Levarizin 5 mg (28 tablets)

The instruction for medical use of LEVARIZIN medicine the Trade name Levarizin Mezhdunarodnoye the unlicensed name Levotsetirizin Lekarstvennaya the Tablet form, coated, 5 mg One tablet contains Structure: active agent: levotsetirizina dihydrochloride of 5 mg, excipients: lactoses monohydrate, cellulose microcrystalline, silicon dioxide colloidal anhydrous, magnesium stearate, gipromelloz, titan dioxide (E 171), macrogoal. Description Round biconvex tablets, coated white color. Pharmacotherapeutic group Antihistaminic drugs of systemic action, piperazin derivatives. Levotsetirizin. ATX R06AE09 code Pharmacokinetics Absorption. At oral administration levotsetirizin it is soaked up quickly and substantially. The maximum concentration (Cmax) in plasma appears in 0.9 hours from reception. Meal does not affect completeness of absorption though its speed decreases. Constant level of concentration is reached in 2 days. Distribution. Levotsetirizin in 90% contacts proteins of plasma. The bioavailability reaches 100%. Metabolism. Is exposed to metabolic change at people less, than 14% of a dose of a levotsetirizin, Due to such weak metabolism and lack of a possibility of slowing down of metabolism, interactions of a levotsetirizin with other substances are a little probable. Removal. Plasma elimination half-life makes at adults 7.9 ± 1.9 hours, at small children it is shortened. Levotsetirizin and his metabolites are allocated, mainly, with urine, on average 85.4% of a dose. At adults the general clearance is 0.63 ml/min. With a stake only 12.9% of a dose are allocated. Renal failures. The visible clearance of a levotsetirizin from an organism depends on clearance of creatinine. Therefore patients with moderate and heavy renal failures are recommended to pick up the corresponding intervals between the next doses of a levotsetirizin, depending on clearance of creatinine. At persons with uraemia and an anury the full clearance of medicine from an organism is reduced by about 80% in comparison with healthy people. The quantity of the levotsetirizin removed during a standard four-hour hemodialysis was also lt, 10%. The pharmacodynamics Active agent of drug – levotsetirizin, R-enantiomer of a tsetirizin, belongs to group of competitive antagonists of a histamine, blocks H1-histamine receptors. The affinity to H1 receptors at a levotsetirizin is twice higher, than at a tsetirizin. Levotsetirizin influences a gistaminozavisimy stage of allergic reactions and also reduces migration of eosinophils, reduces vascular permeability, limits release of mediators of inflammation. Levotsetirizin prevents development and facilitates a course of allergic reactions, possesses antiexudative, antipruritic action, has practically no anticholinergic and antiserotoninovy effect. In therapeutic doses practically does not render sedation. Effect of drug begins in 12 min. after reception of a single dose at 50% of patients, in 1 hour – at 95% and remains within 24 hours. Indications Treatment of the symptoms connected with allergic states, such as: - allergic rhinitis (including constant allergic rhinitis) - a small tortoiseshell the Route of administration and doses Should be accepted inside, swallowing entirely and washing down with liquid. The pill can be taken in time or irrespective of meal. Reception of all dose of medicine is recommended once a day. Children aged from 6 up to 12 years: The recommended dose of medicine makes 5 mg (1 tablet) a day. Adults and teenagers at the age of 12 years are also more senior: the recommended dose of medicine makes 5 mg (1 tablet) a day. Patients at advanced age: selection of a dose is recommended to patients at advanced age with a renal failure of average or heavy degree (see. Patients with renal failures). Adult patients with renal failures: Periods of time between the next doses have to be picked up individually, depending on degree of a renal failure. The dose needs to be picked up according to the table provided below. To use the table of dosing stated below, the data concerning value of clearance of creatinine at this patient (Clkp) in ml/min. of Clkp (ml/min.) are necessary it is possible to calculate on creatinine of serum (mg/dl), using the following formula:
x the body weight (kg)-------------------------------------------------------------(x 0.85 for women) 72 x creatinine of serum (mg/dl) Selection of a dose for patients with renal failures: The Clearance of Creatinine group (ml/min.) the Dose and frequency of reception Normal ≥ 80 1 tablet of 1 times a day the Insignificant 50 - 79 1 tablet of 1 times a day the Moderate 30 - 49 1 tablet each 2 days Heavy & lt, 30 1 tablet each 3 days Uraemia – patients are on dialysis & lt, 10 Use of medicine contraindicated At children with renal failures a dose needs to be selected individually, on the basis of value of renal clearance and body weight. Patients with an abnormal liver function: The patients having only an abnormal liver function do not have need to change a dose. Selection of a dose is recommended only to patients with an abnormal liver function and kidneys (see above Patients with a renal failure). Treatment duration Seasonal allergic rhinitis (symptoms are defined also by lt, 4 days a week or less than 4 weeks keep) it is necessary to treat depending on course of a disease, treatment can be interrupted at once after disappearance of symptoms and to renew in case of their repeated emergence. In case of persistent allergic rhinitis (symptoms & gt, 4 days/week and within more than 4 weeks) continuous therapy can be offered the patient during contact with allergens. For a chronic small tortoiseshell and chronic allergic rhinitis there is a clinical experience of use of a racemate up to one year. Side effects At children at the age of 6-12 years - a headache, drowsiness At teenagers of 12 years and adults - a headache, drowsiness, dryness in a mouth, fatigue the Post - marketing experience. - hypersensitivity, including an anaphylaxis, a Quincke's disease, rash, an itching, a small tortoiseshell - increase in appetite, nausea, vomiting - aggression, excitement, hallucinations, a depression, insomnia, suicide thoughts, spasms, paresthesias, dizziness, a faint, a tremor, a disgeziya, a disorder of vision, the obscured sight - heartbeat, tachycardia - short wind - hepatitis - a dysuria, an ischuria - muscle pain - swelled - increase in weight, the Contraindication abnormal liver function - hypersensitivity to any of components of drug or piperazin derivatives - a severe form of chronic kidney disease (clearance of creatinine less than 10 ml/min.) - children's age up to 6 years - pregnancy and the period of a lactation Medicinal interactions were not conducted the researches concerning interaction of a levotsetirizin with other drugs (including with the inductors CYP3A4), results of researches with racemic connection of a tsetirizin did not show clinically essential side reactions of interaction (with pseudoephedrine, Cimetidinum, ketokonazoly, erythromycin, azithromycin, glipizidy, and diazepam). Small decrease in clearance of a tsetirizin (16%) at multiple dose with theophylline was observed (400 mg of 1 times a day), at the same time, the concomitant use of a tsetirizin did not change placement of theophylline in an organism. Reception of a levotsetirizin with food does not reduce extent of its absorption, however reduces absorption speed. Sensitive patients have a concomitant use of a tsetirizin or a levotsetirizin with alcohol or with other means which are slowing down the central nervous system function can influence the central nervous system though it is proved that racemic connection of a tsetirizin does not strengthen effect of alcohol. Special instructions Patients with chronic kidney disease and advanced age with a moderate and heavy renal failure: correction of the mode of dosing is required (see the Route of administration and doses). To patients with the contributing factors of an ischuria to accept with extra care (for example, defeat of a chord of a spinal cord, a prostate hyperplasia) as levotsetirizin can increase risk of development of an ischuria. Due to presence of lactose, patients with rare hereditary problems of intolerance of a galactose, deficiency of lactase (Lappa type) or glyukozo-galaktozny malabsorption should not take a pill. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms At objective assessment of ability to driving of the car and work with mechanisms any undesirable phenomena are authentically not revealed when assigning of the recommended dose of 5 mg, nevertheless, reasonablly to abstain from the occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions. Overdose Symptoms: reception bigger, than it is recommended, drowsiness can cause doses of the medicine Levarizin in adults, and children can have an excitement and concern, especially motive in the beginning, and then drowsiness. Treatment: it is necessary to stop administration of drug, gastric lavage, intake of activated carbon, symptomatic therapy is necessary. There is no specific antidote. The hemodialysis is not effective. A form of release and packing On 7 tablets, coated, in blister strip packaging or perforated blister strip packaging from aluminum foil. On 1, 2 or 4 planimetric packs or perforated planimetric packings together with the instruction for use in the state and Russian languages in a cardboard pack. To Store storage conditions in original packing, in the place protected from light at a temperature not above 25 °C. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription LLC Biofarm Producer of st. of Valbzhisk 13, 60-198 Poznan, Poland the Name and the country of the owner of the registration certificate of LLC Biofarm, Poland the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products TOO Adalan Timiryazev St. 42, peahens. 23 offices 202, 050057 Almaty
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