Amerika Serikat - Inggris - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 50 mg - sertraline hydrochloride tablets are indicated for the treatment of the following [see clinical studies (14)] : sertraline hydrochloride tablets are contraindicated in patients: risk summary overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. some studies have reported increases for specific major birth defects; however, these study results are inconclusive [see data] . there are clinical considerations regarding neonates exposed to ssris and snris, including sertraline hydrochloride, during the third trimester of pregnancy [see clinical considerations]. although no teratogenicity was observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (mrhd) in rats and doses 3.1 times

Amerika Serikat - Inggris - NLM (National Library of Medicine)

sandoz inc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg - methylphenidate hydrochloride and methylphenidate hydrochloride sustained-release are indicated for the treatment of: • attention deficit hyperactivity disorders (adhd) in pediatric patients 6 years and older and adults • narcolepsy pregnancy category c in studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (mrhd) on a mg/m2 basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the mrhd on a mg/m2 basis). there was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the mrhd on a mg/m2 basis), which was also maternally toxic. the no effect level for embryo-fetal development

Amerika Serikat - Inggris - NLM (National Library of Medicine)

camber pharmaceutical inc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg - methylphenidate hydrochloride tablets are indicated for the treatment of: - attention deficit hyperactivity disorders (adhd) in pediatric patients 6 years and older and adults - narcolepsy - hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [see adverse  reactions (6.1)]. - concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visit htt

Amerika Serikat - Inggris - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - methamphetamine hydrochloride (unii: 997f43z9cv) (methamphetamine - unii:44ral3456c) - methamphetamine hydrochloride 5 mg - attention deficit disorder with hyperactivity: methamphetamine hydrochloride tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. in patients known to be hypersensitive to amphetamine, or other components of methamphetamine hydrochloride tablets, hypersensitivity reactions such as angioedema and anaphylactic reactions have been re

Amerika Serikat - Inggris - NLM (National Library of Medicine)

sandoz inc - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 2.5 mg - dexmethylphenidate hydrochloride is indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)] . pregnancy category c in studies conducted in rats and rabbits, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. no evidence of teratogenic activity was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. when dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, postweaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. at the highest doses tested, plasma levels (aucs) of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with the maximum recommended human dose (mrhd) of 20 mg/day. racemic methylphen

Amerika Serikat - Inggris - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 2.5 mg - dexmethylphenidate hydrochloride tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)]. - hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride tablets. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6.1)] . - concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an moai, because of the risk of hypertensive crises [see drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including dexmethylphenidate hydrochloride tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adh

Amerika Serikat - Inggris - NLM (National Library of Medicine)

mayne pharma commercial llc - methamphetamine hydrochloride (unii: 997f43z9cv) (methamphetamine - unii:44ral3456c) - methamphetamine hydrochloride 5 mg - methamphetamine hydrochloride tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. in patients known to be hypersensitive to amphetamine, or other components of methamphetamine hydrochloride tablets. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetami

Amerika Serikat - Inggris - 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

Amerika Serikat - Inggris - NLM (National Library of Medicine)

american health packaging - 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 2-4% and 15-20%, 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) t

Amerika Serikat - Inggris - NLM (National Library of Medicine)

par pharmaceutical - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 50 mg - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)]. patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)]. teratogenic effects pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 6 to 9 times the maximum recommended human dose (mrhd) of 400 mg/day on mg/m2 in adolescents.  there was also an incr