Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, a Sun Pharma Company, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa
CETIZAL 5 is indicated for the relief of symptoms associated with the following allergic conditions:
The daily recommended dose is one 5 mg tablet.
Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment).
The dosing intervals must be individualised according to renal function. Use the table below to 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 patient’s creatinine clearance can be estimated from the serum creatinine determination using the following formula:
CLcr (mL/min) = [140 – age (years)] x Wt (kg) (x 0, 85 for women) / Scr (μmol/L)
| Dosages in patients with renal impairment | ||
| Renal status | Creatinine clearance (Clcr) | Dose |
| Normal | >80 mL/min | 5 mg once daily |
| Mild impairment | 50 mL/min to 79 mL/min | 5 mg once daily |
| Moderate impairment | 30 mL/min to 49 mL/min | 5 mg every second day |
| Severe impairment | <30 mL/min | 5 mg every third day |
| End stage renal impairment or receiving dialysis | <10 mL/min | Contraindicated |
No dosage adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Renal impairment above).
The daily recommended dose is one 5 mg tablet.
This formulation of CETIZAL 5 is not suitable for children aged 2 – 6 years as no adjusted dosage is possible with CETIZAL 5 which is a film-coated tablet. CETIZAL 5 is therefore not recommended for this age group (see section 4.4).
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 his/her body weight. There are no specific data for children with renal impairment.
The film-coated tablet must be taken orally, swallowed with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake.
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 CETIZAL 5 film-coated tablet is currently available for a 6-month treatment period.
Drowsiness is an expected symptom of overdosage in adults. Overdosage in children may produce agitation and restlessness initially, followed by drowsiness.
There is no known specific antidote to CETIZAL 5. Treatment is symptomatic and supportive. CETIZAL 5 is not effectively removed by haemodialysis.
36 months.
Store at or below 25°C. Protect from moisture.
Do not remove the blister strips from the cartons until required for use.
White opaque HDPE container with white opaque polypropylene, plastic cap containing 30 or 180 tablets.
Cold form blister pack comprising of cold formable laminated film with a backing of hard tempered plain silver aluminium foil containing 10 tablets.
No special requirements.
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