Expiration date: 05/2025

The composition and form of issue:

Tablets, film-coated. 1 tablet contains:

desloratadine 5 mg

excipients: calcium hydrogen phosphate dihydrate microcrystalline cellulose corn starch talc 

shell: lactose monohydrate hydroxypropylmethylcellulose titanium dioxide macrogol 400 (polyethylene glycol) lacquer aluminum blue (indigotine, FD&C No. 2, E132) wax Carnauba wax white 

blistere in 7 or 10 PCs in a carton box 1, 2, 3 blisters.

Syrup. 1 ml contains:

desloratadine 0.5 mg

excipients: propylene glycol sorbitol citric acid anhydrous sodium citrate dihydrate sodium benzoate disodium edetate purified water sucrose flavoring No. 15864 dye yellow No. 6 E110 

in dark glass bottles at 60 and 120 ml complete with measuring spoon in carton of 1 vial.

Description pharmaceutical form:

Tablets: round, biconvex tablets, film-coated light blue color. On one side of the tablet caused the trademark of the company Schering-plough (SP).

Syrup: clear orange colored liquid.

Pharmacokinetics:

Desloratadine begins to be determined in blood plasma of adults and adolescents for 30 minutes after taking the drug inside. Desloratadine is well absorbed from the gastrointestinal tract, Cmax in plasma is reached after approximately 3 h. T1/2 is an average of 27 h (20-30 mph). Associated with the plasma protein to 83-87%. Not observed clinically relevant accumulation of the drug when administered to adults and adolescents at a dose of 5 to 20 mg 1 time per day for 14 days. Simultaneous ingestion of food or grapefruit juice does not affect the distribution of desloratadine used in the dose of 7.5 mg 1 time a day. Desloratadine is not an inhibitor of CYP3A4 and ?YP2D6 and is not a substrate or inhibitor of P-glycoprotein. Desloratadine biotransformiroetsa in the body by hydroxylation with the formation of 3 Oh-desloratadine connected to the glucuronide. A small portion of unchanged drug excreted by the kidneys and intestines.

Description pharmacological action:

Selective blocker of peripheral histamine H1-receptors with a long duration of action, does not cause sedation. Desloratadine is the primary active metabolite of loratadine. Warn development and facilitates the allergic reactions, has antipruritic and protivoekssoudative effect, reduces capillary permeability, prevents the development of tissue edema, spasm of smooth muscles. Does not affect CNS, do not have a sedative effect (no drowsiness) and does not affect the speed of psychomotor reactions. Does not cause lengthening of the QT interval on the ECG.

Ingestion Aerius selectively blocks peripheral histamine H1-receptors, do not penetrate through the GEB. Aerius provides long-lasting (?24 h) anti-allergic and anti-inflammatory effect by suppressing various reactions that underlie the development of allergic inflammation, including the following: allocation of Pro-inflammatory cytokines (including IL-4, IL-6, IL-8, IL-13), proinflammatory chemokines selection, production of superoxide anion activated polymorphonuclear neutrophils adhesion and chemotaxis of eosinophils, expression of adhesion molecules (including P-selectin, etc.) lgE-dependent release of histamine, PG D2 and of leukotriene C4.

The action of Erius begins within 30 minutes after ingestion and lasts for 24 hours

Indications:

• seasonal (pollinosis) and perennial allergic rhinitis (elimination or relief of sneezing, discharge of mucus from the nose, itching and nasal congestion, itching, and redness of eyes, watery eyes, itching of the sky)
  
• chronic idiopathic urticaria (reduction and elimination of pruritus and rash).
  

Contraindications:

• hypersensitivity to the drug or the loratadine
  
• pregnancy
  
• lactation
  
• children up to age 1 year — for syrup
  
• children's age (till 12 years) — for tablets
  
• transmitted hereditary fructose intolerance, malabsorption of glucose-galactose or deficiency of sucrose-isomaltose — for the syrup (due to the presence of sucrose and sorbitol in the composition).
  

With caution: severe renal insufficiency (tablets).

Application of pregnancy and breast-feeding:

The use of the drug in pregnant women is not recommended due to the lack of clinical data on the safe use of Aerius during pregnancy.

Desloratadine is excreted in breast milk, so you should use Aerius during breast feeding is not recommended.

Side effects:

Pills. Fatigue (1.2%), dry mouth (0.8 percent), headache (0.6 percent). Very rarely — tachycardia, palpitations, increased activity of liver enzymes, increased concentration of bilirubin, allergic reactions including anaphylaxis and rash.

Syrup. In children under 2 years if used Aerius syrup were observed the following adverse events whose frequency was slightly higher than with the use of placebo: diarrhea, fever, insomnia.

In children 2-11 years when used Aerius syrup incidence of side effects was the same as when using a placebo.

In adults and adolescents (12 years and older) with the use of Aerius syrup was observed following adverse events whose frequency was slightly higher than with the use of placebo: fatigue, dry mouth, headache.

The application of Aerius syrup in adults and adolescents the recommended dose of 5mg/day, the incidence of drowsiness was not higher than when using a placebo.

Among the very rare side effects observed dizziness, drowsiness, tachycardia, palpitation, abdominal pain, nausea, vomiting, dyspepsia, diarrhea, increased bilirubin, liver enzymes in the serum, allergic reactions (anaphylaxis, angioedema, pruritus, rash, urticaria).

Drug interactions:

Interaction with other medicinal products have not been identified. Aerius does not increase the effects of alcohol on the Central nervous system.

Method of application and dose:

Inside, at the same time of day regardless of meals.

Pills, not liquid, squeezed water, adults and children over 12 years — on 5 mg/day.

Syrup, squeezed small amounts of water, children 1 to 5 years — 1.25 mg/day (2.5 ml) 6 to 11 years — 2.5 mg/day (5 ml) adults and children over 12 years — on 5 mg/day (10 ml).

Overdose:

In clinical trials daily use in adults and adolescents of desloratadine in the dose of 20 mg for 14 days was not accompanied by a statistically or clinically significant changes in the cardiovascular system. In the clinical pharmacological study, the use of desloratadine in the dose of 45 mg/day (9 times higher than recommended) for 10 days did not cause lengthening of the QTc interval and was not accompanied by the appearance of serious side effects.

Treatment: in case of accidental ingestion of a large amount of the drug should immediately consult a doctor. It is recommended gastric lavage, administration of activated charcoal, if necessary — symptomatic therapy. Efficacy of peritoneal dialysis is not installed. Not removed by hemodialysis.

Precautions:

Not the effect of desloratadine in recommended doses on ability to drive vehicles and management mechanisms. In clinical studies, Aerius when taken in the dose of 7.5 mg/day did not affect psychomotor reactions in adults and adolescents.

Use in Pediatrics: safety and efficacy of Aerius syrup in children under 1 year of Aerius tablets in children under 12 years is not established.

Special instructions:

For children 1-11 years of age can apply Aerius syrup.