Generic drug of the therapeutic class: Allergology
Active ingredients: Desloratadine
laboratory: Schering Plow Europe
Box of 30
Aerius is indicated for the symptomatic treatment of:
- allergic rhinitis (see section on pharmacodynamic properties),
- urticaria (see section on pharmacodynamic properties).
Dosage AERIUS 5 mg Orodispersible Tablet Box of 30
- Adults and adolescents (12 years and older): one orodispersible tablet of Aerius 5 mg once daily in the mouth for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section on pharmacodynamic properties).
- The tablet can be taken at the time or outside of meals.
- 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.
- Just before taking, the blister will be opened carefully and the orodispersible tablet will be removed taking care not to crush it. The orodispersible tablet will be placed in the mouth where it will disperse instantly. It is not necessary to swallow the dose with water or any other liquid. The drug should be taken immediately after opening the blister.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
- The efficacy and safety of Aerius orodispersible tablets have not been established in children under 12 years of age.
- This product contains 2.9 mg of phenylalanine per orodispersible tablet of Aerius 5 mg. Phenylalanine may have adverse consequences in people with phenylketonuria.
NOT RECOMMENDED :
Pregnancy: Desloratadine has not shown teratogenic effects in animal studies. The safety of use 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 trials conducted in allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, adverse effects with Aerius tablets 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%). In a clinical study in 578 adolescent patients aged 12 to 17, the most common adverse event was headache; it occurred in 5.9% of patients treated with desloratadine and in 6.9% of patients receiving placebo. 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).