Bandaríkin - enska - NLM (National Library of Medicine)

lannett company, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 18 mg - 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 things; e

Bandaríkin - enska - NLM (National Library of Medicine)

kvk-tech, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg in 5 ml - attention deficit disorders, narcolepsy attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfun

Bandaríkin - enska - NLM (National Library of Medicine)

bryant ranch prepack - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 20 mg - methylphenidate hydrochloride and methylphenidate hydrochloride sustained-release are indicated for the treatment of: • attention deficit hyperactivity disorders (adhd) in pediatric patients 6 years and older and adults • narcolepsy pregnancy category c in studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (mrhd) on a mg/m2 basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the mrhd on a mg/m2 basis). there was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the mrhd on a mg/m2 basis), which was also maternally toxic. the no effect level for embryo-fetal development

Bandaríkin - enska - NLM (National Library of Medicine)

bryant ranch prepack - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 10 mg - attention deficit disorders, narcolepsy attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous

Bandaríkin - enska - NLM (National Library of Medicine)

novel laboratories, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg in 5 ml - attention deficit disorders, narcolepsy attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfun

Bandaríkin - enska - NLM (National Library of Medicine)

sandoz inc - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 5 mg - dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including dexmethylphenidate 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 visit https://womensmentalhealth.org/adhd-medications/. risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy (see clinical considerations ). embryo-fetal

Bandaríkin - enska - NLM (National Library of Medicine)

par pharmaceuticals, inc. - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 15 mg - dexmethylphenidate hydrochloride extended-release capsules is indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)] . - hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release capsules. 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 dexmethylphenidate 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 visit https://womensmentalhealth.org/adhdmedications/. risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. published studies and post-marketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy ( see clinical considerations ). embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (mrhd) of 20 mg/day given to adults based on plasma levels. a decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the mrhd of 20 mg/day given to adults based on plasma levels ( see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions cns stimulants such as dexmethylphenidate hydrochloride 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. animal data in embryo-fetal development studies conducted in rats and rabbits, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. no evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. when dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, postweaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. at the highest doses tested, plasma levels [area under the curve (aucs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with 20 mg/day. plasma levels in adults were comparatively similar to plasma levels in adolescents. racemic methylphenidate has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis. risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. limited published literature, based on milk sampling from seven mothers’ reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. long-term neurodevelopmental effects on infants from stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmethylphenidate hydrochloride extended-release capsules and any potential adverse effects on the breastfed infant from dexmethylphenidate 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 dexmethylphenidate hydrochloride extended-release capsules in pediatric patients less than 6 years have not been established. the safety and effectiveness of dexmethylphenidate hydrochloride extended-release capsules for the treatment of adhd have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials [see clinical studies (14.2)] . the long-term efficacy of dexmethylphenidate 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 dexmethylphenidate 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 racemic methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. a deficit in acquisition of a specific learning task was observed in females only. the doses at which these findings were observed are at least 6 times the mrhd of 60 mg/day given to children on a mg/m 2 basis. in a study conducted in young rats, racemic methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). when these animals were tested as adults (postnatal weeks 13 to14), 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 of racemic methylphenidate given to children on a mg/m 2 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/m 2 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/m 2 basis). the clinical significance of the long-term behavioral effects observed in rats is unknown. dexmethylphenidate hydrochloride extended-release capsules have not been studied in the geriatric population. dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a schedule ii controlled substance. cns stimulants, including dexmethylphenidate hydrochloride extended-release capsules, other methylphenidate-containing products, and amphetamines have a high potential for abuse. abuse is characterized by impaired control over drug use despite harm, and craving. signs and symptoms of cns stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. abusers of cns stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death [see overdosage (10)] . to reduce the abuse of cns stimulants including dexmethylphenidate hydrochloride extended-release capsules, assess the risk of abuse prior to prescribing. after prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of cns stimulants [see how supplied/storage and handling (16)] , monitor for signs of abuse while on therapy, and reevaluate the need for dexmethylphenidate hydrochloride extended-release capsules use. tolerance tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) can occur during chronic therapy with cns stimulants, including dexmethylphenidate hydrochloride extended-release capsules. dependence physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with cns stimulants including dexmethylphenidate hydrochloride extended-release capsules. withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of cns stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Bandaríkin - enska - NLM (National Library of Medicine)

avera mckennan hospital - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 20 mg - dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in patients aged 6 years and older. the effectiveness of dexmethylphenidate hydrochloride extended-release capsules in the treatment of adhd in patients aged 6 years and older was established in 2 placebo-controlled studies in patients meeting dsm-iv criteria for adhd [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 2 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 6 of the following symptoms must have persisted for at least 6 months: lack of atten

Bandaríkin - enska - NLM (National Library of Medicine)

solco healthcare us,llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride tablets are indicated for the treatment of: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visit 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 an

Bandaríkin - enska - NLM (National Library of Medicine)

granules pharmaceuticals inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - 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)] . - hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. 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)]. 8.1 pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride extended-release capsules during pregnancy. healthcare providers are encouraged to register patients by calling t