Medicinal Products

DESLORATADINE BIOGARAN 0.5 mg / mL

Aerius Generic Drug
Therapeutic class: Allergology
Active ingredients: Desloratadine
laboratory: Biogaran

Drinkable solution
Bottle (+ measuring syringe graduated in ml) of 150 ml
All forms

Indication

DESLORATADINE BIOGARAN 0.5 mg / ml oral solution is indicated for the symptomatic treatment of:

- allergic rhinitis (see section on Pharmacodynamic properties )

- urticaria (see section on Pharmacodynamic properties )

Dosage DESLORATADINE BIOGARAN 0.5 mg / mL Oral solution 150 ml bottle (+ measuring syringe graduated in ml)

DESLORATADINE BIOGARAN 0.5 mg / ml oral solution can be taken both at and off-site for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section Pharmacodynamic properties ).

The prescriber should keep in mind that in children under 2 years, the majority of cases of rhinitis is infectious (see section Warnings and precautions for use ) and that there is no data validating the efficacy of DESLORATADINE BIOGARAN 0.5 mg / ml, oral solution for the treatment of infectious rhinitis.

Children from 1 to 5 years: 2.5 ml (1.25 mg) of DESLORATADINE BIOGARAN 0.5 mg / ml oral solution once a day.

Children from 6 to 11 years: 5 ml (2.5 mg) of DESLORATADINE BIOGARAN 0.5 mg / ml oral solution once a day.

Adults and adolescents (12 years and older): 10 ml (5 mg) of DESLORATADINE BIOGARAN 0.5 mg / ml oral solution once a day.

In adolescents aged 12 to 17, there is limited experience with the use of desloratadine in clinical efficacy studies (see Adverse Reactions and Pharmacodynamic Properties ).

Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or less than 4 weeks) should be managed based on a history of the patient's interrupted after the disappearance of symptoms, and restored to their reappearance.

In persistent allergic rhinitis (presence of symptoms over a period of 4 days or more per week and for more than 4 weeks), continuous treatment may be offered to patients during periods of allergen exposure.

Against indications

Hypersensitivity to the active substance, to any of the excipients, or to loratadine.

Side effects Desloratadine Biogaran

In clinical pediatric studies, desloratadine syrup was administered to a total of 246 children aged 6 months to 11 years. The overall incidence of adverse events in children aged 2 years to 11 years was similar in the desloratadine and placebo groups. In infants and young children aged 6 to 23 months, the most commonly reported adverse events with an incidence greater than placebo were: diarrhea (3.7%), fever (2.3%) and insomnia (2.3%). ). In another study, no adverse events were reported in subjects aged between 6 and 11 years after a single dose of 2.5 mg desloratadine oral solution.

At the recommended dose, in clinical studies involving adults and adolescents and conducted in allergic rhinitis and chronic idiopathic urticaria, adverse events were reported in 3% more patients than those treated with placebo. The most commonly reported adverse events with an incidence greater than placebo were: asthenia (1.2%), dry mouth (0.8%) and headache (0.6%). Other adverse effects reported very rarely since marketing are listed in the following table:

Psychiatric disorders

hallucinations

Nervous system disorders

Dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions

Heart conditions

Tachycardia, palpitations

Gastrointestinal disorders

Abdominal pain, nausea, vomiting,

dyspepsia, diarrhea

Hepatobiliary disorders

Increases in liver enzymes, increased bilirubin, hepatitis

Musculoskeletal and systemic disorders

myalgia

General disorders

Hypersensitivity reactions (such as anaphylaxis,

angioedema, dyspnea, pruritus, rash, and urticaria)

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