Name:
Loratadin syrup 5mg5ml in 100ml bottle No. 1
Description:
Transparent colorless or yellowish liquid with a slight fruity odor. The main active ingredient Loratadine Release form syrup Dosage 5 mg Pharmacological properties Pharmacodynamics Blocker of H1-histamine receptors (long-acting). Suppresses the release of histamine and leukotriene C4 from mast cells. Prevents the development and facilitates the course of allergic reactions. It has antiallergic, antipruritic, antiexudative action. Reduces capillary permeability, prevents the development of tissue edema. The antiallergic effect develops after 1-3 hours, reaches a maximum after 8-12 hours and lasts 24 hours. It does not affect the central nervous system (CNS) (because it does not penetrate the blood-brain barrier (BBB)) and is not addictive. Pharmacokinetics Rapidly and completely absorbed from the gastrointestinal tract (GIT). Cmax in the elderly increases by 50%, with alcoholic liver damage – with an increase in the severity of the disease. Loratadine and its active metabolite desloratadine reach maximum plasma concentrations (Tmax) between 1–1.5 hours and 1.5–3.7 hours after dosing, respectively. Loratadine binds to proteins by 97-99%, desloratadine to a lesser extent (73-76%). Css of loratadine and metabolite in plasma are achieved on the 5th day of administration. Does not penetrate the blood-brain barrier. It is metabolized in the liver with the formation of the main active metabolite of desloratadine with the participation of cytochrome CYP3A4 isoenzymes and, to a lesser extent, CYP2D6. Desloratadine is pharmacologically active and contributes significantly to the clinical effect. T? loratadine – 3-20 hours (average 8.4), desloratadine – 8.8-92 hours (average 28 hours); in elderly patients, respectively, 6.7–37 hours (average 18.2 hours) and 11–38 hours (17.5 hours). With alcoholic liver damage T? increases in proportion to the severity of the disease. It is excreted by the kidneys (approximately 40% of the dose taken within 10 days after administration) and with bile (approximately 42% of the dose taken as conjugated metabolites within 10 days after administration). Approximately 27% of the dose is excreted in the first 24 hours after ingestion. Less than 1% of the dose is excreted as active substances (unconjugated loratadine or desloratadine). In patients with chronic renal failure and during hemodialysis, the pharmacokinetics practically does not change. Despite the fact that the maximum concentration and AUC of the drug after administration are higher in such people, the elimination half-life and the elimination time of loratadine do not change significantly in them. In persons with liver disease with severe liver failure, the maximum concentration of the drug in the blood and its AUC increase by more than 2 times, and the half-life of loratadine and desloratadine increase to 24 and 37 hours, respectively. This should be taken into account when choosing the mode of administration of the drug. In elderly patients, the pharmacokinetics of loratadine does not change compared with patients of mature age. Indications for use Symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over 2 years of age. Dosing and Administration Inside, regardless of the meal. Adults and children over 12 years old weighing more than 30 kg – 10 mg 1 time per day (corresponding to 10 ml of syrup). Children aged 2 to 12 years weighing less than 30 kg – 5 mg 1 time per day (corresponding to 5 ml of syrup). Patients with hepatic insufficiency In patients with severe hepatic insufficiency, the initial dose should be reduced due to the risk of reduced clearance of loratadine. For adults and children weighing more than 30 kg, the recommended initial dose is 10 mg (10 ml syrup) every other day; for children weighing 30 kg or less, a dose of 5 mg (5 ml of syrup) every other day is recommended. Individuals with impaired renal function, as well as elderly patients, do not require special dose adjustments. Use during pregnancy and lactation The safety of using loratadine during pregnancy has not been established, so it is advisable to avoid its use. Loratadine is excreted in breast milk, therefore, when prescribing the drug during lactation, the issue of stopping breastfeeding should be resolved. Data on the effect of loratadine on fertility in women and men are not available. Precautions It is recommended to stop treatment at least 48 hours before skin testing for allergens. The syrup contains a small amount of sodium (less than 1 mmol per dose of syrup), so its administration does not require adjustment of dietary salt intake in individuals on a low-salt diet. The syrup contains sorbitol, so it should not be used in patients with rare congenital fructose intolerance. The syrup contains ethyl alcohol in small amounts (less than 100 mg per daily dose). Interaction with other drugs When used simultaneously with inhibitors of cytochromes CYP3A4 or CYP2D6, it is possible to increase the undesirable effects of loratadine due to an increase in its concentration in the blood. Such inhibitors of cytochrome activity as ketoconazole, erythromycin, cimetidine lead to an increase in the plasma concentration of loratadine, but without any clinical manifestations, including electrocardiographic. Loratadine does not affect the effect of ethanol and does not increase the effect of sedatives on the central nervous system. No drug interaction studies have been conducted with loratadine in children. Contraindications Hypersensitivity to the active substance or components of the drug, lactation, children under 2 years of age. Ingredients 5 ml of syrup contain the following active substance: loratadine – 5 mg; excipients: propylene glycol, sodium benzoate E 211, citric acid monohydrate food, sorbitol E 420, rectified ethyl alcohol, flavor “Duchess AN1374”, purified water. Overdose Symptoms of overdose are associated with the anticholinergic effect of loratadine. In case of overdose are possible: headache, drowsiness, tachycardia. Treatment: gastric lavage, activated charcoal, symptomatic and supportive therapy. Hemodialysis is not effective, there is no information on the effectiveness of peritoneal dialysis. Side effects During clinical studies conducted with the participation of adults and adolescents, drowsiness (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%) were most often observed. After registration of loratadine, the following side effects were observed very rarely (<1/10,000 patients): From the immune system: anaphylactic reactions. From the nervous system: dizziness. From the side of the heart: tachycardia, palpitations. From the gastrointestinal tract: nausea, dry mouth, gastritis. From the side of the liver and biliary tract: impaired liver function. From the skin and subcutaneous tissues: rash, baldness. General disorders: fatigue. Laboratory and instrumental data: the frequency is unknown - weight gain. Storage conditions In a place protected from light, at a temperature of 2 ° C to 30 ° C. Keep out of the reach of children. Buy Loratadine syrup 5mg/5ml 100ml №1
INN | LORATADIN |
---|---|
The code | 11 571 |
Barcode | 4 810 201 003 924 |
Dosage | 5mg/5ml 100ml |
Active substance | Loratadine |
Manufacturer | Borisov plant of medical preparations, Belarus |
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