United States - English - NLM (National Library of Medicine)

sumitomo pharma america, inc. - eslicarbazepine acetate (unii: bea68zvb2k) (eslicarbazepine - unii:s5vxa428r4) - eslicarbazepine acetate 200 mg - aptiom is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. aptiom is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see warnings and precautions (5.2, 5.3, and 5.4)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as aptiom, during pregnancy. encourage women who are taking aptiom during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary limited available data with aptiom use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demonstrated developmental toxicity, including increased incidence of malformations (mice), embryolethality (rats), and fetal growth retardation (all species), at clinically relevant doses (see data). advise a pregnant woman of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data when eslicarbazepine acetate was orally administered (150, 350, 650 mg/kg/day) to pregnant mice throughout organogenesis, increased incidences of fetal malformations was observed at all doses and fetal growth retardation was observed at the mid and high doses. a no-effect dose for adverse developmental effects was not identified. at the lowest dose tested, plasma eslicarbazepine exposure (cmax , auc) is less than that in humans at the maximum recommended human dose (mrhd, 1600 mg/day). oral administration of eslicarbazepine acetate (40, 160, 320 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in fetal growth retardation and increased incidences of skeletal variations at the mid and high doses. the no-effect dose (40 mg/kg/day) is less than the mrhd on a mg/m2 basis. oral administration to pregnant rats (65, 125, 250 mg/kg/day) throughout organogenesis resulted in embryolethality at all doses, increased incidences of skeletal variations at the mid and high doses, and fetal growth retardation at the high dose. the lowest dose tested (65 mg/kg/day) is less than the mrhd on a mg/m2 basis. when eslicarbazepine acetate was orally administered to female mice during pregnancy and lactation (150, 350, 650 mg/kg/day), the gestation period was prolonged at the highest dose tested. in offspring, a persistent reduction in offspring body weight and delayed physical development and sexual maturation were observed at the mid and high doses. the lowest dose tested (150 mg/kg/day) is less than the mrhd on a mg/m2 basis. when eslicarbazepine acetate was orally administered (65, 125, 250 mg/kg/day) to rats during pregnancy and lactation, reduced offspring body weight was seen at the mid and high doses. delayed sexual maturation and a neurological deficit (decreased motor coordination) were observed at the highest dose tested. the no-effect dose for adverse developmental effects (65 mg/kg/day) is less than the mrhd on a mg/m2 basis. the rat data are of uncertain relevance to humans because of differences in metabolic profile between species. eslicarbazepine is present in human milk. the effects of aptiom on the breastfed infant or on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for aptiom and any potential adverse effects on the breastfed infant from aptiom or from the underlying maternal condition. contraception use of aptiom with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with lower plasma levels of these hormones. advise women of reproductive potential taking aptiom who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control [see drug interactions (7.4)] . infertility eslicarbazepine acetate was evaluated in rats and mice for potential adverse impact on fertility of the parental and first generation [see nonclinical toxicology (13.1)] . in a fertility study in male and female mice, adverse developmental outcomes were observed in embryos. in a fertility study in male and female rats, impairment of female fertility by eslicarbazepine acetate was shown. safety and effectiveness of aptiom have been established in the age groups 4 to 17 years. use of aptiom in these age groups is supported by evidence from adequate and well-controlled studies of aptiom in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data from clinical studies in 393 pediatric patients 4 to 17 years of age [see adverse reactions (6.1) and clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients below the age of 4 years have not been established. animal data in a juvenile animal study in which eslicarbazepine acetate (40, 80, 160 mg/kg/day) was orally administered to young dogs for 10 months starting on postnatal day 21, adverse effects on bone growth (decreased bone mineral content and density) were seen in females at all doses at the end of the dosing period, but not at the end of a 2-month recovery period. convulsions were seen at the highest dose tested. a no-effect dose for adverse effects in juvenile dogs was not identified. the lowest dose tested is less than the maximum recommended pediatric dose (1200 mg/day) on a body surface area (mg/m2 ) basis. a separate juvenile animal study was conducted to assess possible adverse effects on the immune system. eslicarbazepine acetate (10, 40, 80 mg/kg/day) was orally administered to young dogs for 17 weeks starting on postnatal day 21. no effects on the immune system were observed. there were insufficient numbers of patients ≥65 years old enrolled in the controlled adjunctive epilepsy trials (n=15) to determine the efficacy of aptiom in this patient population. the pharmacokinetics of aptiom were evaluated in elderly healthy subjects (n=12) (figure 1). although the pharmacokinetics of eslicarbazepine are not affected by age independently, dose selection should take in consideration the greater frequency of renal impairment and other concomitant medical conditions and drug therapies in the elderly patient. dose adjustment is necessary if crcl is <50 ml/min [see clinical pharmacology (12.3)]. clearance of eslicarbazepine is decreased in patients with impaired renal function and is correlated with creatinine clearance. dosage adjustment is necessary in patients with crcl<50 ml/min (figure 1) [see dosage and administration (2.4) and clinical pharmacology (12.3)]. dose adjustments are not required in patients with mild to moderate hepatic impairment (figure 1). use of aptiom in patients with severe hepatic impairment has not been evaluated, and use in these patients is not recommended [see clinical pharmacology (12.3)]. aptiom is not a controlled substance. prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence) [see drug abuse and dependence (9.3)]. in a human abuse study in recreational sedative abusers aptiom showed no evidence of abuse. in phase 1, 1.5% of the healthy volunteers taking aptiom reported euphoria compared to 0.4% taking placebo. physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. there was some evidence of physical dependence or a withdrawal syndrome with aptiom in a physical dependence study conducted in healthy volunteers who were maintained at a daily dose of 800 mg aptiom for 4 weeks prior to discontinuation. the primary endpoint was the maximum change from steady-state baseline in the total score of the physician's withdrawal checklist (pwc-34) during the 21-day discontinuation period. aptiom and placebo were shown to be equivalent on the primary endpoint. two out of 8 secondary endpoints (visual analog scales for anxiety and nausea) showed some increase in these symptoms for subjects who were maintained on aptiom and discontinued, versus subjects who were maintained on placebo. in general, aeds should not be abruptly discontinued in patients with epilepsy because of the risk of increased seizure frequency and status epilepticus.

United States - English - NLM (National Library of Medicine)

sumitomo pharma america, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - lunesta® (eszopiclone) is indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, lunesta administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). lunesta is contraindicated in patients who have experienced complex sleep behaviors after taking lunesta [see warnings and precautions (5.1)]. lunesta is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . risk summary available pharmacovigilance data with lunesta use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity. administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowest dose was approximately 200 times the maximum recommended human dose (mrhd) of 3 mg/day based on mg/m2 body surface area (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. data animal data oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (4, 8, or 16 mg/kg/day) throughout organogenesis showed no evidence of teratogenicity up to the highest doses tested. in rats, reduced fetal weight and increased incidences of skeletal variations and/or delayed ossification were observed at the mid and high doses. the no-observed-effect dose for adverse effects on embryofetal development is 200 times the mrhd of 3 mg/day on a mg/m2 basis. no effects on embryofetal development were observed in rabbits; the highest dose tested is approximately 100 times the mrhd on a mg/m2 basis. oral administration of eszopiclone (60, 120, or 180 mg/kg/day) to pregnant rats throughout the pregnancy and lactation resulted in increased post-implantation loss, decreased postnatal pup weights and survival, and increased pup startle response at all doses. the lowest dose tested is approximately 200 times the mrhd on a mg/m2 basis. eszopiclone had no effects on other developmental measures or reproductive function in the offspring. risk summary there are no data on the presence of eszopiclone in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lunesta and any potential adverse effects on the breastfed infant from lunesta or from the underlying maternal condition. safety and effectiveness of lunesta have not been established in pediatric patients. lunesta failed to demonstrate efficacy in controlled clinical studies of pediatric patients with attention-deficit/hyperactivity (adhd) associated insomnia. in a 12-week controlled study, 483 pediatric patients (aged 6-17 years) with insomnia associated with adhd (with 65% of the patients using concomitant adhd treatments) were treated with oral tablets of lunesta (1, 2 or 3 mg tablets, n=323), or placebo (n=160). lunesta did not significantly decrease latency to persistent sleep, compared to placebo, as measured by polysomnography after 12 weeks of treatment. psychiatric and nervous system disorders comprised the most frequent treatment-emergent adverse reactions observed with lunesta versus placebo and included dysgeusia (9% vs. 1%), dizziness (6% vs. 2%), hallucinations (2% vs. 0%) and suicidal ideation (0.3% vs. 0%). nine patients on lunesta (3%) discontinued treatment due to an adverse reaction compared to 3 patients on placebo (2%). in studies in which eszopiclone (2 to 300 mg/kg/day) was orally administered to young rats from weaning through sexual maturity, neurobehavioral impairment (altered auditory startle response) and reproductive toxicity (adverse effects on male reproductive organ weights and histopathology) were observed at doses ≥5 mg/kg/day. delayed sexual maturation was noted in males and females at ≥10 mg/kg/day. the no-effect dose (2 mg/kg) was associated with plasma exposures (auc) for eszopiclone and metabolite (s)-desmethylzopiclone [(s)-dmz] approximately 2 times plasma exposures in humans at the mrhd in adults (3 mg/day). when eszopiclone (doses from 1 to 50 mg/kg/day) was orally administered to young dogs from weaning through sexual maturity, neurotoxicity (convulsions) was observed at doses ≥ 5 mg/kg/day. hepatotoxicity (elevated liver enzymes and hepatocellular vacuolation and degeneration) and reproductive toxicity (adverse effects on male reproductive organ weights and histopathology) were noted at doses ≥10 mg/kg/day. the no-effect dose (1 mg/kg) was associated with plasma exposures (auc) to eszopiclone and (s)-dmz approximately 3 and 2 times, respectively, plasma exposures in humans at the mrhd in adults. a total of 287 subjects in double-blind, parallel-group, placebo-controlled clinical trials who received eszopiclone were 65 to 86 years of age. the overall pattern of adverse events for elderly subjects (median age = 71 years) in 2-week studies with nighttime dosing of 2 mg eszopiclone was not different from that seen in younger adults [see adverse reactions (6)] . lunesta 2 mg exhibited significant reduction in sleep latency and improvement in sleep maintenance in the elderly population. compared with nonelderly adults, subjects 65 years and older had longer elimination and higher total exposure to eszopiclone. therefore, dose reduction is recommended in elderly patients [see dosage and administration (2.2), clinical pharmacology (12.3)] . no dose adjustment is necessary for patients with mild-to-moderate hepatic impairment. exposure was increased in severely impaired patients compared with healthy volunteers. the dose of lunesta should not exceed 2 mg in patients with severe hepatic impairment. lunesta should be used with caution in patients with hepatic impairment [see dosage and administration (2.3), clinical pharmacology (12.3)] . lunesta is a schedule iv controlled substance under the controlled substances act. other substances under the same classification are benzodiazepines and the nonbenzodiazepine hypnotics zaleplon and zolpidem. while eszopiclone is a hypnotic agent with a chemical structure unrelated to benzodiazepines, it shares some of the pharmacologic properties of the benzodiazepines. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the drug for nonmedical purposes, often in combination with other psychoactive substances. physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects. addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. in a study of abuse liability conducted in individuals with known histories of benzodiazepine abuse, eszopiclone at doses of 6 and 12 mg produced euphoric effects similar to those of diazepam 20 mg. in this study, at doses 2-fold or greater than the maximum recommended doses, a dose-related increase in reports of amnesia and hallucinations was observed for both lunesta and diazepam. the clinical trial experience with lunesta revealed no evidence of a serious withdrawal syndrome. nevertheless, the following adverse events included in dsm-iv criteria for uncomplicated sedative/hypnotic withdrawal were reported during clinical trials following placebo substitution occurring within 48 hours following the last lunesta treatment: anxiety, abnormal dreams, nausea, and upset stomach. these reported adverse events occurred at an incidence of 2% or less. use of benzodiazepines and similar agents may lead to physical and psychological dependence. the risk of abuse and dependence increases with the dose and duration of treatment and concomitant use of other psychoactive drugs. the risk is also greater for patients who have a history of alcohol or drug abuse or history of psychiatric disorders. these patients should be under careful surveillance when receiving lunesta or any other hypnotic. some loss of efficacy to the hypnotic effect of benzodiazepines and benzodiazepine-like agents may develop after repeated use of these drugs for a few weeks. no development of tolerance to any parameter of sleep measurement was observed over six months. tolerance to the efficacy of lunesta 3 mg was assessed by 4-week objective and 6-week subjective measurements of time to sleep onset and sleep maintenance for lunesta in a placebo-controlled 44-day study, and by subjective assessments of time to sleep onset and wake time after sleep onset (waso) in a placebo-controlled study for 6 months.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sumitomo chemical australia pty. limited - etoxazole - suspension concentrate - etoxazole ungrouped active 110.0 g/l - insecticide

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sumitomo chemical australia pty. limited - clethodim; clethodim; liquid hydrocarbon; liquid hydrocarbon; liquid hydrocarbon - emulsifiable concentrate - clethodim cyclohexanediones active 360.0 g/l; clethodim cyclohexanediones active 360.0 g/l; liquid hydrocarbon solvent other 534.0 g/l; liquid hydrocarbon solvent other 550.0 g/l; liquid hydrocarbon solvent other 578.4 g/l - herbicide

New Zealand - English - Ministry for Primary Industries

sumitomo chemical australia pty limited - flumioxazin - flumioxazin 500 g/kg - herbicide

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sumitomo chemical australia pty. limited - mandestrobin - suspension concentrate - mandestrobin active 250.0 g/l - fungicide

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sumitomo chemical australia pty. limited - cyphenothrin; d-tetramethrin - aerosol - cyphenothrin pyrethroid active 1.5 g/kg; d-tetramethrin pyrethroid active 1.5 g/kg - household insecticide - domestic pest control | garden shed | homestead | houses | outbuildings - carpet beetle | cockroach infestation - heavy/residual | crawling insect | fly | flying insect | millipede | mosquito | slater | spider | wasp | adult mosquitoes | ants | cockroach - residual control | cockroachs | common pillbug | fleas | flies | mosquitoes | moths | silverfish | woodlice

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sumitomo chemical australia pty. limited - cyphenothrin; d-tetramethrin - aerosol - cyphenothrin pyrethroid active 1.5 g/kg; d-tetramethrin pyrethroid active 1.5 g/kg - household insecticide - domestic pest control | garden shed | homestead | houses | outbuildings - carpet beetle | cockroach infestation - heavy/residual | crawling insect | fly | flying insect | millipede | mosquito | slater | spider | wasp | adult mosquitoes | ants | cockroach - residual control | cockroachs | common pillbug | fleas | flies | mosquitoes | moths | silverfish | woodlice

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sumitomo chemical australia pty. limited - n-octyl bicycloheptene dicarboximide; phenothrin-d - aerosol - n-octyl bicycloheptene dicarboximide bicyclo active 16.0 g/kg; phenothrin-d pyrethroid active 4.0 g/kg - insecticide - animal bedding | domestic pest control | floor coverings | furniture - general | home | hospital | hotel and/or motel | nursing - bed bug | bed bug eggs | dust mite | flea | lice - bovicola spp. | lice - haematopinus spp. | bedbug

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sumitomo chemical australia pty. limited - esfenvalerate - micro emulsion - esfenvalerate pyrethroid active 1.0 g/l - insecticide - commercial premises - general | commercial/industrial premises | domestic premises | indoor plant | industrial and/or domestic p - ant | aphid | bug | carpet beetle | caterpillar | cockroach | cotton budworm or bollworm - see label | flea | fly | grasshopper | leafhopper | mosquito | moth | silverfish | spider | thrip | wasp | weevil | adult | adult mosquitoes | apple dimpling bug | argentine ant | brokenbacked bug | brown smudge bug | budworm | corn earworm | cotton bollworm | ctenocephalides spp. | green mirid | green vegetable bug | ground fleas | heliothis | large cockroach | looper | pharaoh ant | rutherglen bug | small cockroach | thrips spp. | tobacco budworm | tomato grub