Symptomatic treatment of allergic rhinitis (including chronic allergic rhinitis) and chronic idiopathic urticaria.
Composition:
1 tabl powl. contains 5 mg levocetirizine dihydrochloride. The drug contains lactose.
Action:
Levo Cetirizine, a (R) cetirizine-enantiomer, is a potent and selective antagonist of peripheral H-receptors1. It 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. The drug relieves the symptoms of allergic rhinitis, including symptoms of nasal obstruction. The drug is rapidly and extensively absorbed after oral administration. The maximum plasma concentration occurs after 0.9 h after administration. The degree of absorption depends on the dose and does not depend on food intake. It is 90% bound to plasma proteins. Levocetirizine is metabolised in less than 14%. T0,5 in adults it is 7.9 ± 1.9 h. Levocetirizine and its metabolites are mainly excreted in the urine - an average of 85.4% of the administered dose. Only 12.9% of the dose is excreted in the faeces. The apparent clearance of levocetirizine depends on the creatinine clearance.
Contraindications:
Hypersensitivity to levocetirizine, other piperazine derivatives or other components of the preparation. Severe renal failure (creatinine clearance <10 ml / min).
Precautions:
The use of levocetirizine tablets is not recommended in children under the age of 6 years, as it is not possible to adjust the dose accordingly for this form of the drug. Levocetirizine is not recommended for infants and young children under the age of 2 years. Caution should be used when taking the drug together with alcohol. The drug contains lactose - do not use in patients with rare congenital disorders associated with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
Caution should be exercised during pregnancy and during breastfeeding. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development.
Side effects:
Adverse reactions observed in clinical trials - often: headache, drowsiness; dry mouth; fatigue; uncommon: abdominal pain, asthenia. Post-marketing adverse reactions - very rare: hypersensitivity, including anaphylaxis, weight gain, abnormal liver function tests, aggression, agitation, palpitations, blurred vision, shortness of breath, nausea, angioneurotic edema, persistent drug-induced eczema, pruritus , rash, urticaria, muscle pain, hepatitis.
Dosage:
Orally. Adults, adolescents and children from 6 years: 5 mg once a day (1 table). Adult patients with impaired renal function: slight renal impairment (creatinine clearance 50-79 ml / min): 5 mg once daily; moderate renal impairment (creatinine clearance 30-49 ml / min): 5 mg every 2 days; severe renal impairment (creatinine clearance <30 ml / min): 5 mg every 3 days. Use contraindicated in patients with end-stage renal disease (creatinine clearance <10 ml / min - dialysis patients). In children and adolescents with renal impairment, the dose should be adjusted individually taking into account renal clearance and body weight. Treatment of seasonal allergic rhinitis may be discontinued once the symptoms have resolved and resumed if they recur. In the case of chronic allergic rhinitis, the patient may be offered continuous treatment during the period of exposure to allergens. Table. swallow whole with liquid, regardless of the meal.
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