Kestin 10s 10 mg coated tablets

The instruction for medical use of KESTIN® medicine the Trade name of Kestin® the International unlicensed name Ebastin Lekarstvennaya the Tablet form, film coated 10 mg, 20 mg Structure One tablet contains active agent – ebastin 10 mg or 20 mg, excipients: microcrystalline cellulose, starch corn prezhelatinizirovanny, lactoses monohydrate, sodium of a kroskarmelloz, magnesium stearate, structure of a cover: gipromelloza, macrogoal 6000, titan dioxide (E 171). The description Round, white or almost white color of a tablet, film coated, with marking of E/10 on one party. Round, white or almost white color of a tablet, film coated, with marking E 20 on one party. Pharmacotherapeutic group Antihistaminic drugs of systemic action others. Ebastin. The ATX R06AX22 code the Pharmacological Pharmacokinetics Later properties of intake is quickly soaked up and is almost completely metabolized in a liver, turning into an active metabolite karebastin. After single dose of 10 mg or the 20th drug the maximum concentration of a karebastin in plasma is reached in 2.6 - 4 h and makes 80 – 100 ng/ml or 108 – 209 mg/ml respectively. Greasy food accelerates absorption (concentration in blood increases up to 50%). It is removed by kidneys – 60 – 70%, in the form of conjugates. Elimination half-life normal makes 15 - 19 hours. In a renal failure the elimination half-life increases up to 23 – 26 h, in a liver failure - up to 27 h. Does not get through a blood-brain barrier. At daily reception of 10 mg of drug the equilibrium concentration is reached in 3 – 5 days and makes 130 – 160 ng/ml. linking with proteins of plasma of an ebastin and karebastin makes more than 97%. Elimination half-life of a karebastin makes from 15 to 19 hours, 66% of drug are removed in the form of conjugates with urine. When prescribing drug along with meal the concentration of a karebastin increases in blood by 1.6 - 2 times, however it does not lead to change of time of achievement of its maximum concentration and does not influence clinical effects of Kestina®. At patients of advanced age the pharmacokinetic indicators significantly do not change. In a renal failure the elimination half-life increases till 23 - 26 o'clock, and in a liver failure – till 27 o'clock, however concentration of drug at reception of 10 mg/days does not exceed therapeutic values. A pharmacodynamics of Kestin® – a blocker of H1-histamine receptors of long action. Warns the spasms of smooth muscles induced by a histamine and increase in vascular permeability. After administration of drug inside antiallergic action begins in 1 h and lasts for 48 h. After a 5-day course of treatment of Kestinom® the antihistaminic activity remains during 72 h due to action of active metabolites. Drug does not render expressed anticholinergic and sedation. Influence of Kestina® on QT ECG interval when assigning in a dose to 80 mg is noted. Indications - allergic rhinitis seasonal and/or year-round, with allergic conjunctivitis or without it - a small tortoiseshell of various etiology, including an idiopathic chronic small tortoiseshell - allergic dermatitis the Route of administration and doses to Adults and children are more senior than 12 years appoint 10 mg (1 tablet) once a day, at severe forms – 20 mg. Кестин® accept irrespective of meal. In an insignificant and moderate liver failure the usual dose can be applied. In a heavy abnormal liver function the daily dose should not exceed 10 mg. With impaired renal function the correction of a dose is not required from patients. Side effects Classification of undesirable side reactions by development frequency: very often (≥1/10), it is frequent (≥1/100, & lt, 1/10), is not frequent (≥1/1000, & lt, 1/100), is rare (≥1/10,000, & lt, 1/1,000), is very rare (& lt, 1/10,000, including separate messages), frequency is unknown (it is impossible to estimate on the basis of the available data). Very often - a headache Often - drowsiness - dryness in a mouth It is very rare - allergic reactions (anaphylaxis and a Quincke's edema) - nervousness, insomnia - dizziness, paresthesia, a dysgeusia - heartbeat, tachycardia - an abdominal pain, vomiting, nausea, dyspepsia - hepatitis, a cholestasia, disturbances of level of liver enzymes (increase in levels of transaminases, gamma GT, alkaline phosphatase and bilirubin) - urticaria, rash, dermatitis - disturbances of a menstrual cycle - hypostases, an asthenic syndrome of the Contraindication - hypersensitivity to an ebastin and other components of drug - pregnancy and the period of a lactation Medicinal interactions is not recommended to appoint Kestin® along with antifungal drugs from group of azoles (such as ketokonazol and itrakonazol), antibiotics from group of macroleads (such as erythromycin) and antitubercular drugs (such as rifampicin). Кестин® does not interact with theophylline, indirect anticoagulants, Cimetidinum, diazepam, ethanol and etanolsoderzhashchy drugs. Special instructions With care to apply at patients with the increased QT – an interval, a hypopotassemia. At heavy an abnormal liver function the daily dose should not exceed 10 mg. As the therapeutic effect of Kestina® is shown in 1-3 hours after appointment, it is not necessary to appoint drug for elimination of the acute allergic conditions demanding urgent intervention. The patients suffering from hereditary intolerance of a galactose, a lactose intolerance or a syndrome of insufficient absorption of glucose – a galactose should not take the drug. Кестин® can distort results of skin allergy tests. Therefore it is recommended to carry out such tests not earlier than in 5-7 days after drug withdrawal. Use in pediatrics the Data on use of Kestina® of a tablet for children aged up to 12 years are absent. Pregnancy and the period of a lactation is not recommended to take the Drug Kestin® during pregnancy and in the period of a lactation. The feature of influence of medicine on ability to run the vehicle or potentially dangerous Kestin mechanisms in therapeutic doses does not affect ability to run vehicles and mechanisms. However it is necessary to consider that during therapy there can be a drowsiness and dizziness. Overdose Symptoms: strengthening of side effects. Treatment: special antidote for drug does not exist. In case of overdose the gastric lavage, observation of the vital functions of an organism, including the ECG is recommended. Symptomatic treatment. A form of release and packing On 10 tablets in blister strip packaging from a film polyvinylchloride with a polyvinylidene chloride covering and aluminum foil. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a cardboard pack. To Store storage conditions at a temperature not over 30 ºС, in the place protected from light. To store out of children's reach! 3 years not to use a period of storage after expiry date. Prescription status According to the prescription the Producer Indastrias Pharmasyyutikas Almirall S.A., Barcelona, Spain the Owner of the registration certificate S.A. Almirall, Spain the Address of the organization which is in the territory of the Republic of Kazakhstan the accepting claim on quality of medicines from consumers and responsible for post-registration observation of safety of medicine Representation of Alvogen Malta Operations (ROW) Ltd 050008, Almaty, Auezov St., 48, office 3/3 ph. 345 04 05 E-mail address: drugsafety.kz@alvogen.com, website: www.alvogen.com