Name Lordes tabl. p / captive ob. 5mg in bl. in pack. No. 10×1 Main active ingredient Desloratadine Release form tablets Composition The tablet contains: desloratadine 5 mg; excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose PH 102, corn starch, talc, Opadry blue 85F20578 (polyvinyl alcohol, polyethylene glycol (E 1451), titanium dioxide (E 171), talc (E 553 b), FD & C blue # aluminum lacquer (E 132 ), iron oxide yellow (E 172). : – allergic rhinitis – urticaria Contraindications – hypersensitivity to loratadine and other ingredients of the drug – pregnancy and lactation – children under 12 years of age Use during pregnancy and lactation The safety of the drug during pregnancy has not been established. Desloratadine is not recommended during pregnancy.Desloratadine is excreted in breast milk. Therefore, the use of the drug by lactating women is not recommended. Dosage and Administration Adults and adolescents (12 years of age and older): 1 5 mg tablet once daily, with or without food. Therapy for intermittent allergic rhinitis (symptoms less than 4 days per week or less than 4 weeks) should be carried out taking into account the data of the anamnesis, stopped after the disappearance of symptoms and resumed after their reappearance. 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. In patients with renal and hepatic insufficiency, dose adjustment is not required. Clinical studies of desloratadine did not include sufficient numbers of patients aged 65 years and older to determine their dosing patterns compared to younger patients. Clinical experience has not revealed differences between older and younger patients. In general, dosage titration for the elderly patient should be done with caution, given the greater frequency of decreased hepatic, renal, or cardiac function and the presence of concomitant diseases or other drug therapy. There is limited information on the clinical efficacy of desloratadine in adolescents 12 to 17 years of age. If you forget to take your next dose on time, take it as soon as possible and then return to your regular dosing schedule. Do not take a double dose to make up for a missed dose. Side effects In clinical trials for indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended daily dose of 5 mg, adverse effects were reported in the desloratadine group in 3% of patients, which was more than the number of patients with adverse effects in the placebo group. The most common adverse events were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%). Use in children In a clinical study with 578 underage patients aged 12 to 17 years, the most commonly reported adverse effect was headache; this was observed in 5.9% of patients receiving desloratadine and 6.9% of patients receiving placebo. The frequency of adverse effects reported from clinical studies compared with placebo, as well as from the post-marketing period, is shown in the table. Frequency assessment: very often (? 1/10), often (? 1/100, < 1/10); infrequently (? 1/1000, < 1/100); rarely (? 1/10,000, < 1/1000); very rare (<1/10,000). Organ system Frequency Adverse effects observed Psychiatric disorders Very rare Hallucinations Nervous system disorders CommonVery rare Headache Dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions Cardiac disorders Very rare Not known tachycardia, palpitations QT prolongation Gastrointestinal tract disorders CommonVery rare Dry mouth Abdominal pain, nausea, vomiting, dyspepsia, diarrhea Liver disorders Very rareNot known Elevated liver enzymes, elevated bilirubin, hepatitis Jaundice Skin and subcutaneous tissue disorders Not known Photosensitivity Musculoskeletal and musculoskeletal disorders connective tissue disorders Very rare Myalgia General disorders Common Very rare Not known Fatigue Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnea, pruritus, rash, urticaria) it has been found that adverse reactions associated with overdose are similar to those observed against the background of therapeutic doses, but the magnitude of the effects may be greater. Symptoms During multiple dose clinical trials with up to 45 mg of desloratadine (nine clinical doses), no clinically significant effects were observed. Treatment In case of overdose, standard measures are recommended to remove the unabsorbed active substance, symptomatic and supportive therapy. Desloratadine is not removed by hemodialysis; it is also not known whether it is removed by peritoneal dialysis. Pediatric population During post-marketing surveillance, adverse effects associated with overdose have been found to be similar to those seen with therapeutic doses, but the magnitude of the effects may be greater. Interaction with other drugs In clinical studies of desloratadine, clinically significant signs of interaction with erythromycin and ketoconazole have not been established. Desloratadine does not enhance the negative effect of alcohol on psychomotor function. However, cases of alcohol intolerance and intoxication have been reported during the use of the drug. Therefore, it is recommended to be careful when taking alcohol at the same time. Precautions Caution is required when using the drug in patients with severe renal insufficiency. In clinical studies, when prescribing desloratadine at a dose of 20 mg for 14 days, there were no statistically or clinically significant changes in the cardiovascular system. In a clinical pharmacological study, the use of desloratadine at a dose of 45 mg / day (9 times higher than therapeutic) for 10 days did not cause a prolongation of the QT interval on the ECG. When using the drug at the recommended dose of 5 mg, the frequency of drowsiness did not exceed that in the placebo group. In clinical studies, desloratadine did not affect psychomotor function at a dose of 7.5 mg. The efficacy and safety of desloratadine tablets in children under 12 years of age have not been fully established. The composition of the medicinal product includes the dye E 132, which can cause allergic reactions. Storage conditions Store at a temperature not exceeding 25°C in the original packaging to protect from light. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiration date. Buy Lordes tablets p/o 5mg №10x1 Price for Lordes tablets p/o 5mg №10x1
INN | DESLORATADINE |
---|---|
The code | 60 532 |
Barcode | 8 699 540 090 095 |
Dosage | 5mg |
Active substance | Desloratadine |
Manufacturer | Nobel Ilach Sun. wee tick. A.S., Turkey |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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