CLARINEX-D 12 HOUR Extended Release Tablets (desloratadine/pseudoephedrine sulfate)(五)
clinical studies co-administration of desloratadine with cimetidine a histamine H2-receptor antagonist resulted in increased plasma concentrations of desloratadine and 3-hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine [see CLINICAL PHARMACOLOGY (12.3)]
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C: There are no adequate and well-controlled studies of desloratadine and pseudoephedrine in combination in pregnant women. Neither are there animal reproduction studies conducted with the combination of desloratadine and pseudoephedrine. Desloratadine was not teratogenic in rats or rabbits but affected implantation in rats. Because animal reproduction studies are not always predictive of human response, CLARINEX-D 12 HOUR Extended Release Tablets should be used during pregnancy only if clearly needed.
Desloratadine was not teratogenic in rats or rabbits at approximately 210 and 230 times, respectively, the AUC in humans at the recommended daily oral dose). An increase in pre-implantation loss and a decreased number of implantations and fetuses were noted, however, in a separate study in female rats at approximately 120 times the AUC in humans at the recommended daily oral dose). Reduced body weight and slow righting reflex were reported in pups at approximately 50 times or greater than the AUC in humans at the recommended daily oral dose. Desloratadine had no effect on pup development at approximately 7 times the AUC in humans at the recommended daily oral dose). The AUCs in comparison referred to the desloratadine exposure in rabbits and the sum of desloratadine and its metabolites exposures in rats, respectively [see NONCLINICAL TOXICOLOGY (13.2)].
8.3 Nursing Mothers
Desloratadine and pseudoephedrine both pass into breast milk; therefore, a decision should be made whether to discontinue nursing or to discontinue CLARINEX-D 12 HOUR Extended Release Tablets, taking into account the benefit of the drug to the nursing mother and the possible risk to the child.
8.4 Pediatric Use
CLARINEX-D 12 HOUR Extended Release Tablets are not indicated for use in pediatric patients under 12 years of age.
8.5 Geriatric Use
The number of subjects (n=10) ≥65 years old treated with CLARINEX-D 12 HOUR Extended Release Tablets was too limited to make any formal statistical comparison regarding the efficacy or safety of this drug product in this age group, or to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences between the elderly and younger patients, although the elderly are more likely to have adverse reactions to sympathomimetic amines. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see CLINICAL PHARMACOLOGY (12.3)].
Pseudoephedrine, desloratadine, and their metabolites are known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with renal impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor the patient for adverse events [see CLINICAL PHARMACOLOGY (12.3)].
8.6 Renal Impairment
No studies with CLARINEX-D 12 HOUR Extended Release Tablets were conducted in subjects with renal impairmen |
