美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington's disease. tetrabenazine tablets are contraindicated in patients: - who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings and precautions ( 5.1)] . who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings and precautions ( 5.1)] . - with hepatic impairment [see use in specific populations ( 8.6), clinical pharmacology ( 12.3)] . with hepatic impairment [see use in specific populations ( 8.6), clinical pharmacology ( 12.3)] . - taking monoamine oxidase inhibitors (maois). tetrabenazine tablets should not be used in combination with an maoi, or within a minimum of 14 days of discontinuing therapy with an maoi [see drug interactions ( 7.3)] . taking monoamine oxidase inhibitors (maois). tetrabenazine tablets should not be used in combination with an maoi, or within a minimum of 14 days of discontinuing therapy with an maoi [see drug interactions ( 7.3)] . - taking reserpine. at least 20 days should elapse after stopping reserpine before starting tetrabenazine tablets [see drug interactions ( 7.2)] . taking reserpine. at least 20 days should elapse after stopping reserpine before starting tetrabenazine tablets [see drug interactions ( 7.2)] . - taking deutetrabenazine or valbenazine [see drug interactions ( 7.7)] . taking deutetrabenazine or valbenazine [see drug interactions ( 7.7)] . risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality. administration of a major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on the developing fetus and offspring (increased mortality, decreased growth, and neurobehavioral and reproductive impairment). the adverse developmental effects of tetrabenazine and a major human metabolite of tetrabenazine in rats occurred at clinically relevant doses [see data] .   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. the background risk of major birth defects and miscarriage for the indicated population is unknown.   data   animal data tetrabenazine had no clear effects on embryofetal development when administered to pregnant rats throughout the period of organogenesis at oral doses up to 30 mg/kg/day (or 3 times the maximum recommended human dose [mrhd] of 100 mg/day on a mg/m 2 basis). tetrabenazine had no effects on embryofetal development when administered to pregnant rabbits during the period of organogenesis at oral doses up to 60 mg/kg/day (or 12 times the mrhd on a mg/m 2 basis).   when tetrabenazine (5, 15, and 30 mg/kg/day) was orally administered to pregnant rats from the beginning of organogenesis through the lactation period, an increase in stillbirths and offspring postnatal mortality was observed at 15 and 30 mg/kg/day and delayed pup maturation was observed at all doses. a no-effect dose for pre- and postnatal developmental toxicity in rats was not identified. the lowest dose tested (5 mg/kg/day) was less than the mrhd on a mg/m 2 basis.   because  rats dosed orally with tetrabenazine do not produce 9-desmethyl-β-dhtbz, a major human metabolite of tetrabenazine, the metabolite was directly administered to pregnant and lactating rats. oral administration of 9-desmethyl-β-dhtbz (8, 15, and 40 mg/kg/day) throughout the period of organogenesis produced increases in embryofetal mortality at 15 and 40 mg/kg/day and reductions in fetal body weights at 40 mg/kg/day, which was also maternally toxic. when 9-desmethyl-β-dhtbz (8, 15, and 40 mg/kg/day) was orally administered to pregnant rats from the beginning of organogenesis through the lactation period, increases in gestation duration, stillbirths, and offspring postnatal mortality (40 mg/kg/day); decreases in pup weights (40 mg/kg/day); and neurobehavioral (increased activity, learning and memory deficits) and reproductive (decreased litter size) impairment (15 and 40 mg/kg/day) were observed. maternal toxicity was seen at the highest dose. the no-effect dose for developmental toxicity in rats (8 mg/kg/day) was associated with plasma exposures (auc) of 9-desmethyl-β-dhtbz in pregnant rats lower than that in humans at the mrhd. risk summary there are no data on the presence of tetrabenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.   the  developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tetrabenazine and any potential adverse effects on the breastfed infant from tetrabenazine or from the underlying maternal condition.   safety and effectiveness in pediatric patients have not been established. the pharmacokinetics of tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects. because the safety and efficacy of the increased exposure to tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of tetrabenazine in hepatic impairment to ensure safe use. the use of tetrabenazine in patients with hepatic impairment is contraindicated [see contraindications ( 4), clinical pharmacology ( 12.3)] . patients who require doses of tetrabenazine tablets greater than 50 mg per day, should be first tested and genotyped to determine if they are poor (pms) or extensive metabolizers (ems) by their ability to express the drug metabolizing enzyme, cyp2d6. the dose of tetrabenazine should then be individualized accordingly to their status as either poor (pms) or extensive metabolizers (ems) [see dosage and administration ( 2.2), warnings and precautions ( 5.3), clinical pharmacology ( 12.3)] .   poor metabolizers   poor cyp2d6 metabolizers (pms) will have substantially higher levels of exposure to the primary metabolites (about 3-fold for α-htbz and 9-fold for β-htbz) compared to ems. the dosage should, therefore, be adjusted according to a patient’s cyp2d6 metabolizer status by limiting a single dose to a maximum of 25 mg and the recommended daily dose to not exceed a maximum of 50 mg/day in patients who are cyp2d6 pms [see dosage and administration ( 2.2), warnings and precautions ( 5.3), clinical pharmacology ( 12.3)] .   extensive/intermediate metabolizers   in extensive (ems) or intermediate metabolizers (ims), the dosage of tetrabenazine can be titrated to a maximum single dose of 37.5 mg and a recommended maximum daily dose of 100 mg [see dosage and administration ( 2.2), drug interactions ( 7.1), clinical pharmacology ( 12.3)]. tetrabenazine is not a controlled substance. clinical trials did not reveal patients developed drug seeking behaviors, though these observations were not systematic. abuse has not been reported from the postmarketing experience in countries where tetrabenazine has been marketed. as with any cns-active drug, prescribers should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of tetrabenazine misuse or abuse (such as development of tolerance, increasing dose requirements, drug-seeking behavior). abrupt discontinuation of tetrabenazine from patients did not produce symptoms of withdrawal or a discontinuation syndrome; only symptoms of the original disease were observed to re-emerge [see dosage and administration ( 2.4)].

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - primidone (unii: 13afd7670q) (primidone - unii:13afd7670q) - primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. it may control grand mal seizures refractory to other anticonvulsant therapy. primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see actions ).

美国 - 英文 - 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

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium tablets, usp are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium tablets, usp are contraindicated in: - pregnancy warfarin sodium tablets, usp are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see warnings and precautions (5.7) and use in specific populations (8.1) ]. warfarin sodium can cause fetal harm when administered to a pregnant woman. warfarin sodium exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. if warfarin sodium is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see use in specific populations (8.1) ]. warfarin sodium tablets, usp are contraindicated in patients with: - hemorrhagic tendencies or blood dyscrasias - recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces [see warnings and precautions (5.8) ] - bleeding tendencies associated with: active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract central nervous system hemorrhage cerebral aneurysms, dissecting aorta pericarditis and pericardial effusions bacterial endocarditis - active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract - central nervous system hemorrhage - cerebral aneurysms, dissecting aorta - pericarditis and pericardial effusions - bacterial endocarditis - threatened abortion, eclampsia, and preeclampsia - unsupervised patients with conditions associated with potential high level of non-compliance - spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding - hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis) [see adverse reactions (6) ] - major regional or lumbar block anesthesia - malignant hypertension risk summary warfarin sodium tablets, usp are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism, and for whom the benefits of warfarin sodium may outweigh the risks [see warnings and precautions (5.7) ]. warfarin sodium can cause fetal harm. exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring. because these data were not collected in adequate and well-controlled studies, this incidence of major birth defects is not an adequate basis for comparison to the estimated incidences in the control group or the u.s. general population and may not reflect the incidences observed in practice. consider the benefits and risks of warfarin sodium and possible risks to the fetus when prescribing warfarin sodium to a pregnant woman. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 in humans, warfarin crosses the placenta, and concentrations in fetal plasma approach the maternal values. exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring. warfarin embryopathy is characterized by nasal hypoplasia with or without stippled epiphyses (chondrodysplasia punctata) and growth retardation (including low birth weight). central nervous system and eye abnormalities have also been reported, including dorsal midline dysplasia characterized by agenesis of the corpus callosum, dandy-walker malformation, midline cerebellar atrophy, and ventral midline dysplasia characterized by optic atrophy. mental retardation, blindness, schizencephaly, microcephaly, hydrocephalus, and other adverse pregnancy outcomes have been reported following warfarin exposure during the second and third trimesters of pregnancy [see contraindications (4) ]. risk summary warfarin was not present in human milk from mothers treated with warfarin from a limited published study. because of the potential for serious adverse reactions, including bleeding in a breastfed infant, consider the developmental and health benefits of breastfeeding along with the mother's clinical need for warfarin sodium and any potential adverse effects on the breastfed infant from warfarin sodium or from the underlying maternal condition before prescribing warfarin sodium to a lactating woman. clinical considerations monitor breastfeeding infants for bruising or bleeding. data human data based on published data in 15 nursing mothers, warfarin was not detected in human milk. among the 15 full-term newborns, 6 nursing infants had documented prothrombin times within the expected range. prothrombin times were not obtained for the other 9 nursing infants. effects in premature infants have not been evaluated. pregnancy testing warfarin sodium can cause fetal harm [see use in specific populations (8.1) ]. verify the pregnancy status of females of reproductive potential prior to initiating warfarin sodium therapy. contraception females advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the final dose of warfarin sodium. adequate and well-controlled studies with warfarin sodium have not been conducted in any pediatric population, and the optimum dosing, safety, and efficacy in pediatric patients is unknown. pediatric use of warfarin sodium is based on adult data and recommendations, and available limited pediatric data from observational studies and patient registries. pediatric patients administered warfarin sodium should avoid any activity or sport that may result in traumatic injury. the developing hemostatic system in infants and children results in a changing physiology of thrombosis and response to anticoagulants. dosing of warfarin in the pediatric population varies by patient age, with infants generally having the highest, and adolescents having the lowest milligram per kilogram dose requirements to maintain target inrs. because of changing warfarin requirements due to age, concomitant medications, diet, and existing medical condition, target inr ranges may be difficult to achieve and maintain in pediatric patients, and more frequent inr determinations are recommended. bleeding rates varied by patient population and clinical care center in pediatric observational studies and patient registries. infants and children receiving vitamin k-supplemented nutrition, including infant formulas, may be resistant to warfarin therapy, while human milk-fed infants may be sensitive to warfarin therapy. of the total number of patients receiving warfarin sodium in controlled clinical trials for which data were available for analysis, 1885 patients (24.4%) were 65 years and older, while 185 patients (2.4%) were 75 years and older. no overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. patients 60 years or older appear to exhibit greater than expected inr response to the anticoagulant effects of warfarin [see clinical pharmacology (12.3) ]. warfarin sodium is contraindicated in any unsupervised patient with senility. conduct more frequent monitoring for bleeding with administration of warfarin sodium to elderly patients in any situation or with any physical condition where added risk of hemorrhage is present. consider lower initiation and maintenance doses of warfarin sodium in elderly patients [see dosage and administration (2.2, 2.3) ]. renal clearance is considered to be a minor determinant of anticoagulant response to warfarin. no dosage adjustment is necessary for patients with renal impairment. instruct patients with renal impairment taking warfarin to monitor their inr more frequently [see warnings and precautions (5.4) ]. hepatic impairment can potentiate the response to warfarin through impaired synthesis of clotting factors and decreased metabolism of warfarin. conduct more frequent monitoring for bleeding when using warfarin sodium in these patients.

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - prasugrel hydrochloride (unii: g89jq59i13) (prasugrel - unii:34k66tbt99) - prasugrel tablets are indicated to reduce the rate of thrombotic cv events (including stent thrombosis) in patients with acute coronary syndrome (acs) who are to be managed with percutaneous coronary intervention (pci) as follows: - patients with unstable angina (ua) or non-st-elevation myocardial infarction (nstemi). - patients with st-elevation myocardial infarction (stemi) when managed with primary or delayed pci. prasugrel tablets have been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (mi), or nonfatal stroke compared to clopidogrel. the difference between treatments was driven predominantly by mi, with no difference on strokes and little difference on cv death [see clinical studies (14)] . prasugrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage (ich) [see warnings and precautions (5.1) and

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablets are a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use: febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions ( 7)] . risk summary: limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd). no adverse developmental effects were observed in a pre- and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 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 us 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. data: animal data : in an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, febuxostat was not teratogenic and did not affect fetal development or survival at exposures up to approximately 40 times the mrhd (on an auc basis at maternal oral doses up to 48 mg/kg/day). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, febuxostat was not teratogenic and did not affect fetal development at exposures up to approximately 51 times the mrhd (on an auc basis at maternal oral doses up to 48 mg/kg/day). in a pre- and postnatal development study in pregnant female rats dosed orally from gestation day 7 through lactation day 20, febuxostat had no effects on delivery or growth and development of offspring at a dose approximately 11 times the mrhd (on an auc basis at a maternal oral dose of 12 mg/kg/day). however, increased neonatal mortality and a reduction in neonatal body weight gain were observed in the presence of maternal toxicity at a dose approximately 40 times the mrhd (on an auc basis at a maternal oral dose of 48 mg/kg/day). febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues. risk summary: there are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production. febuxostat is present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for febuxostat and any potential adverse effects on the breastfed child from febuxostat or from the underlying maternal condition. data: animal data : orally administered febuxostat was detected in the milk of lactating rats at up to approximately 7 times the plasma concentration. safety and effectiveness of febuxostat in pediatric patients have not been established. no dose adjustment is necessary in elderly patients. of the total number of patients in studies 1, 2, and 3 (clinical studies of febuxostat in the treatment of gout) [see clinical studies ( 14.1)] , 16% were 65 and over, while 4% were 75 and over. comparing patients in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out. the c max and auc 24 of febuxostat following multiple oral doses of febuxostat in geriatric patients (≥65 years) were similar to those in younger patients (18 to 40 years) [see clinical pharmacology ( 12.3)] . no dose adjustment is necessary in patients with mild to moderate renal impairment (cl cr 30 to 89 ml/min). for patients with severe renal impairment (clcr 15 to 29 ml/min), the recommended dosage of febuxostat is limited to 40 mg once daily [see dosage and administration ( 2.2) and clinical pharmacology ( 12.3)] . no dose adjustment is necessary in patients with mild or moderate hepatic impairment (child-pugh class a or b). no studies have been conducted in patients with severe hepatic impairment (child-pugh class c); therefore, caution should be exercised in these patients [see clinical pharmacology ( 12.3)] . no studies have been conducted in patients with secondary hyperuricemia (including organ transplant recipients); febuxostat is not recommended for use in patients whom the rate of urate formation is greatly increased (e.g., malignant disease and its treatment, lesch-nyhan syndrome). the concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - valproic acid (unii: 614oi1z5wi) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - valproic acid capsules are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. valproic acid capsules are indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. complex absence is the term used when other signs are also present. see warnings and precaution (5.1) for statement regarding fatal hepatic dysfunction. because of the risk to the fetus of decreased iq, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unle

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine is indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies ( 14.1)]. quetiapine is indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies ( 14.2)]. quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult patients with bipolar i and bipolar ii disorder [see clinical studies ( 14.2)]. quetiapine is indicated for the maintenance treatment of bipolar i disorder, as an adjunct to lithium or divalproex. efficacy was established in two maintenance trials in adults. the effectiveness of quetiapine as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see clinical studies ( 14.2)]. pediatric schizophrenia and bipolar i disorder are serious mental disorders, however, diagnosis can be challenging. for pediatric schizophrenia, symptom profiles can be variable, and for bipolar i disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. it is recommended that medication therapy for pediatric schizophrenia and bipolar i disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. medication treatment for both pediatric schizophrenia and bipolar i disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions. hypersensitivity to quetiapine or to any excipients in the quetiapine tablet formulation. anaphylactic reactions have been reported in patients treated with quetiapine. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary: neonates exposed to antipsychotic drugs (including quetiapine) during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see clinical considerations). overall available data from published epidemiologic studies of pregnant women exposed to quetiapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are risks to the mother associated with untreated schizophrenia, bipolar i, or major depressive disorder, and with exposure to antipsychotics, including quetiapine, during pregnancy (see clinical considerations) . in animal studies, embryo-fetal toxicity occurred including delays in skeletal ossification at approximately 1 and 2 times the maximum recommended human dose (mrhd) of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the mrhd. in addition, fetal weights were decreased in both species. maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the mrhd in rats and approximately 1-2 times the mrhd in rabbits. the estimated background risk of major birth defects and miscarriage for the indicated populations 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: disease-associated maternal and/or fetal risk: there is a risk to the mother from untreated schizophrenia, or bipolar i disorder, including increased risk of relapse, hospitalization, and suicide. schizophrenia and bipolar i disorder are associated with increased adverse perinatal outcomes, including preterm birth. it is not known if this is a direct result of the illness or other comorbid factors. a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. fetal/neonatal adverse reactions: extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including quetiapine, during the third trimester of pregnancy. these symptoms varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. data: human data : published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. a retrospective cohort study from a medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk of major birth defects. animal data: when pregnant rats and rabbits were exposed to quetiapine during organogenesis, there was no teratogenic effect in fetuses. doses were 25, 50 and 200 mg/kg in rats and 25, 50 and 100 mg/kg in rabbits which are approximately 0.3, 0.6 and 2-times (rats) and 0.6, 1 and 2-times (rabbits) the mrhd for schizophrenia of 800 mg/day based on mg/m 2 body surface area. however, there was evidence of embryo-fetal toxicity including delays in skeletal ossification at approximately 1 and 2 times the mrhd of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the mrhd. in addition, fetal weights were decreased in both species. maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the mrhd in rats and approximately 1-2 times the mrhd (all doses tested) in rabbits. in a peri/postnatal reproductive study in rats, no drug-related effects were observed when pregnant dams were treated with quetiapine at doses 0.01, 0.1, and 0.2 times the mrhd of 800 mg/day based on mg/m 2 body surface area. however, in a preliminary peri/postnatal study, there were increases in fetal and pup death, and decreases in mean litter weight at 3 times the mrhd. risk summary: limited data from published literature report the presence of quetiapine in human breast milk at relative infant dose of <1% of the maternal weight-adjusted dosage. there are no consistent adverse events that have been reported in infants exposed to quetiapine through breast milk. there is no information on the effects of quetiapine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for quetiapine and any potential adverse effects on the breastfed child from quetiapine or from the mother’s underlying condition. infertility: females: based on the pharmacologic action of quetiapine (d2 antagonism), treatment with quetiapine may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see warnings and precautions ( 5.15)]. in general, the adverse reactions observed in children and adolescents during the clinical trials were similar to those in the adult population with few exceptions. increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults. orthostatic hypotension occurred more frequently in adults (4 to 7%) compared to children and adolescents (< 1%) [see warnings and precautions ( 5.7) and adverse reactions ( 6.1)]. schizophrenia: the efficacy and safety of quetiapine in the treatment of schizophrenia in adolescents aged 13 to 17 years were demonstrated in one 6-week, double-blind, placebo-controlled trial [see indications and usage ( 1.1), dosage and administration ( 2.2), adverse reactions ( 6.1), and clinical studies ( 14.1)]. safety and effectiveness of quetiapine in pediatric patients less than 13 years of age with schizophrenia have not been established. maintenance: the safety and effectiveness of quetiapine in the maintenance treatment of bipolar disorder has not been established in pediatric patients less than 18 years of age. the safety and effectiveness of quetiapine in the maintenance treatment of schizophrenia has not been established in any patient population, including pediatric patients. bipolar mania: the efficacy and safety of quetiapine in the treatment of mania in children and adolescents ages 10 to 17 years with bipolar i disorder was demonstrated in a 3-week, double-blind, placebo-controlled, multicenter trial [see indications and usage ( 1.2), dosage and administration ( 2.3), adverse reactions ( 6.1), and clinical studies ( 14.2)]. safety and effectiveness of quetiapine in pediatric patients less than 10 years of age with bipolar mania have not been established. bipolar depression: safety and effectiveness of quetiapine in pediatric patients less than 18 years of age with bipolar depression have not been established. a clinical trial with quetiapine extended-release was conducted in children and adolescents (10 to 17 years of age) with bipolar depression, efficacy was not established. some differences in the pharmacokinetics of quetiapine were noted between children/adolescents (10 to 17 years of age) and adults. when adjusted for weight, the auc and c max of quetiapine were 41% and 39% lower, respectively, in children and adolescents compared to adults. the pharmacokinetics of the active metabolite, norquetiapine, were similar between children/adolescents and adults after adjusting for weight [see clinical pharmacology ( 12.3)]. of the approximately 3,700 patients in clinical studies with quetiapine, 7% (232) were 65 years of age or over. in general, there was no indication of any different tolerability of quetiapine in the elderly compared to younger adults. nevertheless, the presence of factors that might decrease pharmacokinetic clearance, increase the pharmacodynamic response to quetiapine, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period in the elderly. the mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients [see clinical pharmacology ( 12.3) and dosage and administration ( 2.3)] . clinical experience with quetiapine in patients with renal impairment is limited [see clinical pharmacology ( 12.3)]. since quetiapine is extensively metabolized by the liver, higher plasma levels are expected in patients with hepatic impairment. in this population, a low starting dose of 25 mg/day is recommended and the dose may be increased in increments of 25 mg/day to 50 mg/day [see dosage and administration (2.4) and clinical pharmacology ( 12.3)]. quetiapine is not a controlled substance. quetiapine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance or physical dependence. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of quetiapine, e.g., development of tolerance, increases in dose, drug-seeking behavior.

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole tablets are indicated for the treatment of: - schizophrenia [see clinical studies ( 14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.'s abilify ® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.'s marketing exclusivity rights, this drug product is not labeled with that information . aripiprazole tablets are contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)] . pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 o

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 400 mg - carefully consider the potential benefits and risks of ibuprofentablets and other treatment options before deciding to use ibuprofen.use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see warnings ). ibu tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibu tablets are indicated for relief of mild to moderate pain. ibu tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibu tablets in children have not been conducted. ibu tablets are contraindicated in patients with known hypersensitivityto ibuprofen. ibu tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin orother nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions, and pr