미국 - 영어 - NLM (National Library of Medicine)

mylan institutional inc. - clozapine (unii: j60ar2ikic) (clozapine - unii:j60ar2ikic) - clozapine 25 mg - clozapine orally disintegrating tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. because of the risks of severe neutropenia and of seizure associated with its use, clozapine orally disintegrating tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment [see warnings and precautions ( 5.1, 5.5)] . the effectiveness of clozapine in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine and chlorpromazine in patients who had failed other antipsychotics [see clinical studies (14.1)]. clozapine orally disintegrating tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. suicidal behavior refers to actions by a patient that put him/herself at risk for death. the effectiveness of clozapine in reducing the risk of recurrent suicidal behavior was demonstrated over a two-year treatment period in the intersept™ trial [see clinical studies (14.2)] . clozapine orally disintegrating tablets are contraindicated in patients with a history of serious hypersensitivity to clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or stevens-johnson syndrome) or any other component of clozapine orally disintegrating tablets [see adverse reactions (6.2)] . there are no adequate or well-controlled studies of clozapine in pregnant women. reproduction studies have been performed in rats and rabbits at doses up to 0.4 and 0.9 times, respectively, the maximum recommended human dose (mrhd) of 900 mg/day on a mg/m 2 body surface area basis. the studies revealed no evidence of impaired fertility or harm to the fetus due to clozapine. because animal reproduction studies are not always predictive of human response, clozapine orally disintegrating tablets should be used during pregnancy only if clearly needed. consider the risk of exacerbation of psychosis when discontinuing or changing treatment with antipsychotic medications during pregnancy and postpartum. consider early screening for gestational diabetes for patients treated with antipsychotic medications [see warnings and precautions (5.11)] . neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. monitor neonates for symptoms of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding difficulties. the severity of complications can vary from self-limited symptoms to some neonates requiring intensive care unit support and prolonged hospitalization. in embryofetal developmental studies, clozapine had no effects on maternal parameters, litter sizes, or fetal parameters when administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 0.4 and 0.9 times, respectively, the mrhd of 900 mg/day on a mg/m 2 body surface area basis. in peri/postnatal developmental studies, pregnant female rats were administered clozapine over the last third of pregnancy and until day 21 postpartum. observations were made on fetuses at birth and during the postnatal period; the offspring were allowed to reach sexual maturity and mated. clozapine caused a decrease in maternal body weight but had no effects on litter size or body weights of either f1 or f2 generations at doses up to 0.4 times the mrhd of 900 mg/day on a mg/m 2 body surface area basis. clozapine is present in human milk. because of the potential for serious adverse reactions in nursing infants from clozapine orally disintegrating tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. safety and effectiveness in pediatric patients have not been established. there have not been sufficient numbers of geriatric patients in clinical studies utilizing clozapine orally disintegrating tablets to determine whether those over 65 years of age differ from younger subjects in their response to clozapine orally disintegrating tablets. orthostatic hypotension and tachycardia can occur with clozapine treatment [see boxed warningand warnings and precautions (5.3)] . elderly patients, particularly those with compromised cardiovascular functioning, may be more susceptible to these effects. elderly patients may be particularly susceptible to the anticholinergic effects of clozapine, such as urinary retention and constipation [see warnings and precautions (5.16)] . carefully select clozapine orally disintegrating tablets doses in elderly patients, taking into consideration their greater frequency of decreased hepatic, renal, or cardiac function, as well as other concomitant disease and other drug therapy. clinical experience suggests that the prevalence of tardive dyskinesia appears to be highest among the elderly; especially elderly women [see warnings and precautions (5.18)] . dose reduction may be necessary in patients with significant impairment of renal or hepatic function. clozapine concentrations may be increased in these patients, because clozapine is almost completely metabolized and then excreted [see dosage and administration (2.8)and clinical pharmacology (12.3)] . dose reduction may be necessary in patients who are cyp2d6 poor metabolizers. clozapine concentrations may be increased in these patients, because clozapine is almost completely metabolized and then excreted [see dosage and administration (2.8)and clinical pharmacology (12.3)] . for hospice patients (i.e., terminally ill patients with an estimated life expectancy of 6 months or less), the prescriber may reduce the anc monitoring frequency to once every 6 months, after a discussion with the patient and his/her caregiver. individual treatment decisions should weigh the importance of monitoring anc in the context of the need to control psychiatric symptoms and the patient’s terminal illness.

미국 - 영어 - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - clozapine (unii: j60ar2ikic) (clozapine - unii:j60ar2ikic) - clozapine 25 mg - clozapine orally disintegrating tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. because of the risks of severe neutropenia and of seizure associated with its use, clozapine orally disintegrating tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment [see warnings and precautions (5.1, 5.5)] . the effectiveness of clozapine in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine and chlorpromazine in patients who had failed other antipsychotics [see clinical studies (14.1)]. clozapine orally disintegrating tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. suicidal behavi

미국 - 영어 - NLM (National Library of Medicine)

mylan institutional inc. - clozapine (unii: j60ar2ikic) (clozapine - unii:j60ar2ikic) - clozapine 25 mg - clozapine tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. because of the risks of severe neutropenia and of seizure associated with its use, clozapine tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment [see warnings and precautions (5.1, 5.5)] . the effectiveness of clozapine tablets in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine tablets and chlorpromazine in patients who had failed other antipsychotics [see clinical studies (14.1)] . clozapine tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. suicidal behavior refers to actions by a patient that put him/herself at risk for death. the effectiveness of clozapine tablets in reducing the risk of recurrent suicidal behavior was demonstrated over a two-year treatment period in the intersept™ trial [see clinical studies (14.2)] . clozapine tablets are contraindicated in patients with a history of serious hypersensitivity to clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or stevens-johnson syndrome) or any other component of clozapine tablets [see adverse reactions (6.2)] . there are no adequate or well-controlled studies of clozapine in pregnant women. reproduction studies have been performed in rats and rabbits at doses up to 0.4 and 0.9 times, respectively, the maximum recommended human dose (mrhd) of 900 mg/day on a mg/m 2 body surface area basis. the studies revealed no evidence of impaired fertility or harm to the fetus due to clozapine. because animal reproduction studies are not always predictive of human response, clozapine tablets should be used during pregnancy only if clearly needed. consider the risk of exacerbation of psychosis when discontinuing or changing treatment with antipsychotic medications during pregnancy and postpartum. consider early screening for gestational diabetes for patients treated with antipsychotic medications [see warnings and precautions (5.11)] . neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. monitor neonates for symptoms of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding difficulties. the severity of complications can vary from self-limited symptoms to some neonates requiring intensive care unit support and prolonged hospitalization. in embryofetal developmental studies, clozapine had no effects on maternal parameters, litter sizes, or fetal parameters when administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 0.4 and 0.9 times, respectively, the mrhd of 900 mg/day on a mg/m 2 body surface area basis. in peri/postnatal developmental studies, pregnant female rats were administered clozapine over the last third of pregnancy and until day 21 postpartum. observations were made on fetuses at birth and during the postnatal period; the offspring were allowed to reach sexual maturity and mated. clozapine caused a decrease in maternal body weight but had no effects on litter size or body weights of either f1 or f2 generations at doses up to 0.4 times the mrhd of 900 mg/day on a mg/m 2 body surface area basis. clozapine is present in human milk. because of the potential for serious adverse reactions in nursing infants from clozapine tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. safety and effectiveness in pediatric patients have not been established. there have not been sufficient numbers of geriatric patients in clinical studies utilizing clozapine tablets to determine whether those over 65 years of age differ from younger subjects in their response to clozapine tablets. orthostatic hypotension and tachycardia can occur with clozapine tablets treatment [see boxed warningand warnings and precautions (5.3)] . elderly patients, particularly those with compromised cardiovascular functioning, may be more susceptible to these effects. elderly patients may be particularly susceptible to the anticholinergic effects of clozapine tablets, such as urinary retention and constipation [see warnings and precautions (5.16)] . carefully select clozapine tablets doses in elderly patients, taking into consideration their greater frequency of decreased hepatic, renal, or cardiac function, as well as other concomitant disease and other drug therapy. clinical experience suggests that the prevalence of tardive dyskinesia appears to be highest among the elderly; especially elderly women [see warnings and precautions (5.18)] . dose reduction may be necessary in patients with significant impairment of renal or hepatic function. clozapine concentrations may be increased in these patients, because clozapine is almost completely metabolized and then excreted [see dosage and administration (2.7), clinical pharmacology (12.3)] . dose reduction may be necessary in patients who are cyp2d6 poor metabolizers. clozapine concentrations may be increased in these patients, because clozapine is almost completely metabolized and then excreted [see dosage and administration (2.7), clinical pharmacology (12.3)] . for hospice patients (i.e., terminally ill patients with an estimated life expectancy of six months or less), the prescriber may reduce the anc monitoring frequency to once every 6 months, after a discussion with the patient and his/her caregiver. individual treatment decisions should weigh the importance of monitoring anc in the context of the need to control psychiatric symptoms and the patient’s terminal illness.

미국 - 영어 - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - clozapine (unii: j60ar2ikic) (clozapine - unii:j60ar2ikic) - clozapine 25 mg - clozapine tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. because of the risks of severe neutropenia and of seizure associated with its use, clozapine tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment [see warnings and precautions (5.1, 5.5)] . the effectiveness of clozapine tablets in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine tablets and chlorpromazine in patients who had failed other antipsychotics [see clinical studies (14.1)] . clozapine tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. suicidal behavior refers to actions by a patient that put him/herself at risk for death. the effectiveness of clozapine tablets in reducing the risk of recurrent suicidal behavior was demonstrated over a two-year treatment period in the intersept™ trial [see clinical studies (14.2)] . clozapine tablets are contraindicated in patients with a history of serious hypersensitivity to clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or stevens-johnson syndrome) or any other component of clozapine tablets [see adverse reactions (6.2)] . there are no adequate or well-controlled studies of clozapine in pregnant women. reproduction studies have been performed in rats and rabbits at doses up to 0.4 and 0.9 times, respectively, the maximum recommended human dose (mrhd) of 900 mg/day on a mg/m2 body surface area basis. the studies revealed no evidence of impaired fertility or harm to the fetus due to clozapine. because animal reproduction studies are not always predictive of human response, clozapine tablets should be used during pregnancy only if clearly needed. consider the risk of exacerbation of psychosis when discontinuing or changing treatment with antipsychotic medications during pregnancy and postpartum. consider early screening for gestational diabetes for patients treated with antipsychotic medications [see warnings and precautions (5.11)] . neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. monitor neonates for symptoms of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding difficulties. the severity of complications can vary from self-limited symptoms to some neonates requiring intensive care unit support and prolonged hospitalization. in embryofetal developmental studies, clozapine had no effects on maternal parameters, litter sizes, or fetal parameters when administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 0.4 and 0.9 times, respectively, the mrhd of 900 mg/day on a mg/m2 body surface area basis. in peri/postnatal developmental studies, pregnant female rats were administered clozapine over the last third of pregnancy and until day 21 postpartum. observations were made on fetuses at birth and during the postnatal period; the offspring were allowed to reach sexual maturity and mated. clozapine caused a decrease in maternal body weight but had no effects on litter size or body weights of either f1 or f2 generations at doses up to 0.4 times the mrhd of 900 mg/day on a mg/m2 body surface area basis. clozapine is present in human milk. because of the potential for serious adverse reactions in nursing infants from clozapine tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. safety and effectiveness in pediatric patients have not been established. there have not been sufficient numbers of geriatric patients in clinical studies utilizing clozapine tablets to determine whether those over 65 years of age differ from younger subjects in their response to clozapine tablets. orthostatic hypotension and tachycardia can occur with clozapine tablets treatment [see boxed warning and warnings and precautions (5.3)] . elderly patients, particularly those with compromised cardiovascular functioning, may be more susceptible to these effects. elderly patients may be particularly susceptible to the anticholinergic effects of clozapine tablets, such as urinary retention and constipation [see warnings and precautions (5.16)] . carefully select clozapine tablets doses in elderly patients, taking into consideration their greater frequency of decreased hepatic, renal, or cardiac function, as well as other concomitant disease and other drug therapy. clinical experience suggests that the prevalence of tardive dyskinesia appears to be highest among the elderly; especially elderly women [see warnings and precautions (5.18)] . dose reduction may be necessary in patients with significant impairment of renal or hepatic function. clozapine concentrations may be increased in these patients, because clozapine is almost completely metabolized and then excreted [see dosage and administration (2.7), clinical pharmacology (12.3)] . dose reduction may be necessary in patients who are cyp2d6 poor metabolizers. clozapine concentrations may be increased in these patients, because clozapine is almost completely metabolized and then excreted [see dosage and administration (2.7), clinical pharmacology (12.3)] . for hospice patients (i.e., terminally ill patients with an estimated life expectancy of six months or less), the prescriber may reduce the anc monitoring frequency to once every 6 months, after a discussion with the patient and his/her caregiver. individual treatment decisions should weigh the importance of monitoring anc in the context of the need to control psychiatric symptoms and the patient’s terminal illness.

미국 - 영어 - NLM (National Library of Medicine)

mayne pharma - clozapine (unii: j60ar2ikic) (clozapine - unii:j60ar2ikic) - clozapine 25 mg - clozapine tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. because of the risks of severe neutropenia and of seizure associated with its use, clozapine tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment [see warnings and precautions (5.1, 5.5)]. the effectiveness of clozapine tablets in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine and chlorpromazine in patients who had failed other antipsychotics [see clinical studies (14.1)]. clozapine tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. suicidal behavior refers to actions by a patient that put him/herself at

미국 - 영어 - NLM (National Library of Medicine)

golden state medical supply, inc. - clozapine (unii: j60ar2ikic) (clozapine - unii:j60ar2ikic) - clozapine 25 mg - clozapine tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. because of the risks of severe neutropenia and of seizure associated with its use, clozapine tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment [see warnings and precautions (5.1, 5.5)]. the effectiveness of clozapine tablets in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine and chlorpromazine in patients who had failed other antipsychotics [see clinical studies (14.1)]. clozapine tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinic

미국 - 영어 - NLM (National Library of Medicine)

prasco laboratories - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) as monotherapy and as adjunctive therapy to stimulant medications [see clinical studies (14)] . clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including clonidine hydrochloride extended-release 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 visiting https://womensmentalhealth.org/adhd-medications/. risk summary prolonged experience with clonidine in pregnant women over several decades, based on published literature, including control

미국 - 영어 - NLM (National Library of Medicine)

par pharmaceutical, inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) as monotherapy and as adjunctive therapy to stimulant medications [see clinical studies (14)] . clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions (6) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including clonidine hydrochloride extended-release 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 visiting https://womensmentalhealth.org/adhd-medications/. risk summary prolonged experience with clonidine in pregnant women over several decades, based on published literature, including control

미국 - 영어 - NLM (National Library of Medicine)

actavis pharma, inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) as monotherapy and as adjunctive therapy to stimulant medications [see clinical studies (14)] . clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including clonidine hydrochloride extended-release 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 visiting https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/. risk summary prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes. in animal embryofetal studies, increased resorptions were seen in rats and mice administered oral clonidine hydrochloride from implantation through organogenesis at 10 and 5 times, respectively, the maximum recommended human dose (mrhd) given to adolescents on a mg/m2 basis. no developmental effects were seen in rabbits administered oral clonidine hydrochloride during organogenesis at doses up to 3 times the mrhd (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 miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data oral administration of clonidine hydrochloride to pregnant rabbits during the period of embryo/fetal organogenesis at doses of up to 80 mcg/kg/day (approximately 3 times the oral maximum recommended daily dose [mrhd] of 0.4 mg/day given to adolescents on a mg/m2 basis) produced no developmental effects. in pregnant rats, however, doses as low as 15 mcg/kg/day (1/3 the mrhd given to adolescents on a mg/m2 basis) were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating and throughout gestation. increased resorptions were not associated with treatment at the same or at higher dose levels (up to 3 times the mrhd) when treatment of the dams was restricted to gestation days 6 to 15. increases in resorptions were observed in both rats and mice at 500 mcg/kg/day (10 and 5 times the mrhd in rats and mice, respectively) or higher when the animals were treated on gestation days 1 to 14; 500 mcg/kg/day was the lowest dose employed in this study. risk summary based on published lactation studies, clonidine hydrochloride is present in human milk at relative infant doses ranging from 4.1 to 8.4% of the maternal weight-adjusted dosage. although in most cases, there were no reported adverse effects in breastfed infants exposed to clonidine, there is one case report of sedation, hypotonia, and apnea in an infant exposed to clonidine through breast milk. if an infant is exposed to clonidine hydrochloride through breastmilk, monitor for symptoms of hypotension and bradycardia, such as sedation, lethargy, tachypnea and poor feeding (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clonidine hydrochloride extended-release tablets and any potential adverse effects on the breastfed child from clonidine hydrochloride extended-release tablets or from the underlying maternal condition. exercise caution when clonidine hydrochloride extended-release tablets are administered to a nursing woman. clinical considerations monitor breastfeeding infants exposed to clonidine hydrochloride extended-release tablets through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding. infertility based on findings in animal studies revealed that clonidine hydrochloride extended-release tablets may impair fertility in females and males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and efficacy of clonidine hydrochloride extended-release tablets in the treatment of adhd have been established in pediatric patients 6 to 17 years of age. use of clonidine hydrochloride extended-release tablets in pediatric patients 6 to 17 years of age is supported by three adequate and well-controlled studies; a short-term, placebo-controlled monotherapy trial, a short-term adjunctive therapy trial and a longer-term randomized monotherapy trial [see clinical studies (14)] . safety and efficacy in pediatric patients below the age of 6 years has not been established. juvenile animal data in studies in juvenile rats, clonidine hydrochloride alone or in combination with methylphenidate had an effect on bone growth at clinically relevant doses and produced a slight delay in sexual maturation in males at 3 times the maximum recommended human dose (mrhd) for clonidine and methylphenidate. in a study where juvenile rats were treated orally with clonidine hydrochloride from day 21 of age to adulthood, a slight delay in onset of preputial separation (delayed sexual maturation) was seen in males treated with 300 mcg/kg/day, which is approximately 3 times the mrhd of 0.4 mg/day on a mg/m2 basis.  the no-effect dose was 100 mcg/kg/day, which is approximately equal to the mrhd. there was no drug effects on fertility or on other measures of sexual or neurobehavioral development.  in a study where juvenile rats were treated with clonidine alone (300 mcg/kg/day) or in combination with methylphenidate (10 mg/kg/day in females and 50/30 mg/kg/day in males; the dose was lowered from 50 to 30 mg/kg/day in males due to self-injurious behavior during the first week of treatment) from day 21 of age to adulthood, decreases in bone mineral density and mineral content were observed in males treated with 300 mcg/kg/day clonidine alone and in combination with 50/30 mg/kg/day methylphenidate and a decrease in femur length was observed in males treated with the combination at the end of the treatment period. these doses are approximately 3 times the mrhd of 0.4 mg/day clonidine and 54 mg/day methylphenidate on a mg/m2 basis. all these effects in male were not reversed at the end of a 4-week recovery period. in addition, similar findings were seen in males treated with a lower dose of clonidine (30 mcg/kg/day) in combination with 50 mg/kg/day of methylphenidate and a decrease in femur length was observed in females treated with clonidine alone at the end of the recovery period. these effects were accompanied by a decrease in body weight gain in treated animals during the treatment period but the effect was reversed at the end of the recovery period. a delay in preputial separation (sexual maturation) was observed in males treated with the combination treatment of 300 mcg/kg/day clonidine and 50/30 mg/kg/day methylphenidate. there was no effect on reproduction or sperm analysis in these males. the impact of renal impairment on the pharmacokinetics of clonidine in children has not been assessed. the initial dosage of clonidine hydrochloride extended-release tablets should be based on degree of impairment. monitor patients carefully for hypotension and bradycardia, and titrate to higher doses cautiously. since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine hydrochloride extended-release tablets following dialysis. clonidine hydrochloride extended-release tablets are not a controlled substance and have no known potential for abuse or dependence.

미국 - 영어 - NLM (National Library of Medicine)

golden state medical supply, inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) as monotherapy and as adjunctive therapy to stimulant medications [see clinical studies ( 14)] . clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions ( 6) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including clonidine hydrochloride extended-release 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 visiting https://womensmentalhealth.org/adhd-medications/. risk summary prolonged experience with clonidine in p