Ksizal tab n / 5mg film about 10 pc

Description

Composition
Active substance:
1 tablet contains: levocetirizine dihydrochloride – 5.0 mg ;.
Excipients:
Lactose monohydrate 63.50 mg Microcrystalline cellulose 30.00 mg Colloidal silica 0.50 mg magnesium stearate 1.00 mg Opadry Y-1-7000 3,00 mg (62.5% contains hypromellose, titanium dioxide ( E171) 31,25% macrogol 400, 6.25%).
Description:
Oval-shaped tablets, film-coated white or nearly white. On one side of the tablet embossed marking «Y».
Product form:
Film-coated tablets 5 mg.
7 or 10 tablets in a blister made of PVC – aluminum foil. 1 or 2 blisters together with instructions for use in a cardboard package.
Contraindications
Hypersensitivity to levocetirizine or a piperazine derivative, as well as other components of the formulation;
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
End-stage renal failure (creatinine clearance
Children under 6 years (due to the limited data on the safety and effectiveness);
Pregnancy and breast-feeding.
Carefully
In chronic renal failure (necessary correction mode);
Elderly patients (with age-related decrease in glomerular filtration);
Patients with spinal cord injury, prostate hyperplasia, and in the presence of other predisposing factors to urinary retention because levocetirizine may increase the risk of urinary retention;
With simultaneous use of alcohol (see. Interaction with other drugs).
Dosage
5 mg
Indications
Treatment of symptoms year (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis, such as itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia;
Pollinosis (hay fever);
Hives;
Other allergic dermatoses, accompanied by itching and rashes.
Interaction with other drugs
Study of the interaction of levocetirizine with other drugs was conducted. In the study of drug interaction with phenazone racemic cetirizine, pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam clinically significant adverse interactions not revealed.
While the use of theophylline (400 mg / d) total clearance of cetirizine is reduced by 16% (theophylline kinetics does not change).
In the study while receiving ritanovir (600 mg, 2 times daily) and cetirizine (10 mg daily) was shown that exposure of cetirizine increased by 40% and the exposure is varied slightly ritanovir (-11%).
In some cases, while the use of levocetirizine with alcohol or drugs that have a vast impact on the central nervous system (CNS), may enhance their effect on the central nervous system, although it is not shown that the racemate cetirizine potentiate the effect of alcohol.
Overdose
Symptoms: drowsiness (in adults), agitation and anxiety, changing sleepiness (in infants).
Treatment: it is necessary to wash out the stomach or take activated charcoal, if after ingestion little time has passed. Recommended holding of symptomatic and supportive therapy. No specific antidote. Hemodialysis is not effective.
pharmachologic effect
Pharmacological group:
Antiallergic sredstvo- H1-histamine receptor blocker.
Pharmacodynamics:
Levocetirizine – the active drug substance Ksizal® – is R-enantiomer of cetirizine, which belongs to the group of competitive antagonists of histamine and histamine receptors N1- blocks.
Levocetirizine influences gistaminozavisimuyu step of allergic reactions and also reduces the migration of eosinophils, vascular permeability reduces, limits release of inflammatory mediators.
Levocetirizine prevents the development and facilitates the allergic reactions has protivoekssudativnoe, antipruritic effect, almost no anticholinergic and antiserotonin activities. At therapeutic doses substantially no sedative effect.
Pharmacokinetics:
Pharmacokinetic parameters of levocetirizine vary linearly.
After oral administration, the drug is rapidly and completely absorbed from the gastrointestinal tract. Food intake does not affect the absorption of completeness, although reduces its speed. The maximum concentration (Cmax) in plasma achieved by 0.9 h, and 270 ng / ml, the equilibrium concentration reached after 2 days.
Levocetirizine is 90% bound to plasma proteins. The volume of distribution (Vd) is 0.4 l / kg. Bioavailability is 100%.
Less than 14% of the drug is metabolized in the liver to produce pharmacologically inactive metabolite.
The half-life (T1 / 2) in adults is 7.9 ± 1.9 h. In adults, the total clearance of 0.63 mL / min / kg. Approximately 85.4% of the dose of the drug excreted by the kidneys, about 12.9% – through the intestines. In patients with renal failure at a creatinine clearance less than 40 mL / min, clearance of the drug decreases. In patients on hemodialysis total clearance is reduced by 80%, which requires a change in the relevant dosage regimen. Less than 10% of the drug removed during the standard 4-hour dialysis procedure.
Pregnancy and breast-feeding
Preclinical studies did not reveal any direct or indirect adverse effects of levocetirizine on the developing fetus, as well as development in the postnatal period; During pregnancy and childbirth are not changed.
There are no adequate and well-controlled clinical studies on the safety of the drug during pregnancy has not been carried out.
Use of the drug during pregnancy is contraindicated.
Levocetirizine is excreted in breast milk, so if you need to use the drug during lactation should stop breastfeeding.
Conditions of supply of pharmacies
Without recipe.
side effects
During clinical trials in men and women 12-71 years the most common (> 1/100,
special instructions
Effects on ability to drive vehicles and management mechanisms
Levocetirizine may cause increased sleepiness therefore Ksizal® preparation can influence the ability to drive or operate machinery. In the period of treatment should refrain from activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
Stored in a dry place at a temperature not higher than 25 C.
Keep out of the reach of children!.
Dosing and Administration
Tablets film-coated are inside, swallowing whole with meals or on an empty stomach, with a small amount of water.
Adults and children over 6 years of age: a daily dose of 5 mg (1 tablet) once.
Since levocetirizine excreted by the kidneys, while use of the drug in patients with renal failure and patients of advanced age dose should be adjusted according to the degree of renal failure.
Patients with mild renal impairment (creatinine clearance of 50-79 ml / min) a dose adjustment is required.
In patients with moderate renal impairment (creatinine clearance of 30 to 49 ml / min), the recommended dose of 5 mg every other day.
In patients with severe renal failure (creatinine clearance less than 30 mL / min), the recommended dose of 5 mg of 1 every 3 days.
Patients with renal and hepatic insufficiency dosing is carried out according to the above scheme.
Only patients with impaired liver function correct dosing regimen is required.
The duration of the drug:
In the treatment of seasonal (intermittent), rhinitis (presence of symptoms at least 4 days a week, or a total duration of less than 4 weeks), the duration of treatment depends on the duration of symptoms; Treatment can be discontinued when the disappearance of symptoms and resumed if symptoms.
In the treatment year (persistent) allergic rhinitis (presence of symptoms for more than 4 days per week and the total duration of more than 4 weeks) treatment may continue throughout the period of exposure to allergens.
There is clinical experience of continuous use Ksizal® drug in adult patients for up to 6 months.
If you are taking (or have recently taken) other drugs, including non-prescription, notify your doctor.
If you forget to take medication Ksizal® not take a double dose to compensate for a missed, take the next dose at the usual time.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist