Treatment of allergic symptoms (seasonal and perennial) of rhinitis and chronic idiopathic urticaria.
Composition:
1 tabl contains 10 mg of loratadine; tablets contain lactose. 5 ml of the suspension contains 5 mg of loratadine; the suspension contains sucrose and glycerol.
Action:
A tricyclic second generation antihistamines blocking peripheral H-receptors1. Poorly penetrates to o.u.n, it has no clinically significant sedative and anticholinergic effects. After oral administration, they are quickly 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 (DCL) - is pharmacologically active. Maximum concentration of loratadine in the serum occurs after 1-1.5 h and DCL after 1.5-3.7 h. Loratadine is associated with plasma proteins in 97-99% and DCL in 73-76%. Medium T0,5 drug is 8.4 h (3-20 h), the main metabolite - 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. Pregnancy.
Precautions:
Caution should be exercised in patients with impaired hepatic or renal function and during long-term use. The efficacy and safety of use in children under 2 years has not been established. The tablet formulation contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose. The suspension preparation contains sucrose and glycerol - should not be used in patients with rare inherited disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. Large amounts of glycerol can cause headaches and stomach problems.
Pregnancy and lactation:
The use of the drug during pregnancy is contraindicated. Use during breastfeeding is not recommended.
Side effects:
Common: headache, nervousness, drowsiness, tiredness. Uncommon: insomnia, increased appetite. Very rare: anaphylaxis, dizziness, tachycardia, palpitations, syncope, arrhythmia, nausea, dry mouth, gastritis, abnormal liver function, rash, alopecia. In adults and adolescents the most common were: drowsiness, headache, increased appetite and insomnia, and in children aged 2-12, headache, nervousness, and tiredness.
Dosage:
Orally. Adults and children over 12 years of age and children between 2 and 12 years of age. above 30 kg: 10 mg once a day. Children from 2 to 12 years old. less than 30 kg: 5 mg once a day as a suspension (the use of tablets is not indicated). In adults and children about the month of above 30 kg with hepatic impairment, a lower starting dose should be used, followed by a 10 mg dose every other day. Children with impaired liver function, o. less than 30 kg should be given 5 mg loratadine every other day. No dosage adjustment is necessary in the elderly and in patients with impaired renal function. The preparation should be used regardless of meals. Swallow the tablets without chewing, with liquid.
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