Symptomatic treatment of allergic rhinitis (including chronic allergic rhinitis) and urticaria.
Composition:
1 tabl powl. contains 5 mg of levocetirizine in the form of 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 the feeling of nasal congestion. 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 to any of the excipients. Severe renal dysfunction with creatinine clearance less than 10 ml / min. The drug should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
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 due to lack of data on this population. Caution should be used when taking the drug together with alcohol. Caution should be exercised when levocetirizine is used in patients with predisposing factors to retain urine (eg spinal cord injury, prostatic hyperplasia), because levocetirizine increases the risk of urinary retention.
Pregnancy and lactation:
For the sake of caution, it is recommended to avoid the use of the drug during pregnancy. There are no clinical data on the use of levocetirizine during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. It is not known whether levocetirizine is excreted in human milk. The risk 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:
Adverse reactions observed in clinical trials - often: headache, drowsiness; dry mouth; fatigue; uncommon: abdominal pain, weakness. Adverse reactions observed in clinical studies in children and adolescents (6-12 years) - often: headache, drowsiness. Side effects seen after the medicine has been placed on the market - frequency not known: hypersensitivity, including anaphylaxis, increased appetite, aggression, agitation, insomnia, suicidal thoughts, convulsions, paresthesia, dizziness, syncope, tremor, disturbed taste, vertigo, dizziness vision, blurred vision, palpitations, shortness of breath, nausea, hepatitis, painful or difficult urination, urinary retention, angioneurotic edema, persistent drug-induced eczema, pruritus, rash, urticaria, muscle pain, edema, weight gain, abnormal test results liver.
Dosage:
Orally. Adults, adolescents and children> 6 years: 5 mg once a day (1 tablet).Adult patients with impaired renal function: mild 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 allergic rhinitis may be discontinued after symptoms have resolved and resumed if they recur. Table. swallow whole with liquid, regardless of the meal.
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