INSTRUCTIONS FOR MEDICAL USE
DEZLOREM NEO
Trade name of the drug: Dezlorem Neo
Active substance (INN): Desloratadine
Dosage form: Syrup
Contents:
5 ml of syrup contains:
Active substance: Desloratadine-2.5 mg;
Excipients: sodium benzoate, glycerin, sorbitol 70% solution, citric acid (anhydrous), sodium citrate dihydrate, mannitol, propylene glycol, aspartame, potassium acesulfame, essence of mint, FDC red dye 40, purified water.
Description: clear liquid, pink in color, with a minty odor and sweet taste.
Pharmacotherapeutic group: Anti-allergic agent.
ATX code: R06AX27
Pharmacological properties
Pharmacodynamics
The drug has antihistamine, antiallergic and anti-inflammatory action, does not cause drowsiness. When administered orally desloratadine (the primary active metabolite of loratadine) selectively blocks peripheral histamine H1-receptors. It suppresses the cascade of cytostatic reactions: release of proinflammatory cytokines, including interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-13 (IL-13), pro-inflammatory chemokines of RANTES type, production of superoxide anions by activated polymorphonuclear neutrophils, adhesion and chemotaxis of eosinophils, expression of adhesion molecules, including P-selectin. including P-selectin, IgE-mediated release of histamine, prostaglandin D2 and leukotriene C4.
Pharmacokinetics
Desloratadine begins to be determined in blood plasma of adults and adolescents within 30 min after oral administration. Desloratadine is well absorbed from the gastrointestinal tract, Cmax in plasma is reached after approximately 3 hours. T1/2 averages 27 h (20-30 h). It is 83-87% bound to plasma proteins. There is no clinically significant cumulation when administered in adults and adolescents in doses from 5 to 20 mg once daily for 14 days. Simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine administered at a dose of 7.5 mg once daily. Desloratadine is not a CYP3A4 or CYP2D6 inhibitor and is not a P-glycoprotein substrate or inhibitor. Desloratadine is biotransformed in the body by hydroxylation to form 3- OH-desloratadine coupled to glucuronide. A small portion of the unchanged drug is excreted by the kidneys and intestines.
Indications for use
- Seasonal pollen allergy and year-round allergic rhinitis (elimination or relief of sneezing, nasal mucus secretion, itching and stuffy nose, itching and red eyes, lacrimation, itching palate)
- chronic idiopathic urticaria (reduction or elimination of skin itching and rash).
Dosage and administration
Children from 6 to 11 months: 2 ml syrup (1.0 mg) once a day.
Children 1 to 5 years of age are prescribed 2.5 ml (1.25 mg) syrup 1 time per day. Children 6 to 11 years of age are prescribed 5 ml of syrup (2.5 mg) once a day.
Adults and adolescents over 12 years of age take 10 ml of syrup (5 mg) once a day.
The course of treatment and duration of administration is determined by the nature of the disease. In the treatment of seasonal pollen allergy the drug is discontinued after the disappearance of symptoms. In the treatment of allergic rhinitis year-round the drug is used continuously, during the entire period of patient’s contact with the allergen.
Side effects
Increased fatigue, dry mouth, headache. The following side effects have been noted very rarely:
CNS disorders: dizziness, somnolence;
Cardiovascular system: tachycardia, palpitations;
Digestive system: abdominal pain, nausea, vomiting, dyspepsia, diarrhea, increased bilirubin, liver enzymes in blood serum;
Allergic reactions: anaphylaxis, angioneurotic edema, itching, rash, urticaria. In children under 2 years of age: diarrhea, fever, insomnia.
Contraindications
- Hypersensitivity to any of the components that are part of the drug.
Drug interactions
In studies of drug interactions during multiple co-administration of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine, cimetidine no clinically significant changes in plasma concentration of desloratadine were found.
Desloratadine does not increase the effect of alcohol on the central nervous system.
Special indications
Use with caution in patients with severe renal failure. The drug in syrup form is used with caution in patients with diabetes mellitus, because correction of the dose of hypoglycemic agents may be required. Efficacy and safety of using the drug in children under 6 months is not proved.
There are no clinical data on safety of the drug administration during pregnancy; therefore, the drug administration during pregnancy is possible only when the expected benefits to the mother exceed the potential risk to the fetus. Desloratadine penetrates into breast milk, therefore breast-feeding should be discontinued while using the drug. The drug does not affect the ability to drive a vehicle and perform work requiring high speed psychomotor reactions.
Overdose
Symptoms: increased severity of adverse reactions.
Treatment: gastric lavage followed by activated charcoal, symptomatic therapy if necessary. Hemodialysis is ineffective. The effectiveness of peritoneal dialysis is not established.
Form of production
Syrup, 2.5 mg/5 ml – 50 ml or 60 ml in vials, complete with measuring spoon or cup.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25ºC. Keep out of the reach of children!
Shelf life
2 years. Do not use after the expiration date.
Conditions of dispensing from pharmacies.
Released without a prescription.