Cetirizine Dihydrochloride
Visa No.: 893100300500
Product: Cetirizine 10mg
API: Cetirizine Dihydrochloride
Product Category: Cough – Cold – Allergy
Version approved leaflet: 547/QĐ-QLD_15/11/2016_156
INDICATIONS
The product is indicated in children aged 12 years and above, adolescents, and adults for the symptomatic treatment of:
- Persistent allergic rhinitis and seasonal allergic rhinitis.
- Chronic idiopathic urticaria.
- Allergic conjunctivitis.
DOSAGE AND ADMINISTRATION
Adults and children aged 12 years and above: 1 tablet (10 mg) once daily.
May be taken with or without food.
Elderly: No dose reduction is required in elderly patients with normal renal function.
Patients with moderate to severe renal impairment: The dosing interval should be inpidualised according to renal function. Dose adjustment for patients with renal impairment should follow the table below.
| Renal function | Creatinine clearance (mL/min) | Dosage |
| Normal | ≥ 80 | 10 mg once daily |
| Mild renal impairment | 50 - 79 | 10 mg once daily |
| Moderate renal impairment | 30 - 49 | 5 mg once daily* |
| Severe renal impairment | < 30 | 5 mg every 48 hours* |
| End-stage renal disease or haemodialysis | <10 | Contraindicated |
* Do not split the tablet for these indications
Paediatric patients with renal impairment: The dose should be adjusted according to renal clearance and body weight.
Hepatic impairment: No dose adjustment is required in patients with hepatic impairment.
Patients with both hepatic and renal impairment: Dose adjustment is required in this patient population (see dose adjustment in patients with renal impairment).
CONTRAINDICATIONS
Hypersensitivity to any of the components of the product or to hydroxyzine.
Patients with moderate to severe renal impairment with a creatinine clearance < 50 mL/min.
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children
