Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

bryant ranch prepack - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release tablets usp is 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)] . a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. specific etiology of this syndrome is unknown, and there is no single diagnostic test. adequate diagnosis requires the use of medical and special psychological, educational, and social resources. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of dsm-iv characteristics. methylphenidate hydrochloride extended-release tablets are indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational, social). drug treatment may not be indicated for all patients with adhd. stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. 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 patient's symptoms. hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate hydrochloride extended-release tablets. therefore, methylphenidate hydrochloride extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.6)] . methylphenidate hydrochloride extended-release tablets are contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with glaucoma. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with motor tics or with a family history or diagnosis of tourette's syndrome [see adverse reactions (6.4)] . methylphenidate hydrochloride 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 hydrochloride 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 1–2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate hydrochloride 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 hydrochloride extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets have not been studied in patients greater than 65 years of age. methylphenidate is a schedule ii controlled substance under the controlled substances act. as noted in the box warning, methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. frank psychotic episodes can occur, especially with parenteral abuse. in two placebo-controlled human abuse potential studies, single oral doses of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets (54 mg and 108 mg) were compared to ir mph (50 mg and 90 mg), respectively, methylphenidate hydrochloride extended-release tablets produced statistically significantly lower subjective responses on these two scales than ir mph. methylphenidate hydrochloride 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 hydrochloride extended-release tablets is 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 hydrochloride 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 hydrochloride extended-release tablets in the community is unknown. as noted in the box warning, careful supervision is required during withdrawal from abusive use since severe depression may occur. withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

bryant ranch prepack - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release tablets usp is 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)] . a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. specific etiology of this syndrome is unknown, and there is no single diagnostic test. adequate diagnosis requires the use of medical and special psychological, educational, and social resources. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of dsm-iv characteristics. methylphenidate hydrochloride extended-release tablets are indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational, social). drug treatment may not be indicated for all patients with adhd. stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. 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 patient's symptoms. hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate hydrochloride extended-release tablets. therefore, methylphenidate hydrochloride extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.6)] . methylphenidate hydrochloride extended-release tablets are contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with glaucoma. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with motor tics or with a family history or diagnosis of tourette's syndrome [see adverse reactions (6.4)] . methylphenidate hydrochloride 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 hydrochloride 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 1–2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate hydrochloride 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 hydrochloride extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets have not been studied in patients greater than 65 years of age. methylphenidate is a schedule ii controlled substance under the controlled substances act. as noted in the box warning, methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. frank psychotic episodes can occur, especially with parenteral abuse. in two placebo-controlled human abuse potential studies, single oral doses of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets (54 mg and 108 mg) were compared to ir mph (50 mg and 90 mg), respectively, methylphenidate hydrochloride extended-release tablets produced statistically significantly lower subjective responses on these two scales than ir mph. methylphenidate hydrochloride 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 hydrochloride extended-release tablets is 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 hydrochloride 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 hydrochloride extended-release tablets in the community is unknown. as noted in the box warning, careful supervision is required during withdrawal from abusive use since severe depression may occur. withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

bryant ranch prepack - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release tablets usp is 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)] . a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. specific etiology of this syndrome is unknown, and there is no single diagnostic test. adequate diagnosis requires the use of medical and special psychological, educational, and social resources. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of dsm-iv characteristics. methylphenidate hydrochloride extended-release tablets are indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational, social). drug treatment may not be indicated for all patients with adhd. stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. 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 patient's symptoms. hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate hydrochloride extended-release tablets. therefore, methylphenidate hydrochloride extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.6)] . methylphenidate hydrochloride extended-release tablets are contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with glaucoma. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with motor tics or with a family history or diagnosis of tourette's syndrome [see adverse reactions (6.4)] . methylphenidate hydrochloride 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 hydrochloride 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 1–2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate hydrochloride 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 hydrochloride extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets have not been studied in patients greater than 65 years of age. methylphenidate is a schedule ii controlled substance under the controlled substances act. as noted in the box warning, methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. frank psychotic episodes can occur, especially with parenteral abuse. in two placebo-controlled human abuse potential studies, single oral doses of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets (54 mg and 108 mg) were compared to ir mph (50 mg and 90 mg), respectively, methylphenidate hydrochloride extended-release tablets produced statistically significantly lower subjective responses on these two scales than ir mph. methylphenidate hydrochloride 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 hydrochloride extended-release tablets is 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 hydrochloride 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 hydrochloride extended-release tablets in the community is unknown. as noted in the box warning, careful supervision is required during withdrawal from abusive use since severe depression may occur. withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

bryant ranch prepack - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release tablets usp is 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)] . a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. specific etiology of this syndrome is unknown, and there is no single diagnostic test. adequate diagnosis requires the use of medical and special psychological, educational, and social resources. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of dsm-iv characteristics. methylphenidate hydrochloride extended-release tablets are indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational, social). drug treatment may not be indicated for all patients with adhd. stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. 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 patient's symptoms. hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate hydrochloride extended-release tablets. therefore, methylphenidate hydrochloride extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.6)] . methylphenidate hydrochloride extended-release tablets are contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with glaucoma. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with motor tics or with a family history or diagnosis of tourette's syndrome [see adverse reactions (6.4)] . methylphenidate hydrochloride 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 hydrochloride 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 1–2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate hydrochloride 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 hydrochloride extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets have not been studied in patients greater than 65 years of age. methylphenidate is a schedule ii controlled substance under the controlled substances act. as noted in the box warning, methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. frank psychotic episodes can occur, especially with parenteral abuse. in two placebo-controlled human abuse potential studies, single oral doses of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets (54 mg and 108 mg) were compared to ir mph (50 mg and 90 mg), respectively, methylphenidate hydrochloride extended-release tablets produced statistically significantly lower subjective responses on these two scales than ir mph. methylphenidate hydrochloride 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 hydrochloride extended-release tablets is 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 hydrochloride 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 hydrochloride extended-release tablets in the community is unknown. as noted in the box warning, careful supervision is required during withdrawal from abusive use since severe depression may occur. withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

bryant ranch prepack - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release tablets usp is 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)] . a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. specific etiology of this syndrome is unknown, and there is no single diagnostic test. adequate diagnosis requires the use of medical and special psychological, educational, and social resources. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of dsm-iv characteristics. methylphenidate hydrochloride extended-release tablets are indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational, social). drug treatment may not be indicated for all patients with adhd. stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. 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 patient's symptoms. hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate hydrochloride extended-release tablets. therefore, methylphenidate hydrochloride extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.6)] . methylphenidate hydrochloride extended-release tablets are contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with glaucoma. methylphenidate hydrochloride extended-release tablets are contraindicated in patients with motor tics or with a family history or diagnosis of tourette's syndrome [see adverse reactions (6.4)] . methylphenidate hydrochloride 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 hydrochloride 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 1–2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate hydrochloride 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 hydrochloride extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets have not been studied in patients greater than 65 years of age. methylphenidate is a schedule ii controlled substance under the controlled substances act. as noted in the box warning, methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. frank psychotic episodes can occur, especially with parenteral abuse. in two placebo-controlled human abuse potential studies, single oral doses of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets (54 mg and 108 mg) were compared to ir mph (50 mg and 90 mg), respectively, methylphenidate hydrochloride extended-release tablets produced statistically significantly lower subjective responses on these two scales than ir mph. methylphenidate hydrochloride 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 hydrochloride extended-release tablets is 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 hydrochloride 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 hydrochloride extended-release tablets in the community is unknown. as noted in the box warning, careful supervision is required during withdrawal from abusive use since severe depression may occur. withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

stat rx usa llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg - description methylphenidate hydrochloride usp, is a mild central nervous system (cns) stimulant, available as tablets of 5, 10, and 20 mg for oral administration. methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is      methylphenidate 5mg structure image methylphenidate hydrochloride usp is a white, odorless, fine crystalline powder. its solutions are acid to litmus. it is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. its molecular formula is c14 h19 no2 •hcl, and its molecular weight is 269.77. inactive ingredients. methylphenidate hydrochloride tablets: colloidal silicon dioxide, compressible sugar, lactose monohydrate and magnesium stearate. additionally, the 5 mg contains fd and c blue #2 and fd and c red #40; the 10 mg contains fd and c blue #2 and d and c yellow #10; and the 20 mg contains fd and c yellow #6. methylphenidate is a mild central nervous system stimula

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

lannett company, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hcl extended-release capsules cd is contraindicated in patients with marked anxiety, tension and agitation, since the drug may aggravate these symptoms. methylphenidate hcl extended-release capsules cd is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product. methylphenidate hcl extended-release capsules cd contains sucrose. therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. methylphenidate hcl extended-release capsules cd is contraindicated in patients with glaucoma. methylphenidate hcl extended-release capsules cd is contraindicated in patients with motor tics or with a family history or diagnosis of tourette's syndrome (see adverse reactions). methylphenidate hcl extended-release capsules cd is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discon

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

sandoz inc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 20 mg - methylphenidate hydrochloride extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd), in pediatric patients 6 to 12 years of age [see clinical studies (14)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride extended-release capsules during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. risk summary 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) . no effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (mrhd) of 60 mg/day given to adolescents on a mg/m2 basis. however, spina bifida was observed in rabbits at a dose 52 times the mrhd given to adolescents. a decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the mrhd given to 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 methylphenidate hydrochloride extended-release capsules, 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, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the mrhd of 60 mg/day given to adolescents on a mg/m2 basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15 times the mrhd given to adolescents on a mg/m2 basis). there was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the mrhd of 60 mg/day given to adolescents on a mg/m2 basis), which was also maternally toxic. the no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the mrhd on a mg/m2 basis). when methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the mrhd of 60 mg/day given to adolescents on a mg/m2 basis), but no other effects on postnatal development were observed. the no effect level for pre- and post-natal development in rats was 15 mg/kg/day (approximately 2 times the mrhd given to adolescents on a mg/m2 basis). risk summary 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 methylphenidate hydrochloride extended-release capsules and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride extended-release capsules 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 methylphenidate hydrochloride extended-release capsules for the treatment of adhd have been established in pediatric patients aged 6 to 12 years. the safety and effectiveness of methylphenidate hydrochloride extended-release capsules in pediatric patients aged less than 6 years have not been established. the long-term efficacy of methylphenidate hydrochloride extended-release capsules in pediatric patients has not been established. long-term suppression of growth growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride extended-release capsules. 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 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 4 times the mrhd of 60 mg/day given to children on a mg/m2 basis. in a study conducted in young rats, 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/day 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. methylphenidate hydrochloride extended-release capsules have not been studied in the geriatric population. methylphenidate hydrochloride extended-release capsules are schedule ii controlled substance. methylphenidate hydrochloride extended-release capsules 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 hydrochloride extended-release capsules 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 hydrochloride extended-release capsules 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 hydrochloride extended-release capsules, 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 methylphenidate hydrochloride extended-release capsules 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 hydrochloride extended-release capsules include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hydrochloride extended-release capsules 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).

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

bryant ranch prepack - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride oral solution is indicated for the treatment of: • attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years of age and older • narcolepsy methylphenidate hydrochloride oral solution is contraindicated in patients: - with known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions ( 6 )] . - receiving 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 )] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride oral solution, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388. risk summary 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) . no effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 12 and 19 times, respectively, the maximum recommended human dose (mrhd) of 60 mg/day given to adults on a mg/m2 basis. however, spina bifida was observed in rabbits at a dose 65 times the mrhd given to adults. a decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 7 times the mrhd given to 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. fetal/neonatal adverse reactions cns stimulants, such as methylphenidate hydrochloride oral solution, 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. animal data in embryo-fetal development 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. malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 65 times the mrhd of 60 mg/day given to adults on a mg/m2  basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (19 times the mrhd given to adults on a mg/m2  basis). there was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (12 times the mrhd of 60 mg/day given to adults on a mg/m2  basis), which was also maternally toxic. the no effect level for embryo-fetal development in rats was 25 mg/kg/day (4 times the mrhd on a mg/m2  basis). when methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (7 times the mrhd of 60 mg/day given to adults on a mg/m2  basis), but no other effects on postnatal development were observed. the no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the mrhd given to adults on a mg/m2  basis). risk summary 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 methylphenidate hydrochloride oral solution and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride oral solution 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 methylphenidate hydrochloride oral solution for the treatment of adhd have been established in pediatric patients six years of age and older. the safety and effectiveness of methylphenidate hydrochloride oral solution in pediatric patients under six years of age have not been established. the long-term efficacy of methylphenidate in pediatric patients has not been established. long-term suppression of growth growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride oral solution. pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions ( 5.6 )] . juvenile animal toxicity data in a study conducted in young rats, 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 13-14), 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/day 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 (5 mg/kg/day) is less than the mrhd given to children on a mg/m2 basis. the clinical significance of the long-term behavioral effects observed in rats is unknown. methylphenidate hydrochloride oral solution has not been studied in the geriatric population. methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride, a schedule ii controlled substance. methylphenidate hydrochloride oral solution 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)]. methylphenidate hydrochloride oral solution 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 healthcare 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 hydrochloride oral solution, can result in overdose and death [see overdosage ( 10 )],  and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection. physical dependence methylphenidate hydrochloride oral solution 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 include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hydrochloride oral solution 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).

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

bryant ranch prepack - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride oral solution is indicated for the treatment of: • attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years of age and older • narcolepsy methylphenidate hydrochloride oral solution is contraindicated in patients: - with known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions ( 6 )] . - receiving 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 )] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride oral solution, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388. risk summary 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) . no effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 12 and 19 times, respectively, the maximum recommended human dose (mrhd) of 60 mg/day given to adults on a mg/m2 basis. however, spina bifida was observed in rabbits at a dose 65 times the mrhd given to adults. a decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 7 times the mrhd given to 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. fetal/neonatal adverse reactions cns stimulants, such as methylphenidate hydrochloride oral solution, 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. animal data in embryo-fetal development 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. malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 65 times the mrhd of 60 mg/day given to adults on a mg/m2  basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (19 times the mrhd given to adults on a mg/m2  basis). there was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (12 times the mrhd of 60 mg/day given to adults on a mg/m2  basis), which was also maternally toxic. the no effect level for embryo-fetal development in rats was 25 mg/kg/day (4 times the mrhd on a mg/m2  basis). when methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (7 times the mrhd of 60 mg/day given to adults on a mg/m2  basis), but no other effects on postnatal development were observed. the no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the mrhd given to adults on a mg/m2  basis). risk summary 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 methylphenidate hydrochloride oral solution and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride oral solution 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 methylphenidate hydrochloride oral solution for the treatment of adhd have been established in pediatric patients six years of age and older. the safety and effectiveness of methylphenidate hydrochloride oral solution in pediatric patients under six years of age have not been established. the long-term efficacy of methylphenidate in pediatric patients has not been established. long-term suppression of growth growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride oral solution. pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions ( 5.6 )] . juvenile animal toxicity data in a study conducted in young rats, 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 13-14), 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/day 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 (5 mg/kg/day) is less than the mrhd given to children on a mg/m2 basis. the clinical significance of the long-term behavioral effects observed in rats is unknown. methylphenidate hydrochloride oral solution has not been studied in the geriatric population. methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride, a schedule ii controlled substance. methylphenidate hydrochloride oral solution 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)]. methylphenidate hydrochloride oral solution 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 healthcare 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 hydrochloride oral solution, can result in overdose and death [see overdosage ( 10 )],  and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection. physical dependence methylphenidate hydrochloride oral solution 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 include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hydrochloride oral solution 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).