Aerius, syrup 2.5mg/5ml, 60ml

Composition

1 ml of syrup contains:

desloratadine 0.5 mg.

Auxiliary substances:

propylene glycol,

sorbitol,

citric acid anhydrous,

sodium citrate dihydrate,

sodium benzoate,

disodium edetate,

purified water,

sucrose,

flavor No. 15864,

yellow dye No. 6 (E 110).

Pharmacological action

Aerius is a long-acting antihistamine, a blocker of peripheral histamine H1 receptors.

Desloratadine is the primary active metabolite of loratadine. It inhibits the cascade of allergic inflammatory reactions, including the release of pro-inflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, the release of pro – inflammatory chemokines, the production of superoxide anions by activated polymorphonuclear neutrophils, the adhesion and chemotaxis of eosinophils, the release of adhesion molecules such as P-selectin, IgE-mediated release of histamine, prostaglandin D2 and leukotriene C4. Thus, it prevents the development and facilitates the course of allergic reactions, has an antipruritic and antiexudative effect, reduces capillary permeability, prevents the development of tissue edema, smooth muscle spasm.

The drug has no effect on the central nervous system, has practically no sedative effect (does not cause drowsiness) and does not affect the speed of psychomotor reactions. It does not cause prolongation of the QT interval on the ECG. The action of Aerius syrup begins within 30 minutes after ingestion and lasts for 24 hours.

Indications

– Seasonal (pollinosis) and year-round allergic rhinitis (elimination or relief of sneezing, nasal congestion, mucus discharge from the nose, itchy nose, itchy palate, itchy and red eyes, lacrimation).

– Chronic idiopathic urticaria (reduction or elimination of skin itching, rash).

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Contraindications

-Hereditary transmitted diseases due to the presence of sucrose and sorbitol in the composition of the drug: fructose intolerance; glucose/galactose malabsorption; sucrose/isomaltase deficiency in the body. – Pregnancy. – The period of lactation (breastfeeding). – Children under 6 months of age. – Hypersensitivity to the components of the drug. The drug should be used with caution in patients with severe renal insufficiency.

Side effects

In children aged 6 to 23 months, the following side effects were observed, the frequency of which was slightly higher than with placebo (“pacifiers”): diarrhea (in 3.7% of cases), fever (2.3%), insomnia (2.3%).

In children aged 2 to 11 years, the incidence of side effects was similar to that of placebo when using Aerius syrup.

According to the results of clinical studies in children aged 6 to 11 years, no side effects were detected when taking the drug at the recommended doses (2.5 mg/day).

In children aged 12-17 years, according to the results of clinical studies, the most common side effect was headache (5.9%), the frequency of which was no higher than with placebo (6.9%).

In adults and adolescents (12 years and older), according to the results of clinical studies, side effects were recorded in 3% of patients compared to the placebo group, of which the most common were: increased fatigue (1.2%), dry mouth (0.8%), headache (0.6%).

Information on side effects is provided based on the results of clinical studies and observations of the post-marketing period.

According to the World Health Organization (WHO), side effects are classified according to their frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (

From the side of the psyche:  very rarely – hallucinations.

Nervous system disorders:  often-headache; often (in children under 2 years of age) – insomnia; very rarely-dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions.

Liver and biliary tract disorders:  very rarely-increased activity of liver enzymes, increased bilirubin concentration, hepatitis; frequency unknown-jaundice.

From the digestive system:  often – dry mouth, often (in children under 2 years) – diarrhea; very rarely-abdominal pain, nausea, vomiting, dyspepsia, diarrhea.

From the cardiovascular system:  very rarely – tachycardia, palpitations; frequency unknown-prolongation of the QT interval.

From the musculoskeletal system:  very rarely – myalgia.

Skin and subcutaneous tissue disorders:  frequency unknown-photosensitization.

Common disorders:  often-increased fatigue, often (in children under 2 years of age) – fever; very rarely-anaphylaxis, angioedema, shortness of breath, itching, rash, including urticaria; frequency unknown – asthenia.

Post-registration period.

Children:  frequency unknown – prolongation of the QT interval, arrhythmia, bradycardia.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

There was no clinically significant interaction with other drugs.

Aerius does not enhance the effects of ethanol on the central nervous system.

Food intake does not affect the effectiveness of the drug.

How to take, course of use and dosage

The drug is taken orally, regardless of food intake, with a small amount of water.

Children aged 1 to 5 years are prescribed 1.25 mg (2.5 ml of syrup) 1 time/day.

Children aged 6-11 years – 2.5 mg (5 ml of syrup) 1 time/day.

Adults and adolescents over 12 years of age – 5 mg (10 ml of syrup) 1 time/day.

Overdose

Symptoms. Taking a dose exceeding the recommended 5 times did not lead to any symptoms. In clinical trials, daily use of desloratadine in adults and adolescents at a dose of up to 20 mg for 14 days was not accompanied by statistically or clinically significant changes in the cardiovascular system. In a clinical and pharmacological study, the use of desloratadine at a dose of 45 mg per day (9 times higher than recommended) for 10 days did not cause prolongation of the QT interval and was not accompanied by the appearance of serious side effects.

Treatment. If you accidentally take a large amount of the drug inside, you should immediately consult a doctor. Gastric lavage and activated charcoal are recommended; if necessary, symptomatic therapy is recommended. Desloratadine is not eliminated by hemodialysis, and the effectiveness of peritoneal dialysis has not been established.

Description

Looking for a remedy for allergies in children?Aerius in the form of syrup is the latest generation drug with triple activity against allergies: anti-inflammatory, antihistamine and anti-allergic (1), which can be taken by children from 6 months. Aerius helps eliminate 10 allergy symptoms: – Itchy, red and watery eyes-Stuffy, sneezing, itchy and nasal discharge – Itchy palate – Itchy skin, Rashpreparation shown: – for seasonal and year-round allergic rhinitis, – for urticaria, Cyrop Aerius helps to relieve allergy symptoms in children. It surpasses some antihistamines of the second generation (2) in important properties for children: – does not cause drowsiness (possible frequency less than 1 per 10,000 patients);- does not interact with other medications;- can be used regardless of food intake. Method of application: 1 time a day, it is able to start acting within 30 minutes and maintain the effect for 24 hours. Dosed according to the age of the child (6 months 12 years and older)1. Canonica GW., Blaiss M. Antihistaminic, anti-inflammatory, and antiallergic properties of the nonsedating second-generation antihistamine desloratadine: a review of the evidence. World Allergy Organ J. 2011 Feb;4(2): 47-53.2. For example, drowsiness when taking cetirizine reaches 1.8% in children from 6 months to 12 years and up to 9.63% in adults, simultaneous use of cetirizine with drugs that depress the central nervous system may further reduce concentration and reaction speed (instructions for use of the drug Zyrtek); levocetirizine should be taken with meals or on an empty stomach (instructions for use of the drug Suprastinex).

Special instructions

Application in pediatrics

The efficacy and safety of Aerius® syrup in children under 6 months of age has not been established.

Studies of the effectiveness of the drug Aerius® in rhinitis of infectious etiology have not been conducted.

Influence on the ability to drive vehicles and mechanisms

The potential for side effects such as dizziness and drowsiness should be taken into account. If the described adverse events occur, you should refrain from performing these types of activities.

Form of production

Syrup.

Storage conditions

The drug should be stored at a temperature not exceeding 30°C.

Shelf

life is 2 years.

Active ingredient

Desloratadine

Dosage form

solution for oral use

Purpose

For adults, Children over 6 months of age

Indications

Allergic Rhinitis, Allergy, Dermatitis, Diathesis, Pollinosis, Urticaria, Allergic Conjunctivitis