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Description
The instruction for medical use
of LORDES medicine
the Trade name
of LORDES
the International unlicensed
name Dezloratadin Lekarstvennaya
the Tablet form, film coated, 5 mg
Structure
One tablet contains
active agent – dezloratadin 5 mg,
excipients: hydrophosphate calcium dihydrate, cellulose microcrystalline PH 102, starch corn, talc,
structure of a cover of Opadry II Pink 31F240011: gland (III) oxide red (E 172), gland (II, III) oxide black (E172), HPMC 2910/of a gipromelloz 15 sr (E464), makrogol/PEG 4000, lactoses monohydrate, titan dioxide (E 171).
The description
of the Tablet of round shape, with a biconvex surface, film coated light pink color, with marking of the Nobel logo on one party.
Pharmacotherapeutic group
Antihistaminic drugs of systemic action others.
The code of automatic telephone exchange R06AX27
the Pharmacological
Pharmacokinetics Is Revealed properties bioequivalence of drug in the form of tablets and syrup. Dezloratadin begins to be defined in blood plasma within 30 min. after reception. The maximum concentration of a dezloratadin (C max) in plasma is reached on average in 3 h (T max). The bioavailability of a dezloratadin is proportional to a dose from 5 to 20 mg. It is established that food (fat high-calorific breakfast) or grapefruit juice do not influence distribution of a dezloratadin. Dezloratadin moderately (83 – 87%) contacts proteins of plasma. Does not get through a blood-brain barrier, gets through a placental barrier and into breast milk. 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. 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. Extent of cumulation of a dezloratadin corresponds to its elimination half-life and frequency rate of use (once a day). 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. Elimination half-life (T1/2) makes 20–30 h (on average 27 h).
The pharmacodynamics
Dezloratadin, Lordesa active agent, is a selection blocker peripheral histamine H1 receptors. 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. The mechanism of action of a dezloratadin consists in blocking of release of a histamine and C4 leukotriene from mast cells, thereby preventing development and facilitating a course of allergic reactions. Has antiallergic, antipruritic and antiexudative effect. Reduces permeability of capillaries, prevents edematization of fabrics, eliminates a spasm of unstriated muscles. Dezloratadin does not get through a blood-brain barrier, respectively, does not cause drowsiness and does not change the speed of psychomotor reactions.
Indications
– seasonal and year-round allergic rhinitis
– a chronic idiopathic small tortoiseshell
the Route of administration and doses
Inside. To adults and teenagers 12 years are more senior – on 1 tablet (5 mg) of 1 times a day. The tablet should be swallowed entirely, without chewing and to wash down with water. It is regularly desirable to take the drug at the same time day, regardless of meal. The course of treatment is appointed by the doctor individually.
Side effects
Drug is usually well transferred by patients.
– increased fatigue
– dryness in a mouth
– a headache, dizziness, drowsiness, insomnia
– psychomotor hyperactivity, spasms, hallucinations
– tachycardia, heartbeat
– abdominal pains, nausea, vomiting, dyspepsia, diarrhea, increase in activity of enzymes of a liver, increase in concentration of bilirubin, hepatitis
– reactions of hypersensitivity: skin rash, anaphylaxis, asthma.
The contraindication
– hypersensitivity to a loratadin or excipients
– heavy degree of chronic kidney disease
– children’s age up to 12 years (to children 12 years are younger Lordes syrup is intended)
– pregnancy and the period of a lactation
– a hereditary lactose intolerance, disturbance of absorption of a glucose/galactose or a lactose intolerance in an organism
Medicinal interactions
of Clinically significant interactions of a dezloratadin with other medicines is not revealed. LORDES does not strengthen the oppressing effect of ethanol on psychomotor function. Clinically significant interactions with ketokonazoly and erythromycin are not revealed.
The special
instructions Use in pediatrics
For children are younger than 12 years LORDES syrup can be applied.
Features of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms.
Influence of LORDES on driving or work with difficult technical devices was not noted.
Overdose
Symptoms: a headache, dryness in a mouth, fatigue.
Treatment: gastric lavage, intake of activated carbon, symptomatic therapy. LORDES is not removed by means of a hemodialysis.
The form of release and packing
On 10 tablets place in blister strip packaging from a transparent film of PVH/PE/PVDH (polyvinylchloride/polyethylene / poliviniliden-chlorid) and the printing aluminum foil varnished.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer.
To Store storage conditions at a temperature not over 25 ºС, in the dry, protected from light place. To store out of children’s reach!
A period of storage
2 years
not to apply after the storage expiration
Prescription status
According to the prescription
Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer,
Almaty, Shevchenko St. 162 E.
The owner of the registration certificate
of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika
the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika
Republic of Kazakhstan, Almaty, Shevchenko St. 162 E.
Phone number: (+7 727) 399-50-50
Fax number: (+7 727) 399-60-60
E-mail address of nobel@nobel.kz
Additional information
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