Glentset

General characteristics. Structure:

Active agent: a levotsetirizina dihydrochloride – 5 mg.

Excipients: lactoses monohydrate (Tablettoza 100), cellulose microcrystallic (Avitsel PH 112), silicon dioxide colloid (Aerosil 200), magnesium stearate.

Pharmacological properties:

Levotsetirizin is an enantiomer of a tsetirizin, the competitive antagonist of a histamine, blocks H1-histamine receptors to which affinity is twice higher, than at a tsetirizin. Exerts impact on a gistaminozavisimy stage of allergic reactions, reduces migration of eosinophils, vascular permeability, limits release of mediators of an inflammation. Prevents development and facilitates the course of allergic reactions, has anti-exudative, antipruritic effect, has practically no anticholinergic and antiserotoninovy effect. In therapeutic doses sedative action is very poorly expressed.
Action begins in 12 min. after reception of a single dose at 50% of patients, through 1 h - at 95% and continues within 24 hours.

Pharmacokinetics. The pharmacokinetics has linear character. It is quickly soaked up at intake; meal does not exert impact on completeness of absorption, but reduces its speed. Bioavailability - 100%. Time of achievement of the maximum concentration in blood (TCmax) - 0.9 h, the maximum concentration in blood (Cmax) - 207 ng/ml. Distribution volume - 0.4 l/kg. Communication with proteins of plasma - 90%. Less than 14% of drug are metabolized in a liver by O-dealkylation with formation pharmacological of an inactive metabolite. An elimination half-life (T1/2) - 7-10 h. The general clearance - 0.63 ml/min. It is completely brought out of an organism during 96 h. It is removed by kidneys (85,4%). At a renal failure (the clearance of creatine (CC) less than 40 ml/min.) the clearance decreases (at the patients who are on a hemodialysis - by 80%), T1/2 - is extended. Less than 10% leave during a hemodialysis. Gets into breast milk.

Indications to use:

Symptomatic treatment of year-round and seasonal allergic rhinitis and allergic conjunctivitis (itch, sneezing, rhinorrhea, dacryagogue, conjunctiva hyperemia), hay fever (pollinosis).
Symptomatic treatment of a small tortoiseshell, including chronic idiopathic small tortoiseshell; Quincke's edema; other allergic dermatosis which is followed by an itch and rashes.

Route of administration and doses:

Inside, during food or on an empty stomach, washing down with a small amount of water, not chewing.
The recommended dose to adults and children is more senior than 6 years, to elderly patients (on condition of normal function of kidneys) - 5 mg (1 tablet) once a day.
At patients with a chronic renal failure the dose decreases twice (1 tablet every other day) at KK from 30 to 49 ml/min. and by 3 times (1 tablet in 3 days) at KK from 10 to 29 ml/min. Correction of the mode of dosing is not required to patients with a liver failure.

Course of treatment at chronic diseases - up to 18 months.

Features of use:

Respect for care at the simultaneous use with alcohol is required (see Interaction with other medicines).

Influence on ability to manage cars/mechanisms
At objective assessment influence of drug on ability to driving of motor transport and to control of mechanisms is authentically noted at reception in the recommended dose. Nevertheless, during administration of drug it is reasonable to abstain from occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Possible side effects are given below on systems of an organism and frequency of emergence: often (≥1/10), infrequently (≥1/100, <1/10), it is rare (≥1/1000, <1/100), is very rare (≥1/10000, <1/1000).
- From the central nervous system
Infrequently: headache, fatigue, drowsiness.
Seldom: adynamy.
Very seldom: aggression, excitement, hallucinations, depression, spasms.
- From sense bodys:
Very seldom: vision disorder.
- From the alimentary system:
Infrequently: dryness of a mucous membrane of an oral cavity.
Seldom: abdominal pain.
Very seldom: nausea, diarrhea, hepatitis.
- From outside warmly - vascular system:
Very much redkotakhikardiya.
- From system of breath:
Very seldom: диспноэ.
- From a musculoskeletal system:
Very seldom: mialgiya.
- From a metabolism:
Very seldom: increase in body weight.
- Laboratory indicators:
Very seldom: change of functional trials of a liver.
- Allergic reactions:
Very seldom: itch, rash, urticaria, Quincke's disease, anaphylaxis.

Interaction with other medicines:

Theophylline (400mg/days) reduces the general clearance of a levotsetirizin by 16%, at the same time the kinetics of theophylline does not change.
Combined use with macroleads or ketokenazoly did not cause reliable changes on an ECG.
Can strengthen action of the means oppressing the central nervous system and ethanol.

Contraindications:

Hypersensitivity (including to piperazin derivatives), a heavy chronic renal failure (HPN, KK less than 10 ml/min.), pregnancy, the lactation period, children's age up to 6 years. Intolerance of a galactose, deficit of lactase and glyukozo-galaktozny malabsorption.

With care
Chronic renal failure (correction of the mode of dosing is required), advanced age (decrease in glomerular filtering is possible).

Overdose:

Symptoms: drowsiness, children have a concern, irritability.
Lecheniye:promyvaniye of a stomach, absorbent carbon, symptomatic therapy.
There is no specific antidote. The hemodialysis is inefficient.

Storage conditions:

In the dry place protected from light at a temperature not above 30 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated 5 mg.
On 7, 10 and 14 tablets in a strip from aluminum foil or on 7, 10 and 14 tablets in the blister from a white opaque film of PVH/PVDH - aluminum foil.
On 1, 2 or 5 strips and on 1,2 or 5 blisters together with the application instruction in a cardboard pack.