Estados Unidos - inglês - NLM (National Library of Medicine)

rising pharma holdings, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - 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 dysfunction may or may not be warranted. special diagnostic considerations 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 tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the drug. methylphenidate hydrochloride is 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). methylphenidate hydrochloride should not be used in children under six years, since safety and efficacy in this age group have not been established. methylphenidate hydrochloride chewable tablets contain methylphenidate, a schedule ii controlled substance. methylphenidate hydrochloride chewable tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see warningsand precautions). methylphenidate hydrochloride chewable 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 hydrochloride chewable tablets, can result in overdose and death (see overdosage), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. physical dependence methylphenidate hydrochloride chewable 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 hydrochloride chewable tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hydrochloride chewable 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).

Estados Unidos - inglês - 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 hydro

Estados Unidos - inglês - 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. clinical considerations 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. 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 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 including methylphenidate hydrochloride oral solution 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).

Estados Unidos - inglês - NLM (National Library of Medicine)

eywa pharma inc - 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 ar

Estados Unidos - inglês - NLM (National Library of Medicine)

american health packaging - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate 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)] . 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

Estados Unidos - inglês - NLM (National Library of Medicine)

breckenridge pharmaceutical, inc. - 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

Estados Unidos - inglês - NLM (National Library of Medicine)

granules pharmaceuticals inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release 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 extended-release tablets. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [ 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 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 extended-release tablets, during pregnancy. healthcare providers are encouraged to register patients by

Estados Unidos - inglês - NLM (National Library of Medicine)

golden state medical supply, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release 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 extended-release tablets. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [ 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 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 extended-release tablets, during pregnancy. healthcare providers are encouraged to register patients by

Estados Unidos - inglês - NLM (National Library of Medicine)

lannett company, inc. - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies ( 14 )] . - hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride. hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions ( 6.1 )] . hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride. 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 )] . concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment wit

Estados Unidos - inglês - NLM (National Library of Medicine)

ascend laboratories, llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release tablets is 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 extended-release 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 extended-release tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy r