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

preferred pharmaceuticals inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride tablets is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2) ]. patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis. children 6 months to 11 years of age with impaired renal function. pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, levocetirizine dihydrochloride

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

micro labs limited - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 years of age and older. levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. the use of levocetirizine dihydrochloride tablets are contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions ( 6.2) ]. patients with end-stage renal disease (cl cr < 10 ml/min) and patients undergoing hemodialysis children 6 months to 11 years of age with impaired renal function risk summary available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient

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

caraco pharmaceutical laboratories, ltd. - cetirizine hydrochloride (unii: 64o047ktoa) (cetirizine - unii:yo7261me24) - cetirizine hydrochloride 1 mg in 1 ml - cetirizine hydrochloride syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. cetirizine hydrochloride syrup is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months to 5 years of age. it significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus. cetirizine hydrochloride syrup is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine. there is no information to indicate that abuse or dependency occurs with cetirizine hydrochloride.

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

amneal pharmaceuticals llc - cetirizine hydrochloride (unii: 64o047ktoa) (cetirizine - unii:yo7261me24) - cetirizine hydrochloride 5 mg in 5 ml - perennial allergic rhinitis: cetirizine hydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. chronic urticaria: cetirizine hydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. it significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus. cetirizine hydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine. there is no information to indicate that abuse or dependency occurs with cetirizine hydrochloride.

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

bryant ranch prepack - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2) ]. patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis. children 6 months to 11 years of age with impaired renal function. pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, levocetirizine dihydrochloride should be used

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

a-s medication solutions - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2) ]. patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis. children 6 months to 11 years of age with impaired renal function. pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, levocetirizine dihydrochloride should be used

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

heritage pharmaceuticals inc. - cetirizine hydrochloride (unii: 64o047ktoa) (cetirizine - unii:yo7261me24) - cetirizine hydrochloride 1 mg in 1 ml - perennial allergic rhinitis : cetirizine hydrochloride oral solution, usp is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. chronic urticaria: cetirizine hydrochloride oral solution, usp is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. it significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus. cetirizine hydrochloride oral solution, usp is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine. there is no information to indicate that abuse or dependency occurs with cetirizine hydrochloride.

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

preferred pharmaceuticals, inc. - cetirizine hydrochloride (unii: 64o047ktoa) (cetirizine - unii:yo7261me24) - cetirizine hydrochloride 1 mg in 1 ml - perennial allergic rhinitis : cetirizine hydrochloride oral solution, usp is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. chronic urticaria: cetirizine hydrochloride oral solution, usp is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. it significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus. cetirizine hydrochloride oral solution, usp is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine. there is no information to indicate that abuse or dependency occurs with cetirizine hydrochloride.

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

glenmark pharmaceuticals inc., usa - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride tablets are contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2) ]. patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis children 6 months to 11 years of age with impaired renal function risk summary available data from published literature and post-marketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the oral route to pregnant rats and rabbits, during the period of organogenesis, at doses up to 390 times and 470 times, respectively, the maximum recommended human dose (mrhd) in adults. in rats treated during late gestation and the lactation period, cetirizine had no effects on pup development at oral doses up to approximately 60 times the mrhd in adults. in mice treated during late gestation and the lactation period, cetirizine administered by the oral route to the dams had no effects on pup development at a dose that was approximately 25 times the mrhd in adults; however, lower pup weight gain during lactation was observed at a dose that was 95 times the mrhd in adults (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in embryo-fetal development studies, pregnant rats received daily doses of levocetirizine up to 200 mg/kg/day from gestation days 6 to 15 and pregnant rabbits received daily doses of levocetirizine up to 120 mg/kg/day from gestation days 6 to 18. levocetirizine produced no evidence of fetal harm in rats and rabbits at doses up to 390 and 470 times the mrhd, respectively (on a mg/m2 basis with maternal oral doses of 200 and 120 mg/kg/day in rats and rabbits, respectively). no prenatal and postnatal development (ppnd) studies in animals have been conducted with levocetirizine. in a ppnd study conducted in mice, cetirizine was administered at oral doses up to 96 mg/kg/day from gestation day 15 through lactation day 21. cetirizine lowered pup body weight gain during lactation at an oral dose in dams that was approximately 95 times the mrhd (on a mg/m2 basis with a maternal oral dose of 96 mg/kg/day); however, there were no effects on pup weight gain at an oral dose in dams that was approximately 25 times the mrhd (on a mg/m2 basis with a maternal oral dose of 24 mg/kg/day). in a ppnd study conducted in rats, cetirizine was administered at oral doses up to 180 mg/kg/day from gestation day 17 to lactation day 22. cetirizine did not have any adverse effects on rat dams or offspring development at doses up to approximately 60 times the mrhd (on a mg/m2 basis with a maternal oral dose of 30 mg/kg/day). cetirizine caused excessive maternal toxicity at an oral dose in dams that was approximately 350 times the mrhd (on a mg/m2 basis with a maternal oral dose of 180 mg/kg/day). risk summary there are no data on the presence of levocetirizine in human milk, the effects on the breastfed infant, or the effects on milk production. however, cetirizine has been reported to be present in human breast milk. in mice and beagle dogs, studies indicated that cetirizine was excreted in milk (see data) . when a drug is present in animal milk, it is likely the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for levocetirizine dihydrochloride tablets and any potential adverse effects on the breastfed child from levocetirizine dihydrochloride or from the underlying maternal condition. data animal data cetirizine was detected in the milk of mice. no adverse developmental effects on pups were seen when cetirizine was administered orally to dams during lactation at a dose that was approximately 25 times the mrhd in adults [see use in specific populations (8.1) ]. studies in beagle dogs indicated that approximately 3% of the dose of cetirizine was excreted in milk. the concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk. the recommended dose of levocetirizine dihydrochloride for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older [see clinical studies (14)]. the recommended dose of levocetirizine dihydrochloride in patients 6 months to 2 years of age for the treatment of the symptoms of perennial allergic rhinitis and 6 months to 11 years of age with chronic idiopathic urticaria is based on cross-study comparisons of the systemic exposure of levocetirizine dihydrochloride in adults and pediatric patients and on the safety profile of levocetirizine dihydrochloride in both adult and pediatric patients at doses equal to or higher than the recommended dose for patients 6 months to 11 years of age. the safety of levocetirizine dihydrochloride 5 mg once daily was evaluated in 243 pediatric patients 6 to 12 years of age in two placebo-controlled clinical trials lasting 4 and 6 weeks. the safety of levocetirizine dihydrochloride 1.25 mg twice daily was evaluated in one 2-week clinical trial in 114 pediatric patients 1 to 5 years of age and the safety of levocetirizine dihydrochloride 1.25 mg once daily was evaluated in one 2-week clinical trial in 45 pediatric patients 6 to 11 months of age [see adverse reactions (6.1)]. the effectiveness of levocetirizine dihydrochloride 1.25 mg once daily (6 months to 5 years of age) and 2.5 mg once daily (6 to 11 years of age) for the treatment of the symptoms of perennial allergic rhinitis and chronic idiopathic urticaria is supported by the extrapolation of demonstrated efficacy of levocetirizine dihydrochloride 5 mg once daily in patients 12 years of age and older based on the pharmacokinetic comparison between adults and children. cross-study comparisons indicate that administration of a 5 mg dose of levocetirizine dihydrochloride to 6 to 12 year old pediatric patients resulted in about 2-fold the systemic exposure (auc) observed when 5 mg of levocetirizine dihydrochloride was administered to healthy adults. therefore, in children 6 to 11 years of age the recommended dose of 2.5 mg once daily should not be exceeded. in a population pharmacokinetics study the administration of 1.25 mg once daily in children 6 months to 5 years of age resulted in systemic exposure comparable to 5 mg once daily in adults. [see dosage and administration (2.2), clinical studies (14), and clinical pharmacology (12.3)]. clinical studies of levocetirizine dihydrochloride for each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. levocetirizine dihydrochloride is known to be substantially excreted by the kidneys and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. 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 renal function [see dosage and administration (2) and clinical pharmacology (12.3)]. as levocetirizine is mainly excreted unchanged by the kidneys, it is unlikely that the clearance of levocetirizine is significantly decreased in patients with solely hepatic impairment [see clinical pharmacology (12.3)] .

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

taro pharmaceuticals u.s.a., inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 0.5 mg in 1 ml - levocetirizine dihydrochloride oral solution is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. levocetirizine dihydrochloride oral solution is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions (6.2)] . patients with end-stage renal disease (clcr <10 ml/min) and patients undergoing hemodialysis children 6 months to 11 years of age with impaired renal function risk summary available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects,