Zyrtec tab p / 10 mg of the film 20 pc

$8.77

Zyrtec tab p / 10 mg of the film 20 pc

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Description

Composition
Active substance:
1 tablet contains: cetirizine dihydrochloride 10 mg.
Excipients:
Microcrystalline Cellulose 37.00 mg Lactose monohydrate 66.40 mg Colloidal silicon dioxide 0.60 mg magnesium stearate 1.25 mg, opadray® Y-1-7000 3,45 mg (hypromellose (E 464) 2.156 mg Titanium dioxide (E 171) 1.078 mg, 0.216 mg of macrogol 400).
Description:
White oblong film-coated tablet with biconvex surfaces, with one-sided risk engraving and «Y» on both sides of risks.
Product form:
Film-coated tablets 10 mg. At 7 or 10 tablets in blisters (blister) [PVC / aluminum foil]. 1 (7 or 10 tablets) or 2 (10 tablets) blister together with instructions for use in a cardboard package.
Contraindications
Hypersensitivity to cetirizine, hydroxyzine or a piperazine derivative, as well as other components of the formulation;
End-stage renal failure (creatinine clearance
Children under the age of 6 years (for a given dosage form);
Pregnancy;
Hereditary galactose intolerance, the lack of lactase, or syndrome of glucose-galactose malabsorption.
Precautions: – Chronic renal failure (creatinine clearance at> 10 mL per minute required correction mode); – elderly patients (age under reducing glomerular filtration); – epilepsy and patients with increased convulsive readiness; – patients with predisposing factors for urinary retention (see “Special Instructions” section). – the period of breastfeeding.
Dosage
10 mg
Indications
Cetirizine dihydrochloride, 10 mg tablets film-coated is indicated for use in adults and children 6 years and over, to facilitate: – nasal and ocular symptoms year (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis: itching, sneezing, nasal congestion , runny nose, watery eyes, redness of the conjunctiva; – symptoms of chronic idiopathic urticaria.
Interaction with other drugs
Based on the analysis of pharmacodynamic, pharmacokinetic of cetirizine interaction with other drugs are unlikely.
There were no significant interactions with pseudoephedrine or theophylline (400 mg daily) in the special studies of drug interactions.
The simultaneous use of cetirizine with alcohol and other drugs, CNS depressants, can further reduce the concentration and speed of reaction, although cetirizine does not potentiate the effect of alcohol (when its concentration in blood of 0.5 g / l).
Overdose
symptoms:
In single dose of the drug at a dose of 50 mg may experience the following symptoms: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, fatigue, sedation, somnolence, stupor, tachycardia, tremor, urinary retention.
Treatment: Immediately after taking the drug – gastric lavage or induce vomiting. Recommended administration of activated charcoal, conduct of symptomatic and supportive therapy. No specific antidote. Hemodialysis is ineffective.
pharmachologic effect
Pharmacological group:
Antiallergic agent – H1-histamine receptor blocker.
Pharmacodynamics:
Cetirizine – active substance Zirtek® preparation – is a metabolite of hydroxyzine, refers to a group of competitive antagonists and histamine H1-blocking histamine receptors.
In addition to antihistaminic effect and prevents the development of cetirizine facilitates the allergic reactions in a dose of 10 mg once or twice daily inhibits the late phase of aggregation of eosinophils in the skin and conjunctiva of patients prone to atopy.
Clinical efficacy and safety:
Studies in healthy volunteers have shown that cetirizine at doses of 5 or 10 mg significantly inhibit the reaction in the form of rash and redness on administration to the skin in high concentrations of histamine, but not a correlation with efficiency.
In a 6-week placebo-controlled study involving 186 patients with allergic rhinitis and concomitant asthma mild and moderate flow shown that taking cetirizine 10 mg once daily reduces rhinitis symptoms and no effect on lung function.
The results of this study confirm the safety of cetirizine in patients with allergies and asthma of light and medium-heavy currents.
In a placebo-controlled study demonstrated that cetirizine receiving 60 mg daily for 7 days did not cause clinically significant lengthening of the interval QT.
Admission cetirizine at the recommended dose showed improvement in the quality of life of patients with perennial and seasonal allergic rhinitis.
Children
The 35-day study in patients aged 5-12 years, no evidence of immunity to the antihistamine effect of cetirizine. Normal skin reaction to histamine was restored within three days after discontinuation of the drug when it is used repeatedly.
The 7-day placebo-controlled study Zirtek® drug in dosage form, syrup involving 42 patients aged 6 to 11 months demonstrated the safety of the drug. Zirtek® administered at a dose of 0.25 mg / kg twice a day, which corresponded to about 4.5 mg per day (dose range was from 3.4 to 6.2 mg per day).
Use in children 6 to 12 months is possible only by prescription and under strict medical supervision.
Pharmacokinetics:
Pharmacokinetic parameters cetirizine when used in doses from 5 to 60 mg vary linearly.
Suction
The maximum concentration (Cmax) in plasma achieved after 1 ± 0,5 hours and is 300 ng / ml.
Various pharmacokinetic parameters such as maximum plasma concentration and area under the curve “concentration-time” have a homogeneous character.
Food intake does not affect the absorption of cetirizine completeness, though its speed is reduced.
The bioavailability of various dosage forms of cetirizine (solution, capsule, tablet) is comparable.
Distribution
Cetirizine 93 ± 0,3% bound to plasma proteins. The volume of distribution (Vd) is 0.5 l / kg. Cetirizine does not affect the binding of warfarin with proteins.
Metabolism
Cetirizine does not undergo extensive primary metabolism.
breeding
The half-life (T1 / 2) is about 10 hours.
Before the drug in a daily dose of 10 mg of cetirizine accumulation were observed for 10 days.
Approximately 2/3 of the dose of the drug is excreted in the urine unchanged.
Elderly patients:
At 16 elderly persons with single dose of the drug at a dose of 10 mg of T1 / 2 was 50% higher and clearance was 40% lower when compared to individuals not elderly.
Decrease in clearance of cetirizine in elderly patients is likely due to a decrease in renal function in these patients.
Patients with renal insufficiency:
Patients with mild renal impairment (creatinine clearance (CC)> 40 ml / min), the pharmacokinetic parameters are similar to those in healthy volunteers with normal renal function.
In patients with renal insufficiency of moderate severity in patients on hemodialysis (creatinine clearance
For patients with renal failure secondary to severe corresponding change in the dosing regime required (see. The section “Method of administration and dose”).
Cetirizine poorly removed from the body during hemodialysis.
Patients with hepatic insufficiency:
In patients with chronic diseases of the liver (hepatocellular, and cholestatic biliary cirrhosis) under single dose of the drug in a dose of 10 mg or 20 T1 / 2 is increased by about 50%, and the clearance is reduced by 40% as compared with healthy subjects. No dose adjustment is necessary only in case of a patient with hepatic insufficiency, there is also a concomitant renal insufficiency.
Children:
T1 / 2 in children 6 to 12 years of 6 hours from 2 to 6 years – 5 hours from 6 months to 2 years – is reduced to 3.1 hours.
Pregnancy and breast-feeding
Pregnancy
In the analysis of prospective data from more than 700 pregnancy outcomes revealed no cases of the formation of malformations, fetal and neonatal toxicity with a clear cause-and-effect relationship.
Experimental studies in animals have not revealed any direct or indirect adverse effects of cetirizine on the developing fetus (including those in the postnatal period), during pregnancy and postnatal development.
Adequate and well-controlled clinical studies on safety of the drug during pregnancy has not been so Zirtek® should not be used during pregnancy.
Breast-feeding
Cetirizine is excreted in breast milk at a concentration of from 25% to 90% of the plasma concentration of the drug versus time after administration. During the period of breastfeeding used after consulting a doctor, if the intended benefits to the mother outweighs the potential risk to the child.
fertility
Available data on the effect on human fertility is limited, but a negative effect on fertility has not been revealed.
Conditions of supply of pharmacies
Without recipe.
side effects
The data obtained in the clinical studies.
Overview
Results from clinical studies have demonstrated that the use of cetirizine at recommended doses leads to the development of minor adverse effects on the CNS, including drowsiness, fatigue, dizziness and headache. In some cases it was registered paradoxical CNS stimulation.
Despite the fact that cetirizine is a selective blocker of peripheral H1- receptors and almost no anticholinergic action, it was reported a few cases of micturition difficulty, accommodation disturbances and dry mouth.
Reported violations of the liver accompanied the increase in liver enzymes and bilirubin. Most adverse events were resolved after discontinuation of cetirizine dihydrochloride.
The list of undesirable side reactions
There are data obtained during the double-blind controlled clinical studies aimed at comparing cetirizine and placebo or other antihistamines used at the recommended doses (10 mg once daily for cetirizine) in more than 3200 patients on the basis of which it is possible to carry out a reliable analysis safety data.
According to the results of the combined analysis of placebo-controlled studies in the application of cetirizine 10 mg were identified following undesirable reaction with a frequency of 1.0% or higher:
General disorders and disturbances at the injection site: fatigue.
Disorders of the nervous system: dizziness, headache.
Disorders of the gastrointestinal tract: abdominal pain, dry mouth, nausea. Mental disorders: drowsiness.
Violations of the respiratory system, thorax and mediastinum: pharyngitis.
Although the incidence of sleepiness cetirizine group was higher than that in the placebo group, in most cases this undesirable phenomenon was mild or moderate in severity. When an objective assessment, undertaken in other studies, it was confirmed that the use of cetirizine at the recommended daily dose in healthy young volunteers has no effect on their daily activities.
Children
In placebo-controlled trials in children aged 6 months to 12 years revealed the following adverse reactions with a frequency of 1% or higher:
Disorders of the gastrointestinal tract: diarrhea.
Mental disorders: drowsiness.
Violations of the respiratory system, thorax and mediastinum: Rhinitis. General disorders and disturbances at the injection site: fatigue.
Previous post-registration application
In addition to adverse events identified during clinical trials and described above, within the post-registration of the drug following adverse reactions were observed.
Adverse events are shown below in classes MedDRA organ system development and frequency, on the basis of data on post drug application.
The incidence of adverse events was determined as follows: very often (> 1/10), often (> 1/100
special instructions
It is recommended to be careful when using cetirizine with alcohol.
Patients with spinal cord injury, prostate hyperplasia, and in the presence of other predisposing factors to urinary retention, requires compliance caution as cetirizine may increase the risk of urinary retention.
Caution should be exercised in patients with epilepsy and increased convulsive readiness.
Before assigning allergy three samples recommended “washout” period because the H1-histamine receptor blockers inhibit the development of cutaneous allergic reactions.
Cetirizine tablets, film-coated, should not be administered to patients with hereditary galactose intolerance, lactase deficiency syndrome or glucose-galactose malabsorption.
After discontinuation of cetirizine may appear itching and / or rash, even if these symptoms were absent at the beginning of treatment. In some cases, symptoms can be intense and require the reintroduction of cetirizine. The symptoms disappeared when resuming reception of cetirizine.
Children
Cetirizine film-coated tablets, not recommended for children under 6 years since this formulation does not allow appropriate dose for this age group.
It is recommended to use a pediatric formulation (oral drops).
The effect on the ability to operate vehicles, machinery
When an objective assessment of the ability to drive vehicles and management mechanisms do not reliably reveal any adverse effects while taking the drug at the recommended dose. However, patients with symptoms of sleepiness in patients receiving the drug it is advisable to refrain from driving, occupations potentially hazardous activities or control mechanisms that require high concentration and speed of psychomotor reactions.
Storage conditions
At a temperature of not higher than 30 C.
Keep out of the reach of children.
Dosing and Administration
Inside. Tablets recommended drink a glass of water.
Adult, 10 mg (1 tablet) once daily.
Separate groups of patients.
Elderly patients
There is no need to reduce the dosage in elderly patients if the renal function is not impaired.
Patients with renal insufficiency
Since Zirtek® excreted mainly by the kidneys (. Subsection “Pharmacokinetics”), the impossibility of alternative treatment in patients with renal insufficiency drug dosing regimen should be adjusted depending on renal function (creatinine values ​​clearance CC):
QA> 80 ml / min-1 to 10 mg once a day;
FF-50-79 ml / min-1 to 10 mg once a day;
FF-30-49 ml / min to 5 1 mg once a day;
FF-10-29 ml / min, 5 mg every other day;
Patients on dialysis, QC
Patients with impaired liver function
In patients with impaired liver function only correct dosing regimen is required.
Patients with impaired and liver function and kidney function, recommended dosing correction (see. The table above).
Children
Children 6 to 12 years 5 mg (1/2 tablet) twice a day
Children older than 12 years, 10 mg (1 tablet) once daily
Sometimes an initial dose of 5 mg (half tablets) may be sufficient if it is possible to achieve satisfactory control of symptoms.
Children with renal insufficiency dose corrected for QC and body weight.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Zyrtec

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