Tsetirizin - Teva

General characteristics. Structure:

Active agent of a tsetirizin dihydrochloride of 10,00 mg;
excipients: cellulose of microcrystallic 40,00 mg, lactoses monohydrate of 63,50 mg, silicon dioxide of colloid 0,50 mg, magnesium stearate of 1,00 mg;
cover of Opadray of OY-GM-28900 white: gipromelloz (E464) of 0,94 mg, polydextrosum of 0,94 mg, titanium dioxide (E171) of 0,94 mg, macrogoal-4000 of 0,18 mg.

Description
Biconvex tablets of oblong shape, film coated white or almost white color. On one of the parties dividing risk, on another - an engraving of "C10".

Pharmacological properties:

Pharmacodynamics. Tsetirizin is a competitive antagonist of a histamine, Hydroxyzinum metabolite, a blocker of H1-histamine receptors. Inhibits the vasoactive intestinal peptide (VIP), substance P, neuropeptids involved in development of allergic reaction. Prevents development and facilitates the course of allergic reactions, possesses antipruritic and antiexudative action. Influences an early stage of allergic reactions, limits release of mediators of an inflammation at a "late" stage of allergic reaction, reduces migration of eosinophils, neutrophils and basophiles. Reduces permeability of capillaries, edematization of fabrics warns, removes a spasm of smooth muscles.
Eliminates skin reaction to introduction of a histamine, offending allergens, and also to cooling (at a cold urticaria). Reduces a gistaminoindutsirovanny bronkhokonstriktion at bronchial asthma of an easy current. Practically has no anticholinergic and antiserotoninergichesky effect. In therapeutic doses practically does not cause sedation. The therapeutic effect develops in 2 hours after reception, reaching a maximum in 4 hours, and more than 24 p proceed. Against the background of course treatment tolerance to antihistaminic action of a tsetirizin does not develop. After the treatment termination action remains to 3 days.

Pharmacokinetics. Absorption. After intake it is quickly soaked up. The maximum concentration in plasma (Cmax) is reached in 1 h. Administration of drug with food does not influence absorption size, but absorption speed decreases a little (time of achievement of Cmax increases by 1 h).
Distribution. Tsetirizin contacts proteins of a blood plasma for 93%. The volume of distribution (Vd) - 0,5 l/kg. It is allocated with breast milk. Does not kumulirut.
Metabolism. In small amounts it is metabolized with formation pharmacological of an inactive metabolite (unlike other blockers of the H1-histamine receptors which are metabolized in a liver with participation of system of isoenzymes of P450 cytochrome).
Removal. 60% of drug are removed in not changed look by kidneys within 96 hours and about 10% are allocated through intestines. The elimination half-life (T1/2) makes 7-10 h. Practically is not removed at a hemodialysis.
Pharmacokinetics in special clinical cases. T1/2 of children at the age of 6-12 years - 6 h. At patients with renal failures or a liver removal of drug is slowed down, and T1/2 increases.

Indications to use:

To adults and children 12 years are more senior
- Symptomatic therapy of seasonal and year-round allergic rhinitis with the accompanying allergic conjunctivitis;
- chronic idiopathic small tortoiseshell.
To children aged from 6 up to 12 years
- Symptomatic therapy of seasonal and year-round allergic rhinitis;
- chronic idiopathic small tortoiseshell.

Route of administration and doses:

Inside. Tablets are swallowed completely, without chewing, washing down with a small amount of water, preferably in the evening.
Adults, children are more senior than 12 years and with body weight more than 30 kg
On 10 mg (1 tablet) once a day.
Children of 6-12 years
With body weight more than 30 kg. On 10 mg once a day or on 5 mg (1/2 tablets) 2 times a day (in the morning and in the evening).
With body weight less than 30 kg. On 5 mg (1/2 tablets) once a day.
At patients with a renal failure dose adjustment depends on KK value and is presented in the table:

                                     Clearance of Creatinine group (ml/min.)    Dose and frequency of reception
Easy HPN                                       50-79                                       10 of mg once a day
Moderate                                                                         HPN 30 - 49 5 of mg a day
Heavy HPN                                   11-30                                           5 of mg of 1 times each 2 days
HPN end-stage,
the patients who are on
hemodialysis                                      Less than 10                              Drug are contraindicated
Duration of treatment is selected individually depending on disease symptoms. At emergence of drowsiness drug should be accepted in the evening.

Features of use:

Some patients have a prolonged treatment by drug Tsetirizin - Teva can increase risk of development of caries in connection with dryness in an oral cavity. For this reason during treatment by drug careful hygiene of an oral cavity is necessary.
With care use drug Tsetirizin - Teva at patients with a chronic renal failure of average and heavy severity, at patients of advanced age (decrease in glomerular filtering is possible).
Drug Tsetirizin - Teva can strengthen effects of alcohol therefore it is recommended to abstain from alcohol intake during drug use. Drug Tsetirizin - Teva is contraindicated to patients with hereditary intolerance of a galactose, insufficiency of lactase and the broken glucose galactose absorption.

Influence on ability to driving of the car and to control of mechanisms
It is necessary to be careful during drug use Tsetirizin - Teva owing to possible development of side reactions which can negatively influence ability to control of motor transport and performance of potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Frequency of development of side reactions is classified according to recommendations of World Health Organization: very often - not less than 10%; often - not less than 1% and less than 10%; infrequently - not less than 0,1% and less than 1%; seldom - not less than 0,01% and less than 0,1%; very seldom - less than 0,01%, including isolated cases.
From blood and lymphatic system: very seldom - thrombocytopenia.
From immune system: seldom - hypersensitivity reaction; very seldom - an acute anaphylaxis.
From a nervous system: infrequently - paresthesia, excitement; seldom - spasms, motive frustration, aggression, confusion, a depression, hallucinations, sleeplessness; very seldom - disturbance of flavoring feeling, a syncope.
From cardiovascular system: seldom - tachycardia, a heart consciousness.
From an organ of sight: very seldom - disorders of accommodation, indistinct sight, okulogirny crisis.
From digestive tract: infrequently - diarrhea.
From a liver and biliary tract: seldom - increase in activity of "hepatic" transaminases, an alkaline phosphatase, γ-glutamiltransferaza; very seldom - hepatitis.
From skin and hypodermic fabrics: infrequently - an itch, rash; seldom - a small tortoiseshell; very seldom - a Quincke's disease, a mnogoformny erythema.
From kidneys and urinary tract: very seldom - a dysuria, an urine incontience, the complicated urination.
Others: infrequently - an adynamy, discomfort; seldom - hypostasis, increase in body weight.

Interaction with other medicines:

Pharmacokinetic interaction with pseudoephedrine, Cimetidinum, ketokonazoly, erythromycin, azithromycin, diazepam and glipizidy is not revealed.
Simultaneous use with theophylline (400 mg/days) leads to decrease in the general clearance of a tsetirizin (the kinetics of theophylline does not change).
Myelotoxic medicines strengthen manifestations of a gematotoksichnost of a tsetirizin.
Use of a tsetirizin needs to be stopped three days before carrying out allergy tests.
It is recommended to be careful at simultaneous use of the drugs making the oppressing impact on TsNS.

Contraindications:

Hypersensitivity to a tsetirizin, other components of drug and derivatives of piperazin; children's age up to 6 years; pregnancy; breastfeeding period; end-stage of a renal failure (clearance of creatinine (CC) less than 10 ml/min.); the patients who are on a hemodialysis; lactose intolerance, deficit of lactase; syndrome of glyukozo-galaktozny malabsorption.

With care
Chronic renal failure of average and heavy degree; the age is more senior than 65 years; simultaneous use with the medicines making the oppressing impact on the central nervous system (CNS) such as barbiturates, opioid analgetics, ethanol, benzodiazepine derivatives, zolpidy, etc.

Use during pregnancy and breastfeeding
Tsetirizin is contraindicated to use for pregnant women since there are not enough data on safety and efficiency.
There are no data on allocation of a tsetirizin with breast milk, цетиризин it is not necessary to apply during breastfeeding.

Overdose:

Symptoms: drowsiness, concern, an acrimony, an urination delay, dryness in a mouth, a lock, a mydriasis, tachycardia.
Treatment: drug withdrawal, gastric lavage, reception of absorbent carbon, symptomatic therapy.

Storage conditions:

To store at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated 10 mg.
On 10 tablets in blisters from an aluminum foil / PVC / PVDH.
On 1, 2 or 3 blisters place in a cardboard pack together with the application instruction.