Generic drug of the therapeutic class: Allergology
active ingredients: Desloratadine, Desloratadine
laboratory: Sandoz
Case of 15
All forms
Indication
Desloratadine is indicated for the symptomatic treatment of:
- allergic rhinitis (see Proprietary pharmacodynamics )
- urticaria (see section on Proprietary pharmacodynamics )
Dosage DESLORATADINE GNR 5 mg tablets film case of 15
Desloratadine is indicated for the symptomatic treatment of:
- allergic rhinitis (see Proprietary pharmacodynamics )
- urticaria (see section on Proprietary pharmacodynamics )
Against indications
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Side effects Desloratadine Gnr
Summary of the safety profile
In clinical trials conducted in various indications, such as allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg per day, undesirable effects with desloratadine were reported in 3% of patients more than those treated by the placebo. The most frequently reported adverse effects with a higher incidence of placebo were: asthenia (1.2%), dryness (0.8%) and cephalitis (0.6%).
Pediatric population
In a clinical study performed in 578 adolescent patients, aged 12 to 17 years, the most common undesirable effect was cephalitis; it occurred in 5.9% of patients treated with desloratadine and in 6.9% of patients receiving placebo.
Summary table of undesirable effects
The frequency of undesirable effects reported in clinical trials with an incidence greater than placebo and other undesirable effects reported since marketing are listed in the following table. Frequencies are defined as: very frequent (≥ 1/10), frequent (≥ 1/100 to "<1/10), not very frequent (≥ 1/1000 to" <1/100), rare (≥ 1 / 10, 000 Ã "<1/1000), very rare (<1 / 10, 000) and undetermined frequency (can not be estimated on the basis of available data).
Classes of organs | FrÚquence | Undesirable effects reported with Desloratadine |
Psychiatric disorders | Very rare | hallucinations |
Nervous system disorders | FrÚquent Very rare | CÚphalÚes Dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions |
Cardiac disorders | Very rare Indeterminate Frequency | Tachycardia, palpitations QT interval prolongation |
Gastrointestinal disorders | FrÚquent Very rare | Oral dryness Abdominal pain, nausea, vomiting, dyspepsia, diarrhea |
Hospital disorders | Very rare Indeterminate Frequency | Hepatic enzyme elevations, increased bilirubin, hepatitis IctÞre |
Skin and subcutaneous tissue disorders | Indeterminate Frequency | PhotosensibilitÚ |
Musculoskeletal and systemic disorders | Very rare | myalgia |
General disorders and administration site abnormalities | FrÚquent Very rare Indeterminate Frequency | AsthÚnie Hypersensitivity Reactions (such as anaphylaxis, angioedema, dyspnea, pruritus, rash and urticaria) AsthÚnie |
Pediatric population
Other undesirable effects reported since marketing with undetermined frequency in pediatric patients include QT prolongation, arrhythmia, and bradycardia.
Declaration of suspected undesirable effects
The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Healthcare professionals declare any suspected adverse effects via the national system of declaration: National Agency for the Safety of Medicines and Health Products (ANSM) and the Network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.
