The instruction for medical use of DELORIKS medicine the Trade name of Delorix the International unlicensed name Dezloratadin Lekarstvennaya the Tablet form, film coated, 5 mg Structure One tablet, film coated, contains active agent – a dezloratadin of 5.000 mg, excipients: microcrystalline cellulose, sodium of starch stearate, gland glikolit And, magnesium (III) oxide red (E 172). The description of the Tablet of round shape, with a biconvex surface, pink color, with risky on one party, with a diameter of 7 mm. Pharmacotherapeutic group Antihistaminic drugs of systemic action. Antihistaminic drugs of systemic action others. Dezloratadin. The ATX R06AX27 code the Pharmacological Pharmacokinetics Absorption Later properties of administration of drug inside dezloratadin is well absorbed from the digestive tract (DT), at the same time the defined concentration of a dezloratadin in blood plasma are reached within 30 min., and the maximum concentration in plasma (C max) – approximately in 3 h. Intake of food or alcohol practically does not change pharmacological properties of drug. Distribution Linking of a dezloratadin with proteins of plasma makes 83-87%. At use in a dose from 5 mg to 20 mg of 1 times a day within 14 days of signs of clinically significant cumulation of a dezloratadin it is not revealed. Intake of food or grapefruit juice does not influence distribution of a dezloratadin (at reception in a dose of 7.5 mg of 1 times a day). Does not get through a blood-brain barrier (GEB). Metabolism Is exposed to intensive metabolism by hydroxylation with education 3-ON-dezloratadina, connected to a glucuronide. Is not inhibitor of isoenzymes of CYP3A4 and CYP2D6 and is not substrate or inhibitor of the R-glycoprotein. Removal Is brought out of an organism in the form of glyukuronidny connection and in a small amount in not changed look, a small part is removed by kidneys (2%) and with stool (7%). Elimination half-life (T1/2) averages 27 h (20-30 h). The pharmacodynamics of Delorix has antihistaminic, antiallergic and anti-inflammatory effect, does not cause drowsiness. At intake dezloratadin (primary active metabolite of a loratadin) peripheral histamine H1 receptors selectively block. Suppresses a cascade of cytostatic reactions: discharge of pro-inflammatory cytokines, including interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-13 (IL-13), pro-inflammatory RANTES chemokines, products of superoxidic anions the activated polymorphonuclear neutrophils, adhesion and a chemotaxis of eosinophils, an expression of molecules of adhesion, including. R-selectin, the IgE-mediated discharge of a histamine, D2 prostaglandin and C4 leukotriene. Indications – a seasonal pollinosis and allergic rhinitis (elimination or simplification of sneezing, mucifying from a nose, an itching and congestion of a nose, an itching and reddening of eyes, dacryagogues, the nagger of the sky), – a small tortoiseshell (reduction or elimination of a skin itching and rash). The route of administration and doses of Delorix accept inside, irrespective of meal, washing down with a small amount of water. Adult: on 1 tablets (5 mg) of 1 times a day. The course of treatment and duration of reception is defined by the nature of a disease. At treatment of a seasonal pollinosis the administration of drug is stopped after disappearance of symptoms. Side effects Usually dezloratadin it is well transferred, but emergence of side effects is sometimes possible. Side reactions on drug are placed on frequency: very often (≥ 1/10), it is frequent (≥ 1/100, & lt, 1/10), infrequently (≥ 1/1000, ≤ 1/100) is rare (≥ 1/10000, ≤ 1/1000), is very rare (≤ 1/10000). Mental disorders: very seldom – hallucinations. From nervous system: often – a headache, it is very rare – dizziness, drowsiness, insomnia, psychomotor hyperactivity, spasms. From heart: very seldom – tachycardia, strong heartbeat. From digestive tract: often – dryness in a mouth, it is very rare – diarrhea, an abdominal pain, nausea, vomiting, dyspepsia. From a gepatobiliarny system: very seldom – increase in activity of liver enzymes, increase in level of bilirubin, hepatitis. From a skeletal and muscular system and connective tissue: very seldom – myalgia. General disturbances: often – increased fatigue, it is very rare – reactions of hypersensitivity (including an anaphylaxis, a Quincke’s disease, an asthma, an itching, rashes and a small tortoiseshell). Contraindications – hypersensitivity to drug components – children’s age up to 18 years – pregnancy and the period of a lactation. Medicinal interactions When studying medicinal interaction at repeated combined use of a dezloratadin with ketokonazoly, erythromycin, azithromycin, fluoxetine, Cimetidinum of clinically significant changes of concentration of a dezloratadin in plasma it is not revealed. Dezloratadin does not strengthen effect of alcohol on the central nervous system. Special instructions With care to apply at patients with a heavy renal failure. Pregnancy and the period a lactation Safety of use of drug during pregnancy is not established therefore use of Delorix during pregnancy is not recommended. Dezloratadin gets into breast milk therefore during use of Delorix the breastfeeding should be stopped. The feature of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms of Delorix does not affect ability to drive the car and to perform the works demanding the high speed of psychomotor reactions. However patients should be informed that emergence of drowsiness is seldom or never possible. Overdose Symptoms: strengthening of expressiveness of side reactions. Treatment: gastric lavage with the subsequent intake of activated carbon, if necessary – symptomatic therapy. The hemodialysis is inefficient. The efficiency of peritoneal dialysis is not established. The form of release and packing On 10 tablets place in blister strip packaging from a film polychlorotrifluoroethylene / polyvinylchloride (PHTFE/PVH) and aluminum foil. On 1 or 3 planimetric pack together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C. To store in original packing for protection against moisture. 2 years not to apply a period of storage after an expiration date. Prescription status According to the prescription Saneca Pharmaceuticals a.s. Producer, the Slovak republic the Owner of the registration certificate of Ksantis Pharm Ltd, Cyprus the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine: Limited liability partnership Xantis Pharma (Ksantis of Pharm), Kazakhstan 050008, Kazakhstan, Almaty, Auezov St. 48, 3 floor, office 3/2 Phone number, fax: +7 (727) 344 93 14 e-mail: email@example.com firstname.lastname@example.org
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