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Zetrinal 10 mg (10 tablets)




The instruction for use
of medicine for experts

the Trade name
of Zetrinal®

the International unlicensed

name Tsetirizin Lekarstvennaya a form
of the Tablet of 10 mg

One tablet contains
active agent – a tsetirizin dihydrochloride of 10 mg,
excipients: corn starch, lactose, polyvinylpirrolidone, magnesium stearate,
cover: dioxide, talc eudragit % E12.5, polyethyleneglycol, the titan.

The description
White or almost white tablets, coated oblong shape and risky from two parties

Pharmacotherapeutic group
Antihistaminic drugs for system use.
Piperazin derivatives.
The code of automatic telephone exchange R06AE07

the Pharmacological

Pharmacokinetics Quickly properties is soaked up at intake. The maximum concentration in blood serum is reached in 1 h after oral administration. Meal does not affect completeness of absorption, but extends process of absorption on 1 h
93% of a tsetirizin contacts blood proteins. Pharmacokinetic parameters of a tsetirizin have linear dependence. Distribution volume – 0.5 l/kg. In small amounts it is metabolized in a liver in the way About – a dezalkirovaniye with formation pharmacological of an inactive metabolite (unlike other blockers H1-gistaminoretseptorov which are metabolized in a liver with participation of a system of P450 cytochrome). Does not kumulirut. 2/3 drugs are removed in not changed look by kidneys and about 10% – with stool. System clearance – 53 ml/min. Elimination half-life makes 7–10 h, children have 6–12 years – 6 h. At elderly patients the elimination half-life increases by 50%, system clearance – for 40%. Drug is practically not removed at a hemodialysis. Gets into breast milk.
The pharmacodynamics
Zetrinal is strong antihistamine. Has no significant sedation, possesses antiallergic action, has antiexudative, antipruritic effect.
Zetrinal – is a selection antagonist of N1-of receptors, has no antitikholinergichesky and antiserotoninovy effect.
Zetrinal does not get through a blood-brain barrier, brakes a gistaminooposredovanny early phase of allergic reactions, reduces migration of the inflamed cells and eosinophils, discharge of the mediators participating in late allergic reaction oppresses. At reception of a zetrinal at patients with bronchial asthma the hyperreactivity of a bronchial tree arising in response to release of a histamine significantly goes down. These properties of drug are not followed by the central action.
Zetrinal provides fast effect and long control over an allergy.

Symptomatic treatment:
– year-round and seasonal allergic rhinitis and allergic conjunctivitis
– hay fever
– a pollinosis
– urticaria (including a chronic idiopathic small tortoiseshell)
– a Quincke’s edema
– the allergic dermatosis which is followed by an itching and rashes
– psoriasis, eczema
– the stings of insects accompanied with allergic reactions.

The route of administration and doses
appoint Drug inside.
Adult – 10 mg once a day, children are more senior than 6 years – on 5 mg 2 times a day or 10 mg once. Sometimes the initial dose of 5 mg can be sufficient for achievement of therapeutic effect.
The patient with a moderate or severe form of a renal failure appoint a half of the recommended dose.
With normal function of kidneys of dose adjustment it is not required to elderly patients.
The course of treatment is defined by the attending physician.

Side effects
– feeling of fatigue
– a headache
– dizziness, an incoordination of movements, a tremor, a hyperkinesia, spasms of gastrocnemius muscles
– nausea, dryness in a mouth, dyspepsia
– the concern (increase in physical activity)
is rare:
– reactions of hypersensitivity (vascular hypostasis, rash) (≤2%). The intensity of above-mentioned side effects can be reduced, having divided a daily dose into two receptions.

– hypersensitivity to drug
– pregnancy, feeding by a breast
– a renal failure and a liver.

Medicinal interactions
pharmacokinetic interaction and clinical effect at joint prescribing of drug with pseudoephedrine, Cimetidinum, ketokonazoly, erythromycin, azithromycin, diazepam, glipizidy is noted. At joint appointment with theophylline in a dose of 400 mg the decrease in clearance of creatinine by 16% was noted once a day. At joint appointment with macroleads and ketokonazoly changes on the ECG are noted.

The special
instructions Recommended Day Dose to the patients having a renal failure of 5 mg (half of a tablet)
Use in pediatrics
This dosage form it is not appointed to children up to 6 years
of Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
With care to apply in operating time to drivers of vehicles and people whose profession is connected with the increased concentration of attention

Symptoms: strengthening of side effects.
Treatment: gastric lavage, prescribing of activated carbon, the supporting and symptomatic therapy.

The form of release and packing
of the Tablet of 10 mg in cardboard packing with the instruction for use

to Store Storage conditions in blister No. 10 at a temperature not above +25C.
To store in places inaccessible for children!

3 years
not to apply a period of storage after the expiration date specified on packing

Prescription status
According to the prescription

of Hadymkaya-Stambul

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