Name:
Lordes syrup.
Description:
Orange orange syrup with a characteristic odor, transparent. The main active ingredient Desloratadine Release form Syrup Composition 1 ml of syrup contains: desloratadine 0.5 mg; 5 ml syrup contains: desloratadine 2.5 mg. Excipients: propylene glycol, anhydrous citric acid, sodium citrate, sodium benzoate (E211), disodium edetate, sucrose, liquid crystallizing sorbitol (E420), sunset yellow (E110), tutti-frutti flavor AG7322, purified water. Dosage 0.5 mg Pharmacological properties Pharmacodynamics Desloratadine is a non-sedating long-acting selective antagonist of peripheral histamine H1 receptors. After oral administration, it selectively blocks peripheral histamine H1 receptors and does not penetrate the blood-brain barrier. Numerous studies have shown that in addition to antihistamine activity, desloratadine has anti-allergic and anti-inflammatory effects. It has been established that desloratadine inhibits a cascade of various reactions underlying the development of allergic inflammation, namely: Release of anti-inflammatory cytokines, including IL-4, IL-6, IL-8, IL-13; Release of anti-inflammatory chemokines such as RANTES; Production of superoxide anion by activated polymorphonuclear neutrophils; Adhesion and chemotaxis of eosinophils; Expression of adhesion molecules such as P-selectin; lgE-dependent release of histamine, prostaglandin D2 and leukotriene C4; Acute allergic bronchospasm in animal studies. The safety of desloratadine in children has been demonstrated in 3 clinical studies. The drug was administered to children aged 6 months-11 years who needed antihistamine therapy, at a daily dose of 1 mg (age group 6-11 months), 1.25 mg (age group 1-5 years) or 2.5 mg (age group 6-11 years old). The treatment was well tolerated, which was confirmed by the results of clinical laboratory studies, the state of vital signs of the body and ECG data (including the length of the QT interval). In a multidose clinical study, when taking up to 20 mg of desloratadine for 14 days, there were no significant clinically significant changes in the cardiovascular system. In a clinical pharmacological study, desloratadine was used at a dose of 45 mg per day (nine times the clinical dose) for 10 days; however, no prolongation of the QT interval was noted on the ECG. There were no clinically relevant changes in plasma concentrations of desloratadine with the simultaneous use of ketoconazole and erythromycin in the interaction study. Desloratadine does not cross the blood-brain barrier. In controlled clinical trials with the recommended daily dose of 5 mg, there was no increase in the incidence of drowsiness compared with placebo. In clinical studies, when using a single daily dose of 7.5 mg, no effect on psychomotor activity was noted. The use of a daily dose of 5 mg did not cause drowsiness in adults. In patients with allergic rhinitis, desloratadine objectively relieved the symptoms of runny nose, itching and nasal congestion, as well as lacrimation, itching and redness of the eyes, itching of the palate. Desloratadine effectively controlled the symptoms for 24 hours. In addition to the existing classification of allergic rhinitis, it can be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to the duration of the symptoms. Intermittent allergic rhinitis is defined as symptoms on less than 4 days per week, or for 4 weeks. Persistent allergic rhinitis is characterized by the presence of symptoms for 4 or more days per week and for more than 4 weeks. Desloratadine was effective in alleviating complicated seasonal allergic rhinitis in a quality of life questionnaire in patients with rhinoconjunctivitis. Chronic idiopathic urticaria was investigated as a concomitant similar pathophysiology regardless of etiology, since patients with chronic disease are more easily recruited into a prospective study. Since the cause of all urticaria is histamine release, desloratadine is expected to be effective in relieving the symptoms of other urticaria conditions in addition to chronic idiopathic urticaria. In two placebo-controlled studies over 6 weeks in patients with chronic idiopathic urticaria, desloratadine produced relief of pruritic symptoms and reduced the size and number of rashes by the end of the first dosing interval. In each study, the effect lasted 24 hours after the dose. As in other studies of the use of antihistamines for the treatment of chronic idiopathic urticaria, there were patients who did not respond to treatment with antihistamines – they were excluded from the study. Reduction in pruritus symptoms was noted in more than 55% of patients treated with desloratadine and in 19% of patients treated with placebo. The effect of desloratadine on sleep and daily activity was also assessed on a 4-point scale. Pharmacokinetics Desloratadine is determined in plasma 30 minutes after taking the drug. Desloratadine is well absorbed and reaches its maximum plasma concentration after 3 hours; the half-life is 27 hours. The degree of accumulation of desloratadine corresponds to the half-life (approximately 27 hours), which makes it possible to prescribe the drug once a day. The bioavailability of desloratadine is proportional to the dose in the range of 5 mg – 20 mg. Desloratadine is moderately bound (83% – 97%) to plasma proteins. There was no clinically relevant cumulation of the drug after a single dose of a single dose (5 mg – 20 mg) of desloratadine for 14 days. When conducting cross-comparative studies with the same dose of the drug, the bioequivalence of the drug in the form of tablets and syrup was revealed. Desloratadine is efficiently converted to the active metabolite 3-hydroxy-desloratadine and then glucuronidated. Currently, the enzyme responsible for the metabolism of desloratadine has not been established, therefore, interaction with other drugs cannot be completely excluded. Desloratadine does not inhibit CYP3A4 in in vivo studies. In vitro studies have shown that the drug does not inhibit CYP2D6 and is not a substrate and inhibitor of P-glycoprotein. Studies of the effects of multiple doses of desloratadine in children have not been conducted. When conducting pharmacokinetic studies in pediatric practice, it was found that the AUC and Cmax of desloratadine (when used at recommended doses) were comparable to those in adults taking desloratadine syrup at a dose of 5 mg. In a pharmacokinetic study in patients with seasonal allergic rhinitis and similar demographics, only 4% of patients had higher concentrations of desloratadine. This percentage varies depending on the ethnic population. The maximum concentration of desloratadine is 3 times higher after 7 hours with a terminal elimination half-life of 89 hours. The safety profile of these patients did not differ from that of the general population. In a study of a single dose of desloratadine 7.5 mg, no effect of food (high in fat and high in calories) on the distribution of desloratadine was noted. In another study, grapefruit juice had no effect on the distribution of desloratadine. Desloratadine is excreted in the urine and feces as metabolic products. Patients with impaired renal function There is no experience of repeated use of desloratadine in renal insufficiency. In patients with stable renal dysfunction of varying severity, the AUC of desloratadine after administration of its single dose was increased by 1.5-2.5 times, and the concentration of 3-hydroxydesloratadine changed minimally. By hemodialysis, desloratadine is excreted only in a small amount (0.3%). In addition, plasma protein binding of desloratadine and 3-hydroxy-desloratadine was not altered in renal disease; as a result, the concentration of unbound active substance remained unchanged. Patients with hepatic impairment In patients with moderate hepatic impairment, AUC may increase 3-fold. Plasma protein binding of desloratadine and 3-hydroxy-desloratadine was not altered in patients with liver disease. The incidence of adverse effects during treatment for a maximum of 10 days and in patients with moderate liver damage did not increase. In a study with a single dose of desloratadine at a dose of 7.5 mg, it was found that food (fat high-calorie breakfast) or grapefruit juice did not affect the distribution of desloratadine. Indications for use To relieve symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, swelling and nasal congestion, as well as itchy and red eyes, watery eyes, itchy palate and cough. To relieve symptoms associated with hives such as itching and rash. Contraindications Hypersensitivity to the active ingredient, to loratadine or to excipients. Warnings The efficacy and safety of desloratadine syrup in children under 6 months of age have not been established. In clinical pharmacology studies, co-administration of alcohol did not increase alcohol-induced behavioral disturbance and did not increase drowsiness. There was no significant difference in the results of psychomotor activity between the groups treated with desloratadine and placebo, both with monotherapy and with simultaneous intake of alcohol. Desloratadine should be used with caution in patients with severe renal insufficiency. The medicinal product contains sucrose and sorbitol; therefore, it is not recommended for patients with hereditary problems of fructose intolerance, with glucose-galactose malabsorption or sucrase-isomaltase deficiency. This medicinal product contains the dye E110, which may cause an allergic reaction. Influence on the ability to drive a car and work with mechanisms In clinical studies, there was no effect of the drug on the patient’s reaction rate when driving vehicles or working with other mechanisms. However, patients should be informed that in very rare cases, drowsiness is possible, which may affect the ability of patients to drive and operate machines. Use during pregnancy and lactation The safety of using desloratadine in pregnant women has not been established, so it is not recommended to prescribe it during pregnancy. Desloratadine passes into breast milk, so women who are breastfeeding should not be given desloratadine. Dosage and administration To eliminate the symptoms associated with allergic rhinitis (including intermittent and persistent) and urticaria, Lordes is taken regardless of food intake in the following doses: Children: – aged 6 to 11 months: 2.0 ml of syrup ( 1 mg desloratadine) 1 time per day; at the age of 1 to 5 years: 2.5 ml of syrup (1.25 mg of desloratadine) 1 time per day; at the age of 6 to 11 years: 5.0 ml of syrup (2.5 mg of desloratadine) 1 time per day. Adults and adolescents (≥ 12 years of age): 10.0 ml syrup (5.0 mg desloratadine) once daily. Therapy for intermittent allergic rhinitis (symptoms less than 4 days per week or less than 4 weeks) should be based on the history, stopped after the disappearance of symptoms and resumed after the recurrence of symptoms. In persistent allergic rhinitis (symptoms more than 4 days a week or more than 4 weeks), treatment should be continued throughout the entire period of exposure to the allergen. Additional Information on Special Patient Populations Elderly Patients: The safety and efficacy of Lordes in the elderly has not been established. Patients with impaired renal function: In patients with severe renal insufficiency, Lordes should be taken with caution. Patients with hepatic impairment: There are no data from the use of Lordes in patients with hepatic impairment. Side effects In clinical studies with the use of the drug Lordes according to the indications for use, including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg / day, the frequency of adverse events was 3% higher than in the placebo group. The most common (compared with placebo) adverse events were fatigue (1.2%), dry mouth (0.8%), headache (0.6%). Overdose In case of overdose, standard measures to remove unabsorbed drug are recommended. Symptomatic and supportive treatment is recommended. In a single-dose clinical study, doses of 45 mg/day (9 times the clinical dose) were used; no clinically significant effects were observed. Desloratadine is not excreted by hemodialysis; it is not known whether the drug is excreted by peritoneal dialysis. Interactions with other drugs There were no clinically significant interactions of desloratadine tablets with erythromycin or ketoconazole in clinical studies. Desloratadine does not enhance the inhibitory effect of alcohol on psychomotor function. Storage conditionsStore at a temperature not exceeding 25°C in the original packaging, protected from light. Keep away from children. Buy Lordes syrup 2.5mg/5ml 150ml №1 Price for Lordes syrup 2.5mg/5ml 150ml №1
INN | DESLORATADINE |
---|---|
The code | 137 077 |
Barcode | 8 699 540 009 912 |
Active substance | Desloratadine |
Manufacturer | Nobel Ilach Sun. wee tick. A.S., Turkey |
Importer | IOOO "Interfarmaks", Republic of Belarus, 223028, Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Zvezdnaya, 19A-5, pom. 5-2; Komfarm LLC, Minsk, 220131 Minsk, Sosnovy Bor st., 4, room 1; SOOO "Brititrade", 223021, Minsk district, Shchomyslitsky s / s, 18; Foreign unitary trade and manufacturing enterprise "Belinvestfarma", Minsk, Leshchinskogo st., 8/4-2; "VitPharmMarket" LLC Vitebsk, Republic of Belarus, 210004 Vitebsk, 5th Kooperativnaya st., 8; Limited Liability Company "Farmiko", Minsk district, Senitsky s / s, Kolyadichi village, Lazurnaya st., 9; Additional Liability Company "Farmin", 220125 Minsk, Independence Avenue, 177, room 62; Closed joint-stock company "Unipharm", 223060, Minsk region, Novodvorsky s / council, 40-1, room. 36, district of the village of Bolshoye Stiklevo |
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