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Zirtek 10 mg / ml 10 ml oral drops




The instruction for medical use of Zirtek Torgovoye medicine a name of Zirtek® the International unlicensed name Tsetirizin Lekarstvennaya the Drop form for intake of 10 mg/ml, 10 ml Structure of 1 ml of drops for intake contains active agent – a tsetirizin dihydrochloride of 10 mg, excipients: glycerin, propylene glycol, methylparahydroxybenzoate, propilparagidroksibenzoat, saccharinate of sodium, sodium acetate, the ice acetic acid, water purified. The description Transparent colourless liquid with a smell of acetic acid. Pharmacotherapeutic group Antihistaminic drugs of systemic action. Piperazin derivatives. Tsetirizin. The ATX R06AE07 code the Pharmacological Pharmacokinetics Equilibrium Maximum Concentration properties in plasma makes about 300 ng/ml and is reached through 1.0 ± 0.5 h. Cumulation of a tsetirizin at the subsequent reception of a daily dose of 10 mg within 10 days is not observed. Volunteers have pharmacokinetic parameters (Smakh and AUC) and distribution have unimodal character. Extent of absorption of a tsetirizin does not decrease with meal though the speed of absorption decreases. Degree of bioavailability is similar when using a tsetirizin in the form of drops for intake, capsules or tablets. The confirmed volume of distribution is 0.50 l/kg. Linking of a tsetirizin with proteins of plasma makes 93 ± 0.3%. Tsetirizin does not influence linking of warfarin with proteins. Tsetirizin is not exposed to the significant predistemny metabolism. About two thirds of a dose are removed in not changed view with urine. Final elimination half-life makes about 10 hours. Tsetirizin shows linear kinetics in the range from 5 to 60 mg. Patients of advanced age After intake of a single dose of 10 mg, elimination half-life at 16 elderly patients in comparison with normal subjects increases approximately by 50%, and the clearance decreased by 40%. Decrease in absorption of a tsetirizin at elderly volunteers appeared, is connected with reduced function of kidneys. Children of 6-12 years Elimination half-life of a tsetirizin makes about 6 hours. Patients with renal failures At patients to a slight renal failure (the clearance of creatinine [CC] & gt, 40 ml/min.) the pharmacokinetics of drug is similar to pharmacokinetics of healthy volunteers. In a moderate renal failure the elimination half-life increases by 3 times and the clearance decreases by 70% in comparison with normal volunteers. Patients on a hemodialysis (KK & lt, 7 ml/min.), at single dose of 10 mg of a tsetirizin observed 3-fold increase in elimination half-life and 70% decrease in clearance in comparison with the healthy volunteer. Tsetirizin badly leaves by means of a hemodialysis. In a moderate or heavy renal failure the dose adjustment is necessary. Patients with abnormal liver functions Patients with chronic diseases of a liver (hepatocellular, cholestatic and biliary cirrhosis) which applied 10 or 20 mg of a tsetirizin as a single dose observed 50% increase in elimination half-life and also 40% decrease in clearance in comparison with healthy people. Correction of a dose is necessary only for patients with a simultaneous abnormal liver function and kidneys. The pharmacodynamics Tsetirizin, active ingredient of the drug Zirtek®, represents Hydroxyzinum metabolite, is a powerful and selection antagonist of peripheral H1 – histamine receptors. In experiments on linking with receptors in the conditions of in vivo the measured affinity of drug to the receptors different from H1 is not revealed. Under natural conditions experiments on mice showed that system use of a tsetirizin significantly does not influence brain H1 receptors. In addition to anti-H1 – histamine to effect, tsetirizin shows antiallergic action: in a dose of 10 mg one or twice a day, it inhibits in a late phase an accumulation of inflammatory cells, especially eosinophils, in skin and a conjunctiva at the persons suffering from an atopy after contact with antigens. In a dose of 30 mg/days suppresses inflow of eosinophils to a bronchoalveolar system during a late phase of the bronchial konstriktion induced by inhalation of allergen of bronchial asthma. Moreover, tsetirizin brakes a final phase of the inflammatory reaction induced by intracutaneous administration of kallikrein to patients with a chronic small tortoiseshell. It also reduces the level of the expressed molecules of adhesion, such as ICAM-1 and VCAM-1 which are indicators of allergic inflammation. The beginning of action after single use of 10 mg of drug comes within 20 minutes in 50% of cases and within one hour – in 95% of cases. This activity remains within not less than 24 hours after single use. At treatment tsetiriziny, inflammatory process stops after repeated introduction, skin recovers the normal reactivity to a histamine within 3 days. Indications For adults and for children aged from 2 years – simplification of nasal and eye symptoms of seasonal and year-round allergic rhinitis – relief of symptoms of a small tortoiseshell the Route of administration and doses For intake. Before use of a drop it is necessary to dilute with a small amount of water. Children aged from 2 up to 6 years of 2.5 mg 2 times a day (5 drops) Children aged from 6 up to 12 years of 5 mg 2 times a day (10 drops) Teenagers of 12 years are also more senior, adult 10 mg once a day (20 drops). The initial dose of 10 drops can be offered if it leads to satisfactory control of symptoms. Elderly people Are not present the data demonstrating that the dose has to be reduced for elderly patients provided that function of kidneys is normal. A moderate and heavy renal failure Dosing has to be individual depending on function of kidneys. Address the following table for correction of a dose as it is specified. When using this table of a dosage, assessment of removal of creatinine (CLcr) in ml/min. is not required. CLcr (ml/min.) can be estimated on the serum of creatinine (mg/dl) determined by the following formula: [140 – age (years)] x the weight (kg) of CLcr =——————————————–×0.85 (for women) 72 x creatinine of serum (mg/dl) Correction of a dosage for adult patients with impaired renal function. A stage Removal of creatinine (ml/min.) the Dosage and frequency of use Norma ≥80 10 mg once, daily Weak 50-79 10 mg once, daily Moderate 30-49 5 mg once, daily Heavy ˂30 5 mg, each two days Patients, with a final stage of a renal failure, being on dialysis ˂10 are contraindicated For the pediatric patients having a renal failure, the dose has to be picked up on an individual basis taking into account renal clearance of the patient and his body weight. The liver failure Dose adjustment is not required for patients with a liver failure. Patients with a liver and renal failure the Dose decreases depending on clearance of creatinine (see the table of correction of a dosage higher). Side effects – drowsiness – fatigue, weakness – dizziness, a headache – abdominal pain, dryness in a mouth, nausea, diarrhea – pharyngitis, rhinitis Post-marketing experience Infrequently (≥ 1/1000 to & lt, 1/100) – agitation – paresthesia – diarrhea – an itching, rash – weakness, an indisposition Is rare (≥1/10000 up to ˂1/1000) – hypersensitivity, a small tortoiseshell, swelled – aggression, confusion of consciousness, a depression, hallucinations, insomnia, spasms – tachycardia – disturbances of functions of a liver (increase in transaminases, alkaline phosphatase, gamma GT and bilirubin) – increase in body weight is Very rare (˂ 1/10000), – thrombocytopenia – an acute anaphylaxis, a Quincke’s disease – a tic, disturbances of taste, a syncope, a tremor – deterioration in sight, accommodation disturbance (indistinct image), an okulogiration – dyskinesia, dystonia, – a dysuria, enuresis It is unknown – the increased appetite – suicide thoughts, amnesia, memory disturbance, dizziness – the Contraindication ischuria – hypersensitivity to Hydroxyzinum, other derivatives of piperazin or any component of drug, – to children under 2 years (because of limited data in safety and efficiency of drug) – patients with a heavy renal failure and clearance of creatinine less than 10 ml/min. – pregnancy and the period of a lactation Medicinal interactions Pharmacokinetic researches of interaction of a tsetirizin and pseudoephedrine, antipyrine, Cimetidinum, a ketokonazol, erythromycin, azithromycin of a glipizid, diazepam, theophylline (400 mg once a day) did not reveal proofs of clinically significant pharmakodinamichesky interactions. Co-administration of a tsetirizin with macroleads (for example, azithromycin, erythromycin) or ketokonazoly did not lead to clinically significant changes of the ECG. At a research of several doses of a ritonavir (600 mg twice a day) and a tsetirizina (10 mg a day) it was revealed that extent of influence of a tsetirizin was increased approximately by 40%, and the arrangement of a ritonavir was slightly changed (-11%) in addition to the accompanying reception of a tsetirizin. Tsetirizin weakens anticoagulating effect of heparin. Azilastin, to alprazola, buprenorphine, a haloperidol, Hydroxyzinum, diazepam, Droperidolum, zolpidy, flurazepam, kvetiapin, Fluphenazin, clozapine, trifluoperazin, thioridazine, phenobarbital, fentanyl, temazepam, risperidon, propofol, remifentanit, promethazine, Perfenazinum, codeine, lorazepam, olanzapine, oxazepam, midazolam, Chlorpromazinum, chlordiazepoxide, to estazola – strengthens (mutually) a deprimation and reduction in the rate of psychomotor reactions. Metohexital, ketamine, izofluran, enfluran, in the post-narcotic period – strengthens (mutually) a deprimation and reduction in the rate of psychomotor reactions. Ethanol strengthens (mutually) a deprimation and reduction in the rate of psychomotor reactions, for the period of treatment it is recommended to refuse alcoholic drinks. Extent of absorption of a tsetirizin does not decrease with meal though the speed of absorption decreases for 1 hour. Tests for a skin allergy are suppressed with antihistamines, their washing away happens in 3 days, it is recommended to obatit on this attention before carrying out them. Special instructions In therapeutic doses clinically significant interaction with alcohol is not revealed (on the blood alcohol level of 0.5 g/l). Nevertheless, it is recommended to observe precautionary measures if alcohol is accepted along with drug. At patients with hypersensitivity, simultaneous use of drug with alcohol or other depressants of central nervous system can arise additional decrease in vigilance and deterioration in performance. Special attention is recommended to be paid to patients with the contributing ischuria factors (for example, problems with a spinal cord, a benign hyperplasia of a prostate) as tsetirizin can increase risk of an ischuria. Special attention to patients with epilepsy and patients with risk of developing spasms is recommended. Tests for a skin allergy are suppressed with antihistamines, their washing away happens within 3 days, it is recommended to pay attention to it before carrying out them. Excipients which are a part: methylparahydroxybenzoate and propilparagidroksibenzoat – allergic reactions (perhaps late manifestation) can cause. The lactation period Tsetirizin is allocated in breast milk in number of 25%-90% of concentration in blood plasma, depending on sampling time after introduction. Therefore it is necessary to stop breastfeeding for treatment. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Patients who need to be engaged in potentially dangerous types of activity or to work with the equipment, should not exceed the recommended doses and take reaction to medicine into account. Overdose the Symptoms observed after overdose of a tsetirizin are generally connected with central nervous system or with the effects similar to anticholinergic effect. The undesirable phenomena revealed after reception of the dose exceeding the recommended day dose at least by 5 times: confusion of consciousness, diarrhea, dizziness, fatigue, headache, indisposition, expansion of pupils, naggers, concern, sedation, drowsiness, stupor, tachycardia, tremor, and ischuria. Treatment there are no Known antidotes. Symptomatic or maintenance therapy is recommended. Gastric lavage should be made at once at emergence of collateral symptoms. The hemodialysis is ineffective for removal of a tsetirizin. The form of release and packing On 10 ml of drug place in the bottles of dark glass (type 3) supplied with a polyethylene cover and the system of protection against children. Bottles are supplied with covers droppers from white polyethylene of the low density allowing to release 20 drops (1 ml). 1 bottle together with the instruction for medical use in the state and Russian languages is placed in a cardboard box. To Store storage conditions at a temperature not above 30 °C to Store out of children’s reach! A period of storage of 5 years After opening of a bottle – to use drug no more than 3 months. Not to apply after the expiration of the period of storage specified on packing. Prescription status According to the prescription the Producer Eysika Pharmasyyutikalz of Neuter. L., Italy (Via Praglia 15, 10044 Pianezza (TO)) Packer Eysika Pharmasyyutikalz of Neuter. L., Italy (Via Praglia 15, 10044 Pianezza (TO)) the Owner of the registration certificate of GlaksoSmitKlyayn Export Limited, Great Britain (980 Great West Road, Brentford, Middlesex, TW8 9GS) the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of GlaksoSmitKlyayn Export Ltd in Kazakhstan 050059, Almaty, Furmanov St., 273 Phone number: +7 727 258 28 92, +7 727 259 09 96 Fax number: + 7 727 258 28 90 E-mail address:
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