Descrizione Clinica
Cetirizine eg 7cpr riv 10mg Eg Spa
CETIRIZINA EG 10 MG STATEMENTS WITH FILM
active ingredients
A film-coated tablet contains 10 mg of excipient cetirizine: a film-coated tablet contains 52.30 mg of monohydrate lactose. For the full list of excipients, see paragraph 6.1.
Excellent
Cellulose microcrystalline Lactose monohydrate Silice anidra colloidal Magnesium stearate. Coating: opadry II white (constituted by ipromellose, titanium dioxide (E171), polydestrose (E1200), talc, maltodextrin, medium chain triglycerides)
Therapeutic indications
Adults and pediatric patients from 6 years of age: – Cetirizine is indicated for the treatment of nasal and eye symptoms of seasonal and perennial allergic rhinitis. – Cetirizina is indicated for the symptomatic treatment of idiopathic chronic urticaria.
Contraindications
History of hypersensitivity to the active ingredient, to any of the excipients, to hydroxyzine or to any derivative of piperazin. Patients with severe kidney failure with creatinine clearance less than 10 ml/min.
Population
Children aged between 6 and 12 years: 5 mg twice a day (half compressed twice a day). Adults and children over the age of 12: 10 mg once a day (1 tablet). The tablets should be taken with a glass of liquid. Senior patients: on the basis of the available data, in elderly individuals with normal kidney function no reduction of the dose is necessary. Patients with renal degree failure from moderate to severe: there are no data that documents the effectiveness/security ratio in patients with kidney failure. Since cetirizine is mainly excreted by renal (see paragraph 5.2), in cases where alternative treatments cannot be used, the intervals between doses must be customized according to kidney function. Please refer to the following table and adjust the dose as indicated. To use this posological table, it is necessary to have an estimate of creatinine clearance (CLcr) of the patient expressed in ml/min. The CLcr (ml/min) can be obtained from the value of sierica creatinine (mg/dl) using the following formula:
| CLCR = | [140 – età(anni) x peso (kg)] | (x 0,85 in women) |
| 72 x sierica creatinine (mg/dl) |
Adaptation of adult posology with compromised kidney function
| Group | Creatine clearance (ml/min) | Dosage and frequency |
| Normal | ≥ 80 | 10 mg once a day |
| Lie | 50–79 | 10 mg once a day |
| Moderate | 30–49 | 5 mg once a day |
| Grave | 5 mg once every 2 days | |
| Renal disease at the last stage – Patients in dialysis | Contraindicated |
In pediatric patients suffering from kidney failure, the dose should be individually adapted, taking into account kidney clearance, age and body weight of the patient. Patients with liver failure: patients suffering only from liver failure do not need any adaptation of posology. Patients with liver and kidney failure: an adaptation of posology is recommended (see above Patients with moderate to severe kidney failure).
Conservation
This drug does not require any special condition for conservation.
Warnings
At therapeutic doses, clinically significant interactions with alcohol were not highlighted (for blood levels of 0.5 g/l). However, caution is recommended in case of concomitant alcohol intake. Caution should be given in patients with urinary retention factors (e.g. spinal cord injury, prostatic hyperplasia) since cetirizine can increase the risk of urinary retention. Caution is recommended in epileptic patients and patients at risk of seizures. Pediatric population The use of the formulation in tablets coated with film is not recommended in children under 6 years of age, since this formulation does not allow an appropriate adaptation of the dose. The skin tests for allergy are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. Patients suffering from rare hereditary problems of galactose intolerance, lactase deficiency or glucose–galactose mal absorption should not take this medicine.
Interactions
For the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, there are no interactions with this antihistamine. In drug–pharmac interaction studies, in fact, no significant pharmacodynamic interactions or pharmacokinetic interactions have been reported, particularly with pseudophedrine or theophylline (400 mg/die). The degree of absorption of cetirizine is not reduced by food intake, although the absorption rate is decreased.
Effects
Clinical studies have shown that cetirizine at the recommended dosage has minor side effects at SNC level, which include drowsiness, fatigue, dizziness and headache. In some cases, paradox stimulation of the SNC.BenchCetirizine is a selective inhibitor of peripheral H1 receptors and is relatively devoid of anti-linergical activity, rare cases of difficulty in urination, eye tampering disorders and dry mouth have been reported. Abnormal hepatic function cases have been reported with elevated hepatic enzymes accompanied by high bilirubin, most of which resolved following discontinuation of treatment with cetirizine dichloride. Clinical trials In the context of double-blind clinical trials or clinical pharmacology studies, in which cetirizine was compared to placebo or other antihistamines to the recommended dosage (10 mg per day for cetirizine), for which there are quantitative safety data, more than 3200 subjects were treated with cetirizine. Based on this data, the following adverse events were reported in placebo controlled trials with an incidence equal to or greater than 1.0% with cetirizine 10 mg:
| Adverse events (WHO–ART) | Cetirizine 10 mg (n=3260) | Placebo (n=3061) |
| Body as a whole – general pathologies | ||
| Fatigue | 1.63% | 0,95% |
| Central and peripheral nervous system pathologies | ||
| Heads | 1.0% | 0,98% |
| Cefa | 7,42% | 8,07% |
| Gastro-intestinal system pathologies | ||
| Abdominal pain | 0,98% | 1,08% |
| Dry mouth | 2,09% | 0,82% |
| Nausea | 1,07% | 1.4% |
| Psychiatric disorders | ||
| Sleep | 9,63% | 5,00% |
| Diseases of the respiratory system | ||
| Pharisees | 1.29% | 1.34% |
Although statistically the incidence of drowsiness with cetirizine was more common than with the placebo, this event resulted from small to moderate entities in most cases. Further studies in which objective tests have been carried out have shown that the usual daily activities are not compromised at the recommended daily dose, in healthy young volunteers. Adverse reactions with an incidence equal to or greater than 1.0% in children aged between 6 months and 12 years, in clinical studies controlled towards placebo or clinical pharmacology studies, are:
| Adverse reactions (WHO–ART) | Cetirizine (n=1656) | Placebo (n=1294) |
| Gastro-intestinal system pathologies | ||
| Diarrea | 1.0% | 0,6% |
| Psychiatric disorders | ||
| Sleep | 1.8% | 1.4% |
| Diseases of the respiratory system | ||
| Rehabilitation | 1.4% | 1.1% |
| Body as a whole – general pathologies | ||
| Fatigue | 1.0% | 0.3% |
Post-marketing experience The adverse events encountered during the clinical trials listed in the previous paragraph should be added to the isolated cases of the following adverse reactions reported in the post-marketing experience. The side effects are described according to the MedDRA classification for systems and organs and according to the frequency defined on the basis of the post-marketing experience. The frequencies are defined as follows: very common (≥1/10); common (≥1/100, pathologies of the emolinfopoietic system: Very rare: trombocytopenia Immune system disorders: Rare: hypersensitivity Very rare: anaphylactic shock Disorders of metabolism and nutrition: Notable: increased appetite Psychiatric disorders: Not common: Rare agitation: aggressiveness, confusion, depression, hallucinations, insomnia Very rare: tic Notable: suicidal idea Diseases of the nervous system: Not common: parestesia Raro: convulsioni Very rare: disgeusia, distonia, discinesia, sincope, tremor Not known: amnesia, impairment of memory Pathologies of the eye: Very rare: ailment disorder, blurred vision, oculogira crisis Ear and labyrinth pathologies: Notable: vertigo Heart disease: Rare: tachycardia Gastrointestinal diseases: Not common: diarrhea Hepatobiliary diseases: Rare: altered liver function (increasing transaminese, alkaline phosphatease, γ–GT and bilirubin) Pathologies of skin and subcutaneous tissue: Not common: itching, rash Rare: hives Very rare: angioneurotic edema, fixed eruption by drugs Kidney and urinary pathologies: Very rare: disuria, enurei Not known: urinary retention Systemic pathologies and conditions for administration: Not common: asthenia, Rare malaise: edema Diagnostic examinations: Rare: weight gain Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.
Overdosing
Synonyms Symptoms observed as a result of a cetirizine overdose are mainly associated with effects on the central nervous system or effects that may suggest anti-linergic activity. As a result of taking a dose of at least 5 times the recommended daily dose, the following adverse events were reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, midriasis, itching, restlessness, sedation, drowsiness, astonishment, tachycardia, tremor and urinary retention. Treatment A specific antidote to cetirizine is not known. In case of overdose, symptomatic or support treatment is recommended. Following recent ingestion, gastric lavender is recommended. Cetirizine is not effectively removed by dialysis.
Pregnancy
For cetirizine there are very few clinical data on pregnancies exposed to treatment. Animal studies show no direct or indirect harmful effects regarding pregnancy, embryo/fetal development, childbirth or post-natal development. Prescription to pregnant women must be done with caution.
Food
Cetirizine is excreted in breast milk at concentrations representing 25% to 90% of those measured in plasma, depending on the sampling time after administration. Therefore the prescription to nursing women must be carried out with caution.
Source: Farmadati
