Medicinal Products

AERIUS 0.5 mg / mL

Generic drug of the therapeutic class: Allergology
Active ingredients: Desloratadine
laboratory: Msd Limited

Drinkable solution
Bottle (+ graduated syringe 2.5 and 5 ml) 150 ml
All forms

Indication

Aerius is indicated for the symptomatic treatment of:
- allergic rhinitis (see section on pharmacodynamic properties),
- urticaria (see section on pharmacodynamic properties).

Dosage AERIUS 0.5 mg / mL Oral solution Bottle (+ 2.5 ml and 5 ml graduated syringe) 150 ml

- Aerius 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 5.1).
- 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 There is no data validating the effectiveness of Aerius in the treatment of infectious rhinitis.
- Children from 1 to 5 years: 2.5 ml (1.25 mg) of Aerius oral solution once a day.
- Children from 6 to 11 years: 5 ml (2.5 mg) of Aerius oral solution once a day.
- Adults and adolescents (12 years and older): 10 ml (5 mg) of Aerius oral solution once a day.
- In adolescents aged 12 to 17, the experience of using desloratadine in clinical efficacy studies is limited (see sections on adverse effects 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 the patient's history of to be 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

CONTRAINDICATED:
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
- The efficacy and safety of Aerius oral solution have not been established in children under 1 year of age.
- This medicine contains sorbitol ; therefore, it should not be administered in rare patients with fructose intolerance.
NOT RECOMMENDED :
Pregnancy: Desloratadine has not shown teratogenic effects in animal studies. The safety of the product during pregnancy has not been established. As a result, the use of Aerius during pregnancy is not recommended.
- Breast-feeding: Desloratadine is excreted in breast milk, therefore Aerius is not recommended for breastfeeding women.

Aerius side effects

- In clinical pediatric studies, desloratadine 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.
. Cardiac disorders: Tachycardia, palpitations.
. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, dyspepsia, diarrhea.
. Hepatobiliary disorders: Increases in hepatic 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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