Aerius Generic Drug
Therapeutic class: Allergology
Active ingredients: Desloratadine
laboratory: Zydus France
Case of 30
DESLORATADINE ZYDUS is indicated for the symptomatic treatment of:
• allergic rhinitis (see section on Pharmacodynamic properties ),
• urticaria (see section on Pharmacodynamic properties ).
Dosage DESLORATADINE ZYDUS 5 mg Film-coated tablet Case of 30
Adults and adolescents (12 years and older): one tablet once daily, at or away from meals for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section Pharmacodynamic properties ).
In adolescents aged 12 to 17 years, experience with the use of desloratadine in clinical efficacy studies is limited (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.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Undesirable effects Desloratadine Zydus
In clinical trials conducted in allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, 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%). 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:
Nervous system disorders
Dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions
Abdominal pain, nausea, vomiting, dyspepsia, diarrhea
Increases in liver enzymes, increased bilirubin, hepatitis
Musculoskeletal and systemic disorders
Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria)