Dezlorem Neo – film-coated tablets

INSTRUCTIONS FOR MEDICAL USE

DEZLOREM NEO

Trade name of the drug: Dezlorem Neo

Active substance (INN): Desloratadine

Dosage form: film-coated tablets

Composition:

1 tablet contains:

Active ingredient: desloratadine 5 mg

Excipients: microcrystalline cellulose, corn starch, povidone, crosspovidone, colloidal silica, magnesium stearate

Excipients of the shell: hydroxypropylmethylcellulose, polyethylene glycol 4000, titanium dioxide, iron oxide red

Description: Round, biconvex pink film-coated tablets.

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

The drug is taken orally, with a small amount of water, regardless of meals. Children 6 to 11 years of age: 1/2 tablet (2.5 mg) once a day.

Adults: 1 tablet (5 mg) 1 time per day.

The course of treatment and duration of administration are determined by the nature of the disease. In the treatment of seasonal pollinosis the drug is discontinued after the disappearance of symptoms. When treating year-round allergic rhinitis, the drug is used continuously, for the entire period of patient’s contact with the allergen.

Side effect

Increased fatigue, dry mouth, headache. The following side effects have been reported 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.

Contraindications

Hypersensitivity to the drug components, children under 6 years of age.

Drug interactions

In the study of drug interactions during multiple co-administration of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine, cimetidine no clinically significant changes in the 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 insufficiency. Efficacy and safety of using the drug in children under 6 months has not been proved.

There are no clinical data about safety of this medicine use during pregnancy, therefore during pregnancy the medicine can be used only in case when the expected benefits for a mother exceed the potential risk for a 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

film-coated tablets, 5 mg in carton packs.

Storage conditions

Store in a dry, dark place at temperatures 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.

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