In adults and adolescents over 12 years old

· Cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis

· Cetirizine is indicated for the treatment of symptoms of chronic idiopathic urticaria.


Dosage

Adults and adolescents over 12 years: 10 mg once a day (one tablet).
Elderly patients: there is no need to adjust the dosage in elderly subjects with normal renal function

Renal impairment, moderate to severe: data available does not allow to document benefit / risk ratio in case of renal insufficiency

Based on its elimination, which is essentially renal (see section 4.8 Pharmacokinetic properties), and if it can not be used as an alternative treatment, cetirizine will be administered in these situations by adjusting dosage and space between catch According to renal clearance according to the following table:

Creatinine clearance (CL cr) can be estimated (in ml / min), based on the serum creatinine measurement (mg / dl) according to the following formula
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CL cr '= [140-age (year)] x weight (kg) x (0.85 for women)
72 x serum creatinine (mg / dl)

Dose adjustment in patients with renal insufficiency

Group

Creatinine clearance (ml / min)

Dose and frequency of administration

Function, normal renal

Mild renal insufficiency

Moderate renal impairment

Severe renal impairment

End-stage renal insufficiency and patients, dialysis

³ 80

50 - 79

30 - 49




Objective measures of ability to conduct, vigilance and reaction time did not demonstrate clinically significant effect at the recommended dose of 10 mg.

Patients who are likely to drive a vehicle or handle a potentially hazardous tool or machine should not exceed the recommended dose and evaluate their response to treatment beforehand. Concomitant use of alcohol or other central nervous system (CNS) depressants may result in impairment of alertness or performance in sensitive patients


· Known hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to piperazine derivatives

· Severe renal impairment with clearance, creatinine less than 10 ml / min

At therapeutic doses, no clinically significant interaction was demonstrated with alcohol intake (for blood concentrations up to 0.5 g / l). However, caution is advised in the event of concomitant use of alcohol.

Cetirizine should be administered with caution in patients who are epileptic or at risk of convulsions

Based on data from pharmacokinetics, pharmacodynamics, and tolerance profile, no interaction with cetirizine is expected. To date, no significant pharmacodynamic or pharmacokinetic interaction has been reported in studies of drug interactions, including pseudoephedrine or theophylline (400 mg / day). >

The rate of absorption of cetirizine is not diminished by the feed, although the rate of absorption is reduced.

Without object.

Symptoms

The symptoms observed after an overdose of cetirizine are mainly associated with effects on the CNS or effects suggestive of anticholinergic action

Adverse effects, reported after taking a dose at least five times greater than the recommended daily dose are: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, agitation, sedation, drowsiness, stupor, Tachycardia, tremor and urinary retention.

What to do in case of overdose

There is no known antidote to cetirizine.

In case of overdose: treatment, symptomatic and clinical monitoring. A gastric lavage may be considered in the case of recent ingestion.

Cetirizine is not effectively eliminated by hemodialysis

Very little clinical data are available on exposed pregnancies with cetirizine. Studies in the animal did not reveal any direct or indirect adverse effect on pregnancy, embryonic and fetal development, parturition and postnatal development

Caution is advised when prescribing to pregnant women or in case of breastfeeding as a result of the passage of cetirizine in the maternal milk

Non-serious adverse effects on the central nervous system, including somnolence, fatigue, dizziness and headache have been observed in clinical trials with cetirizine at the recommended dose. In some cases, a paradoxical effect of stimulation of the central nervous system has been observed.
Despite its antagonistic effect, selective peripheral H1 receptors and the relatively low anticholinergic activity, isolated cases of micturition difficulties, problem, accommodation and dry mouth have been reported.

Cases of abnormal liver function with increased liver enzymes associated with increased bilirubin have been reported. Anomalies were regressed in most cases with cessation of treatment with cetirizine dihydrochloride.
Clinical trials

More than 3,200 subjects exposed to cetirizine were included in double-blind controlled clinical trials or in pharmaco-clinical trials comparing cetirizine at the recommended dosage of 10 mg daily, placebo, Other antihistamines, during which the quantified tolerance data are available.

In all of this population, adverse reactions reported in placebo-controlled, placebo-controlled trials with an incidence of 1.0% or more were Br>
Undesirable effects

(WHO-ART)

Cetirizine 10 mg

(N '= 3260)

Placebo

(N '= 3061)

Disorders of the state, general

Fatigue

1.63%

0.95%

Central and peripheral nervous system disorders

Vertigo

Headache

1.10%

7,42%

0.98%

8,07%

Gastrointestinal system disorders

Abdominal pain

Mouth dryness

Nausea

0.98%

2.09%

1.07%

1.08%

0.82%

1.14%

Psychiatric disorders

Somnolence

9.63%

5,00%

Respiratory disorders

Pharyngitis

1.29%

1.34%

Sleepiness was statistically more frequent than placebo, but of mild to moderate intensity in the majority of cases. Tests, targets, validated by other studies, have shown that, in healthy young volunteers, daily routine activities are not affected at the recommended daily dose.
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Adverse reactions reported with an incidence of 1% or more in children aged 6 months to 12 years included in trials, placebo-controlled or pharmacokinetic studies are

Undesirable effects

(WHO-ART)

Cetirizine 10 mg

(N '= 1656)

Placebo

(N '= 1294)

Disorders of the gastrointestinal system

Diarrhea

1.0%

0.6%

Psychiatric disorders

Somnolence

1.8%

1.4%

Respiratory disorders

Rhinite

1.4%

1.1%

Disorders of the state, general

Fatigue

1.0%

0.3%

Effects, undesirable reported since the marketing

In addition to adverse reactions reported in clinical trials and listed above, isolated cases of adverse reactions have been reported since commercialization of the product. (Uncommon: ³ 1/1000 and