CETIRIZATION ZENTIVA 10 MG COMPRESENT RIVES WITH FILM
active ingredients
A film coated tablet contains 10 mg of cetirizine dichloride. Excipients with known effects: a film coated tablet contains 73.4 mg of lactose monohydrate. For the full list of excipients, see paragraph 6.1
Excellent
Compressed core Lactose monohydrate Corn starch Povidone 30 Magnesium stearate
Coating of the tablet Ipromellosa 2910/5 (E464) Macrogol 6000 Talco Titanio dioxide (E171) Simeticone emulsion SE 4
Therapeutic indications
Cetirizina Zentiva is indicated in adults and pediatric patients from 6 years of age - to relieve nasal and eye symptoms of seasonal and perennial allergic rhinitis. - to alleviate the symptoms of idiopathic chronic urticaria.
Contraindications
Hypersensitivity to the active ingredient, to any of the excipients listed in paragraph 6.1, to hydroxyzine or any derivative of piperazin. Patients with severe kidney damage with creatinine clearance less than 10 ml/min.
Population
Population Adults and teenagers over the age of 12: 10 mg once a day (1 tablet).
Special popularity Seniors: on the basis of the available data, in elderly persons with normal kidney function no reduction of the dose is necessary.
Year of renal grade from moderate to severe: there are no data that documents the effectiveness/security ratio in patients with kidney damage. 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 weight (kg) | (x 0,85 for women) |
| 72 x sierica creatinine (mg /dl) |
Adaptation of dose for adults 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 |
Epathetic Comprogation: no dose adjustment is required in patients suffering only from liver impairment.
Hepatic comprogation and kidney damage: an adaptation of the dose is recommended (see above " Patients with kidney damage of moderate to severe degree).
Pediatric population The formulation in tablets should not be used in children under 6 years of age since it does not allow the necessary dosage adjustments. Children between 6 and 12 years old: 5 mg twice a day (half compressed twice a day). In pediatric patients suffering from kidney damage, the dose should be individually adapted, taking into account kidney clearance, age and body weight of the patient. Method of administration The tablets should be taken with a glass of liquid.
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 is recommended in patients with urinary retention predisposition factors (such as 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. The response to skin allergic tests is inhibited by antihistamine drugs, so a wash-out period (of 3 days) is recommended before testing. Itching and/or hives may occur when the treatment with cetirizine is interrupted, even if such symptoms were not present before the start of treatment. In some cases, symptoms can be intense and you may need to start treatment again. Symptoms should resolve when you start treatment again. 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. It is recommended to use a pediatric formulation of cetirizine available on the market. Cetirizina Zentiva contains lactose monohydrate. 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-pharmaceutical 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 has decreased. In sensitive patients, the simultaneous intake of cetirizine with alcohol or other substances with depressing action on SNC may cause further decrease in alert status and performance impairment, although cetirizine does not enhance the effect of alcohol (0,5 g/L of blood levels).
Effects
Clinical studies
Overview 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.BenchIs cetirizine both a selective antagonist of peripheral H1 receptors and is relatively devoid of anti-linergical activity, rare cases of difficulty in urination, eye tamodation disorders and dryness of the oral cable have been reported. Anomalous hepatic function has been reported with elevated liver enzymes accompanied by high bilirubin, most of which are resolved as a result of discontinuation of treatment with cetirizine dichloride.
List of side effects In the context of double-blind controlled clinical trials, 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 3,200 subjects have been treated with cetirizine. Based on this data, the following adverse events with an incidence of 1.0% or more with cetirizine 10 mg were reported in placebo tests:
| Adverse reactions (WHO-ART) | Cetirizina 10 mg (n= 3.260) | Placebo (n = 3.061) |
| Psychiatric disorders | | |
| Sleep | 9,63% | 5,00% |
| Diseases of the nervous system | | |
| Heads | 1,10 % | 0,98 % |
| Cefa | 7.42 % | 8.07 % |
| Respiratory, chest and mediastinic pathologies | | |
| Pharisees | 1.29% | 1.34% |
| Gastrointestinal diseases | | |
| Abdominal pain | 0,98 % | 1,08 % |
| Dry mouth | 2,09 % | 0,82 % |
| Nausea | 1,07 % | 1,14 % |
| Systemic pathologies and conditions for administration | | |
| Fatigue | 1,63 % | 0,95 % |
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. Pediatric Population Adverse reactions with an incidence of 1.0% or more in children aged between 6 months and 12 years in placebo controlled clinical trials are:
| Adverse reactions (WHO-ART) | Cetirizina (n=1.656) | Placebo (n = 1.294) |
| Psychiatric disorders Sleep | 1.8 % | 1,4% |
| Respiratory, chest and mediastinic pathologies Riniti | 1,4 % | 1.1 % |
| Gastrointestinal pathologies Diarrea | 1.0 % | 0.6 % |
| Systemic pathologies and conditions relating to the administration address | 1.0% | 0.3% |
Post-marketing experience The adverse events encountered during the clinical studies listed in the previous paragraph should be added to the isolated cases of the following adverse reactions reported in the post-marketing experience. Undesirable effects are described in accordance with
Classification for systems and organs according to MedDRA and the frequency is defined on the basis of the post-marketing experience. The frequencies are defined in the following way: very common ((≥1/10); common (≥1/100, a
| Classification for systems and organs | Frequency | Adverse reactions |
| Emolinfopoietic system pathologies | Very rare | trombocytopenia |
| Immune system disorders | Rare | hypersensitivity |
| Very rare | anaphylactic shock |
| Disorders of metabolism and nutrition | Notable | increased appetite |
| Psychiatric disorders | Not common | agitation |
| Rare | aggressiveness, confusion, depression, hallucinations, insomnia |
| Very rare | tick |
| Notable | suicidal idea |
| Diseases of the nervous system | Not common | the week |
| Rare | convulsions |
| Very rare | dysgeusia, syncope, tremor, dystonia, dyskinesia |
| Notable | amnesia, impairment of memory |
| Pathologies of the eye | Very rare | ailment disorder, blurred vision, oculorotation |
| Ear and labyrinth pathologies | Notable | dizziness |
| Heart disease | Rare | tachycardia |
| Gastrointestinal diseases | Not common | diarrhea |
| Hepatobiliary diseases | Rare | altered liver function (increasing transaminase, alkaline phosphatease, γ-GT and bilirubin) |
| Pathologies of skin and subcutaneous tissue | Not common | itching, rash |
| Rare | hives |
| Very rare | anjourotic edema, fixed eruption from drugs |
| Kidney and urinary pathologies | Very rare | disuria, enuresi |
| Notable | urinary retention |
| Systemic pathologies and conditions for administration | Not common | astenia, malaise |
| Rare | 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 to theindirizzowww.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Overdosing
(a)
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.
b) Treatment A specific antidote to cetirizine is not known. In case of overdose, symptomatic or support treatment is recommended. Gastric lavender can be considered immediately after ingestion of the drug. Cetirizine is not effectively removed for hemodilysis.
Pregnancy
Perspective data collected for cetirizine on pregnancy outcomes do not suggest potential toxicity to the mother or fetus/embry above the basic values. 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 human milk at concentrations representing 25 - 90% of those measured in plasma, these depend on sampling time after administration. So you should pay attention when cetirizine is prescribed to nursing women.
Fertility
Limited human fertility data are available, but safety issues have not been identified. Animal data shows no safety issues for human reproduction.
Source: Farmadati
