Ship in Europe, Find out rates!
Adults and pediatric patients from 6 years of age: • Cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis • Cetirizine is indicated for the symptomatic treatment of chronic idiopathic urticaria.
Children aged 6 to 12 years : 5 mg twice a day (half tablet twice a day). Adults and adolescents over 12 years of age : 10 mg once daily (1 tablet) Elderly patients : Based on available data, no dose reduction is required in elderly subjects with normal renal function. Patients with moderate to severe renal impairment : No data are available documenting the efficacy / safety ratio in patients with renal impairment. Since cetirizine is mainly excreted via the kidney (see section 5.2), in cases where alternative treatment is not possible, the intervals between doses should be individualized according to renal function. Refer to the table below and adjust the dose as indicated. Use of the table requires an estimate of the patient's creatinine clearance (CL cr ) in ml / min. CL cr (ml / min) can be obtained on the basis of the determination of serum creatinine (mg / dl) according to the following formula:
CL cr = | [140 - age (years)] x weight (kg) | (x 0.85 for women ) |
72 x serum creatinine (mg / dL) |
Group | Creatinine clearance (ml / min) | Dose and frequency |
Normal | ≥ 80 | 10 mg once a day |
Mild | 50–79 | 10 mg once a day |
Moderate | 30–49 | 5 mg once a day |
Serious | <30 | 5 mg once every 2 days |
End-stage renal disease - dialysis patients | <10 | Contraindicated |
Symptoms Symptoms observed following an overdose of cetirizine are mainly associated with CNS effects or effects that may suggest an anticholinergic effect. Following a dose of at least 5 times the recommended daily dose, the following adverse events have been reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, drowsiness, tachycardia , tremors and urinary retention. Treatment There is no known antidote for cetirizine. In the event of an overdose, symptomatic or supportive treatment is recommended. Following recent ingestion, gastric lavage is recommended. Cetirizine is not effectively removed by hemodialysis.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to hydroxyzine or to any derivative of piperazine. Patients with severe renal impairment, with creatinine clearance less than 10 ml / min.
Clinical studies have shown that cetirizine at the recommended dosage has minor CNS side effects, including somnolence, fatigue, dizziness and headache. Paradoxical CNS stimulation has been reported in some cases. Although cetirizine is a selective peripheral H 1 receptor antagonist and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disturbances and dry mouth have been reported. There have been reports of abnormal liver function, with elevation of liver enzymes accompanied by elevated bilirubin. Most of these cases resolve upon discontinuation of cetirizine dichlorohydrate treatment. Clinical trials Double-blind controlled clinical trials or clinical pharmacology studies have been performed, comparing cetirizine versus placebo or other antihistamines at the recommended dose (cetirizine 10 mg / days), for which quantitative safety data are available, based on over 3200 subjects exposed to cetirizine. Based on these data, the following adverse events were reported in placebo-controlled trials with an incidence of 1.0% or greater with cetirizine 10 mg:
Adverse Events (WHO – ART) | Cetirizine 10 mg (n = 3260) | Placebo (n = 3061) |
Organism as a whole - systemic pathologies | ||
Fatigue | 1.63% | 0.95% |
Central and peripheral nervous system disorders | ||
Dizziness | 1.10% | 0.98% |
Headache | 7.42% | 8.07% |
Disorders of the gastrointestinal system | ||
Abdominal pain | 0.98% | 1.08% |
Dry mouth | 2.09% | 0.82% |
Nausea | 1.07% | 1.14% |
Psychiatric disorders | ||
Drowsiness | 9.63% | 5.00% |
Respiratory system disorders | ||
Pharyngitis | 1.29% | 1.34% |
Adverse event (WHO – ART) | Cetirizine 10 mg (n = 1656) | Placebo (n = 1294) |
Disorders of the gastrointestinal system | ||
Diarrhea | 1.0% | 0.6% |
Psychiatric disorders | ||
Drowsiness | 1.8% | 1.4% |
Respiratory system disorders | ||
Rhinitis | 1.4% | 1.1% |
Organism as a whole systemic pathologies | ||
Exhaustion | 1.0% | 0.3% |
Pregnancy Very few clinical data on exposed pregnancies are available for cetirizine. Animal studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Caution should be exercised when prescribing the product to pregnant women. Breastfeeding Cetirizine is excreted in breast milk at concentrations ranging from 0.25 to 0.90 of that measured in plasma, depending on the sampling times from administration. Therefore, caution should be exercised when prescribing the product to lactating women.
At therapeutic doses, no clinically significant interactions with alcohol were shown (for blood alcohol levels of 0.5 g / L). However, caution is recommended in case of concomitant alcohol intake. Caution should be exercised in patients with predisposing factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia), as cetirizine may increase the risk of urinary retention. Caution is advised in epileptic patients and in patients at risk for seizures. Use of the film-coated tablet formulation is not recommended in children below 6 years of age as this formulation does not allow for appropriate dose adjustment. Allergy skin tests are inhibited by antihistamines, therefore a wash-out period (3 days) is required before performing them. Pediatric population Use of the film-coated tablet formulation is not recommended in children below 6 years of age as this formulation does not allow for appropriate dose adjustment. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine does not require any special storage conditions.
Each film-coated tablet contains 10 mg of cetirizine dichlorohydrate. Excipient with known effect: lactose monohydrate (66 mg). For the full list of excipients, see section 6.1.
Core : Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate Coating : Titanium dioxide (E171) Hypromellose (E464) Macrogol
Destination | Cost | Detail |
---|---|---|
Italy | €5,90* | 24/72H |
Austria, France, Germany, Slovenia | € 13* | 3 days |
Belgium, Luxembourg, Portugal, Netherlands, Spain | € 14* | 4 days |
Bulgary, Cechia, Hungary, Poland, Romania, Slovakia | € 19* | 5 days |
Denmark, Estonia, Finland, Ireland, Lithuania, Latvia ,Sweden | € 22* | 5 days |
United Kingdom, Switzerland, Greece | € 30* | 7 days |
Canada, USA | € 40 | 7 Days |