therapies [65:<65 years old). The oral total body clearance (CL/F) when normalized for body weight was similar between the 2 age groups. The mean plasma elimination half-life of desloratadine was 33.7 hr in subjects 65 years old. The pharmacokinetics for 3-hydroxydesloratadine appeared unchanged in older vs. younger subjects. These age-related differences are unlikely to be clinically relevant and no dosage adjustment is recommended in elderly patients. Pediatric Subjects: Clarinex-D 24 Hour Extended Release Tablets are not an appropriate dosage form for use in pediatric patients below 12 years of age. Renally Impaired: Following a single dose of desloratadine 7.5 mg, pharmacokinetics were characterized in subjects with mild (n=7; creatinine clearance 51-69 mL/min/1.73 m 2 ), moderate (n=6; creatinine clearance 34-43 mL/min/1.73 m 2 ), and severe (n=6; creatinine clearance 5-29 mL/min/1.73 m 2 ) renal impairment or hemodialysis dependent (n=6) subjects. In subjects with mild and moderate renal impairment, median C max and AUC values increased by approximately 1.2- and 1.9-fold, respectively, relative to subjects with normal renal function. In subjects with severe renal impairment or who were hemodialysis dependent, C max and AUC values increased by approximately 1.7- and 2.5-fold, respectively. Minimal changes in 3-hydroxydesloratadine concentrations were observed. Desloratadine and 3-hydroxydesloratadine were poorly removed by hemodialysis. Plasma protein binding of desloratadine and 3-hydroxydesloratadine was unaltered by renal impairment. Pseudoephedrine is primarily excreted unchanged in the urine as unchanged drug; the remainder is apparently metabolized in the liver. Therefore, pseudoephedrine may accumulate in patients with renal impairment. Hepatically Impaired: Following a single oral dose of desloratadine, pharmacokinetics were characterized in subjects with mild (n=4), moderate (n=4), and severe (n=4) hepatic impairment as defined by the Child-Pugh classification of hepatic impairment and 8 subjects with normal hepatic function. Subjects with hepatic impairment, regardless of severity, had approximately a 2.4-fold increase in AUC as compared with normal subjects. The apparent oral clearance of desloratadine in subjects with mild, moderate, and severe hepatic impairment was 37%, 36%, and 28% of that in normal subjects, respectively. An increase in the mean elimination half-life of desloratadine in subjects with hepatic impairment was observed. For 3-hydroxydesloratadine, the mean C max and AUC values for subjects with hepatic impairment were not statistically significantly different from subjects with normal hepatic function. Gender: Female subjects treated for 14 days with CLARINEX Tablets had 10% and 3% higher desloratadine C max and AUC values, respectively, compared with male subjects. The 3-hydroxydesloratadine C max and AUC values were also increased by 45% and 48%, respectively, in females compared with males. However, these apparent differences are not considered to be clinically relevant. Race: Following 14 days of treatment with CLARINEX Tablets, the C max and AUC values for desloratadine were 18% and 32% higher, respectively, in Blacks compared with Caucasians. For 3-hydroxydesloratadine there was a corresponding 10% reduction in C max and AUC values in Blacks compared to Caucasians. These differences are not considered to be clinically relevant. Drug Interaction: In 2 controlled crossover clinical pharmacology studies in healthy male (n=12 in each study) and female (n=12 in each study) subjects, desloratadine 7.5 mg (1.5 times the daily dose) once daily was co-administered with erythromycin 500 mg every 8 hours or ketoconazole 200 mg every 12 hours for 10 days. In 3 separate controlled, parallel group clinical pharmacology studies, desloratadine at the clinical dose of 5 mg has been co-administered with azithromycin 500 mg followed by 250 mg once daily for 4 days (n=18) or with fluoxetine 20 mg once daily for 7 days after a 23-day pretreatment period with fluoxetine (n=18) or with cimetidine 600 mg every 12 hours for 14 days (n=18) under steady state conditions to healthy male and female subjects. Although increased plasma concentrations (C max and AUC 0-24 hrs ) of desloratadine and 3-hydroxydesloratadine were observed (see Table 2 ), there were no clinically relevant changes in the safety profile of desloratadine, as assessed by electrocardiographic parameters (including the corrected QT interval), clinical laboratory tests, vital signs and adverse events. Table 2: Changes in Desloratadine and 3-hydroxydesloratadine Pharmacokinetics in Healthy Male and Female Subjects Desloratadine 3-hydroxydesloratadine C max AUC 0-24 hrs C max AUC 0-24 hrs Erythromycin (500 mg Q8h) +24% +14% +43% +40% Ketoconazole (200 mg Q12h) +45% +39% +43% +72% Azithromycin (500 mg Day 1, 250 mg QD x 4 days) +15% +5% +15% +4% Fluoxetine (20 mg QD) +15% +0% +17% +13% Cimetidine (600 mg Q12h) +12% +19% -11% -3% Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility There are no animal or laboratory studies on the combination product of desloratadine and pseudoephedrine sulfate to evaluate carcinogenesis, mutagenesis, or impairment of fertility. Carcinogenicity Studies: The carcinogenic potential of desloratadine was assessed using a loratadine study in rats and a desloratadine study in mice. In a 2-year study in rats, loratadine was administered in the diet at doses up to 25 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 30 times the AUC in humans at the recommended daily oral dose). A significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg/day of loratadine and in males and females given 25 mg/kg/day of loratadine. The estimated desloratadine and desloratadine metabolite exposures in rats given 10 mg/kg of loratadine were approximately 7 times the AUC in humans at the recommended daily oral dose. The clinical significance of these findings during long-term use of desloratadine is not known. In a 2-year dietary study in mice, males and females given up to 16 mg/kg/day and 32 mg/kg/day desloratadine, respectively, did not show significant increases in the incidence of any tumors. The estimated desloratadine and desloratadine metabolite exposures in mice at these doses were 12 and 27 times, respectively, the AUC in humans at the recommended daily oral dose. Genotoxicity Studies: In genotoxicity studies with desloratadine, there was no evidence of genotoxic potential in a reverse mutation assay ( Salmonella/E. coli mammalian microsome bacterial mutagenicity assay) or in 2 assays for chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micronucleus assay). Impairment of Fertility: There was no effect on female fertility in rats at desloratadine doses up to 24 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 130 times the AUC in humans at the recommended daily oral dose). A male specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and motility, and histopathologic testicular changes, occurred at an oral desloratadine dose of 12 mg/kg in rats (estimated desloratadine and desloratadine metabolite exposures were approximately 45 times the AUC in humans at the recommended daily oral dose). Desloratadine had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 8 times the AUC in humans at the recommended daily oral dose). Animal Toxicology and/or Pharmacology Reproductive Toxicology Studies: Desloratadine was not teratogenic in rats at doses up to 48 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 210 times the AUC in humans at the recommended daily oral dose) or in rabbits at doses up to 60 mg/kg/day (estimated desloratadine exposures were approximately 230 times the AUC in humans at the recommended daily oral dose). In a separate study, an increase in pre-implantation loss and a decreased number of implantations and fetuses were noted in female rats at 24 mg/kg (estimated desloratadine and desloratadine metabolite exposures were 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 doses of 9 mg/kg/day or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 50 times or greater than the AUC in humans at the recommended daily oral dose). Desloratadine had no effect on pup development at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 7 times the AUC in humans at the recommended daily oral dose). Clinical Studies Seasonal Allergic Rhinitis The clinical efficacy and safety of Clarinex-D 24 Hour Extended Release Tablets was evaluated in two 2-week multicenter, randomized parallel group clinical trials involving 2852 subjects 12 to 78 years of age with seasonal allergic rhinitis, 708 of whom received Clarinex-D 24 Hour Extended Release Tablets. In the 2 trials, subjects were randomized to receive Clarinex-D 24 Hour Extended Release Tablets once daily, CLARINEX Tablets 5 mg once daily, or sustained-release pseudoephedrine tablet 240 mg once daily for two weeks. The majority of patients were between 18 and> <65 years of age with a mean age of 34.3 years and were predominantly women (63%). Patient ethnicity was 79% Caucasian, 10% Black, 8% Hispanic and 3% Asian/other ethnicity. Primary efficacy variable was twice-daily reflective patient scoring of 4 nasal symptoms (rhinorrhea, nasal stuffiness/congestion, nasal itching, and sneezing) and 4 non-nasal symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears/palate) on a four point scale (0=none, 1=mild, 2=moderate, and 3=severe). In both trials, the antihistaminic efficacy of Clarinex-D 24 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 24 Hour Extended Release Tablets, as measured by nasal stuffiness/congestion, was significantly greater than CLARINEX (desloratadine alone) over the 2-week treatment period. Primary efficacy variable results from 1 of 2 trials are shown in Table 3 . Table 3: Changes in Symptoms in a 2-Week Clinical Trial in Subjects With Seasonal Allergic Rhinitis Treatment Group (n) Mean Baseline * (SEM) Change (% change) from Baseline (SEM) CLARINEX-D 24 HOUR Comparison to components (P-value) SEM=Standard Error of the Mean * To qualify at Baseline, the sum of the twice-daily diary reflective scores for the 3 days prior to Baseline and the morning of the Baseline visit were to total 42 for total nasal symptom score (sum of 4 nasal symptoms of rhinorrhea, nasal stuffiness/congestion, nasal itching, and sneezing) and a total of 35 for total non-nasal symptoms score (sum of 4 non-nasal symptoms of itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears/palate), and a score of 14 for each of the individual symptoms of nasal stuffiness/congestion and rhinorrhea. Each symptom was scored on a 4-point severity scale (0=none, 1=mild, 2=moderate, 3=severe). Mean reduction in score averaged over the 2-week treatment period. The comparison of interest is shown bolded. Total Symptom Score (Excluding Nasal Congestion) Clarinex-D 24 Hour Extended Release Tablets (333) 14.84 (0.15) -5.71 (-37.4) (0.22) - Pseudoephedrine tablet 240 mg (337) 15.03 (0.15) -4.95 (-32.0) (0.22) p=0.015 CLARINEX 5 mg Tablets (337) 15.06 (0.15) -4.78 (-30.8) (0.22) p=0.003 Nasal Stuffiness/Congestion Clarinex-D 24 Hour Extended Release Tablets (333) 2.56 (0.020) -0.85 (-32.3) (0.034) - Pseudoephedrine tablet 240 mg (337) 2.54 (0.020) -0.70 (-27.1) (0.034) p=0.002 CLARINEX 5 mg Tablets (337) 2.57 (0.020) -0.65 (-24.8) (0.034) p> <0.001 There were no significant differences in the efficacy of Clarinex-D 24 Hour Extended Release Tablets across subgroups of subjects defined by gender, age, or race. How Supplied/Storage and Handling Clarinex-D 24 Hour Extended Release Tablets are oval-shaped, light blue coated tablets with "D24" branded in black on one side containing 5 mg desloratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate USP in an extended release core. Clarinex-D 24 Hour Extended Release Tablets are supplied in high-density polyethylene bottles of 100 (NDC 0085-1317-01). Storage: Store at 25 C (77 F); excursions permitted to 15 -30 C (59 -86 F) [see USP Controlled Room Temperature]. Heat Sensitive. Avoid exposure at or above 30 C (86 F). Protect from excessive moisture. Protect from light. Patient Counseling Information See FDA-approved patient labeling (Patient Information) . Cardiovascular and Central Nervous System Effects Patients should be informed that pseudoephedrine, one of the active ingredients in Clarinex-D 24 Hour Extended Release Tablets may cause cardiovascular or central nervous system effects such as insomnia, dizziness, tremor, or arrhythmia. Dosing Patients should be advised not to increase the dose or dosing frequency of Clarinex-D 24 Hour Extended Release Tablets. Additional Antihistamines and/or Decongestants Patients should be advised against the concurrent use of Clarinex-D 24 Hour Extended Release Tablets with other antihistamines and/or decongestants. Monoamine Oxidase (MAO) Inhibitors Patients should be informed that due to its pseudoephedrine component, they should not use Clarinex-D 24 Hour with a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor. Coexisting Conditions Patients with severe hypertension or severe coronary artery disease, narrow-angle glaucoma, or urinary retention should be advised not to use Clarinex-D 24 Hour Extended Release Tablets. Instructions for Use Patients should be instructed not to break, crush or chew the tablet. The tablet should be swallowed whole, and can be taken without regard to meals. Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA For patent information: www.merck.com/product/patent/home.html Copyright 2005, 2009 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. uspi-mk4117a-t-d24-1403r006 PATIENT INFORMATION CLARINEX-D (CLA-RI-NEX) 24 Hour Extended Release Tablets (desloratadine and pseudoephedrine sulfate) Read the Patient Information that comes with Clarinex-D 24 Hour Extended Release Tablets before you start taking it and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients. Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment. What is CLARINEX-D 24 Hour Extended Release Tablets? Clarinex-D 24 Hour Extended Release Tablets is a prescription medicine that contains the medicines desloratadine (an antihistamine) and pseudoephedrine (a nasal decongestant). Clarinex-D 24 Hour Extended Release Tablets is used to help control the symptoms of seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in adults and children 12 years and older. Clarinex-D 24 Hour Extended Release Tablets is not for children under 12 years of age. Who should not take CLARINEX-D 24 Hour Extended Release Tablets? Do not take Clarinex-D 24 Hour Extended Release Tablets if you: are allergic to desloratadine or pseudoephedrine sulfate or any of the ingredients in Clarinex-D 24 Hour Extended Release Tablets. See the end of this leaflet for a complete list of ingredients in Clarinex-D 24 Hour Extended Release Tablets. are allergic to loratadine (Alavert, Claritin) have narrow angle glaucoma have problems with urination (urinary retention) take a Monoamine Oxidase Inhibitor (MAOI) medicine to treat depression, or if you stopped taking an MAOI medicine within the last 2 weeks. Ask your doctor or pharmacist if you are not sure if you take an MAOI medicine. have severe high blood pressure have severe heart disease Talk to your doctor before taking this medicine if you have any of these conditions. What should I tell my doctor before taking CLARINEX-D 24 Hour Extended Release Tablets? Before you take Clarinex-D 24 Hour Extended Release Tablets, tell your doctor if you: have any of the conditions listed in the section "Who should not take Clarinex-D 24 Hour Extended Release Tablets?" diabetes hyperthyroidism have prostate problems have liver or kidney problems have any other medical conditions are pregnant or plan to become pregnant. It is not known if Clarinex-D 24 Hour Extended Release Tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. are breast-feeding or plan to breast-feed. Clarinex-D 24 Hour Extended Release Tablets can pass into your breast milk . Talk to your doctor about the best way to feed your baby if you take Clarinex-D 24 Hour Extended Release Tablets. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Clarinex-D 24 Hour Extended Release Tablets may affect the way other medicines work, and other medicines may affect how Clarinex-D 24 Hour Extended Release Tablets works. Especially tell your doctor if you take: Monoamine Oxidase Inhibitors (MAOIs). You should not use Clarinex-D 24 Hour Extended Release Tablets if you take an MAOI or within 2 weeks of stopping an MAOI. methyldopa reserpine (Serpalan) digitalis (Digoxin, Lanoxicaps, Lanoxin) ketoconazole (Nizoral) erythromycin (Ery-tab, Eryc, PCE) azithromycin (Zithromax, Zmax) antihistamines other decongestant medicines Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. How should I take Clarinex-D 24 Hour Extended Release Tablets? Take Clarinex-D 24 Hour Extended Release Tablets exactly as your doctor tells you to take it. Clarinex-D 24 Hour Extended Release Tablets can be taken with or without food. Swallow Clarinex-D 24 Hour Extended Release Tablets whole. Do not break, crush, or chew Clarinex-D 24 Hour Extended Release Tablets before swallowing. If you can not swallow Clarinex-D 24 Hour Extended Release Tablets whole, tell your doctor. You may need a different medicine. Take 1 Clarinex-D 24 Hour Extended Release Tablet every day. What are the possible side effects of CLARINEX-D 24 Hour Extended Release Tablets? Clarinex-D 24 Hour Extended Release Tablets may cause serious side effects, including: Cardiovascular and central nervous system effects, such as unable to sleep (insomnia) dizziness weakness tremor irregular heart beat seizure low blood pressure Increased sleepiness or tiredness can happen if you take more Clarinex-D 24 Hour Extended Release Tablets than your doctor prescribed to you. Allergic reactions. Stop taking Clarinex-D 24 Hour Extended Release Tablets and call your doctor right away or get emergency help if you have any of these symptoms: rash itching hives swelling of your lips, tongue, face, and throat shortness of breath or trouble breathing The most common side effects of Clarinex-D 24 Hour Extended Release Tablets include: dry mouth headache unable to sleep (insomnia) tiredness sore throat sleepiness nausea dizziness nervousness restlessness poor appetite Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Clarinex-D 24 Hour Extended Release Tablets. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store CLARINEX-D 24 Hour Extended Release Tablets? Store Clarinex-D 24 Hour Extended Release Tablets at 59 F to 86 F (15 C to 30 C) Keep Clarinex-D 24 Hour Extended Release Tablets dry and out of the light. Keep Clarinex-D 24 Hour Extended Release Tablets and all medicines out of the reach of children. General information about CLARINEX-D 24 Hour Extended Release Tablets Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Clarinex-D 24 Hour Extended Release Tablets for a condition for which it was not prescribed. Do not give Clarinex-D 24 Hour Extended Release Tablets to other people, even if they have the same condition you have. It may harm them. This patient information leaflet summarizes the most important information about Clarinex-D 24 Hour Extended Release Tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clarinex-D 24 Hour Extended Release Tablets that is written for health professionals. For more information, go to www.CLARINEX.com. What are the ingredients in CLARINEX-D 24 Hour Extended Release Tablets? Active ingredients: desloratadine and pseudoephedrine sulfate Inactive ingredients: hypromellose USP, ethylcellulose NF, dibasic calcium phosphate dihydrate USP, magnesium stearate NF, povidone USP, silicone dioxide NF, talc USP, polyacrylate dispersion, polyethylene glycol NF, simethicone USP, Blue Lake Blend 50726 (FD&C Blue No. 2 Lake, titanium dioxide USP and edetate disodium USP), and ink (Opacode S-1-17746 or Opacode S-1-4159). Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA For patent information: www.merck.com/product/patent/home.html Copyright 2005, 2009 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Revised: 03/2014 usppi-mk4117a-t-d24-1403r005 PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label NDC 0085-1317-01 100 Tablets CLARINEX -D 24 HOUR (desloratadine 5 mg/ pseudoephedrine sulfate, USP 240 mg) EXTENDED RELEASE TABLETS Rx only actual size Clarinex-D 24 Hour desloratadine and pseudoephedrine sulfate tablet, film coated, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0085-1317 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength desloratadine (desloratadine) desloratadine 5 mg pseudoephedrine sulfate (pseudoephedrine) pseudoephedrine sulfate 240 mg Inactive Ingredients Ingredient Name Strength hypromelloses ethylcellulose (100 MPA.S) calcium phosphate, dibasic, dihydrate magnesium stearate povidones silicon dioxide talc polyethylene glycols FD&C Blue No. 2 aluminum oxide titanium dioxide edetate disodium Product Characteristics Color BLUE (light blue) Score no score Shape OVAL Size 18mm Flavor Imprint Code D;24 Contains Packaging # Item Code Package Description 1 NDC:0085-1317-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021605 03/03/2005 Labeler - Merck Sharp & Dohme Corp. (001317601) Establishment Name Address ID/FEI Operations Merck Sharp & Dohme Corp. 010185964 MANUFACTURE(0085-1317) Establishment Name Address ID/FEI Operations Schering-Plough (Avondale) Company 985098519 API MANUFACTURE(0085-1317) Establishment Name Address ID/FEI Operations BASF PharmaChemikalien GmbH & Co. KG 328633636 API MANUFACTURE(0085-1317) Revised: 03/2014 Merck Sharp & Dohme Corp. Next Interactions Print this page Add to My Med List More about Clarinex-D 24 Hour (desloratadine / pseudoephedrine) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: upper respiratory combinations Consumer resources Clarinex-D 24 Hour Other Formulations Clarinex Clarinex-D 12 Hour Clarinex Reditabs Related treatment guides Allergic Rhinitis> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug WADA Class Anti-Doping Classification Drug Class Upper respiratory combinations Related Drugs upper respiratory combinations Promethazine DM , Cheratussin AC , Mucinex DM Allergic Rhinitis prednisone , Zyrtec , promethazine , fluticasone nasal , loratadine , cetirizine , Flonase , triamcinolone nasal , montelukast , Claritin , Singulair , diphenhydramine , Benadryl , fexofenadine , budesonide nasal , Medrol , dexamethasone , Nasonex , methylprednisolone , azelastine nasal , mometasone nasal , levocetirizine , Allegra , More... 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