Australia - English - Department of Health (Therapeutic Goods Administration)

adiramedica pty ltd - desloratadine, quantity: 0.5 mg/ml - oral liquid, syrup - excipient ingredients: glycerol; propylene glycol; disodium edetate; sunset yellow fcf; sodium benzoate; citric acid monohydrate; sodium citrate; sucrose; purified water; flavour - desloratadine syrup is indicated for: - relief from hayfever, year-round allergies and hives. - relief of symptoms including sneezing, runny or itchy nose, itchy or watery eyes, itchy palate, itchy skin and hives.

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - desloratadine - syrup - desloratadine 0.5 mg/ml - desloratadine - for the relief of symptoms associated with allergic rhinitis and/or chronic idiopathic urticaria in adults and children 1 year of age and above.

United States - English - NLM (National Library of Medicine)

bionpharma inc. - desloratadine (unii: fvf865388r) (desloratadine - unii:fvf865388r) - desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older. desloratadine tablets are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older. desloratadine tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see warnings and precautions (5.1) and adverse reactions ( 6.2)]. risk summary the limited available data with desloratadine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. there are no adequate and well-controlled studies in pregnant women. desloratadine given during organogenesis to pregnant rats was

United States - English - NLM (National Library of Medicine)

sandoz inc - desloratadine (unii: fvf865388r) (desloratadine - unii:fvf865388r) - desloratadine 5 mg

United States - English - NLM (National Library of Medicine)

paddock laboratories, llc - desloratadine (unii: fvf865388r) (desloratadine - unii:fvf865388r) - desloratadine 5 mg

United States - English - NLM (National Library of Medicine)

a-s medication solutions - desloratadine (unii: fvf865388r) (desloratadine - unii:fvf865388r) - desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older. desloratadine tablets are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older. desloratadine tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see warnings and precautions (5.1) and adverse reactions (6.2) ]. risk summary the limited available data with desloratadine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. there are no adequate and well-controlled studies in pregnant women. desloratadine given during organogenesis to pregnant rats was not teratogenic at the summed area under the concentration-time curve (auc)-based exposures of desloratadine and its metabolite approximately 320 times that at the recommended human daily oral dose (rhd) of 5 mg/day. desloratadine given during organogenesis to pregnant rabbits was not teratogenic at the auc-based exposures of desloratadine approximately 230 times that at the rhd. desloratadine given to pregnant rats during organogenesis through lactation resulted in reduced body weight and slow righting reflex of f1 pups at the summed auc-based exposures of desloratadine and its metabolite approximately 70 times or greater than that at the rhd [see data ]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data 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). no fetal malformations were present. reduced fetal weights and skeletal variations noted at doses of 24 and 48 mg/kg/day were likely secondary to the maternal toxicities of reduced body weight gain and food consumption observed at the same doses. 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). no adverse effects to the fetus were noted. reduced maternal body weight gain was noted in rabbits at 60 mg/kg/day. in a peri- and post-natal development study, desloratadine was given to rats orally during the perinatal (gestation day 6) through lactation periods (postpartum day 21) at doses of 3, 9 and 18 mg/kg/day. reduced body weight and slow righting reflex were reported in f1 pups at doses of 9 mg/kg/day or greater (approximately 70 times or greater than the summed auc-based exposure of desloratadine and its metabolite at the rhd). desloratadine had no effect on f1 pup development at 3 mg/kg/day (approximately 10 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). maternal toxicities including reduced body weight gain and food consumption were noted at 18 mg/kg/day for f0 dams. f1 offspring were subsequently mated and there was no developmental toxicity for f2 pups observed. risk summary desloratadine passes into breast milk. there are not sufficient data on the effects of desloratadine on the breastfed infant or the effects of desloratadine on milk production. the decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the developmental and health benefits of breastfeeding, the nursing mother's clinical need, and any potential adverse effects on the breastfed infant from desloratadine or from the underlying maternal condition. infertility there are no data available on human infertility associated with desloratadine. there were no clinically relevant effects of desloratadine on female fertility in rats. a male specific decrease in fertility occurred at an oral desloratadine dose of 12 mg/kg or greater in rats (approximately 65 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). male fertility was unaffected at a desloratadine dose of 3 mg/kg (approximately 10 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). [see nonclinical toxicology (13.1) .] the recommended dose of desloratadine oral solution in the pediatric population is based on cross-study comparison of the plasma concentration of desloratadine in adults and pediatric subjects. the safety of desloratadine oral solution has been established in 246 pediatric subjects aged 6 months to 11 years in three placebo-controlled clinical studies. since the course of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria and the effects of desloratadine are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients. the effectiveness of desloratadine oral solution in these age groups is supported by evidence from adequate and well-controlled studies of desloratadine tablets in adults. the safety and effectiveness of desloratadine tablets or desloratadine oral solution have not been demonstrated in pediatric patients less than 6 months of age. [see clinical pharmacology (12.3). ] clinical studies of desloratadine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences between the elderly and younger patients. 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). ] dosage adjustment for patients with renal impairment is recommended [see dosage and administration (2.5) and clinical pharmacology (12.3) ]. dosage adjustment for patients with hepatic impairment is recommended [see dosage and administration (2.5) and clinical pharmacology (12.3) ]. there is no information to indicate that abuse or dependency occurs with desloratadine tablets.

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - desloratadine (unii: fvf865388r) (desloratadine - unii:fvf865388r), pseudoephedrine sulfate (unii: y9dl7qpe6b) (pseudoephedrine - unii:7cuc9ddi9f) - desloratadine 2.5 mg - clarinex-d® 12 hour extended release tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. clarinex-d 12 hour extended release tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired [see clinical pharmacology (12)] . clarinex-d 12 hour extended release tablets are contraindicated in: - patients with hypersensitivity to any of its ingredients, or to loratadine [see warnings and precautions (5.4) and post-marketing experience (6.2)] - patients with narrow angle glaucoma - patients with urinary retention - patients receiving monoamine oxidase (mao) inhibitor therapy or within fourteen (14) days of stopping such treatment [see drug interactions (7.1)] . - patients with severe hypertension or severe coronary artery disease pregnancy category c: there are no adequate and well-controlled stu

United States - English - NLM (National Library of Medicine)

merck sharp & dohme corp. - desloratadine (unii: fvf865388r) (desloratadine - unii:fvf865388r), pseudoephedrine sulfate (unii: y9dl7qpe6b) (pseudoephedrine - unii:7cuc9ddi9f) - desloratadine 2.5 mg - clarinex-d® 12 hour extended release tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. clarinex-d 12 hour extended release tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired [see clinical pharmacology (12)]. clarinex-d 12 hour extended release tablets are contraindicated in: - patients with hypersensitivity to any of its ingredients, or to loratadine [see warnings and precautions (5.4) and adverse reactions (6.2)] - patients with narrow-angle glaucoma - patients with urinary retention - patients receiving monoamine oxidase (mao) inhibitor therapy or within fourteen (14) days of stopping such treatment [see drug interactions (7.1)] - patients with severe hypertension or severe coronary artery disease risk summary the limited available data with clarinex-d 12 hour in pregnant wom

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

aurobindo sa-nv - desloratadine 5 mg - film-coated tablet - 5 mg - desloratadine 5 mg - desloratadine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - desloratadine 0,5 mg/ml - oral solution - 0,5 mg/ml - desloratadine 0.5 mg/ml - desloratadine