Ksizal - histamine H 1 receptor blocker; antiallergic agent with antipruritic and antiexudative action. When taken in therapeutic doses, practically does not have anticholinergic, antiserotoninovogo and sedative effect.
Release form and composition
- Film-coated tablets: oval, white or almost white in color, “Y” marking is squeezed out on one side (7 or 10 pieces in blisters, in a cardboard pack of 1 or 2 blisters);
- Drops for oral administration: a colorless, slightly opalescent solution (10 or 20 ml in dark glass bottles, equipped with a dropper, in a cardboard bundle 1 bottle).
The active ingredient of the drug is levocetirizine dihydrochloride: in 1 tablet and 1 ml of drops - 5 mg.
Additional components of tablets:
- Excipients: microcrystalline cellulose, magnesium stearate, lactose monohydrate, colloidal silicon dioxide;
- The composition of the shell: opadry Y-1-7000 (macrogol 400, titanium dioxide (E171) and hypromellose).
Auxiliary components of the drops: purified water, propyl parahydroxybenzoate, methyl parahydroxybenzoate, sodium saccharinate, propylene glycol, acetic acid, sodium acetate, glycerol 85%.
Indications for use
Symptomatic treatment of allergic conditions and diseases:
- Urticaria (including chronic idiopathic);
- Pollinosis (hay fever);
- Quincke’s edema;
- Seasonal (intermittent) and year-round (persistent) allergic rhinitis and allergic conjunctivitis (rhinorrhea, pruritus, conjunctival hyperemia, nasal congestion, sneezing, watery eyes);
- Other allergic dermatosis, accompanied by itching and rashes.
- Children's age up to 6 years - for tablets, up to 2 years - for drops;
- Lactation (or breastfeeding should be stopped);
- End-stage renal disease (creatinine clearance less than 10 ml / min);
- Hypersensitivity to the drug components, especially in patients with severe lactose intolerance or galactosemia (for tablets);
- Hypersensitivity to levocetirizine, auxiliary components or piperazine derivatives.
With extreme caution, the drug should be used for older people and patients with chronic renal failure.
Dosing and Administration
Both dosage forms of Xizal must be taken orally on an empty stomach or during a meal. The tablets are taken whole, without chewing, with water, and the drops - in pure form or diluted immediately before taking in a small amount of water.
- Children over 6 years old and adults - 5 mg 1 time per day (1 tablet or 20 drops);
- Children 2-6 years old - 1.25 mg (5 drops), 2 times a day.
Patients with renal insufficiency dose is determined depending on the amount of creatinine clearance (CK):
- CC 50-79 - dose adjustment is not required (5 mg per day);
- CC 30-49 - 5 mg 1 time in 2 days;
- CC <30-5 mg 1 time in 3 days.
Patients in whom renal insufficiency is combined with hepatic, dosing is carried out in the same way as in renal failure.
Patients with impaired liver function dose adjustment is not required.
Duration of use is determined individually depending on the evidence. For the treatment of pollinosis, it may take from 1 to 6 weeks, for chronic diseases (atopic dermatitis, year-round rhinitis), the duration of therapy may be extended to 18 months.
- Central nervous system (CNS): infrequently 1 - drowsiness, headache and fatigue; rarely 2 - asthenia; very rarely 3 - blurred vision, agitation, hallucinations, depression, aggression, convulsions;
- Musculoskeletal system: very rarely - myalgia;
- Cardiovascular system: very rarely - tachycardia;
- Digestive system: infrequently - dry mouth; rarely - abdominal pain; very rarely - diarrhea, nausea, changes in liver function tests, hepatitis;
- Metabolism: very rarely - weight gain;
- Respiratory system: very rarely - dyspnea;
- Allergic reactions: very rarely - urticaria, rash, itching, anaphylaxis, angioedema.
1 rarely - in more than 1 patient out of 100, but less than in 1 out of 10.
2 rarely - in more than 1 patient out of 1000, but less than 1 in 100.
3 very rarely - in more than 1 patient out of 10,000, but less than 1 in 1000.
With an overdose of Kzizal, drowsiness is observed in adults, in children, anxiety and agitation, alternating with drowsiness. In the case of taking an excessive dose of the drug should be done as soon as possible gastric lavage or induce vomiting and take activated charcoal. There is no specific antidote for levocetirizine. Hemodialysis is ineffective. Further treatment is symptomatic.
With an objective assessment of the ability of a patient taking Ksizal in the dose recommended by a doctor, to engage in activities requiring quick reactions and increased concentration of attention, no negative effect of the drug was identified. However, during treatment it is recommended to refrain from driving and performing potentially hazardous types of work.
Particular care should be exercised while drinking alcohol.
The interaction of levocetirizine with other drugs has not been studied.
In some cases, with the simultaneous use of drugs that have a depressant effect on the central nervous system and ethanol, their effects on the central nervous system can be enhanced.
Terms and conditions of storage
Store in a dark, dry (tablets), out of reach of children at temperature: tablets - up to 25 ºС, drops - up to 30 ºС.
Shelf life of tablets - 4 years, drops - 3 years, after opening the bottle - 3 months.