Zodak Express tablets p / o 5mg, No. 28
Expiration Date: 05/2027
Russian Pharmacy name:
Зодак Экспресс таблетки п/о 5мг, №28
Treatment of symptoms of perennial (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis, such as itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia;
hay fever (hay fever);
urticaria (including chronic idiopathic urticaria);
other allergic dermatoses, accompanied by itching and rashes.
The tablet should be taken orally, without chewing and with a liquid, regardless of the meal. It is recommended to take the daily dose in one dose.
Adults, adolescents and children over 6 years of age The
recommended daily dose is 5 mg (1 tablet).
If after treatment there is no improvement or new symptoms appear, you should consult your doctor.
Use the drug only according to the method of administration and in the doses indicated in the instructions. If necessary, please consult your doctor before using this medication.
Elderly patients
In elderly patients with renal insufficiency, moderate and severe renal insufficiency, a dose adjustment is recommended (see. 'Patients with renal impairment').
Patients with impaired renal function
When prescribing the drug to patients with impaired renal function in the case when an alternative treatment cannot be prescribed, the dose should be adjusted depending on the CC value, since levocetirizine is excreted mainly by the kidneys.
Patients with impaired liver function
In isolated impaired liver function, dose adjustment is not required.
For adult patients with impaired liver and kidney function, dosing is carried out according to the table above.
Duration of treatment
In the treatment of seasonal (intermittent) rhinitis (symptoms less than 4 days a week or their total duration is less than 4 weeks), the duration of treatment depends on the duration of the symptomatology; treatment can be stopped when symptoms disappear and resumed when symptoms appear.
In the treatment of perennial (persistent) allergic rhinitis (the presence of symptoms more than 4 days a week and their total duration of more than 4 weeks, treatment can be continued during the entire period of exposure to allergens.
There is clinical experience of continuous use of levocetirizine in the dosage form of 5 mg film-coated tablets in adult patients for up to 6 months.
If you are taking or have recently taken other drugs, tell your doctor.
If you forget to take ZodacЃ Express, do not take a double dose to compensate for the missed dose, take the next dose at the usual time.
1 tablet contains:
Active ingredient: levocetirizine dihydrochloride - 5.00 mg.
Excipients:
core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate;
film shell: hypromellose 2910/5, macrogol - 6000, talc, titanium dioxide E171.
Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, and other piperazine derivatives or to any of the auxiliary components of the drug;
end-stage renal failure (CC less than 10 ml / min);
age up to 6 years (for this dosage form);
congenital galactose intolerance, lactase deficiency or malabsorption of glucose - galactose (due to the content of lactose in the preparation).
Carefully
Chronic renal failure (correction of the dosage regimen is required);
in elderly patients (with age-related decrease in the glomerular filtration rate);
in patients with predisposing factors for urinary retention (spinal cord injury, prostatic hyperplasia, etc.);
chronic liver disease (hepatocellular, cholestatic or biliary cirrhosis) (dose adjustment is required only with a concomitant decrease in the glomerular filtration rate);
simultaneous intake with alcohol (see the section 'Interaction with other medicinal products');
during pregnancy and during breastfeeding.
Trade name:
ZodakЃ Express
International non-proprietary name:
levocetirizine
Dosage form:
film-coated tablets
Composition
1 tablet contains:
Active ingredient: levocetirizine dihydrochloride - 5.00 mg.
Excipients:
core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate;
film shell: hypromellose 2910/5, macrogol - 6000, talc, titanium dioxide E171.
Description
Oblong biconvex film-coated tablets, white or almost white, with an 'e' engraving on one side.
Pharmacotherapeutic group
Antiallergic agent - H1-histamine receptor blocker.
Pharmacological properties
Pharmacodynamics
Levocetirizine - the active substance of the drug - is the R-enantiomer of cetirizine, a powerful and selective histamine antagonist that blocks H1-histamine receptors.
Levocetirizine affects the histamine-dependent stage of allergic reactions, and also reduces the migration of eosinophils, reduces vascular permeability, and limits the release of inflammatory mediators.
Levocetirizine prevents the development and facilitates the course of allergic reactions, has an antiexudative, antipruritic effect, practically does not have an anticholinergic and antiserotonin effect. In therapeutic doses, it has practically no sedative effect.
After oral administration, the antiallergic effect of levocetirizine continues for 24 hours.
Pharmacokinetics The
pharmacokinetic parameters of levocetirizine vary linearly and practically do not differ from the pharmacokinetics of cetirizine.
Absorption
After oral administration, the drug is rapidly and completely absorbed from the gastrointestinal tract. Food intake does not affect the completeness of absorption, although its rate decreases. In adults, after a single dose of the drug in a therapeutic dose (5 mg), the maximum concentration (Cmax) in the blood plasma is reached after 0.9 hours and is 270 ng / ml, after repeated administration at a dose of 5 mg - 308 ng / ml. Equilibrium concentration is reached after 2 days.
Distribution
Levocetirizine is 90% bound to plasma proteins. The volume of distribution (Vd) is 0.4 l / kg. Bioavailability reaches 100%.
Metabolism
In small amounts (<14%), levocetirizine is metabolized in the body by N- and O-dealkylation (unlike other antagonists of H1-histamine receptors, which are metabolized in the liver by the cytochrome system) with the formation of a pharmacologically inactive metabolite.
Due to the insignificant metabolism and lack of metabolic potential, the interaction of levocetirizine with other drugs seems unlikely.
Withdrawal
In adults, the half-life (T1 / 2) is 7.9 ± 1.9 h; in young children, T1 / 2 is shortened. In adults, the total clearance is 0.63 ml / min / kg. About 85.4% of the taken dose of the drug is excreted by the kidneys unchanged by glomerular filtration and tubular secretion; about 12.9% - through the intestines.
Pharmacokinetics in special groups of patients
Patients with renal insufficiency
In patients with renal insufficiency (creatinine clearance (CC) <40 ml / min), the clearance of the drug decreases, and T1 / 2 is lengthened (for example, in patients on hemodialysis, the total clearance decreases by 80 %), which requires a corresponding change in the dosage regimen. Less than 10% of levocetirizine is removed during a standard 4-hour hemodialysis procedure.
Children
Data on the study of the pharmacokinetics of the drug in 14 children aged 6 to 11 years with a body weight of 20 to 40 kg with oral administration of a single dose of 5 mg of levocetirizine showed that the Cmax and area under the curve (AUC) values ??are approximately two times higher than those in healthy adults with cross-control. The average Cmax was 450 ng / ml, the maximum concentration was reached on average after 1.2 hours, the total body weight-based clearance was 30% higher, and the half-life was 24% shorter in children than in adults. A retrospective pharmacokinetic analysis was performed in 324 patients (children aged 1 to 11 and adults aged 18 to 55) who received one or more doses of levocetirizine from 1.25 mg to 30 mg. The data obtained during the analysis showedthat taking the drug at a dose of 1.25 mg in children under 5 years of age leads to a plasma concentration corresponding to that in adults when taking 5 mg of the drug once a day.
Elderly Patients
Pharmacokinetic data in elderly patients are limited. With repeated administration of 30 mg of levocetirizine once a day for 6 days in elderly patients (ages 65 to 74 years), the total clearance was approximately 33% lower than that in younger adults. The distribution of cetirizine racemate has been shown to be more dependent on renal function than age. This statement may also apply to levocetirizine, since both levocetirizine and cetirizine are excreted primarily in the urine. Therefore, in elderly patients, the dose of levocetirizine should be adjusted depending on renal function.
Indications for use
Treatment of symptoms of perennial (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis, such as itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia;
hay fever (hay fever);
urticaria (including chronic idiopathic urticaria);
other allergic dermatoses, accompanied by itching and rashes.
Contraindications
Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, and other piperazine derivatives or to any of the auxiliary components of the drug;
end-stage renal failure (CC less than 10 ml / min);
age up to 6 years (for this dosage form);
congenital galactose intolerance, lactase deficiency or malabsorption of glucose - galactose (due to the content of lactose in the preparation).
Carefully
Chronic renal failure (correction of the dosage regimen is required);
in elderly patients (with age-related decrease in the glomerular filtration rate);
in patients with predisposing factors for urinary retention (spinal cord injury, prostatic hyperplasia, etc.);
chronic liver disease (hepatocellular, cholestatic or biliary cirrhosis) (dose adjustment is required only with a concomitant decrease in the glomerular filtration rate);
simultaneous intake with alcohol (see the section 'Interaction with other medicinal products');
during pregnancy and during breastfeeding.
Application during pregnancy and during breastfeeding
Pregnancy
Data on the use of levocetirizine during pregnancy are practically absent or limited (less than 300 pregnancy outcomes). However, the use of cetirizine, levocetirizine racemate, during pregnancy (more than 1000 pregnancy outcomes) was not accompanied by malformations and intrauterine and neonatal toxic effects. In animal studies, no direct or indirect adverse effects on the course of pregnancy, embryonic and fetal development, childbirth and postnatal development have been revealed.
Caution should be exercised when prescribing levocetirizine to pregnant women.
Breastfeeding
Cetirizine, the racemate of levocetirizine, is excreted in breast milk. Therefore, the excretion of levocetirizine in breast milk is also likely. In children who are breastfed, adverse reactions to levocetirizine may occur. Therefore, care must be taken when prescribing levocetirizine during breastfeeding.
Fertility There are no
clinical data on levocetirizine.
Method of administration and dosage
The tablet should be taken orally, without chewing and with a liquid, regardless of the meal. It is recommended to take the daily dose in one dose.
Adults, adolescents and children over 6 years of age The
recommended daily dose is 5 mg (1 tablet).
If after treatment there is no improvement or new symptoms appear, you should consult your doctor.
Use the drug only according to the method of administration and in the doses indicated in the instructions. If necessary, please consult your doctor before using this medication.
Elderly patients
In elderly patients with renal insufficiency, moderate and severe renal insufficiency, a dose adjustment is recommended (see. 'Patients with renal impairment').
Patients with impaired renal function
When prescribing the drug to patients with impaired renal function in the case when an alternative treatment cannot be prescribed, the dose should be adjusted depending on the CC value, since levocetirizine is excreted mainly by the kidneys.
Patients with impaired liver function
In isolated impaired liver function, dose adjustment is not required.
For adult patients with impaired liver and kidney function, dosing is carried out according to the table above.
Duration of treatment
In the treatment of seasonal (intermittent) rhinitis (symptoms less than 4 days a week or their total duration is less than 4 weeks), the duration of treatment depends on the duration of the symptomatology; treatment can be stopped when symptoms disappear and resumed when symptoms appear.
In the treatment of perennial (persistent) allergic rhinitis (the presence of symptoms more than 4 days a week and their total duration of more than 4 weeks, treatment can be continued during the entire period of exposure to allergens.
There is clinical experience of continuous use of levocetirizine in the dosage form of 5 mg film-coated tablets in adult patients for up to 6 months.
If you are taking or have recently taken other drugs, tell your doctor.
If you forget to take ZodacЃ Express, do not take a double dose to compensate for the missed dose, take the next dose at the usual time.
Side effect
According to the World Health Organization (WHO), undesirable effects are classified according to their frequency of development as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, < 1/100), rarely (? 1/10000, <1/1000) and very rarely (<1/10000); the frequency is unknown (the frequency of occurrence of the events cannot be determined from the available data).
Clinical studies
During clinical studies in men and women 12 - 71 years old, the most common adverse reactions were: headache, drowsiness, dry mouth, fatigue, infrequently: asthenia and abdominal pain.
During clinical trials, headaches and drowsiness were most common in children aged 6 to 12 years.
Post-registration studies
During the period of post- registration use of the drug, the following side effects were observed, the frequency of which is unknown.
Immune system disorders
Hypersensitivity reactions, including anaphylactic reactions.
Mental disorders
Anxiety, aggressiveness, agitation, hallucinations, depression, insomnia, suicidal thoughts.
Nervous system disorders
Convulsions, sinus thrombosis of the dura mater, paresthesia, dizziness, fainting, tremor, dysgeusia.
Metabolic and nutritional disorders
Increased appetite.
Hearing disorders and labyrinthine disorders of
Vertigo.
Violations of the organ of vision
Visual impairment, blurred vision, inflammatory manifestations.
Cardiac disorders
Angina pectoris, palpitations, tachycardia
Vascular disorders
Jugular vein thrombosis.
Disturbances from the respiratory system, chest and mediastinal organs Dyspnea, increased symptoms of rhinitis.
Ќарушени¤ со стороны желудочно - кишечного тракта
“ошнота, рвота, диаре¤.
Ќарушени¤ со стороны печени и желчевывод¤щих путей
vепатит.
Ќарушени¤ со стороны почек и мочевывод¤щих путей
?изури¤, задержка мочи.
Ќарушени¤ со стороны кожи и подкожных тканей
јнгионевротический отек, кожный зуд, кожна¤ сыпь, стойка¤ лекарственна¤ эритема, крапивница, гипотрихоз, трещины, фотосенсибилизаци¤.
Ќарушени¤ со стороны скелетно - мышечной и соединительной ткани
ћиалги¤, артралги¤.
ќбщие расстройства и нарушени¤ в месте введени¤
ѕериферические отеки, сухость слизистых оболочек.
¬ли¤ние на результаты лабораторных и инструментальных исследований
ќтклонение от нормы показателей функции печени, увеличение массы тела, перекрестна¤ реактивность.
?сли любые из указанных побочных эффектов усугубл¤ютс¤, или ¬ы заметили любые другие побочные эффекты не указанные в инструкции, сообщите об этом врачу.
ѕередозировка
—имптомы
—имптомы передозировки могут включать сонливость у взрослых, возбуждение и беспокойство, смен¤ющиес¤ сонливостью, у детей.
Ћечение
—пецифических антидотов левоцетиризина нет.
¬ случае передозировки рекомендуетс¤ симптоматическое или поддерживающее лечение. ?сли после приема препарата прошло немного времени, следует провести промывание желудка. Ћевоцетиризин практически не выводитс¤ при гемодиализе.
¬заимодействие с другими лекарственными средствами
»зучение взаимодействи¤ левоцетиризина с другими лекарственными препаратами, включа¤ исследовани¤ с индукторами изофермента CYP3A4, не проводилось.
ѕри изучении лекарственного взаимодействи¤ рацемата цетиризина с антипирином, феназоном, псевдоэфедрином, циметидином, кетоконазолом, эритромицином, азитромицином, глипизидом и диазепамом клинически значимых лекарственных взаимодействий не вы¤влено.
ѕри одновременном назначении с теофиллином (400 мг в сутки) общий клиренс цетиризина снижаетс¤ на 16 % (кинетика теофиллина не мен¤етс¤).
¬ исследовании при одновременном приеме ритановира (600 мг 2 раза в день) и цетиризина (10 мг в день) показано, что экспозици¤ цетиризина увеличивалась на 40 %, а экспозици¤ ритонавира измен¤лась незначительно (-11 %).
¬ р¤де случаев при одновременном применении левоцетиризина с алкоголем или лекарственными препаратами, оказывающими подавл¤ющее вли¤ние на центральную нервную систему (?Ќ—), возможно усиление их вли¤ни¤ на ?Ќ—, хот¤ не доказано, что рацемат цетиризина потенцирует эффект алкогол¤.
ќсобые указани¤
ѕрименение препарата в форме таблеток, покрытых пленочной оболочкой, не рекомендуетс¤ у детей в возрасте менее 6 лет, так как така¤ форма выпуска не обеспечивает возможности коррекции дозы.
ѕациентам с почечной недостаточностью умеренной степени т¤жести и т¤желой почечной недостаточностью рекомендуетс¤ увеличение интервалов между приемами препарата «одакЃ Ёкспресс в соответствии с показателем .
ѕри применении препарата «одакЃ Ёкспресс у пациентов с повреждением спинного мозга, гиперплазией предстательной железы, а также при наличии других предрасполагающих факторов к задержке мочи, требуетс¤ соблюдение осторожности, так как левоцетиризин может увеличивать риск развити¤ задержки мочи.
¬о врем¤ применени¤ препарата «одакЃ Ёкспресс пациентам рекомендуетс¤ воздержатьс¤ от употреблени¤ алкогольных напитков.
¬ состав продукта входит лактозы моногидрат; пациентам с редкими наследственными заболевани¤ми, сопровождающимис¤ непереносимостью галактозы, дефицитом лактазы (дефицит лактазы Ћаппа) или при синдроме мальабсорбции глюкозы/галактозы не следует принимать данный лекарственный препарат.
¬нимательно прочтите инструкцию перед тем, как начать применение препарата. —охраните инструкцию, она может понадобитьс¤ вновь. ?сли у ¬ас возникли вопросы, обратитесь к врачу. Ћекарственный препарат, которым ¬ы лечитесь предназначен лично ¬ам, и его не следует передавать другим лицам, поскольку оно может причинить им вред даже при наличии тех же симптомов, что и у ¬ас.
¬ли¤ние лекарственного препарата на способность управл¤ть транспортными средствами и механизмами
Ћевоцетиризин может привести к повышенной сонливости, следовательно, он может оказывать вли¤ние на способность управл¤ть автомобилем или работать с техникой. ¬ период лечени¤ необходимо воздерживатьс¤ от зан¤тий потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций
‘орма выпуска
Film-coated tablets, 5 mg.
7 or 10 tablets in PVC / Aclar / PVC / Al or Al / Al blister. 1 or 4 blisters of 7 tablets; 2 blisters of 10 tablets, together with instructions for use, are placed in a cardboard box.
Storage conditions
Store at a temperature not exceeding 25 ? C.
Keep out of the reach of children.
Shelf life
3 years.
Do not use after the expiration date printed on the package.
Conditions of dispensing from pharmacies
Available without a prescription.