USA - engelsk - NLM (National Library of Medicine)

novel laboratories, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg - attention deficit disorders, narcolepsy attention deficit disorders  (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is 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 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 dysfun

USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 2.5 mg - attention deficit disorders , narcolepsy attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride chewable 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 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. specific etiology of this syndrome is unknown, and there is no single diagnostic test. adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal eeg. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. drug treatment is not indicated for all children with this syndrome. stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is generally necessary. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. methylphenidate hydrochloride chewable tablet is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the drug. methylphenidate hydrochloride chewable tablets are contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

USA - engelsk - 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

USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 2.5 mg - dexmethylphenidate hydrochloride tablet is 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 maoi, because of the risk of hypertensive crises [see drug interactions (7.1)] . risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy (see clinical considerations) . embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (mrhd) of 20 mg/day given to adults based on plasma levels. a decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the mrhd of 20 mg/day given to adults based on plasma levels. plasma levels in adults were comparatively similar to plasma levels in adolescents (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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions cns stimulants such as dexmethylphenidate hydrochloride, can cause vasoconstriction and thereby decrease placental perfusion. no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. data animal data in embryo-fetal development 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 malformations 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, post-weaning 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 [area under the curves (aucs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with the mrhd of 20 mg/day. racemic methylphenidate has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis. risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. long-term neurodevelopmental effects on infants from stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmethylphenidate hydrochloride and any potential adverse effects on the breastfed infant from dexmethylphenidate hydrochloride or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. the safety and effectiveness of dexmethylphenidate hydrochloride have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials [see clinical studies (14)]. the safety and effectiveness of dexmethylphenidate hydrochloride in pediatric patients less than 6 years have not been established. the long-term efficacy of dexmethylphenidate hydrochloride in pediatric patients has not been established. long term suppression of growth growth should be monitored during treatment with stimulants, including dexmethylphenidate hydrochloride tablets. pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.7)] . juvenile animal toxicity data rats treated with racemic methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. a deficit in acquisition of a specific learning task was observed in females only. the doses at which these findings were observed are at least 6 times the mrhd of 60 mg/day given to children on a mg/m2 basis. in a study conducted in young rats, racemic methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). when these animals were tested as adults (postnatal weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the mrhd of 60 mg of racemic methylphenidate given to children on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the mrhd given to children on a mg/m2 basis). the no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the mrhd given to children on a mg/m2 basis). the clinical significance of the long-term behavioral effects observed in rats is unknown. dexmethylphenidate hydrochloride has not been studied in the geriatric population. dexmethylphenidate hydrochloride tablet contains dexmethylphenidate hydrochloride, a schedule ii controlled substance. dexmethylphenidate hydrochloride tablet has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1) ]. dexmethylphenidate hydrochloride tablet can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse ofcns stimulants, including dexmethylphenidate hydrochloride tablets, can result in overdose and death [see overdosage (10) ], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. physical dependence dexmethylphenidate hydrochloride tablets may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including dexmethylphenidate hydrochloride tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance dexmethylphenidate hydrochloride tablets may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 10 mg - methylphenidate hydrochloride extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in pediatric patients 6 to 15 years of age. methylphenidate hydrochloride extended-release capsules are contraindicated in patients with: - known hypersensitivity to methylphenidate or other component of methylphenidate hydrochloride extended-release capsules. angioedema has been reported in patients treated with methylphenidate hydrochloride extended-release capsules. anaphylactic reactions have been reported in patients treated with other methylphenidate products [see adverse reactions (6)] . - concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crisis [see drug interactions (7)] . - methylphenidate hydrochloride extended-release capsules contain sucrose. therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorpti

USA - engelsk - NLM (National Library of Medicine)

specgx llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 10 mg - methylphenidate hcl extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in pediatric patients 6 to 15 years of age. methylphenidate hcl extended-release capsules are contraindicated in patients with: - known hypersensitivity to methylphenidate or other component of methylphenidate hcl extended-release capsules. angioedema has been reported in patients treated with methylphenidate hcl extended-release capsules. anaphylactic reactions have been reported in patients treated with other methylphenidate products [see adverse reactions (6)] . - concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crisis [see drug interactions (7)] . - methylphenidate hcl extended-release capsules contain sucrose. therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate 20 mg - attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is 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 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 war

USA - engelsk - NLM (National Library of Medicine)

novel laboratories, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 2.5 mg - attention  deficit  disorders , narcolepsy attention  deficit  disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride chewable 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 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 centra

USA - engelsk - NLM (National Library of Medicine)

camber pharmaceuticals inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 2.5 mg - attention deficit disorders, narcolepsy attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride chewable 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 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

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 18 mg - methylphenidate hydrochloride (hcl) extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents and adults up to the age of 65 [see clinical studies (14)] . hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate hcl extended-release tablets. therefore, methylphenidate hcl extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.5)] . methylphenidate hcl extended-release tablets are contraindicated during treatment with monoamine oxidase (mao) inhibitors, and also within a minimum of 14 days following discontinuation of a mao inhibitor (hypertensive crises may result) [see drug interactions (7.1)] . pregnancy category c methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively. a reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose of methylphenidate hcl extended-release tablets on a mg/kg and mg/m2 basis, respectively. the approximate plasma exposure to methylphenidate plus its main metabolite ppaa in pregnant rats was 1 to 2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate hcl extended-release tablets based on the auc. the safety of methylphenidate for use during human pregnancy has not been established. there are no adequate and well-controlled studies in pregnant women. methylphenidate hcl extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of methylphenidate hcl extended-release tablets on labor and delivery in humans is unknown. it is not known whether methylphenidate is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised if methylphenidate hcl extended-release tablets are administered to a nursing woman. in lactating female rats treated with a single oral dose of 5 mg/kg radiolabeled methylphenidate, radioactivity (representing methylphenidate and/or its metabolites) was observed in milk and levels were generally similar to those in plasma. methylphenidate hcl extended-release tablets should not be used in children under six years, since safety and efficacy in this age group have not been established. long-term effects of methylphenidate in children have not been well established. methylphenidate hcl extended-release tablets have not been studied in patients greater than 65 years of age. methylphenidate hydrochloride extended-release tablets contain methylphenidate a schedule ii controlled substance. methylphenidate hcl extended-release tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1)] . methylphenidate hcl extended-release tablets can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including methylphenidate hcl extended-release tablets, can result in overdose and death [see overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. in two placebo-controlled human abuse potential studies, single oral doses of methylphenidate hcl extended-release tablets were compared to single oral doses of immediate-release methylphenidate (ir mph) and placebo in subjects with a history of recreational stimulant use to assess relative abuse potential. for the purpose of this assessment, the response for each of the subjective measures was defined as the maximum effect within the first 8 hours after dose administration. in one study (n=40), both methylphenidate hcl extended-release tablets (108 mg) and 60 mg ir mph compared to placebo produced statistically significantly greater responses on the five subjective measures suggestive of abuse potential. in comparisons between the two active treatments, however, methylphenidate hcl extended-release tablets (108 mg) produced variable responses on positive subjective measures that were either statistically indistinguishable from (abuse potential, drug liking, amphetamine and morphine benzedrine group [euphoria]) or statistically less than (stimulation – euphoria) responses produced by 60 mg ir mph. in another study (n=49), both doses of methylphenidate hcl extended-release tablets (54 mg and 108 mg) and both doses of ir mph (50 mg and 90 mg) produced statistically significantly greater responses compared to placebo on the two primary scales used in the study (drug liking, euphoria). when doses of methylphenidate hcl extended-release tablets (54 mg and 108 mg) were compared to ir mph (50 mg and 90 mg), respectively, methylphenidate hcl extended-release tablets produced statistically significantly lower subjective responses on these two scales than ir mph. methylphenidate hcl extended-release tablets (108 mg) produced responses that were statistically indistinguishable from the responses on these two scales produced by ir mph (50 mg). differences in subjective responses to the respective doses should be considered in the context that only 22% of the total amount of methylphenidate in methylphenidate extended-release tablets are available for immediate release from the drug overcoat [see system components and performance (11.1)] . although these findings reveal a relatively lower response to methylphenidate hcl extended-release tablets on subjective measures suggestive of abuse potential compared to ir mph at roughly equivalent total mph doses, the relevance of these findings to the abuse potential of methylphenidate hcl extended-release tablets in the community is unknown. physical dependence methylphenidate hcl extended-release tablets may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including methylphenidate hcl extended-release tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hcl extended-release tablets may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).