Zodak pills p/o 10mg №10×3

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Zodak table cover p / o 10 mg in bl. in pack. No. 10×3
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Oblong white or almost white film-coated tablets with a score line on one side. The tablet can be divided into equal halves. The main active ingredient Cetirizine dihydrochloride Release form Tablets Dosage 10 mg in bl. in pack. No. 10×3 Special instructions Patients with impaired renal function, liver and elderly patients should consult a doctor before taking the drug. The simultaneous use of drugs that depress the central nervous system, alcohol is not recommended. Note for diabetic patients The drops do not contain sugar, so they can be prescribed to patients with diabetes mellitus. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, patients should refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. PharmacodynamicsCetirizine, a hydroxyzine metabolite, is a potent and selective peripheral H1 receptor antagonist. In vitro studies have shown the impossibility of affinity for receptors other than H1 receptors. It has a pronounced anti-allergic effect (10 mg of the drug 1-2 times a day blocks the process of division of eosinophils in patients with atopic dermatitis), prevents the development and facilitates the course of allergic reactions. Studies in healthy volunteers have shown that cetirizine at doses of 5 and 10 mg significantly reduces reactions such as wheals and flushing caused by high concentrations of histamine in the skin, but no correlation with efficacy has been established. In a 35-day study involving children aged 5 to 12 years, no tolerance was found to the antihistamine effects of cetirizine (suppression of reactions such as wheals and flushing). After stopping the use of cetirizine, the normal reactivity of the skin to histamine is restored within 3 days. In a six-week placebo-controlled study in 186 patients with allergic rhinitis and associated mild to moderate asthma, cetirizine 10 mg daily improved rhinitis symptoms without altering lung function. This study confirms the safety of cetirizine in patients with allergic rhinitis and mild to moderate asthma. In a placebo-controlled study, cetirizine at a daily dose of 60 mg for seven days did not cause a statistically significant prolongation of the QT interval. At the recommended dosage, cetirizine has been shown to improve the quality of life of patients with year-round and seasonal allergic rhinitis. Pharmacokinetics Absorption The maximum plasma concentration is approximately 300 ng / ml and is reached after approximately 30-90 minutes. When taking a dose of 10 mg for 10 days, cetirizine does not accumulate in the body. Eating does not have a significant effect on the amount of absorption, however, in this case, the absorption rate is slightly reduced. The bioavailability of the active substance is the same for all dosage forms of the drug: syrup, drops and tablets. Distribution The apparent volume of distribution is 0.50 l/kg. The degree of binding of cetirizine to plasma proteins is about 93±0.3%. Cetirizine has no effect on the binding of warfarin to plasma proteins. Biotransformation Cetirizine does not undergo extensive first pass metabolism. Elimination Cetirizine is minimally metabolized in the liver to an inactive metabolite and is excreted unchanged mainly by the kidneys. The drug does not accumulate in the body (data during treatment with a daily dose of 10 mg for 10 days), about two-thirds of the dose of cetirizine is excreted unchanged in the urine. The half-life of cetirizine is approximately 10 hours. When taking 5-60 mg of cetirizine, linear kinetics are observed. Special populations Elderly: After a single dose of cetirizine 10 mg to sixteen elderly patients, the half-life increased by approximately 50%, clearance decreased by 40% compared with the usual group of patients. It turned out that a decrease in the clearance of cetirizine in elderly volunteers is associated with a decrease in kidney function. Children: The half-life of cetirizine is approximately 6 hours in children 6-12 years of age and 5 hours in children 2-6 years of age. In infants and infants aged 6 to 24 months, the elimination half-life is reduced to 3.1 hours. Patients with impaired renal function: The pharmacokinetics of the drug in patients with mild renal insufficiency (creatinine clearance above 40 ml / min) does not differ from healthy volunteers. In patients with moderate renal impairment, as well as in patients on hemodialysis, the half-life increases by 3 times, clearance decreases by 70% compared with healthy volunteers. Hemodialysis is ineffective. In patients with moderate or severe renal insufficiency, it is recommended to adjust the dose of the drug (see section Dosage and administration). Patients with impaired liver function: In patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis), when taking a single dose of cetirizine 10 or 20 mg, an increase in half-life by 50% and a decrease in clearance by 40% are observed compared with healthy volunteers . Dose adjustment is required only in case of concomitant renal insufficiency. Preclinical Safety Data A review of safety data from preclinical studies from conventional studies of dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity did not reveal any specific hazards to humans. Indications for use The drug is indicated for use in adults and children over 6 years of age: To relieve nasal and ocular symptoms of seasonal and year-round allergic rhinitis (itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia); To relieve the symptoms of chronic idiopathic urticaria. Dosage and administration Inside, regardless of the meal, with a glass of water. Children 6 to 12 years of age: 5 mg cetirizine (1/2 tablet) twice daily. In the case of treatment of symptoms of seasonal rhinitis and conjunctivitis, the duration of use should not exceed 4 weeks. Adults and children over 12 years of age: 10 mg of cetirizine (1 tablet) 1 time per day. Elderly: Dose adjustment is not required if renal function is normal. Patients with renal insufficiency: data on the ratio of efficacy / safety of the use of cetirizine in patients with impaired renal function are not available. Since cetirizine is mainly excreted through the kidneys (see Pharmacokinetics section), in cases where alternative therapy is not possible, the dosage regimen should be selected individually depending on the state of renal function. Dose adjustment is carried out in accordance with the instructions in the table below. To use this table, it is necessary to estimate the patient’s creatinine clearance (CC) in ml / min. CC (ml / min) can be calculated from the established serum creatinine concentration (mg / dl) using the following formula: Dose adjustment in patients with impaired renal function: Group Creatine clearance (ml / min) Dose and frequency of administration Normal? 80 10 mg 1 time/day Mild 50-79 10 mg 1 time/day Moderate 30-49 5 mg 1 time/day Severe <30 5 mg once every 2 days End-stage renal disease patients undergoing hemodialysis < 10 Contraindicated Pediatric patients suffering from renal insufficiency: The dose should be adjusted individually, taking into account the renal clearance, age and body weight of the patient. Patients with hepatic impairment: No dose adjustment is required in patients with hepatic impairment alone. Patients with renal and hepatic insufficiency: It is recommended to adjust the dose (see section Patients with renal insufficiency above). If you forget to take Zodak: Do not take a double dose to make up for a missed dose! If a dose is missed, a new dose should be taken as soon as possible, but the next dose should be taken no earlier than 24 hours later. Side Effects Clinical Studies Overview Clinical studies have shown that cetirizine at the recommended dosage has minor CNS side effects of drowsiness, fatigue, dizziness and headache. In some cases, paradoxical CNS excitation has been reported. Despite the fact that cetirizine is a selective peripheral H1 receptor antagonist and does not have anticholinergic activity, isolated cases of difficulty in urination, disturbance of accommodation and dry mouth have been reported. Hepatic impairment with elevated liver enzymes accompanied by elevated bilirubin has been reported. In most cases, these manifestations disappear after the termination of the course of treatment with cetirizine. Adverse Reactions In a double-blind, controlled clinical trial in 3200 volunteers comparing cetirizine with placebo and other antihistamines at the recommended doses (10 mg cetirizine per day), the following adverse events were reported with an incidence greater than 1.0%: Cetirizine 10 mg (n= 3260): Fatigue 1.63%, Dizziness 1.10%, Headache 7.42%, Abdominal pain 0.98%, Dry mouth 2.09%, Nausea 1.07%, Drowsiness 9.63%, Pharyngitis 1.29% Placebo (n=3061): Fatigue 0.95%, Dizziness 0.98%, Headache 8.07%, Abdominal pain 1.08%, Dry mouth 0.82%, Nausea 1.14%, Drowsiness 5.00%, Pharyngitis 1.34% placebo group, in most cases its degree was regarded as mild to moderate. Objective studies in healthy young volunteers have shown that the recommended daily dose of cetirizine does not affect daily activities. Adverse reactions to the drug in children aged 6 months to 12 years who took part in placebo-controlled clinical trials, the frequency of which is more than 1%: Cetirizine (n = 1656): Diarrhea 1.0%, Drowsiness 1.8%, Rhinitis 1.4%, Fatigue 1.0% Placebo (n = 1294): Diarrhea 0.6%, Drowsiness 1.4%, Rhinitis 1.1%, Fatigue 0.3%. Post-Marketing Experience: In addition to the adverse reactions reported in clinical studies and listed above, the following adverse drug reactions have been reported in post-marketing experience with cetirizine. Side effects observed during its use are classified into categories depending on the frequency of their occurrence: infrequently? 1/1000, < 1/100; rarely ? 1/10000, < 1/1000; very rarely < 1/10000, frequency unknown (cannot be determined from the available data). Uncommon: agitation, paresthesia, pruritus, rash, asthenia, malaise, diarrhea. Rare: hypersensitivity, aggression, confusion, depression, hallucinations, insomnia, convulsions, tachycardia, changes in liver function tests (increased levels of transaminases, alkaline phosphatase, GGT and bilirubin), urticaria, edema, weight gain (after discontinuation of cetirizine, the appearance of itching and/or urticaria). Very rare: Thrombocytopenia, anaphylactic shock, tics, taste disturbances, faintness, tremor, dystonia, dyskinesia, disturbances of accommodation, oculogeric crisis, blurred vision, angioedema, drug-resistant erythema, dysuria, enuresis Not known: increased appetite, suicidal ideation, amnesia , memory impairment, dizziness, urinary retention Reporting suspected adverse reactions If you experience any adverse reactions, please consult your physician. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Use in Pregnancy and Lactation Prospectively collected data for cetirizine on pregnancy outcome do not indicate a potential increase in maternal or fetal/fetal toxicity above baseline values. Animal studies have shown no direct or indirect adverse effects on pregnancy, embryonic/fetal development, childbirth or postnatal development. For pregnant women, the drug is prescribed with caution. Lactation Cetirizine passes into breast milk and reaches a concentration of 25% to 90% in plasma, depending on the time of sampling after application. As a result, caution should be exercised when prescribing cetirizine during breastfeeding. Fertility Data on the effect of cetirizine on human fertility are limited, and no cases have been identified that affect the safety of the drug. Animal studies have shown no effect on human reproduction. Precautions When taken at therapeutic doses, no clinically significant interactions with alcohol were observed (at a blood alcohol level of 0.5 g / l). However, caution should be exercised when taking the drug with alcohol. Caution is advised when prescribing the drug to patients predisposed to urinary retention (for example, patients with spinal cord injury or prostatic hyperplasia), due to the fact that cetirizine may increase the risk of urinary retention. Caution is advised when prescribing the drug to patients with epilepsy and patients at risk of developing seizures. Skin tests for allergic reactions are inhibited when taking antihistamines, so a period of 3 days without taking the drug is necessary before testing. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take cetirizine film-coated tablets. Itching and urticaria may occur upon discontinuation of cetirizine treatment, even if these symptoms were not present before the start of treatment. In some cases, the manifestation of these symptoms may be intense and may require the resumption of treatment. Symptoms should disappear after treatment is resumed. The use of film-coated tablets is not recommended for children under the age of 6 years, since this form of release does not allow the dose to be adjusted accordingly. Interaction with other drugs Simultaneous use of azithromycin. cimetidine, erythromycin, ketoconazole or pseudoephedrine does not affect the pharmacological parameters of cetirizine. Pharmacodynamic interactions were not observed. According to in vitro studies, cetirizine does not affect the binding of warfarin to proteins. Concomitant use with azithromycin, erythromycin, ketoconazole, theophylline and pseudoephedrine showed no significant changes in clinical laboratory parameters, vital signs and ECG parameters. In a study of concomitant use of theophylline (400 mg/day) and cetirizine (20 mg/day), there was a slight, statistically significant increase in 24-hour AUC of 19% for cetirizine and 11% for theophylline, as well as an increase in maximum plasma levels by 7.7% and 6.4% for cetirizine and theophylline, respectively. At the same time, against the background of the use of cetirizine in patients previously treated with theophylline, the clearance of cetirizine decreased by -16%, theophylline by -10%. However, prior treatment with cetirizine had little effect on the pharmacological parameters of theophylline. The degree of absorption of cetirizine does not depend on food intake, while the rate of absorption slows down by 1 hour. In sensitive patients, the combined use of cetirizine with alcohol or other substances that depress the functions of the central nervous system may lead to an additional decrease in attention and performance, although after taking a single dose of cetirizine 10 mg, the effect of alcohol (0.8%o in the blood) did not increase significantly; one of 16 psychometric tests confirmed a statistically significant interaction with diazepam 5 mg. Co-administration of cetirizine 10 mg daily with glipizide resulted in a slight decrease in blood glucose levels. This action is not of clinical significance. Despite this, a separate dose is recommended, glipizide in the morning, and cetirizine in the evening. In a multiple-dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), cetirizine exposure was increased by approximately 40%, while ritonavir exposure was not significantly affected by co-administration of cetirizine (-11%). Contraindications Hypersensitivity to the components of the drug, hydroxyzine or any other piperazine derivatives. Severe renal failure (creatinine clearance less than 10 ml / min). Cetirizine film-coated tablets should not be used in patients with rare hereditary problems of galactose intolerance, lactose intolerance or glucose-lactose malabsorption syndrome. Composition One film-coated tablet contains: active substance: cetirizine dihydrochloride 10 mg excipients: core: lactose monohydrate, corn starch, povidone 30 (E1201), magnesium stearate (E470); film shell: hypromellose 2910/5 (E464), macrogol 6000 (E1521), talc (E553), titanium dioxide (E171), emulsion of simethicone SE 4. OverdoseSymptoms: The symptoms observed with an overdose of cetirizine are mainly related to the action on the central nervous system and anticholinergic action. Confusion, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, sedation, drowsiness, lethargy, tachycardia, tremor, and urinary retention may occur (most commonly with five times the daily dose of cetirizine). Treatment: No specific antidote has been identified. Symptomatic or supportive therapy is recommended. Hemodialysis is ineffective. Gastric lavage is carried out, activated charcoal is prescribed, provided that the overdose has occurred recently. Side effects The drug is generally well tolerated. Adverse reactions are rare and transient. Determining the frequency of adverse reactions: very often (?1/10), often (?1/100, <1/10), infrequently (?1/1000, <1/100), rarely (?1/10000, <1 / 1000), very rarely (< 1/10 000), the frequency is unknown (according to the available data, it is not possible to determine the frequency of side effects). From the hemopoietic system: very rarely - thrombocytopenia. From the immune system: rarely - hypersensitivity reactions; very rarely - anaphylactic shock. From the nervous system: often - headache, drowsiness, fatigue, dizziness; infrequently - paresthesia; rarely - convulsions, impaired motor function; very rarely - taste perversions, dyskinesia, dystonia, fainting, tremor, tick; frequency unknown - memory impairment, incl. amnesia. Mental disorders: infrequently - agitation; rarely - aggression, confusion, depression, hallucinations, sleep disturbance; frequency unknown - suicidal ideation. On the part of the organ of vision: very rarely - disturbances of accommodation, blurred vision, nystagmus. On the part of the organ of hearing and balance: the frequency is unknown - vertigo. From the digestive system: often - dry mouth, nausea; infrequently - diarrhea, abdominal pain. From the side of the cardiovascular system: rarely - tachycardia. From the respiratory system: often - rhinitis, pharyngitis. From the side of metabolism: rarely - weight gain. From the urinary system: very rarely - dysuria, enuresis; frequency unknown - urinary retention. On the part of laboratory parameters: rarely - a change in liver function tests (increased activity of hepatic transaminases, alkaline phosphatase, GGT and bilirubin concentration); very rarely - thrombocytopenia. From the skin and subcutaneous tissues: infrequently - rash, itching; very rarely - persistent erythema. Allergic reactions: rarely - urticaria; very rarely - angioedema. General reactions: infrequently - asthenia, malaise; rarely - peripheral edema; frequency unknown - increased appetite. Storage conditionsDoes not require special storage conditions. Keep out of the reach of children! Buy Zodak pills p/o 10mg No. 10x3