Drug useful in case of allergic rhinitis and chronic idiopathic urticaria
Indications
Cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
Cetirizine is indicated for the symptomatic treatment of chronic idiopathic urticaria.
Composition
Active ingredients
Each tablet contains 10 mg of cetirizine dihydrochloride. Excipient: one film-coated tablet contains 81.80 mg of lactose monohydrate. For the full list of excipients, see section 6.1.
Excipients
Tablet core: Microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica. Tablet coating: hypromellose, lactose monohydrate, macrogol 4000, colouring agent: titanium dioxide.
Directions for use and dosage
Children aged 6 to 12 years: 5 mg twice daily (half a tablet twice daily).
Adults and children over 12 years of age: 10 mg once daily (1 tablet).
style="text-decoration: underline;">Elderly patients Based on available data, no dose reduction is necessary in elderly subjects with normal renal function.
Patients with moderate to severe renal impairment No data are available to document the efficacy/safety balance in patients with renal impairment. Since cetirizine is predominantly excreted via the kidney (see section 5.2), in cases where alternative treatments cannot be used, dosing intervals should be individualized based on 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 (CLCT) expressed in ml/min is required. CLcr (ml/min) can be adjusted. be derived from the serum creatinine value (mg/dl) using the following formula:
| CLcr | [140–age (years)] x weight (kg) | (x 0.85 for women) |
| 72 x serum creatinine (mg/dl) |
Dosage adjustment for adults 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 – Dialysis patients | <10 | Contraindicated |
In paediatric patients with renal impairment, the dose should be adjusted individually, taking into account the renal clearance, age and body weight of the patient. Patients with hepatic impairment Patients with only hepatic impairment do not require any dosage adjustment. Patients with both hepatic and renal impairment A dosage adjustment is recommended (see above Patients with moderate to severe renal impairment).
Method of administration: The tablets should be taken with a glass of liquid.
Warnings
Read the package leaflet carefully before starting treatment.
Pregnancy and breastfeeding
Very limited clinical data on exposed pregnancies are available for cetirizine.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development.
Prescribing to pregnant women should be done with caution.
Cetirizine is excreted in breast milk at concentrations representing 0.25-0.90 of those measured in plasma, depending on the sampling time after administration.
Therefore, caution should be exercised when prescribing cetirizine to breastfeeding women.
Storage
This medicinal product does not require any special storage conditions.
Format
7 coated tablets
Product Code:FRCM117442
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