DOSAGE AND ADMINISTRATION
Administration
CETIRIZIN BOSTON is administered orally. Take the whole
tablet with a glass of water.
Dosage:
Adults: 10 mg once daily (1 tablet)
Special patient populations:
Elderly:
No dose adjustment is necessary for elderly with normal
renal function.
Renal impairment:
The safety and efficacy of cetirizine in patients with
renal impairment have not been established. As cetirizin
is eliminated primarily by kidneys, in case alternative
medicine is not available, the dosing interval must be
adjusted for each patient individually based on their
renal function.
Dosage adjustment for adults by renal function are as
follow:
|
Renal function
|
ClCr (ml/min)
|
Recommended 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 once every 2 days (*)
|
|
End-stage renal disease and patient undergoing
dialysis
|
< 10
|
Contra-indication
|
(*): at dose level of 5 mg, CETIRIZIN BOSTON could not
have assurance of dose division for these patients. They
should refer to another medicine with an appropriate
dosage.
Patients with hepatic impairment
- No dose adjustment is necessary. Dosage adjustment is
recommended for patients with renal and hepatic
impairment.
Children
- Adults and children over 12 years: 10 mg (1 tablet) once
daily.
- Children 6-12 years: 5 mg once daily. At dose level of 5
mg, CETIRIZIN BOSTON could not have assurance of dose
division for these patients. They should refer to another
medicine with an appropriate dosage.
- Children under 6 years: do not use for children under 6
years as dose division could not be assured. Another
medicine with an appropriate dosage should be recommended.
- For children with renal impairment, dosage must be
calculated for each individual by renal function, age and
weight.
CONTRAINDICATIONS
Patient with history hypersensitivity to cetirizine
hydrochloride, hydroxyzine, the piperazine derivatives or
to any of the ingredients.
Moderate to severe renal impairment with ClCr < 10
ml/min.
WARNINGS AND PRECAUTIONS
- At therapeutic doses, no clinically significant
interactions have been demonstrated with alcohol (for a
blood alcohol level of 0.5 g/1). Nevertheless, precaution
is recommended if alcohol or food is taken concomitantly.
- 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.
- Patients with renal and hepatic impairment should
consult doctors before use. If necessary, the dosage for
these patients could be adjusted.
- Caution is recommended in epileptic patients and
patients at risk of convulsions.
- Allergy skin tests are inhibited by antihistamines and a
wash-out period (of 3 days) is required before performing
them.
- Rashes and/or urticaria may occur upon discontinuation
of cetirizine, even if these symptoms did not appear prior
to initiation of treatment. In some cases, symptoms may
worsen and require treatment. Treatment of symptoms should
be completed before restarting treatment with cetirizine.
- This medicine is not recommended in children aged less
than 6 years and patients with moderate to severe renal
impairment since this formulation does not allow for
appropriate dose adaptation.
Precautions with excipients:
- This product contains lactose. Patients with rare
hereditary problems of galactose intolerance, the Lapp
lactase deficiency of glucose-galactose malabsorption
should not take cetirizine film-coated tablets.
- This product contains ponceau 4R colour, which could
cause an allergic reaction.
SHELF-LIFE: 36 months from the
manufacturing date.
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