You may report side effects to FDA at 1-800-FDA-1088.Keep CLARINEX-D 24 Hour Extended Release Tablets and all In another pharmacokinetic study, food and grapefruit juice had no effect on the bioavailability (Cmax and AUC) of desloratadine.For pseudoephedrine, the mean Tmax occurred at 8 to 9 hours post dose and mean peak plasma concentrations (Cmax) and AUC(tf) of 328 ng/mL and 6438 ng∙hr/mL, respectively, were observed. Methodological limitations of these studies included small sample size, selection bias, recall bias, inadequate adjustment for risk factors, residual confounding, exposure misclassification, and lack of information regarding dose and timing of exposure.No animal reproduction studies were conducted with the combination of desloratadine and pseudoephedrine or pseudoephedrine alone.Desloratadine was given orally during organogenesis to pregnant rats at doses of 6, 24 and 48 mg/kg/day (approximately 50, 200 and 320 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). Neither are there animal reproduction studies conducted with the combination of desloratadine and pseudoephedrine. Desloratadine had no effect on male fertility in rats at 3 mg/kg/day (approximately 10 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD).Fertility studies with pseudoephedrine have not been conducted.The clinical efficacy and safety of Clarinex-D 12 Hour Extended Release Tablets was evaluated in two 2-week multicenter, randomized parallel group clinical trials involving 1248 subjects 12 to 78 years of age with seasonal allergic rhinitis, 414 of whom received Clarinex-D 12 Hour Extended Release Tablets. Available for Android and iOS devices. Extended Release Tablets, and who discontinued from the clinical trials because There may be new information. The majority of patients were between 18 and <65 years of age with a mean age of 35.8 years and were predominantly women (64%). A few case-control studies conducted reported potential associations with isolated congenital disorders.

The QT interval was corrected for heart rate (QTFollowing oral administration of Clarinex-D 12 Hour Extended Release Tablets twice daily for 14 days in healthy volunteers, steady-state conditions were reached on Day 10 for desloratadine, 3-hydroxydesloratadine and pseudoephedrine. A human is slightly soluble in water, but very soluble in ethanol and propylene glycol. the In controlled clinical studies co-administration of desloratadine There was no difference in the prevalence of poor metabolizers across age groups. core.Store at 25°C (77°F); excursions permitted to 15°-30°C In both trials, the antihistaminic efficacy of Clarinex-D 12 Hour Extended Release Tablets, as measured by total symptom score excluding nasal congestion, was significantly greater than pseudoephedrine alone over the 2-week treatment period; and the decongestant efficacy of Clarinex-D 12 Hour Extended Release Tablets, as measured by nasal stuffiness/congestion, was significantly greater than CLARINEX (desloratadine alone) over the 2-week treatment period. oral dose. Administer CLARINEX-D 24 HOUR Extended Release Tablet by The 3-hydroxydesloratadine Cmax and AUC values were also increased by 45% and 48%, respectively, in females compared with males. Analysis of plasma 3-hydroxydesloratadine showed similar Tmax and half-life values compared to desloratadine.The mean elimination half-life of pseudoephedrine is dependent on urinary pH. The elimination half-life is approximately 3 to 6 or 9 to 16 hours when the urinary pH is 5 or 8, respectively.Pseudoephedrine is primarily excreted unchanged in the urine as unchanged drug with the remainder apparently being metabolized in the liver.

Subjects who are poor metabolizers of desloratadine cannot be prospectively identified and will be exposed to higher levels of desloratadine following dosing with the recommended dose of desloratadine. the recommended dose as desloratadine and pseudoephedrine, the active components 2 Lake, titanium Tablets daily for up to 15 days. V. Dosage and Administration Drug Name Indication Dosing Regimen Maximum Dose . Release Tablets have not demonstrated increased effectiveness. generally be avoided in patients with Patients should be informed that pseudoephedrine, one of

important information about CLARINEX-D 24 Hour Extended Release Tablets. Increased ectopic … Do not break, chew, or crush the tablet. administered dose of pseudoephedrine hydrochloride is excreted unchanged in the