Desal solution for oral administration 100ml
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Active ingredients
Desloratadine
Release form
Solution
Composition
Desloratadine 0.5 mg. Adjuvants: sorbitol - 147.15 mg, propylene glycol - 102.3 mg, citric acid monohydrate - 21.06 mg, sodium citrate dihydrate - 16.38 mg, hypromellose 2910 - 2 mg, sucralose - 1 mg, disodium edetate - 0.04 mg, flavor - Frutti - 0.03 mg.
Pharmacological effect
The intake of desloratadine in the form of an oral solution is equivalent to its use in the form of pills containing the same amount of the active substance. Absorption After taking the drug inside, desloratadine is well absorbed from the gastrointestinal tract. Determined in blood plasma after 30 min, and Cmax is reached in approximately 3 hours. No clinically significant changes in plasma concentration of desloratadine were observed upon repeated administration of ketoconazole and erythromycin. The bioavailability of desloratadine is proportional to the dose when taking a dose in the range from 5 mg to 20 mg. Distribution Binding to plasma proteins is 83-87%. When used in adults and adolescents for 14 days at a dose of 5 mg to 20 mg 1 time / day, there is no evidence of clinically significant cumulation of desloratadine. The degree of cumulation of desloratadine is consistent with the value of T1 / 2 and the frequency of its use 1 time / day. The AUC and Cmax values in children were similar to those in adults who received 5 mg of desloratadine. Simultaneous ingestion of food or grapefruit juice does not affect the distribution of desloratadine (when taken in a dose of 7.5 mg 1 time / day). Does not penetrate through the BBB. Metabolism The enzymes responsible for the metabolism of desloratadine are not yet known; therefore, interactions with certain drugs cannot be completely ruled out. It is not an inhibitor of CYP3A4 and CYP2D6 and is not a substrate or inhibitor of P-glycoprotein. It is extensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, which then glucuronizes. Excretion of T1 / 2 is about 27 hours. Desloratadine is eliminated from the body as a glucuronide compound and in a small amount in an unchanged form (with urine less than 2% and through intestine - less than 7%).
Pharmacokinetics
Long-acting antihistamine, peripheral histamine H1 receptor blocker. Desloratadine is the primary active metabolite of loratadine.Inhibits a cascade of reactions of allergic inflammation, incl. release of pro-inflammatory cytokines including the interleukins IL-4, IL-6, IL-8, IL-13, the release of proinflammatory chemokines superoxide anion production by activated polymorphonuclear neutrophils adhesion and chemotaxis eosinophils selection adhesion molecules such as P-selectin, IgE- mediated release of histamine, prostaglandin D2 and leukotriene C4. Thus, the drug prevents the development and facilitates the course of allergic reactions, has antipruritic and anti-exudative action, reduces capillary permeability, prevents the development of tissue edema, smooth muscle spasm. affects the speed of psychomotor reactions when taken in recommended doses. Does not cause lengthening of the QT interval on the ECG. The action of desloratadine begins within 30 minutes after ingestion and lasts for 24 hours.
Indications
To alleviate or eliminate the symptoms: - allergic rhinitis (sneezing, nasal congestion, rhinorrhea, itching of the nose, itching of the palate, itching and redness of the eyes, watering eyes);
Contraindications
- hypersensitivity to the active or any auxiliary substance of the drug; - pregnancy; - lactation period (breastfeeding); - children under 1 year old (efficacy and safety not established); hereditary diseases - fructose intolerance, impaired glucose / galactose absorption or insufficiency of sucrase / isomaltase in the body (due to the presence of sorbitol in the composition of the drug). With caution, you should use the drug in case of severe renal failure.
Precautionary measures
Use for violations of renal functionWith caution, you should use the drug for severe renal failure.Application in childrenIt is contraindicated for children under the age of 12 years, because efficacy and safety not established.
Use during pregnancy and lactation
The purpose of the drug during pregnancy is contraindicated due to the lack of clinical data on the safety of its use in this period. Desloratadine is excreted in breast milk, so its use during breastfeeding is contraindicated.
Dosage and administration
Accept inside, irrespective of meal. To children aged from 1 year to 5 years - on 2.5 ml of solution (1.25 mg) 1 time / day. To children aged from 6 to 11 years - on 5 ml of solution (2.5 mg) 1 time / day. Adults and adolescents (12 years and older) - 10 ml of solution (5 mg) 1 time / day.
Side effects
In children aged 2 to 11 years with the use of desloratadine, the frequency of side effects was the same as with placebo. In children under 2 years of age with the use of desloratadine, the following side effects were noted, the frequency of which was slightly higher than with placebo: diarrhea (3.7%), fever (2.3%), insomnia (2.3%). In adults and adolescents aged 12 years and older, the following side effects were observed with the use of desloratadine, the frequency of which was slightly higher than with placebo: increased at swabbiness (1.2%), dry mouth (0.8%), headache (0.6%). When using the drug in adults and adolescents at the recommended dose of 5 mg / day, the frequency of drowsiness is no higher than with placebo. During post-marketing follow-up The following adverse reactions were very rarely observed. Mental disorders: hallucinations. For the central nervous system: dizziness, drowsiness, insomnia, psychomotor hyperactivity. For the cardiovascular system: tachycardia, heartbeat. For the digestive system: pain in the abdomen, tosch Ota, vomiting, dyspepsia, Diarea.so the liver and biliary tract: increased activity of the liver enzyme, increasing the concentration of bilirubin, Gepatit.so the musculoskeletal system: mialgiya.Allergicheskie reactions: anaphylaxis, angioedema, pruritus, rash, urticaria.
Overdose
Symptoms: Reception at a dose in excess of the recommended 9 times (45 mg) did not lead to the appearance of any clinically significant symptoms. Drowsiness may develop. Treatment: gastric lavage, taking activated carbon; if necessary, symptomatic therapy. Desloratadine is not excreted by hemodialysis, the effectiveness of peritoneal dialysis has not been established. If a large amount of the drug is accidentally ingested, the patient should immediately see a doctor.
Interaction with other drugs
No clinically significant interaction with other drugs was revealed (incl.with ketoconazole and erythromycin). Desloratadine does not enhance the effect of ethanol on the central nervous system.