Aerius Generic Drug
Therapeutic class: Allergology
Active ingredients: Desloratadine
laboratory: Ranbaxy Pharma Generic
Case of 30
DESLORATADINE RANBAXY 5 mg film-coated tablets are indicated for the symptomatic treatment of:
· Allergic rhinitis
Dosage DESLORATADINE RANBAXY 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, 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.
Hypersensitivity (allergy) to desloratadine, to any of the excipients (see List of Excipients under Composition ) or to loratadine.
Side effects Desloratadine Ranbaxy
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
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.