLUTION is currently available for a 6-month treatment period.
For oral administration.
Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children.
There is no known specific antidote to CETAWAY SOLUTION. Should overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine is not effectively removed by haemodialysis.
36 months.
Shelf-life after first opening of the pack: 3 months.
Store at or below 25°C. Keep the bottle tightly closed.
Do not refrigerate.
Keep in the original package.
CETAWAY SOLUTION is packed in brown Type III glass bottles containing 60 ml, 100 ml, 150 ml or 200 ml solution and closed with a white polypropylene childproof screw cap.
The bottle is labelled and packed in a cardboard box with or without a calibrated oral syringe for dosing. The main graduation per 1 ml is marked on the syringe by bold line and number. Additional graduation per 0,5 ml is marked by a thin line.
Not all pack sizes are necessarily marketed.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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