Treatment of symptoms: seasonal and perennial allergic rhinitis, chronic idiopathic urticaria.
Composition:
1 tabl contains 10 mg of loratadine.
Action:
Antihistamine with selective antagonistic effect on peripheral H-receptors1. It does not show any clinically relevant sedative or anticholinergic effects in most people. After oral administration, loratadine is rapidly and well absorbed from the gastrointestinal tract. It is extensively metabolised in the first-pass process of the liver, mainly mediated by CYP3A4 and CYP2D6. The main metabolite - desloratadine is pharmacologically active and largely responsible for the clinical effect. The maximum concentration of loratadine in the blood occurs after 1-1.5 h, and desloratadine after 1.5-3.7 h after administration. Loratadine is 97-99% bound to plasma proteins, and desloratadine is 73-76%. Medium T0,5 loratadine is 8.4 h (3-20 h), desloratadine - 28 h (8.8-92 h). Loratadine and its metabolites are excreted in urine (approximately 40%) and faeces (approximately 42%).
Contraindications:
Hypersensitivity to loratadine or to any of the excipients.
Precautions:
Caution should be exercised in patients with severe hepatic impairment. The efficacy and safety of the medicine in children <2 years has not been established.
Pregnancy and lactation:
Data obtained from a large number of applications during pregnancy (over 1000 pregnant women) indicate that loratadine does not cause malformations and does not harm the fetus / newborn. As a precautionary measure, avoid using it during pregnancy. Loratadine is excreted in breast milk, therefore it is not recommended for breast-feeding women.
Side effects:
In adults and adolescents, drowsiness was often observed; uncommon: headache, increased appetite, insomnia. In children between 2 and 12 years of age, headache, nervousness and fatigue were frequently observed. Other side effects observed very rarely after marketing: hypersensitivity reactions (including vasomotor and anaphylaxis), dizziness, seizures, tachycardia, palpitations, nausea, dry mouth, gastritis, abnormal liver function, rash, alopecia, fatigue.
Dosage:
Orally. Adults and children> 12 years: 10 mg once a day. Children 2-12 years old: mc. > 30 kg - 10 mg once a day, bw <30 kg - 5 mg once a day. In children aged 2-6 years, the use of tablets is not recommended - loratadine in the form of a syrup is recommended in these patients (5 mg).Special groups of patients. In patients with severe hepatic impairment a lower starting dose should be used as the clearance of loratidine may be reduced. In adults and children about the month of > 30 kg with severe hepatic impairment, it is recommended to start treatment with a dose of 10 mg every other day, and in children with ≤30 kg from a dose of 5 mg (> 6 years - half a tablet, 2-6 years - in the form of a syrup) every other day. There is no need to change the dose in elderly patients or in patients with renal insufficiency.Way of giving. The preparation can be used independently of meals. The tablet can be divided into halves.
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