Symptomatic treatment of allergic rhinitis (including chronic allergic rhinitis) and chronic idiopathic urticaria in adults, adolescents and children over the age of 6 years.
Composition:
1 tabl powl. contains 5 mg levocetirizine dihydrochloride equivalent to 4.2 mg levocetirizine. The preparation contains lactose.
Action:
Antihistamine - a strong and selective antagonist of peripheral histamine H receptors1. Levocetirizine inhibits endothelial migration of eosinophils through skin and lung cells. The effect of a dose of levocetirizine equal to half the dose of Cetirizine is comparable to that of Cetirizine, both on the skin and on the nasal mucosa. It absorbs quickly and to a significant extent from the gastrointestinal tract, the food does not reduce the degree of absorption, but reduces its speed. The maximum concentration in the blood occurs within 0.9 h after administration. It is 90% bound to plasma proteins. Levocetirizine and its metabolites are mainly excreted in the urine, which is on average 85.4% of the administered dose. 12.9% of the dose is excreted in the faeces. T0,5 in adults it is 7.9 ± 1.9 hours, in young children it is shorter.
Contraindications:
Hypersensitivity to levocetirizine, other piperazine derivatives or to any of the preparation ingredients. Severe renal dysfunction with creatinine clearance less than 10 ml / min. Due to the lactose content, do not use the preparation in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Precautions:
Caution should be exercised in patients at risk of urinary retention (eg spinal cord injury, prostatic hyperplasia) because levocetirizine may increase the risk of urinary retention. It is not recommended to administer the drug in the form of tablets. powl. children under the age of 6 years, as it is not possible to adjust the dose accordingly for this form of the drug. Caution should be used when taking the drug together with alcohol.
Pregnancy and lactation:
Avoid use during pregnancy (no data on the use of levocetirizine in pregnant women). There are no adequate data on the penetration of levocetirizine and its metabolites in human milk. A danger for newborns and children can not be excluded. A decision should be made whether to discontinue breast-feeding or discontinue the drug taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Side effects:
Common: headache, drowsiness, dryness of the oral mucosa, fatigue. Uncommon: weakness, abdominal pain. Not known: hypersensitivity, including anaphylaxis; increased appetite; aggression, agitation, insomnia, suicidal thoughts; convulsions, parasthesia, dizziness (of central origin), fainting, tremor, dysgeusia; dizziness (labyrinthine origin); blurred vision, blurred vision; palpitations; dyspnoea; nausea, hepatitis; painful or difficult urination, urinary retention; angioneurotic edema, persistent drug eczema, pruritus, rash, urticaria; muscle aches; edema; weight gain, abnormal liver function tests. Children and adolescents - often or very often: diarrhea, vomiting, constipation, drowsiness, sleep disorders.
Dosage:
Orally. Adults and adolescents aged 12 years and over: 5 mg (1 table total) per day; children from 6 to 12 years of age: 5 mg (1 table) daily.Special flu patients. In patients with impaired renal function, dosing should be dependent on creatinine clearance - ≥ 80 ml / min: 5 mg once a day; 50-79 ml / min: 5 mg once a day; 30-49 ml / min: 5 mg every other day; <30 ml / min: 5 mg every third day; <10 ml / min: the drug is contraindicated. In children with impaired renal function, the dose should be determined individually based on the patient's renal clearance and body weight. No dosage adjustment is necessary for patients with hepatic impairment.Duration of treatment. Periodic allergic rhinitis (symptoms <4 days in a weekor lasting less than 4 weeks) should be treated in accordance with the course of the disease; treatment may be discontinued immediately after the symptoms have resolved and resumed at the time of their recurrence. In chronic allergic rhinitis (symptoms> 4 days in the week and lasting longer than 4 weeks), the patient may be advised to continue treatment during exposure to allergens. Clinical experience on the use of 5 mg levocetirizine in the form of area, includes 6 months period of treatment. Clinical experience with the use of racemate (cetirizine) in chronic urticaria and chronic allergic rhinitis refers to up to 1 year.Way of giving. Table. powl. swallow whole with liquid. Take it with or without food.
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