Название документа
  • Allertek of the tab. of p/o of 10 mg No. 20

Allertek – antihistamine for system use for symptomatic therapy:

  • nasal and eye symptoms of seasonal and constant allergic rhinitis;
  • a chronic idiopathic small tortoiseshell.

Structure

  • active ingredient: tsetirizina dihydrochloride;
  • 1 tablet, coated, supports a tsetirizin of dihydrochloride of 10 mg;
  • other components: lactose, monohydrate; microcrystalline cellulose; corn starch; K-25 povidone; magnesium stearate; sodium krakhmalglikolit (type C); silicon dioxide colloidal anhydrous; sodium lauryl sulfate;
  • structure of a cover: gipromelloza, macrogoal 6000.

Contraindication

Hypersensitivity to the active ingredient or any excipient which is a part of drug, Hydroxyzinum or any derivative piperazin.

Heavy renal failures (clearance of creatinine less than 10 ml/min.).

Rare hereditary forms of intolerance of a galactose, deficiency of Lappa lactase or malabsorption of glucose galactose.

Side reactions

Clinical trials showed that tsetirizin in usual doses (10 mg/days) can cause undesirable reactions from the central nervous system, drowsiness, increased fatigue, a headache and dizziness. They are mild and are temporary.

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In certain cases observed paradoxical excitement of central nervous system.

Though tsetirizin is a selection antagonist of H1 receptors and it is almost deprived of cholinolytic activity, special cases of the complicated urination, disturbance of accommodation of an eye and dryness of a mucous oral cavity were celebrated. Also the abnormal liver function was observed: increase in activity of liver enzymes and increase in concentration of bilirubin. In most cases these symptoms disappeared after the termination of reception of a tsetirizin.

Route of administration

is Applied orally, washing down a tablet with a glass of water. To swallow of tablets without chewing.

Children from 6 to 12 years: 5 mg (½ tablets) 2 times a day.

Adults and children of 12 years: 10 mg (1 tablet) of 1 times a day.

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Feature of use

At reception in therapeutic doses did not observe clinically significant interactions with alcohol (at the blood alcohol level of 0.5 g/l), however it is recommended to avoid simultaneous alcohol intake.

Use during pregnancy or feeding by a breast

Pregnancy.

Should appoint by

with care medicament to pregnant women only when, according to the doctor, the advantage of use exceeds potential risk for a fruit.

feeding Period breast.

Tsetirizin gets into breast milk in the concentration making 25–90% of concentration in blood plasma depending on time which passed after medicament use. Therefore with care it is necessary to appoint medicament nursing.

Children Drug to appoint

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to children of 6 years. Drug in the form of tablets, coated, children are not recommended to apply up to 6 years as this dosage form does not give the chance to pick up the necessary dose.

Ability to influence speed of response at control of motor transport or other mechanisms

Objective researches using a tsetirizin showed that in a usual dose (10 mg/days) medicament does not involve essential drowsiness and decrease in psychophysical activity therefore influence on ability to drive the car slightly.

Patients who are going to drive the car, to serve mobile mechanical devices or to perform the work demanding the raised psychoemotional loading should not exceed a usual daily dose; and they should consider possible reaction of an organism to administration of drug. Sensitive patients have a concomitant use of medicament with other means suppressing activity of the central nervous system can lead to additional deterioration in concentration of attention and decrease in productivity.

Overdose

Symptoms.

Symptoms of overdose of a tsetirizin are connected by

, first of all, with influence on central nervous system or with manifestations which can remind anticholinergic effect.

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After considerable overdose (exceeding a usual daily dose at least by 5 times) noted confusion of consciousness, diarrhea, dizziness, increased fatigue, a headache, an indisposition, a mydriasis, an itching, concern, sedation, drowsiness, a stupor, and a stupor.

Treatment.

is not present

Specific antidote.

At overdose needs to wash out a stomach if from the moment of use of medicament passed no more than an hour, and to carry out symptomatic treatment.

Dialysis is not an effective method of removal of a tsetirizin from an organism.

Interaction with other medicines and other types of interactions

conducted Researches of pharmacokinetic interaction for a tsetirizin and pseudoephedrine, Cimetidinum, a ketokonazol, erythromycin, azithromycin; Pharmacokinetic interactions were not observed. In a research of repeated use of theophylline (400 mg of 1 times a day) and a tsetirizina decrease in clearance of a tsetirizin whereas indicators of theophylline were not broken at a concomitant use of a tsetirizin was observed insignificant (16%).

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In researches of use

irizin with Cimetidinum, glipizidy, diazepam and pseudoephedrine did not reveal proofs of collateral pharmakodinamichesky interactions.

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In researches of use of a tsetirizin with azithromycin, erythromycin, ketokonazoly and theophylline did not reveal proofs of collateral clinical interactions. Besides, simultaneous use of a tsetirizin with macroleads or ketokonazoly never led to clinically significant changes of the ECG.

In a research of repeated use of a ritonavir (600 mg 2 times a day) and a tsetirizina (10 mg/days) duration of exposure of a tsetirizin increased approximately by 40% whereas exposure of a ritonavir was a little broken (-11%) at a concomitant use of a tsetirizin.

Storage conditions

to Store

at a temperature not above 25 °C in protected from moisture, light and the place, inaccessible for children.

Characteristics
Active ingredients Tsetirizin
Amount of active ingredient 10 mg
Applicant Warsaw Federal Law Polfa
Code of automatic telephone exchange R06AE07 Tsetirizin
Interaction with food It doesn't matter
Light sensitivity Sensitive
Market status The branded generic
Origin Chemical
Prescription status Without prescription
Primary packing blister
Producer PHARMACEUTICAL. POLFARM S.A PLANT.
Quantity in packing 20 tablets
Release form tablets for internal use
Route of administration Oral
Sign Import
Storage temperature from 5 °C to 25 °C
Trade name Allertek

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Allertek of the tab. of p/o of 10 mg No. 20

  • Product Code: 181672
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  • $24.15


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