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

turf culture pty ltd - fosetyl-aluminium - water dispersible granule - fosetyl-aluminium organophosphorus active 800.0 g/kg - fungicide

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

chartwell rx, llc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - lymepak is indicated for the treatment of early lyme disease (as evidenced by erythema migrans) due to borrelia burgdorferi in adults and pediatric patients 8 years of age and older weighing 45 kg and above. to reduce the development of drug-resistant bacteria and maintain the effectiveness of lymepak and other antibacterial drugs, lymepak should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. lymepak is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. risk summary lymepak, like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered dur

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

chartwell rx, llc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 2 years of age and older weighing at least 10 kg. none. p r eg n an cy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the  antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (tdf) (2.1%) compared with the background rate for major birth defects of 2.7% in a u.s. refe

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

chartwell rx, llc - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride oral solution is indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m 2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral mem

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

chartwell rx, llc. - diethylpropion hydrochloride (unii: 19v2pl39ng) (diethylpropion - unii:q94yyu22b8) - diethylpropion hydrochloride tablets, 25 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (bmi) of 30 kg/m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. below is a chart of bmi based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds divided by 2.2 = kg; inches × 0.0254 = meters. body mass index (bmi), kg/m 2 weight (pounds) height (feet, inches)  5'0"  5'3"  5'6"  5'9"  6'0"  6'3"  140  27  25  23  21  19  18  150  29  27  24  22  20  19  160  31  28  26  24  22  20  170  33  30  28  25  23  21  180  35  32  29  27  25  23  190  37  34  31  28  26  24  200  39  36  32  30  27  25  210  41  37  34  31  29  26  220

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

chartwell rx, llc. - diethylpropion hydrochloride (unii: 19v2pl39ng) (diethylpropion - unii:q94yyu22b8) - diethylpropion hydrochloride extended release tablets, 75 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (bmi) of 30 kg/m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. below is a chart of bmi based on various heights and weights. bmi is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. metric conversions are as follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters. body mass index (bmi), kg/m 2 weight (pounds) height (feet, inches) 5’0” 5’3” 5’6” 5’9” 6’0” 6’3” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 23

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

chartwell rx, llc - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (greater than or equal to 500 mg/dl) hypertriglyceridemia. usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of tg-lowering drug therapy. limitations of use: the effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. the effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined. omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters capsules or any of its components. risk summary the available data from published case reports and the pharmacovigilance database on the use of omega-3-acid ethyl esters in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, omega-3-acid ethyl esters given orally to female rats prior to mating through lactation did not have adverse effects on reproduction or development when given at doses 5 times the maximum recommended human dose (mrhd) of 4 grams/day, based on a body surface area comparison. omega-3-acid ethyl esters given orally to rats and rabbits during organogenesis was not teratogenic at clinically relevant exposures, based on body surface area comparison (see data) . 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. data animal data: in female rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) beginning 2 weeks prior to mating through lactation, no adverse effects were observed at 2,000 mg/kg/day (5 times the mrhd based on body surface area [mg/m 2 ]). in a dose-ranging study, female rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) beginning 2 weeks prior to mating through postpartum day 7 had decreased live births (20% reduction) and pup survival to postnatal day 4 (40% reduction) at or greater than 3,000 mg/kg/day in the absence of maternal toxicity at 3,000 mg/kg/day (7 times the mrhd based on body surface area [mg/m 2 ]). in pregnant rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses at a maternally toxic dose (increased food consumption) of 6,000 mg/kg/day (14 times the mrhd based on body surface area [mg/m 2 ]). in pregnant rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) from gestation day 14 through lactation day 21, no adverse effects were observed at 2,000 mg/kg/day (5 times the mrhd based on body surface area [mg/m 2 ]). in pregnant rabbits given oral doses of omega-3-acid ethyl esters (375, 750, or 1,500 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses given 375 mg/kg/day (2 times the mrhd based on body surface area [mg/m 2 ]). however, at higher doses, increases in fetal skeletal variations and reduced fetal growth were evident at maternally toxic doses (reduced food consumption and body weight gain) greater than or equal to 750 mg/kg/day (4 times the mrhd), and embryolethality was evident at 1,500 mg/kg/day (7 times the mrhd). risk summary published studies have detected omega-3 fatty acids, including epa and dha, in human milk. lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. there are no data available on the effects of omega­3 fatty acid ethyl esters on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for omega-3-acid ethyl esters and any potential adverse effects on the breastfed child from omega-3-acid ethyl esters or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. a limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid ethyl esters. safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.

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

chartwell rx, llc - risperidone (unii: l6uh7zf8hc) (risperidone - unii:l6uh7zf8hc) - risperidone is indicated for the treatment of schizophrenia. efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see clinical studies (14.1)] . monotherapy risperidone is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see clinical studies (14.2)] . adjunctive therapy risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder. efficacy was established in one short-term trial in adults [see clinical studies (14.3)] . risperidone is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see clinical studies (14.4)] . risperidone is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. paliperidone is a metabolite of risperidone. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, 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 during the third trimester of pregnancy 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 risperidone 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 or bipolar i disorder and with exposure to antipsychotics, including risperidone, during pregnancy (see clinical considerations) . oral administration of risperidone to pregnant mice caused cleft palate at doses 3 to 4 times the maximum recommended human dose (mrhd) with maternal toxicity observed at 4-times mrhd based on mg/m 2 body surface area. risperidone was not teratogenic in rats or rabbits at doses up to 6-times the mrhd based on mg/m 2 body surface area. increased still births and decreased birth weight occurred after oral risperidone administration to pregnant rats at 1.5-times the mrhd based on mg/m 2 body surface area. learning was impaired in offspring of rats when the dams were dosed at 0.6-times the mrhd and offspring mortality increased at doses 0.1 to 3 times the mrhd based on mg/m 2 body surface area. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/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. 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 risperidone, during the third trimester of pregnancy. these symptoms have 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 prospective observational study including 6 women treated with risperidone demonstrated placental passage of risperidone. a retrospective cohort study from a medicaid database of 9,258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. there was a small increase in the risk of major birth defects (rr=1.26, 95% ci 1.02–1.56) and of cardiac malformations (rr=1.26, 95% ci 0.88–1.81) in a subgroup of 1,566 women exposed to risperidone during the first trimester of pregnancy; however, there is no mechanism of action to explain the difference in malformation rates. animal data oral administration of risperidone to pregnant mice during organogenesis caused cleft palate at 10 mg/kg/day which is 3 times the mrhd of 16 mg/day based on mg/m 2 body surface area: maternal toxicity occurred at 4 times the mrhd. risperidone was not teratogenic when administered orally to rats at 0.6 to 10 mg/kg/day and rabbits at 0.3 to 5 mg/kg/day, which are up to 6 times the mrhd of 16 mg/day risperidone based on mg/m 2 body surface area. learning was impaired in offspring of rats dosed orally throughout pregnancy at 1 mg/kg/day which is 0.6 times the mrhd and neuronal cell death increased in fetal brains of offspring of rats dosed during pregnancy at 1 and 2 mg/kg/day which are 0.6 and 1.2 times the mrhd based on mg/m 2 body surface area; postnatal development and growth of the offspring were also delayed. rat offspring mortality increased during the first 4 days of lactation when pregnant rats were dosed throughout gestation at 0.16 to 5 mg/kg/day which are 0.1 to 3 times the mrhd of 16 mg/day based on mg/m 2 body surface area. it is not known whether these deaths were due to a direct effect on the fetuses or pups or to effects on the dams; a no-effect dose could not be determined. the rate of stillbirths was increased at 2.5 mg/kg or 1.5 times the mrhd based on mg/m 2 body surface area. in a rat cross-fostering study the number of live offspring was decreased, the number of stillbirths increased, and the birth weight was decreased in offspring of drug-treated pregnant rats. in addition, the number of deaths increased by day 1 among offspring of drug-treated pregnant rats, regardless of whether or not the offspring were cross-fostered. risperidone also appeared to impair maternal behavior in that offspring body weight gain and survival (from day 1 to 4 of lactation) were reduced in offspring born to control but reared by drug-treated dams. all of these effects occurred at 5 mg/kg which is 3 times the mrhd based on mg/m 2 and the only dose tested in the study. risk summary limited data from published literature reports the presence of risperidone and its metabolite, 9-hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3% and 4.7% of the maternal weight-adjusted dosage. there are reports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) in breastfed infants exposed to risperidone (see clinical considerations) . there is no information on the effects of risperidone on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for risperidone and any potential adverse effects on the breastfed child from risperidone or from the mother's underlying condition. clinical considerations infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements). infertility females based on the pharmacologic action of risperidone (d 2 receptor antagonism), treatment with risperidone 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 (5.6)] . approved pediatric indications schizophrenia the efficacy and safety of risperidone in the treatment of schizophrenia were demonstrated in 417 adolescents, aged 13 to 17 years, in two short-term (6 and 8 weeks, respectively) double-blind controlled trials [see indications and usage (1.1), adverse reactions (6.1), and clinical studies (14.1)] . additional safety and efficacy information was also assessed in one long-term (6-month) open-label extension study in 284 of these adolescent patients with schizophrenia. safety and effectiveness of risperidone in children less than 13 years of age with schizophrenia have not been established. bipolar i disorder the efficacy and safety of risperidone in the short-term treatment of acute manic or mixed episodes associated with bipolar i disorder in 169 children and adolescent patients, aged 10 to 17 years, were demonstrated in one double-blind, placebo-controlled, 3-week trial [see indications and usage (1.2), adverse reactions (6.1), and clinical studies (14.2)]. safety and effectiveness of risperidone in children less than 10 years of age with bipolar disorder have not been established. autistic disorder the efficacy and safety of risperidone in the treatment of irritability associated with autistic disorder were established in two 8-week, double-blind, placebo-controlled trials in 156 children and adolescent patients, aged 5 to 16 years [see indications and usage (1.3), adverse reactions (6.1)and clinical studies (14.4)]. additional safety information was also assessed in a long-term study in patients with autistic disorder, or in short- and long-term studies in more than 1,200 pediatric patients with psychiatric disorders other than autistic disorder, schizophrenia, or bipolar mania who were of similar age and weight, and who received similar dosages of risperidone as patients treated for irritability associated with autistic disorder. a third study was a 6-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of a lower than recommended dose of risperidone in subjects 5 to 17 years of age with autistic disorder and associated irritability, and related behavioral symptoms. there were two weight-based, fixed doses of risperidone (high-dose and low-dose). the high dose was 1.25 mg per day for patients weighing 20 to less than 45 kg, and it was 1.75 mg per day for patients weighing greater than or equal to 45 kg. the low dose was 0.125 mg per day for patients for patients weighing 20 to less than 45 kg, and it was 0.175 mg per day for patients weighing greater than or equal to 45 kg. the study demonstrated the efficacy of high-dose risperidone, but it did not demonstrate efficacy for low-dose risperidone. adverse reactions in pediatric patients tardive dyskinesia in clinical trials in 1,885 children and adolescents treated with risperidone, 2 (0.1%) patients were reported to have tardive dyskinesia, which resolved on discontinuation of risperidone treatment [see also warnings and precautions (5.4)]. weight gain weight gain has been observed in children and adolescents during treatment with risperidone. clinical monitoring of weight is recommended during treatment. data derive from short-term placebo-controlled trials and longer-term uncontrolled studies in pediatric patients (ages 5 to 17 years) with schizophrenia, bipolar disorder, autistic disorder, or other psychiatric disorders. in the short-term trials (3 to 8 weeks), the mean weight gain for risperidone-treated patients was 2 kg, compared to 0.6 kg for placebo-treated patients. in these trials, approximately 33% of the risperidone group had weight gain greater than or equal to 7%, compared to 7% in the placebo group. in longer-term, uncontrolled, open-label pediatric studies, the mean weight gain was 5.5 kg at week 24 and 8 kg at week 48 [see warnings and precautions (5.5)and adverse reactions (6.1)]. somnolence somnolence was frequently observed in placebo-controlled clinical trials of pediatric patients with autistic disorder. most cases were mild or moderate in severity. these events were most often of early onset with peak incidence occurring during the first two weeks of treatment, and transient with a median duration of 16 days. somnolence was the most commonly observed adverse reaction in the clinical trial of bipolar disorder in children and adolescents, as well as in the schizophrenia trials in adolescents. as was seen in the autistic disorder trials, these adverse reactions were most often of early onset and transient in duration [see adverse reactions (6.1and 6.2)]. patients experiencing persistent somnolence may benefit from a change in dosing regimen [see dosage and administration ( 2.1, 2.2, and 2.3)]. hyperprolactinemia risperidone has been shown to elevate prolactin levels in children and adolescents as well as in adults [see warnings and precautions (5.6)]. in double-blind, placebo-controlled studies of up to 8 weeks duration in children and adolescents (aged 5 to 17 years) with autistic disorder or psychiatric disorders other than autistic disorder, schizophrenia, or bipolar mania, 49% of patients who received risperidone had elevated prolactin levels compared to 2% of patients who received placebo. similarly, in placebo-controlled trials in children and adolescents (aged 10 to 17 years) with bipolar disorder, or adolescents (aged 13 to 17 years) with schizophrenia, 82 to 87% of patients who received risperidone had elevated levels of prolactin compared to 3 to 7% of patients on placebo. increases were dose-dependent and generally greater in females than in males across indications. in clinical trials in 1,885 children and adolescents, galactorrhea was reported in 0.8% of risperidone-treated patients and gynecomastia was reported in 2.3% of risperidone-treated patients. growth and sexual maturation the long-term effects of risperidone on growth and sexual maturation have not been fully evaluated in children and adolescents. juvenile animal studies juvenile dogs were treated with oral risperidone from weeks 10 to 50 of age (equivalent to the period of childhood through adolescence in humans), at doses of 0.31, 1.25, or 5 mg/kg/day, which are 1.2, 3.4, and 13.5 times the mrhd of 6 mg/day for children, based on mg/m 2 body surface area. bone length and density were decreased with a no-effect dose of 0.31 mg/kg/day; this dose produced plasma auc of risperidone plus its active metabolite paliperidone (9-hydroxy-risperidone) that were similar to those in children and adolescents receiving the mrhd of 6 mg/day. in addition, sexual maturation was delayed at all doses in both males and females. the above effects showed little or no reversibility in females after a 12 week drug-free recovery period. juvenile rats, treated with oral risperidone from days 12 to 50 of age (equivalent to the period of infancy through adolescence in humans) showed impaired learning and memory performance (reversible only in females), with a no-effect dose of 0.63 mg/kg/day which is 0.5 times the mrhd of 6 mg/day for children, based on mg/m 2 body surface area. this dose produced plasma auc of risperidone plus paliperidone about half the exposure observed in humans at the mrhd. no other consistent effects on neurobehavioral or reproductive development were seen up to the highest tested dose of 1.25 mg/kg/day which is 1 time the mrhd and produced plasma auc of risperidone plus paliperidone that were about two thirds of those observed in humans at the mrhd of 6 mg/day for children. clinical studies of risperidone in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, a lower starting dose is recommended for an elderly patient, reflecting a decreased pharmacokinetic clearance in the elderly, as well as a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)and dosage and administration ( 2.4, 2.5)] . while elderly patients exhibit a greater tendency to orthostatic hypotension, its risk in the elderly may be minimized by limiting the initial dose to 0.5 mg twice daily followed by careful titration [see warnings and precautions (5.7)] . monitoring of orthostatic vital signs should be considered in patients for whom this is of concern. this drug is substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.4)] . in patients with moderate to severe (clcr 59 to 15 ml/min) renal disease, clearance of the sum of risperidone and its active metabolite decreased by 60%, compared to young healthy subjects. risperidone doses should be reduced in patients with renal disease [see dosage and administration (2.4)] . while the pharmacokinetics of risperidone in subjects with liver disease were comparable to those in young healthy subjects, the mean free fraction of risperidone in plasma was increased by about 35% because of the diminished concentration of both albumin and α 1 -acid glycoprotein. risperidone doses should be reduced in patients with liver disease [see dosage and administration (2.4)] . patients with parkinson’s disease or dementia with lewy bodies can experience increased sensitivity to risperidone. manifestations can include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with neuroleptic malignant syndrome. risperidone is not a controlled substance. risperidone has not been systematically studied in animals or humans for its potential for abuse. 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 risperidone misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). risperidone has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.

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

turf culture pty ltd - fosetyl-aluminium - wettable powder - fosetyl-aluminium organophosphorus active 800.0 g/kg - fungicide

New Zealand - English - Ministry for Primary Industries

adria new zealand ltd - fosetyl-aluminium - fosetyl-aluminium 800 g/kg - fungicide