Medicinal Products

DESLORATADINE GNR 5 mg

Generic drug of the therapeutic class: Allergology
active ingredients: Desloratadine, Desloratadine
laboratory: Sandoz

Filmstrip
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.

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