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zydus pharmaceuticals usa inc. - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson's disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregna

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

sandoz inc - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson's disease. none. pregnancy: teratogenic effects pregnancy category c there are no adequate and well-controlled studies in pregnant women. pramipexole dihydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pramipexole was given to female rats throughout pregnancy, implantation was inhibited at a dose of 2.5 mg/kg/day (5 times the maximum recommended human dose (mrhd) for parkinson’s disease of 4.5 mg/day on a body surface area (mg/m2 ) basis). administration of 1.5 mg/kg/day of pramipexole to pregnant rats during the period of organogenesis (gestation days 7 through 16) resulted in a high incidence of total resorption of embryos. the plasma auc in rats at this dose was 4 times the auc in humans at the mrhd. these findings are thought to be due to the prolactin-lowering effect of pramipexole, since prolactin is necessary for implantation and maintenance

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yiling pharmaceutical, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - 1.2 chronic idiopathic urticaria levocetirizine dihydrochloride 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 tablet is contraindicated in: 4.1 patients with known hypersensitivity 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)]. 4.2 patients with end-stage renal disease patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis 4.3 pediatric patients with impaired renal function children 6 months to 11 years of age with impaired renal function 8.1 pregnancy risk summary available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-ass

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avkare, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - 1.2 perennial allergic rhinitis levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older. the use of levocetirizine dihydrochloride tablet is contraindicated in: 4.1 patients with known hypersensitivity 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)]. 4.2 patients with end-stage renal disease patients with end-stage renal disease (clcr < 10 ml/min) and patients undergoing hemodialysis 4.3 pediatric patients with impaired renal function children 6 months to 11 years of age with impaired renal function 8.1 pregnancy pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictiv

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camber pharmaceuticals, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - 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 (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, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the

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remedyrepack inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - 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 to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evid

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

pd-rx pharmaceuticals, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - 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 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 (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 to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence

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

rising pharma holdings, inc. - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson's disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. this increase in embryolethality is thought to result from the prolactin-lowering effect of pramipexole; prolactin is necessary for implantation and maintenance of early pregnancy in rats but not in rabbits or humans. because of pregnancy disruption and early embryonic loss in this study, the teratogenic potential of pramipexole could not be adequately assessed in rats. the highest no-effect dose for embryolethality in rats was associated with maternal plasma drug exposures (auc) approximately equal to those in humans receiving the maximum recommended human dose (mrhd) of 4.5 mg/day. there were no adverse effects on embryo-fetal development following oral administration of pramipexole (0.1, 1, or 10 mg/kg/day) to pregnant rabbits during organogenesis (plasma auc up to approximately 70 times that in humans at the mrhd). postnatal growth was inhibited in the offspring of rats treated with pramipexole (0.1, 0.5, or 1.5 mg/kg/day) during the latter part of pregnancy and throughout lactation. the no-effect dose for adverse effects on offspring growth (0.1 mg/kg/day) was associated with maternal plasma drug exposures lower than that in humans at the mrhd. risk summary there are no data on the presence of pramipexole in human milk, the effects of pramipexole on the breastfed infant, or the effects of pramipexole on milk production. however, inhibition of lactation is expected because pramipexole inhibits secretion of prolactin in humans. pramipexole or metabolites, or both, are present in rat milk [see data] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pramipexole dihydrochloride and any potential adverse effects on the breastfed infant from pramipexole dihydrochloride or from the underlying maternal condition. data in a study of radio-labeled pramipexole, pramipexole or metabolites, or both, were present in rat milk at concentrations three to six times higher than those in maternal plasma. safety and effectiveness of pramipexole dihydrochloride in pediatric patients has not been established. pramipexole total oral clearance is approximately 30% lower in subjects older than 65 years compared with younger subjects, because of a decline in pramipexole renal clearance due to an age-related reduction in renal function. this resulted in an increase in elimination half-life from approximately 8.5 hours to 12 hours. in clinical studies with parkinson’s disease patients, 38.7% of patients were older than 65 years. there were no apparent differences in efficacy or safety between older and younger patients, except that the relative risk of hallucination associated with the use of pramipexole dihydrochloride tablets was increased in the elderly. in clinical studies with rls patients, 22% of patients were at least 65 years old. there were no apparent differences in efficacy or safety between older and younger patients. the elimination of pramipexole is dependent on renal function. pramipexole clearance is extremely low in dialysis patients, as a negligible amount of pramipexole is removed by dialysis. caution should be exercised when administering pramipexole dihydrochloride tablets to patients with renal disease [see dosage and administration (2.2) ,   warnings and precautions (5.7) , and clinical pharmacology (12.3) ].

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synthon 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 seasonal allergic rhinitis in adults and children 6 years of age and older. pediatric use information in pediatric patients (age 2 to 5 years) with seasonal allergic rhinitis is approved for ucb inc.'s levocetirizine dihydrochloride drug product. however, due to ucb inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older. pediatric use information in pediatric patients (age 6 months to 5 years) with perennial allergic rhinitis is approved for ucb inc.'s levocetirizine dihydrochloride drug product. however, due to ucb inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. levocetirizine dihydrochloride tablets are indicated for the trea

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macleods pharmaceuticals limited - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment parkinson's disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls).  none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1,