Expiration date: 02/2025

Release form, composition and packaging

Syrup transparent, colorless, with a smell of almonds.

1 ml contains:

the desloratadine hemisulfate 0.578 mg

that corresponds to the content of desloratadine 0.5 mg

Excipients: propylene glycol 150 mg, sorbitol (liquid rekristallizatsiya) 70% - 150 mg, citric acid 4.6 mg sodium citrate dihydrate - 1.26 mg, sodium cyclamate, 5 mg, hypromellose -2910 - 3.5 mg of disodium edetate dihydrate - 0.25 mg, flavor almond - 0.75 mg water to 1 ml.

60 ml - vials dark glass (1) complete with dosing cups - packs of cardboard.

120 ml - vials dark glass (1) complete with dosing cups - packs of cardboard.

150 ml - vials dark glass (1) complete with dosing cups - packs of cardboard.

Clinico-pharmacological group: Blocker of histamine H1-receptors. Antiallergic medication

Pharmaco-therapeutic group: H1-histamine receptor blocker

Testimony

— allergic rhinitis (relief or elimination of sneezing, nasal congestion, excretion of mucus from the nose, itching nose, itching of the palate, redness and itching of eyes, watery eyes);

— urticaria (reduction or elimination of skin itching, rash).

The dosage regimen

Inside. The syrup should be taken regardless of meals, squeezed small amounts of water.

Children at the age from 1 year to 5 years: 1.25 mg (2.5 ml syrup) 1 times/day.

Children aged 6 to 11 years: 2.5 mg (5 ml syrup) 1 times/day.

Adults and adolescents 12 years of age: 5 mg (10 ml syrup) 1 times/day.

For proper dosing you should use the supplied plastic dosing Cup graduated from 2.5 ml to 20 ml.

Side effects

In children under 2 years of age when applying Largestin syrup 0.5 mg/ml, were observed the following adverse reactions, frequency of which was higher than when using a placebo: diarrhea, fever, insomnia.

In children aged 2 to 11 years when using Largestin syrup 0.5 mg/ml the frequency of side effects was the same as when using a placebo.

In adults and adolescents (12 years and older) when using Largestin syrup 0.5 mg/ml was observed following adverse events whose frequency was higher than with the use of placebo: fatigue (1.2%), dry mouth (0.8%), headache (0.6%).

When using Largestin syrup 0.5 mg/ml in adults and adolescents the recommended dose of 5 mg per day the incidence of drowsiness was not higher than when using a placebo.

During post-marketing use other side effects occurred very rarely (1/10 000 appointments (less than 0.01%)):

The immune system: allergic reactions (anaphylaxis, angioedema, itching, rash, hives, shortness of breath).

From the nervous system: dizziness, drowsiness, hallucinations, psychomotor hyperactivity, seizures.

Heart: tachycardia, palpitations.

Gastrointestinal: abdominal pain, nausea, vomiting, dyspepsia, diarrhea.

The liver and biliary tract: increased concentration of bilirubin in blood plasma, increased activity of "liver" enzymes, hepatitis.

From the musculoskeletal and connective tissue: myalgia.

The skin and subcutaneous tissue: photosensitivity.

The deterioration for any of these reactions or the emergence of new, You should immediately consult a doctor.

Contraindications

• hypersensitivity to the drug component;
  
• pregnancy and lactation;
  
• the age of 1 year;
  
• hereditary transmitted disorders - intolerance or malabsorption of sorbitol, lack of arbitrairement (Largestin syrup 0/5 mg/ml contains sorbitol. Intolerance or malabsorption sorbitol is often accompanied by intolerance of other sugars, e.g., fructose).
  

With caution

• severe renal insufficiency.
  

Application of pregnancy and breastfeeding

The use of the drug in pregnant women is contraindicated due to the lack of clinical data on the safety of Largestin syrup 0.5 mg/ml during pregnancy.

Desloratadine is excreted in breast milk, so you should use Largestin* syrup 0.5 mg/ml in lactation is contraindicated.

Application for violations of renal function

With caution the drug to patients with severe renal insufficiency.

The children

The drug is contraindicated to children under the age of 1 year.

Children at the age from 1 year to 5 years: 1.25 mg (2.5 ml syrup) 1 times/day.

Children aged 6 to 11 years: 2.5 mg (5 ml syrup) 1 times/day.

Adults from 12 years: 5 mg (10 ml syrup) 1 times/day.

Special instructions

The shelf life after first opening of bottle is 28 days.

The children

The effectiveness and safety of using Largestin syrup 0.5 mg/ml in children under 1 year of age not established.

In most cases rhinitis in children under 2 years of age has an infectious nature. Studies on the effectiveness of Largestin syrup 0.5 mg/ml in rhinitis infectious etiology was conducted.

The differential diagnosis between allergic rhinitis and rhinitis of a different origin in children under 2 years of age presents certain difficulties. In the differential diagnosis should pay attention to the presence or absence of foci of infection or structural abnormalities of the upper respiratory tract, to conduct a thorough history and physical examination, laboratory studies and skin tests.

Severe renal insufficiency

In patients with severe renal insufficiency or hemodialysis is an increase in the concentration of desloratadine in the plasma of 1.7 and 2.5 times, respectively. Revealed minimal change in the concentration of 3-hydroxydesloratadine. Desloratadine and 3-hydroxydesloratadine poorly removed by dialysis The impaired renal function has no effect on the binding of desloratadine and 3-hydroxydesloratadine with blood plasma proteins. Based PA pharmacokinetics Largestin syrup 0.5 mg/ml, care should be taken when using the drug in patients with renal insufficiency.

Effects on ability to drive vehicles and operate machinery

In recommended doses Largestin syrup 0.5 mg/ml does not affect the ability to drive vehicles and operate machinery.

Overdose

Symptoms

Doses greater than the recommended five times, does not result in any symptoms. In clinical trials, daily use of desloratadine in adults and adolescents at a 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 QT interval and was not accompanied by the occurrence 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, reception activated carbon; if necessary, - symptomatic therapy. Desloratadine is not displayed in hemodialysis, the efficiency of peritoneal dialysis is not installed.

Drug interactions

In the study of drug interactions when multiple coadministration of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine clinically significant changes of concentration of desloratadine in the plasma na revealed. Food intake does not influence PA effectiveness of the drug. Largestin syrup 0.5 mg/ml enhances the effect of alcohol on the Central nervous system.

There was no interaction with ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine