Cetiboston

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration

CETIBOSTON for oral use, Swallow or drink the tablet whole with a glass of water.

Posology

- Adults and adolescents 12 years of age and over: 10 mg once daily (1 capsule)

Used in special objects

Elderly subjects

- No dose adjustment is needed for elderly subjects provided that the renal function is normal.

Patients with hepatic impairment

- No dose adjustment is needed in patients with solely hepatic impairment.

Patients with  renal impairment

- Since cetirizine is mainly excreted via the renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function. In this case,it is necessary to determine the dose according to the serum creatinine clearance (ml/min), the creatinine clearance (Clcr) is calculated according to the following formula:

SCr: Creatinine clearance (mg/dl)

Dosing adjustment according to ClCr is as follows:

(*):The product has an unsuitable dosage form (soft capsule) for patients with moderate and severe renal impairment.

- 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 body weight.

- Patients with hepatic impairment and renal impairment: Adjustment of the dose is recommended (see Patients with renal impairment above)

- CONTRAINDICATIONS

Hypersensitivity to cetirizine dihydrochloride, to hydroxyzine, to any piperazine derivatives, to soya, peanut, or to any ingredient in the drug product.

Patients with moderate to severe renal impairment at less than 50 ml/min creatinine clearance (inappropriate dosage form)

- WARNINGS AND PRECAUTIONS

At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/L). However, precaution should still be exercised when using these two substances at the same time.

Patients with both liver and kidney disease should consult a physician before use. If necessary, the dose for this subject can be determined

Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.

Caution in epileptic patients and patients at risk of convulsions is recommended.

Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

If symptoms persist or worsen, stop use and consult a physician.

The use of the capsule formulation is not recommended in children aged less than 12 years since because of unsuitable dosage forms.

- Shelf-life

36 months from the manufacturing date. Do not use after the expiry date

- Al/Al blisters. Box of 03 blisters x 10 soft capsules  

- Al/Al blisters. Box of 05 blisters x 10 soft capsules  

- Al/Al blisters. Box of 10 blisters x 10 soft capsules