the Trade name
Mezhdunarodnoye the unlicensed
name Dezloratadin Lekarstvennaya
the Tablet form, coated, 5 mg
One tablet contains
active agent – dezloratadin 5 mg,
excipients: hydrophosphate calcium dihydrate, cellulose microcrystalline, starch corn, talc,
structure of a cover: Opadri II blue (85F30571): polyvinyl alcohol, polyethyleneglycol 6000, titan dioxide (E 171), FDC indigo carmine blue 2 (E132), talc, ferrous oxide red (E 172).
of the Tablet of round shape with a biconvex surface, coated blue color.
Other antihistaminic drugs for system use.
The ATX R06AX27 code
Pharmacokinetics Dezloratadin properties begins to be defined in blood plasma within 30 min. after reception. The maximum concentration of a dezloratadin in plasma is reached on average in 3 h, elimination half-life averages 27 h. Extent of cumulation of a dezloratadin corresponds to its elimination half-life (about 27 h) and frequency rate of use (once a day). The bioavailability of a dezloratadin was proportional to a dose in the range from 5 to 20 mg. Is exposed to intensive metabolism. The main way of metabolism of a dezloratadin – hydroxylation in provision 3 with education 3-OH dezloratadin, connected to a glucuronide. Does not get through a blood-brain barrier. Dezloratadin moderately (83 – 87%) contacts proteins of plasma. At use of a dezloratadin in a dose from 5 to 20 mg once a day within 14 days of signs of clinically significant cumulation of drug it is not revealed. The bioequivalence of drug in the form of tablets and syrup is revealed. It is established that food (fat high-calorific breakfast) or grapefruit juice do not influence distribution of a dezloratadin.
Dezloratadin is brought from an organism in the form of glyukuronidny connection. A small part of a dose is removed in not changed view with a stake and urine.
Dezloratadin is a selection blocker peripheral histamine H1 receptors which do not render sedation. Dezloratadin is primary active metabolite of a loratadin. Qualitative or quantitative divergences of toxicity of a dezloratadin and a loratadin in comparable doses (taking into account concentration of a dezloratadin) are not revealed. After oral administration Dezlor selectively blocks peripheral H1-histamine receptors and does not get through a blood-brain barrier. Except antihistaminic activity dezloratadin has antiallergic and anti-inflammatory effect. It is established that dezloratadin the cascade of various reactions which are the cornerstone of development of allergic inflammation oppresses namely:
– discharge of pro-inflammatory cytokines,
– discharge of pro-inflammatory chemokines,
– products of superoxidic anion the activated polymorphonuclear neutrophils,
– adhesion and a chemotaxis of eosinophils,
– an expression of molecules of adhesion,
– dependent discharge of a histamine, prostaglandin and leukotriene,
– a sharp allergic bronchospasm.
Drug is appointed to adults and teenagers from 18 years which need performing antihistaminic therapy. Dezlor does not get through a blood-brain barrier, does not cause drowsiness and does not influence psychomotor function.
– a pollinosis, allergic rhinitis (sneezing, discharges from a nose, an itching, hypostasis and congestion of a nose and also an itching of eyes, dacryagogue and reddening of eyes, naggers in the field of the sky and cough)
– a small tortoiseshell (elimination of symptoms of a skin itching, rash).
Route of administration and doses
Inside. To adults and teenagers of 18 years – on 1 tablet (5 mg) of 1 times a day. The tablet should be swallowed entirely, without chewing and to wash down with water. Time of day, regardless of meal is desirable to take the drug regularly in one and too. The course of treatment is appointed by the doctor individually.
– increased fatigue
– dryness in a mouth
– a headache, dizziness, hallucinations, drowsiness, insomnia
– psychomotor hyperactivity, spasms
– tachycardia, heartbeat
– abdominal pains
– dyspepsia, including nausea, vomiting, diarrhea
– increase in activity of liver enzymes, a hyperbilirubinemia, hepatitis
– allergic reactions (rash, urticaria, a Quincke’s disease, an asthma, an anaphylaxis).
– hypersensitivity to components of drug or to a loratadin
– the period of pregnancy and a lactation
– children’s and teenage age up to 18 years.
Interaction with other medicines is not revealed. Meal does not influence efficiency of drug. Dezlor does not strengthen the oppressing effect of ethanol on psychomotor function.
Should be applied with care at heavy HPN.
Pregnancy and a lactation
Safety of use of Dezlor for pregnant women is not established therefore it is not recommended to appoint it during pregnancy.
Dezloratadin gets into breast milk therefore the women nursing should not appoint Dezlor.
With care Dezlor to apply in a heavy renal failure.
The feature of influence of medicine on ability to run transport and potentially dangerous mechanisms
of Influence Dezlor on driving or work with difficult technical devices was not noted. However it is necessary to consider that in rare instances after administration of drug the drowsiness which can influence ability to drive the car is observed and to work with other mechanisms.
Symptoms: reception of the dose of a dezloratadin exceeding 25 mg did not lead to emergence of any symptoms.
Treatment: gastric lavage with the subsequent intake of activated carbon as adsorbent and purpose of symptomatic treatment. Dezloratadin is not brought by means of a hemodialysis. 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 of polyvinylchloride and printing aluminum foil.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!
not to use a period of storage after an expiration date.
According to the prescription
VIVA FARM LLP Producer
2nd Ostroumova St., 33, Almaty, Republic of Kazakhstan
the Owner of the registration certificate
of VIVA FARM LLP, the Republic of Kazakhstan