Symptoms of allergic (seasonal and perennial) rhinitis. Symptoms of chronic idiopathic urticaria.
Composition:
1 tabl contains 10 mg of loratadine. The preparation contains lactose.
Action:
Antihistamine. It acts partially selectively on peripheral histamine H-receptors1 and poorly penetrates the CNS. In the majority of people, loratadine used at the recommended doses has no clinically significant central sedative or anticholinergic activity. Loratadine has no significant effect on H-receptors2, does not inhibit noradrenaline reuptake and has virtually no effect on cardiovascular function and cardiac conduction activity. After oral administration, loratadine is rapidly and well absorbed from the gastrointestinal tract. The drug is extensively metabolised in the first-pass process of the liver, mainly involving CYP3A4 and CYP2D6. The main metabolite, desloratadine (DCL), is pharmacologically active and largely responsible for clinical action. Cmax Serum loratadine and DCL occur after: 1-1.5 h and 1.5-3.7 h after treatment. Loratadine largely (97-99%) binds to plasma proteins. Its active metabolite is moderately bound to plasma proteins (73-76%). Medium T0,5 is for loratadine 8.4 h (range 3-20 h), and for the main metabolite 28 h (range 8.8-92 h). Within 10 days, about 40% of the dose is excreted in the urine and 42% in the faeces, mainly in the form of conjugated metabolites. Less than 1% of the active substance is excreted as unchanged loratadine and its active metabolite.
Contraindications:
Hypersensitivity to loratadine or to any of the excipients.
Precautions:
Caution should be exercised during long-term treatment. The drug should be used with caution in patients with severe hepatic impairment. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
Data obtained from a large number of applications during pregnancy (over 1,000 pregnant women) do not indicate that loratadine induces congenital malformations or exerts toxic effects on the fetus and / or newborn child. 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:
Adults and adolescents: drowsiness (1.2%), headache (0.6%), increased appetite (0.5%), insomnia (0.1%); very rare (post-marketing): hypersensitivity reactions (including angioneurotic edema and anaphylaxis), dizziness, seizures, tachycardia, palpitations, nausea, dry mouth, gastritis, abnormal liver function, Rash, baldness, tiredness. Children from 2 to 12 years old: headache (2.7%), nervousness (2.3%) and fatigue (1%).
Dosage:
Orally. Adults and children over 12 years: 10 mg (1 tablet) once a day. Children from 2 to 12 years old and from greater than 30 kg: 10 mg once a day. It is not advisable to use 10 mg tablets in children at birth. less than 30 kg. The efficacy and safety of use in children under the age of 2 years has not been established.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 more than 30 kg, it is recommended to administer 10 mg (1 tablet) every other day. In elderly patients and in patients with impaired renal function, no dose adjustment is necessary.Method of administration. The tablets should be swallowed without chewing, with liquid; take regardless of meals.
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