Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

methylphenidate patch

mylan pharmaceuticals inc. - methylphenidate (unii: 207zz9qz49) (methylphenidate - unii:207zz9qz49) - methylphenidate transdermal system is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in pediatric patients 6 to 17 years of age. methylphenidate transdermal system is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product (fluoropolymer-coated polyester, hydrophobic colloidal silica, mineral oil, polyester/ethylene vinyl acetate laminate film backing, polyisobutylene adhesive and white ink). the white ink contains acrylic polymers, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and titanium dioxide [see description (11) ] . methylphenidate transdermal system is contraindicated during treatment with monoamine oxidase inhibitors, and within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (hypertensive crises may result). there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate transdermal system, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/. published studies and post-marketing reports on methylphenidate use during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the fetus associated with the use of cns stimulants during pregnancy (see clinical considerations) . no effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis. however, spina bifida was observed in rabbits when given oral doses of 200 mg/kg/day. when methylphenidate was administered orally to rats throughout pregnancy and lactation, offspring growth and survival were decreased at maternally toxic doses (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 clinical recognized pregnancies is 2-4% and 15-20%, respectively. cns stimulants, such as methylphenidate transdermal system, can cause vasoconstriction and thereby decrease placental perfusion. no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. animal reproduction toxicity studies with transdermal methylphenidate have not been performed. in embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally to pregnant animals during the period of organogenesis, at doses up to 100 and 200 mg/kg/day, respectively. no evidence of morphological development effects was found either of the species; however, increased incidences of fetal skeletal variations were observed in rats at 60 mg/kg or greater and an increase in fetal visceral variations was seen in rabbits at the highest dose. in a previous study, methylphenidate was shown to have malformations (increased incidence of fetal spina bifida) in rabbits when given oral doses of 200 mg/kg/day. when methylphenidate was administered orally to rats throughout pregnancy and lactation at doses of up to 60 mg/kg/day, offspring growth and survival were decreased at maternally toxic doses. in a study in which oral methylphenidate was given to rats throughout pregnancy and lactation at doses up to 60 mg/kg/day, offspring weights and survival were decreased at 40 mg/kg/day and above; these doses caused some maternal toxicity. limited published literature, based on breast milk sampling from five mothers, reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. long-term neurodevelopmental effects on infants from stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate transdermal system and any potential adverse effects on the breastfed infant from methylphenidate or from the underlying maternal condition. monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. the safety and effectiveness of methylphenidate transdermal system in pediatric patients less than 6 years have not been established. long-term effects of methylphenidate in children have not been well established. the safety and effectiveness of methylphenidate transdermal system for the treatment of adhd have been established in pediatric patients 6 to 17 years. growth should be monitored during treatment with stimulants, including methylphenidate transdermal system. children who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.8)] . rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. a deficit in acquisition of a specific learning task was observed in females only. studies with transdermal methylphenidate have not been performed in juvenile animals. in a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). when these animals were tested as adults (postnatal weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose. the no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day. the clinical significance of the long-term behavioral effects observed in rats is unknown. methylphenidate transdermal system has not been studied in patients greater than 65 years of age. methylphenidate transdermal system contains methylphenidate, a schedule ii controlled substance. methylphenidate transdermal system has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1)] . methylphenidate transdermal system can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including methylphenidate transdermal system, can result in overdose and death [see overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. methylphenidate transdermal system may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including methylphenidate transdermal system include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. methylphenidate transdermal system may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). methylphenidate transdermal system   cii (meth'' il fen' i date) 1. methylphenidate transdermal system dosing chart each carton of methylphenidate transdermal systems contains a methylphenidate transdermal system dosing chart to help you keep track of your methylphenidate transdermal system including: to use the methylphenidate transdermal system dosing chart, follow these instructions: methylphenidate transdermal system schedule for 9 hour dosing if you put the transdermal system on at: on the same day, remove the transdermal system at: 5:00 a.m. 2:00 p.m. 6:00 a.m. 3:00 p.m. 7:00 a.m. 4:00 p.m. 8:00 a.m. 5:00 p.m. 9:00 a.m. 6:00 p.m. 10:00 a.m. 7:00 p.m. 11:00 a.m. 8:00 p.m. 12:00 p.m. 9:00 p.m. 2. where to apply methylphenidate transdermal system figure a 3. before you apply methylphenidate transdermal system make sure your skin: 4. how to apply methylphenidate transdermal system figure b the methylphenidate transdermal system has 4 layers. the 4 layers are pictured below. the pictures show both sides of the transdermal system: figure c                                                                                  figure d layers: figure e figure f figure g figure h 5 . how to remove and throw away methylphenidate transdermal system this instructions for use has been approved by the u.s. food and drug administration. manufactured for: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. revised: 1/2024 mpn:r5

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

diazepam tablet

asclemed usa, inc. - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. diazepam tablets are contraindicated in patients with a known hypersensitivity to diazepam and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age. diazepam tablets are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome. they may be used in patients with open-angle glaucoma who are receiving appropriate therapy, but are contraindicated in acute narrow-angle glaucoma. diazepam tablets contain diazepam, a schedule iv controlled substance. diazepam is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction ). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). diazepam may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses), those who have had longer durations of use (see warnings: dependence and withdrawal reactions ). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of diazepam tablets and warnings: dependence and withdrawal reactions ). acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines. tolerance to diazepam may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of diazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lurasidone hydrochloride tablet, film coated

dr. reddys laboratories inc - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for:   • monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)] .   • adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)].   • known  hypersensitivity  to  lurasidone  hcl  or  any  components  in  the  formulation. angioedema has been observed with lurasidone [see adverse reactions ( 6.1)] . • strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see drug interactions ( 7.1)]. • strong cyp3a4 inducers (e.g., rifampin, avasimibe, st.  john’s wort, phenytoin, carbamazepine, etc.) [see drug interactions ( 7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

finasteride tablet, film coated

proficient rx lp - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (bph) in men with an enlarged prostate to:      -     improve symptoms      -    reduce the risk of acute urinary retention      -    reduce the risk of the need for surgery including transurethral resection of the prostate (turp) and prostatectomy. finasteride tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of bph (a confirmed ≥ 4 point increase in american urological association (aua) symptom score). finasteride tablets are not approved for the prevention of prostate cancer.   finasteride tablets are contraindicated in the following:   risk summary finasteride tablets are contraindicated in pregnant females and not indicated for use in females. based on animal studies and the mechanism of action, finasteride tablets may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female [see warnings

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

alprazolam c-iv tablet

direct_rx - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - alprazolam tablets are indicated for the: acute treatment of generalized anxiety disorder (gad) in adults. treatment of panic disorder (pd), with or without agoraphobia in adults. alprazolam tablets are contraindicated in patients: with known hypersensitivity to alprazolam or other benzodiazepines. angioedema has been reported [see adverse reactions (6.2)]. taking strong cytochrome p450 3a (cyp3a) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see dosage and administration (2.6), warnings and precautions (5.5), drug interactions (7.1)] 8.1 pregnancy pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/. risk summary neonates born

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lurasidone hydrochloride tablet

aurobindo pharma limited - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for: - treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see clinical studies (14.1)]. - monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies (14.2)]. - adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies (14.2)]. - known hypersensitivity to lurasidone hydrochloride or any components in the formulation. angioedema has been observed with lurasidone [see adverse reactions (6.1)] . - strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see drug interactions (7.1)].   - strong cyp3a4 inducers (e.g., rifampin, avasimibe, st. john’s wort, phenytoin, carbamazepine, etc.) [see drug interactions (7.1)]. pregnancy exposure registry there is a pregna

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lurasidone hydrochloride tablet, film coated

american health packaging - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for: - monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies (14.2)]. - adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies (14.2)]. - known hypersensitivity to lurasidone hcl or any components in the formulation. angioedema has been observed with lurasidone [see adverse reactions (6.1)]. - strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see drug interactions (7.1)]. - strong cyp3a4 inducers (e.g., rifampin, avasimibe, st. john’s wort, phenytoin, carbamazepine, etc.) [see drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

abilify asimtufii- aripiprazole injection, suspension, extended release

otsuka america pharmaceutical, inc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - abilify asimtufii is indicated: - for the treatment of schizophrenia in adults - for maintenance monotherapy treatment of bipolar i disorder in adults abilify asimtufii is contraindicated in patients with a known hypersensitivity to aripiprazole, or any of the excipients. hypersensitivity reactions ranging from pruritus/urticaria to anaphylaxis have been reported in patients receiving aripiprazole [see adverse reactions (6.1)] . 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 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . risk summary neonates exposed to antipsychotic drugs, including abilify asimtufii, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms (see clinical considerations) . there are insufficient data with abilify asimtufii use in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses 10 and 11 times, respectively, the maximum recommended human oral dose (mrhd) produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses 10 times the oral mrhd produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival (see data) . consider the benefits and risks of abilify asimtufii and possible risks to the fetus when prescribing abilify asimtufii to a pregnant woman. advise pregnant women of potential fetal risk. the background risk of major birth defects and miscarriage for the indicated population are unknown. 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. clinical considerations 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 oral aripiprazole, during the third trimester of pregnancy. these symptoms have varied in severity. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. monitor neonates exhibiting extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. data animal data no developmental toxicity studies were conducted with intramuscular aripiprazole suspension. in animal oral or intravenous studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits. pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day which are approximately 1 to 10 times the oral mrhd of 30 mg/day on mg/m2 basis of aripiprazole during the period of organogenesis. treatment at the highest dose caused a slight prolongation of gestation and delay in fetal development, as evidenced by decreased fetal weight and undescended testes. delayed skeletal ossification was observed at 3 and 10 times the oral mrhd on mg/m2 basis. at 3 and 10 times the oral mrhd on mg/m2 basis, delivered offspring had decreased body weights. increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed in offspring from the highest dose group (the other dose groups were not examined for these findings). postnatally, delayed vaginal opening was seen at 3 and 10 times the oral mrhd on mg/m2 basis and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) along with some maternal toxicity were seen at the highest dose; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. in pregnant rats treated with aripiprazole intravenously at doses of 3, 9, and 27 mg/kg/day, which are 1 to 9 times the oral mrhd on mg/m2 basis, during the period of organogenesis, decreased fetal weight and delayed skeletal ossification were seen at the highest dose which also caused maternal toxicity. in pregnant rabbits treated with oral doses of 10, 30, and 100 mg/kg/day which are 2 to 11 times human exposure at the oral mrhd based on auc and 6 to 65 times the oral mrhd of aripiprazole on mg/m2 basis during the period of organogenesis, decreased maternal food consumption and increased abortions were seen at the highest dose as well as increased fetal mortality. decreased fetal weight and increased incidence of fused sternebrae were observed at 3 and 11 times the oral mrhd based on auc. in pregnant rabbits receiving aripiprazole injection intravenously at doses of 3, 10, and 30 mg/kg/day, which are 2 to 19 times the oral mrhd on mg/m2 basis during the period of organogenesis, the highest dose caused pronounced maternal toxicity that resulted in decreased fetal weight, increased fetal abnormalities (primarily skeletal), and decreased fetal skeletal ossification. the fetal no-effect dose was 5 times the human exposure at the oral mrhd based on auc and is 6 times the oral mrhd on mg/m2 basis. in rats treated with oral doses of 3, 10, and 30 mg/kg/day, which are 1 to 10 times the oral mrhd of aripiprazole on a mg/m2 basis, peri- and post-natally (from day 17 of gestation through day 21 postpartum), slight maternal toxicity and slightly prolonged gestation were seen at the highest dose. an increase in stillbirths and decreases in pup weight (persisting into adulthood) and survival were also seen at this dose. in rats treated with aripiprazole intravenously at doses of 3, 8, and 20 mg/kg/day which are 1 to 6 times the oral mrhd on mg/m2 basis from day 6 of gestation through day 20 postpartum, increased stillbirths were seen at 3 and 6 times the oral mrhd on mg/m2 basis, and decreases in early postnatal pup weight and survival were seen at the highest dose; these doses produced some maternal toxicity. there were no effects on postnatal behavioral and reproductive development. risk summary aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for abilify asimtufii and any potential adverse effects on the breastfed infant from abilify asimtufii or from the underlying maternal condition. safety and effectiveness of abilify asimtufii in pediatric patients have not been established. juvenile animal studies no juvenile animal studies were conducted with intramuscular aripiprazole suspension. a study with oral aripiprazole in juvenile rats caused mortality, cns clinical signs, impaired memory and learning, and delayed sexual maturation when administered at doses of 10, 20, 40 mg/kg/day from weaning (21 days old) through maturity (80 days old). at 40 mg/kg/day, mortality, decreased activity, splayed hind limbs, hunched posture, ataxia, tremors and other cns signs were observed in both genders. in addition, delayed sexual maturation was observed in males. at all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary (atrophy), adrenals (adrenocortical hypertrophy), mammary glands (hyperplasia and increased secretion), and female reproductive organs (vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea) were observed. the changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. a no observed adverse effect level (noael) could not be determined and, at the lowest tested dose of 10 mg/kg/day, there is no safety margin relative to the systemic exposures (auc0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended oral pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies. aripiprazole in juvenile dogs (2 months old) caused cns clinical signs of tremors, hypoactivity, ataxia, recumbency and limited use of hind limbs when administered orally for 6 months at 3, 10, 30 mg/kg/day. mean body weight and weight gain were decreased up to 18% in females in all drug groups relative to control values. a noael could not be determined and, at the lowest tested dose of 3 mg/kg/day, there is no safety margin relative to the systemic exposures (auc0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended oral pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2-month recovery period. clinical studies of abilify asimtufii did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience and pharmacokinetic data have not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in single-dose and multiple-dose pharmacokinetic studies with oral aripiprazole, there was no detectable age effect in the population pharmacokinetic analysis in schizophrenia patients. no dosage adjustments are recommended based on age alone. abilify asimtufii is not approved for the treatment of patients with dementia-related psychosis [see also boxed warning and warnings and precautions (5.1)]. dosage adjustment is recommended in known cyp2d6 poor metabolizers due to high aripiprazole concentrations. approximately 8% of caucasians and 3% to 8% of black/african americans cannot metabolize cyp2d6 substrates and are classified as poor metabolizers (pm) [see dosage and administration (2.4)] . no dosage adjustment for abilify asimtufii is required on the basis of a patient's renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 ml/minute) [see dosage and administration (2.4)] . no dosage adjustment for abilify asimtufii is required on the basis of a patient's hepatic function (mild to severe hepatic impairment, child-pugh score between 5 and 15). abilify asimtufii (a-bil-i-fy ah-sim-tuh-fye) (aripiprazole) extended-release injectable suspension the following information is intended for medical or healthcare professionals only and should be read by the medical or healthcare professional in conjunction with the full prescribing information. - read the complete instructions for preparation and administration below before administering abilify asimtufii. - to be prepared and administered only by a healthcare professional once every two months. - abilify asimtufii pre-filled syringe is single-dose only . re-use may lead to infection or other illness/injury. - for gluteal intramuscular injection only. do not administer by any other route. - prior to administration, visually inspect abilify asimtufii pre-filled syringe for particulate matter and discoloration. the suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in color. do not use abilify asimtufii pre-filled syringe if the suspension is discolored, or particulate matter is present. contents of kit each kit contains one sterile pre-filled syringe containing abilify asimtufii (aripiprazole) 720 mg or 960 mg extended-release injectable suspension and two safety needles: - one sterile 1 ½ inch 22 gauge needle (in black packaging) - one sterile 2 inch 21 gauge needle (in green packaging) preparation prior to administration - remove the abilify asimtufii pre-filled syringe from the package. - tap the syringe on your hand at least 10 (ten) times (figure 1). - after tapping, shake the syringe vigorously for at least 10 (ten) seconds until the medication is uniform (figure 2). figure 1

figure 2

figure 1 figure 2 select the appropriate needle needle selection is determined by patient body type. for gluteal intramuscular administration only. - for non-obese patients - 22-gauge, 1.5-inch (38 mm) safety needle with needle protection device (needle in black packaging) - for obese patients - 21-gauge, 2-inch (51 mm) safety needle with needle protection device (needle in green packaging) refer to table 1 below for needle information: attach the needle - twist and pull off the pre-filled syringe tip-cap (figure 3). - while holding the base of the needle, ensure the needle is firmly seated on the safety device with a push. gently twist clockwise until securely fitted (figure 3). figure 3 expel air - when you are ready to administer the injection of abilify asimtufii, hold the pre-filled syringe upright and remove the needle-cap straight up (figure 4). do not twist the needle-cap, as this may loosen the needle from the syringe. figure 4 - slowly advance the plunger rod upward to expel the air and until the suspension fills needle base (figure 5). figure 5 inject the dose - slowly inject the entire contents of the pre-filled syringe intramuscularly into the gluteal muscle of the patient (figure 6). do not administer by any other route. do not massage the injection site. figure 6 disposal procedure - after the injection, press the safety shield on a hard surface to cover and lock shield over the needle (figure 7 and 8) figure 7 figure 8 - immediately discard used syringe and the unused needle in an approved sharps container (figure 9). - the unused needle should not be saved for future use. figure 9

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

izervay- avacincaptad pegol injection

astellas pharma us, inc. - avacincaptad pegol sodium (unii: k86enl12i5) (avacincaptad pegol - unii:tt0v5jlg5b) - izervay™ is indicated for the treatment of geographic atrophy (ga) secondary to age-related macular degeneration (amd). izervay is contraindicated in patients with ocular or periocular infections. izervay is contraindicated in patients with active intraocular inflammation. risk summary there are no adequate and well-controlled studies of izervay administration in pregnant women. the use of izervay may be considered following an assessment of the risks and benefits. administration of avacincaptad pegol to pregnant rats and rabbits throughout the period of organogenesis resulted in no evidence of adverse effects to the fetus or pregnant female at intravenous (iv) doses 5.1 times and 3.2 times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 2 mg once monthly, respectively (see data) . in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15%-20%, respectively. data animal data an embryo fetal developmental toxicity study was conducted with pregnant rats. pregnant rats received daily intravenous (iv) injections of avacincaptad pegol from day 6 to day 17 of gestation at 0.1, 0.4, 1.2 mg/kg/day. no maternal or embryofetal adverse effects were observed at any dose evaluated. an increase in the incidence of a non-adverse skeletal variation, described as short thoracolumbar (ossification site without distal cartilage) supernumerary ribs, was observed at all doses evaluated. the clinical relevance of this finding is unknown. plasma exposures at the high dose were 5.1 times the mrhd, based on area under the curve (auc). an embryo fetal developmental toxicity study was conducted with pregnant rabbits. pregnant rabbits received daily iv injections of avacincaptad pegol from day 7 to day 19 of gestation at 0.12, 0.4, 1.2 mg/kg/day. no maternal or embryofetal adverse effects were observed at any dose evaluated. plasma exposure in pregnant rabbits at the highest dose of 1.2 mg/kg/day was 3.2 times the human exposure at the mrhd, based on auc. risk summary there is no information regarding the presence of avacincaptad pegol in human milk, the effects of the drug on the breastfed infant, or the effects of avacincaptad pegol on milk production. many drugs are transferred in human milk with the potential for absorption and adverse reactions in the breastfed child. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for izervay, and any potential adverse effects on the breastfed infant from izervay. safety and effectiveness of izervay in pediatric patients have not been established. of the total number of patients who received izervay in the two clinical trials, 90% (263/292) were ≥65 years and 61% (178/292) were ≥75 years of age. no significant differences in efficacy or safety of avacincaptad pegol were seen with increasing age in these studies. no dose adjustment is required in patients 65 years and above.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

xiidra- lifitegrast solution/ drops

bausch & lomb incorporated - lifitegrast (unii: 038e5l962w) (lifitegrast - unii:038e5l962w) - xiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (ded). xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation [see adverse reactions (6.2)]. risk summary there are no available data on xiidra use in pregnant women to inform any drug-associated risks. intravenous (iv) administration of lifitegrast to pregnant rats, from premating through gestation day 17, did not produce teratogenicity at clinically relevant systemic exposures. intravenous administration of lifitegrast to pregnant rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [rhod], based on the area under the curve [auc] level). since human systemic exposure to lifitegrast following ocular administration of xiidra at the rhod is low, the applicability of animal findings to the risk of xiidra use in humans during pregnancy is unclear [see clinical pharmacology (12.3)] data animal data lifitegrast administered daily by iv injection to rats, from premating through gestation day 17, caused an increase in mean pre-implantation loss and an increased incidence of several minor skeletal anomalies at 30 mg/kg/day, representing 5,400-fold the human plasma exposure at the rhod of xiidra, based on auc. no teratogenicity was observed in the rat at 10 mg/kg/day (460-fold the human plasma exposure at the rhod, based on auc). in the rabbit, an increased incidence of omphalocele was observed at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the rhod, based on auc), when administered by iv injection daily from gestation days 7 through 19. a fetal no observed adverse effect level (noael) was not identified in the rabbit. risk summary there are no data on the presence of lifitegrast in human milk, the effects on the breastfed infant, or the effects on milk production. however, systemic exposure to lifitegrast from ocular administration is low [see clinical pharmacology( 12.3)] . the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for xiidra and any potential adverse effects on the breastfed child from xiidra. safety and efficacy in pediatric patients below the age of 17 years have not been established. no overall differences in safety or effectiveness have been observed between elderly and younger adult patients. instructions for use xiidra ® [zye-druh] (lifitegrast ophthalmic solution) 5% for topical ophthalmic use read this instructions for use before you start using xiidra and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your doctor about your medical condition or your treatment. important information you need to know before using xiidra: - xiidra is for use in the eye. - wash your hands before each use to make sure you do not infect your eyes while using xiidra. - if you wear contact lenses, remove them before using xiidra. - xiidra single‑use containers are packaged in a foil pouch. do not remove from the foil pouch until you are ready to use xiidra. - do not let the tip of the xiidra single-use container touch your eye or any other surfaces. - use one drop of xiidra in each eye two times each day (one drop in the morning and one drop in the evening, approximately 12 hours apart). each single‑use container of xiidra will give you enough medicine to treat both of your eyes, one time. there is some extra xiidra in each single‑use container in case you miss getting a drop into your eye. after you have applied the drops, throw away the single‑use container and any unused xiidra. do not save any unused xiidra. follow steps 1 to 9 each time you use xiidra. step 1. take a foil pouch out of the xiidra box. open the pouch and remove the strip of single‑use containers (see figure a ). - pull off one single‑use container from the strip (see figure b ). - figure a - figure b step 2. put the remaining strip of single‑use containers back in the pouch (see figure c ). - figure c - fold the edge to close the pouch (see figure d ). - figure d step 3. hold the xiidra container upright (see figure e ). - tap the top of the container until all of the solution is in the bottom part of the container (see figure f ). figure e figure f step 4. open the xiidra single‑use container by twisting off the tab. make sure that the tip of the single‑use container does not touch anything, to avoid contamination (see figure g ). figure g step 5. tilt your head backwards. if you are not able to tilt your head, lie down. step 6. gently pull your lower eyelid downwards and look up. step 7. place the tip of the xiidra single‑use container close to your eye, but be careful not to touch your eye with it. step 8. gently squeeze the single‑use container and let one drop of xiidra fall into the space between your lower eyelid and your eye. if a drop misses your eye, try again ( see figure h ). figure h step 9. repeat steps 5 to 8 for your other eye. there is enough xiidra in one single‑use container for both eyes. - once you have applied a drop to both eyes, throw away the opened single‑use container with any remaining solution. - if you use contact lenses, wait for at least 15 minutes before placing them back in your eyes. distributed by: bausch & lomb americas inc., bridgewater, nj 08807 usa patented. see https://patents.bausch.comfor us patent information. xiidra is a trademark of bausch & lomb incorporated or its affiliates. © 2023 bausch & lomb incorporated or its affiliates this instructions for use has been approved by the u.s. food and drug administration. revised: december 2023 9800800