BIFOTEC
BIFOTEC
Active ingredient: Cetirizine dihydrochloride 10 mg.
Dosage form: Film-coated tablet
Packaging: Box of 10 blisters x 10 tablets
Expiry date: 36 months from the date of manufacture.
Posology
10 mg once daily (1 tablet).
Special populations
Elderly
Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.
Renal impairment
There are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly excreted via renal route (see section Pharmacokinetic properties), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function (refer to the following table and adjust the dose as indicated). The creatinine clearance (ClCr) in ml/min may be estimated from serum creatinine (mg/dl) determination using the following formula:
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 | Contra-indicated |
Hepatic 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 Renal impairment above).
Paediatric population
The tablet formulation should not be used in children under 6 years of age as it does not allow the necessary dose adjustments.
- Children aged 6 to 12 years: 5 mg twice daily (a half tablet twice daily).
- Adolescents above 12 years: 10 mg once daily (1 tablet).
In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance, age and body weight of the patient.
Administration
Oral use.
The tablets need to be swallowed with a glass of liquid.
INDICATIONS
Cetirizine hydrochloride tablets are indicated in adults and paediatric patients 6 years and above:
- For the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- For the relief of symptoms of chronic idiopathic urticaria.
CONTRAINDICATIONS
Hypersensitivity to cetirizine hydrochloride, to any of the other constituents, to hydroxyzine or to any piperazine derivatives.
Patients with severe renal impairment with a creatinine clearance below 10 ml/min.
