Лордес®

General characteristics. Structure:

Active ingredient: 5 mg of a dezloratadin.

Excipients: hydrophosphate calcium dihydrate, cellulose microcrystallic PH 102, starch corn, talc,

Structure of a cover: Opadry II Pink 31F240011: gland (III) oxide red (Е 172), gland (II, III) oxide black (E172), HPMC 2910/of a gipromelloz 15 Wednesday (E464), makrogol/PEG 4000, lactoses monohydrate, titanium dioxide (Е 171).

Pharmacological properties:

Pharmacodynamics. Dezloratadin, active agent of Lordes, is the selection blocker peripheral histamine H1 receptors. Dezloratadin is primary active metabolite of a loratadin. High-quality or quantitative discrepancies of toxicity of a dezloratadin and 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 the course of allergic reactions. Has antiallergic, antipruritic and antiexudative effect. Reduces permeability of capillaries, edematization of fabrics warns, 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.

Pharmacokinetics. Bioequivalence of drug in the form of tablets and syrup is revealed. Dezloratadin begins to be defined in a blood plasma within 30 min. after reception. The maximum concentration of a dezloratadin (Cmax) in plasma is reached on average in 3 h (T max). Bioavailability of a dezloratadin is proportional to a dose from 5 to 20 mg. It is established that food (a 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 - a hydroxylation in situation 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. The elimination half-life (T1/2) makes 20–30 h (on average 27 h).

Indications to use:

- seasonal and year-round allergic rhinitis;

- chronic idiopathic small tortoiseshell.

Route of administration and doses:

Inside. To adults and teenagers 12 years - on 1 tablet (5 mg) of 1 times a day are more senior. The tablet should be swallowed entirely, without chewing and to wash down with water. It is regularly desirable to accept drug at the same time days, regardless of meal. The course of treatment is appointed by the doctor individually.

Features of use:

Use in pediatrics. For children 12 years are younger it can to be applied ЛОРДЕС® syrup.

Features of influence of medicine on ability to manage the vehicle and potentially dangerous mechanisms. Influence of Lordes® on driving or work with difficult technical devices was not noted.

Side effects:

Drug is usually well transferred by patients.

- increased fatigue;

- dryness in a mouth;

- headache, dizziness, drowsiness, sleeplessness;

- 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;

- hypersensitivity reactions: skin rash, anaphylaxis, asthma.

Interaction with other medicines:

Clinically significant interactions of a dezloratadin with other medicines are not revealed. Лордес® does not strengthen the oppressing effect of ethanol on psychomotor function. Clinically significant interactions with ketokonazoly and erythromycin are not revealed.

Contraindications:

- hypersensitivity to a loratadin or excipients;

- heavy degree of a chronic renal failure;

- children's age up to 12 years (to children 12 years are younger syrup Lordes is intended);

- pregnancy and period of a lactation;

- a hereditary lactose intolerance, disturbance of absorption of a glucose/galactose or a lactose intolerance in an organism.

Overdose:

Symptoms: a headache, dryness in a mouth, fatigue.

Treatment: gastric lavage, reception of absorbent carbon, symptomatic therapy. ЛОРДЕС® it is not removed by means of a hemodialysis.

Storage conditions:

To store at a temperature not over 25 ºС, in the dry, protected from light place. To store in the place, unavailable to children! Period of storage 3 years. Not to apply after the storage expiration.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets place in a blister strip packaging from a transparent film of PVH/PE/PVDH (поливинилхлорид/полиэтилен/поливинилиден-хлорид) and printing aluminum foil varnished.

On 1 planimetric packaging together with the instruction on a medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer.