It allows continued monitoring of the benefit/risk balance of the medicinal product. Loratadine selectively works to inhibit H1-receptors primarily located on respiratory smooth muscle cells, vascular endothelial cells, the gastrointestinal tract, and immune cells. Chemokines have chemotactic properties on leukocyte subsets whose modulation plays a pivotal role in allergic inflammatory processes. In both studies, changes in exposure (AUC and CDesloratadine is the primary active metabolite of loratadine. Treatment with desloratadine also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.Desloratadine plasma concentrations can be detected within 30 minutes of administration. At very high doses, is also an antagonist at various subtypes of the muscarinic acetylcholine receptors. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizuresAbdominal pain, nausea, vomiting, dyspepsia, diarrhoeaElevations of liver enzymes, increased bilirubin, hepatitisHypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and aggression.A retrospective observational safety study indicated an increased incidence of new-onset seizure in patients 0 to 19 years of age when receiving desloratadine compared with periods not receiving desloratadine. After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system. As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy.Desloratadine has been identified in breastfed newborns / infants of treated women. Therefore, caution is recommended if alcohol is taken concomitantly.A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto / neonatal toxicity of desloratadine. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. Desloratadine was also given orally during organogenesis to pregnant rabbits at doses of 15, 30 and 60 mg/kg/day (approximately 30, 70 and 230 times the AUC- based exposure of Desloratadine at the RHD). After oral administration, desloratadine selectively blocks peripheral histamine H 1 -receptors because the substance is excluded from entry to the central nervous system.
The clinical relevance of histamine wheal skin testing is unknown.Single daily doses of 45 mg were given to normal male and female volunteers for 10 days. However, the CA single dose of either 2.5 mL or 1.25 mL of Desloratadine oral solution containing 1.25 mg or 0.625 mg, respectively, of Desloratadine was administered to subjects 6 to 11 months of age and 12 to 23 months of age. Place the tablet on your tongue and allow it to dissolve, without chewing. As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy.Desloratadine has been identified in breastfed newborns/infants of treated women. In a single dose, crossover study of desloratadine, the tablet and the syrup formulations were found to be bioequivalent. Our present study was designed to investigate the anti-allergic and anti-inflammatory properties of desloratadine citrate disodium injection (DLC) and elucidate the molecular mechanisms of its anti-inflammatory properties. In another study, grapefruit juice had no effect on the disposition of desloratadine.The pharmacokinetics of desloratadine in patients with chronic renal insufficiency (CRI) was compared with that of healthy subjects in one single-dose study and one multiple dose study.
However, the safety of desloratadine syrup formulation, which contains the same concentration of desloratadine as Desloratadine oral solution, was demonstrated in three paediatric trials. Patients should be informed that most people do not experience drowsiness. Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours. This percentage may vary according to ethnic background. In controlled clinical trials, at the recommended dose of 5 mg daily for adults and adolescents, there was no excess incidence of somnolence as compared to placebo. The mechanism of action of desloratadine is as a Histamine H1 Receptor Antagonist.