الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years and older. dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsule administration is contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/othermedications/ . risk summary

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

oxford pharmaceuticals, llc - dipyridamole (unii: 64alc7f90c) (dipyridamole - unii:64alc7f90c) - dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement. hypersensitivity to dipyridamole and any of the other components.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

eugia us llc - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketamine hydrochloride injection is indicated: - as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. - for the induction of anesthesia prior to the administration of other general anesthetic agents. - as a supplement to other anesthetic agents. - ketamine hydrochloride is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see warnings and precautions (5.1)]. - ketamine hydrochloride is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see adverse reactions (6)]. risk summary there are no adequate and well-controlled studies of ketamine hydrochloride in pregnant women. in animal reproduction studies in rats developmental delays (hypoplasia of skeletal tissues) were noted at 0.3 times the human intramuscular dose of 10 mg/kg. in rabbits, developmental delays and increased fetal resorptions were noted at 0.6 times the human dose. published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block nmda receptors and/or potentiate gaba activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. there are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans. 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 ketamine hydrochloride use in pregnancy, including obstetrics (either vaginal or abdominal delivery), is not recommended because safe use has not been established [see warnings and precautions (5.5), use in specific populations (8.4) and nonclinical toxicology (13.2)] . data animal data pregnant rats were treated intramuscularly with 20 mg/kg ketamine (0.3 times the human dose of 10 mg/kg im based on body surface area) on either gestation days 6 to 10 or gestation days 11 to 15. ketamine treatment produced an increased incidence of hypoplastic skull, phalanges, and sternebrae in the pups. pregnant rabbits were treated intramuscularly with 20 mg/kg ketamine (0.6 times the human dose of 10 mg/kg im based on body surface area) on either gestation days 6 to 10 or gestation days 11 to 15. an increase in resorptions and skeletal hypoplasia of the fetuses were noted. additional pregnant rabbits were treated intramuscularly with a single dose 60 mg/kg (1.9 times the human dose of 10 mg/kg im based on body surface area) on gestation day 6 only. skeletal hypoplasia was reported in the fetuses. in a study where pregnant rats were treated intramuscularly with 20 mg/kg ketamine (0.3 times the human dose of 10 mg/kg im based on body surface area) from gestation day 18 to 21. there was a slight increase in incidence of delayed parturition by one day in treated dams of this group. no adverse effects on the litters or pups were noted; however, learning and memory assessments were not completed. three (3) pregnant beagle dogs were treated intramuscularly with 25 mg/kg ketamine (1.3 times the human dose of 10 mg/kg im based on body surface area) twice weekly for the three weeks of the first, second, and third trimesters of pregnancy, respectively, without the development of adverse effects in the pups. in a published study in primates, administration of an anesthetic dose of ketamine for 24 hours on gestation day 122 increased neuronal apoptosis in the developing brain of the fetus. in other published studies, administration of either isoflurane or propofol for 5 hours on gestation day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. with respect to brain development, this time period corresponds to the third trimester of gestation in the human. the clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits [see warnings and precautions (5.5), use in specific populations (8.4), and nonclinical toxicology (13.2)] . safety and effectiveness in pediatric patients below the age of 16 have not been established. published juvenile animal studies demonstrate that the administration of anesthetic and sedation drugs, such as ketamine hydrochloride, that either block nmda receptors or potentiate the activity of gaba during the period of rapid brain growth or synaptogenesis, results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life but may extend out to approximately 3 years of age in humans. in primates, exposure to 3 hours of ketamine that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer of isoflurane increased neuronal cell loss. data from isoflurane-treated rodents and ketamine-treated primates suggest that the neuronal and oligodendrocyte cell losses are associated with prolonged cognitive deficits in learning and memory. the clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures with the potential risks suggested by the nonclinical data [see warnings and precautions (5.5), use in specific populations (8.1), and nonclinical toxicology (13.2)] . clinical studies of ketamine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has 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. ketamine hydrochloride contains ketamine, a schedule iii controlled substance under the controlled substance act. individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of ketamine hydrochloride. abuse is the intentional, non-therapeutic use of a drug, even once, for its 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. in a context of drug abuse, ketamine hydrochloride may produce a variety of symptoms including anxiety, dysphoria, disorientation, insomnia, flashback, hallucinations, and feelings of floating, detachment and being "spaced out". recurrent high-dose ketamine misuse or abuse may be associated with memory and/or attention impairment. physical dependence has been reported with prolonged use of ketamine. 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 significant dosage reduction of a drug. withdrawal symptoms have been reported after the discontinuation of frequently used (more than weekly), large doses of ketamine for long periods of time. reported symptoms of withdrawal associated with daily intake of large doses of ketamine include craving, fatigue, poor appetite, and anxiety. tolerance has been reported with prolonged use of ketamine. 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).

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

solco healthcare us,llc - lisdexamfetamine dimesylate (unii: sjt761gegs) (lisdexamfetamine - unii:h645gul8kj) - lisdexamfetamine dimesylate capsules are indicated for the treatment of: limitations of use: lisdexamfetamine dimesylate capsules are contraindicated in patients with: click here to enter use in specific populations risk summary the limited available data from published literature and postmarketing reports on use of lisdexamfetamine dimesylate capsules in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines [see clinical considerations] . in animal reproduction studies, lisdexamfetamine dimesylate (a prodrug of d-amphetamine) had no effects on embryo-fetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis. pre- and postnatal studies were not conducted with lisdexamfetamine dimesylate. however, amphetamine (d- to l- ratio of 3:1) administration to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine. in addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine [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 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions amphetamines, such as lisdexamfetamine dimesylate capsules, cause vasoconstriction and thereby may decrease placental perfusion. in addition, amphetamines can stimulate uterine contractions increasing the risk of premature delivery. infants born to amphetamine-dependent mothers have an increased risk of premature delivery and low birth weight. monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness. data animal data lisdexamfetamine dimesylate had no apparent effects on embryo-fetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 40 and 120 mg/kg/day, respectively. these doses are approximately 5.5 and 33 times, respectively, the maximum recommended human dose (mrhd) of 70 mg/day given to adults, on a mg/m2 body surface area basis. a study was conducted with amphetamine (d- to l- enantiomer ratio of 3:1) in which pregnant rats received daily oral doses of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. all doses caused hyperactivity and decreased weight gain in the dams. a decrease in pup survival was seen at all doses. a decrease in pup body weight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks, such as preputial separation and vaginal opening. increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at 5 weeks postweaning. when pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg. a number of studies from the literature in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d, l-) at doses similar to those used clinically can result in long‑ term neurochemical and behavioral alterations. reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. risk summary lisdexamfetamine is a pro-drug of dextroamphetamine. based on limited case reports in published literature, amphetamine (d-or d, l-) is present in human milk, at relative infant doses of 2% to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5. there are no reports of adverse effects on the breastfed infant. long-term neurodevelopmental effects on infants from amphetamine exposure are unknown. it is possible that large dosages of dextroamphetamine might interfere with milk production, especially in women whose lactation is not well established. because of the potential for serious adverse reactions in nursing infants, including serious cardiovascular reactions, blood pressure and heart rate increase, suppression of growth, and peripheral vasculopathy, advise patients that breastfeeding is not recommended during treatment with lisdexamfetamine dimesylate capsules. adhd safety and effectiveness of lisdexamfetamine dimesylate capsules have been established in pediatric patients with adhd ages 6 to 17 years [see dosage and administration (2.3), adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)] . safety and effectiveness of lisdexamfetamine dimesylate capsules have not been established in pediatric patients below the age of 6 years. safety and efficacy of lisdexamfetamine dimesylate capsules were evaluated in a double-blind, randomized, parallel-group, placebo-controlled, fixed-dose study in pediatric patients ages 4 to 5 years with adhd, followed by a 1-year open-label extension study. in these studies, patients experienced elevated rates of adverse reactions, including weight loss, decreased bmi, decreased appetite, insomnia, infections (upper respiratory and nasopharyngitis), irritability, and affect lability. with the same lisdexamfetamine dimesylate capsules dose, mean steady state exposure of dextroamphetamine was approximately 44% higher in pediatric patients ages 4 to 5 years compared to the pediatric patients ages 6 to 11 years. bed safety and effectiveness of lisdexamfetamine dimesylate capsules have not been established in pediatric patients with bed less than 18 years of age. growth suppression growth should be monitored during treatment with stimulants, including lisdexamfetamine dimesylate capsules, and pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.5) and adverse reactions (6.1)] . juvenile animal data studies conducted in juvenile rats and dogs at clinically relevant doses showed growth suppression that partially or fully reversed in dogs and female rats but not in male rats after a four-week drug-free recovery period. a study was conducted in which juvenile rats received oral doses of 4, 10, or 40 mg/kg/day of lisdexamfetamine dimesylate from day 7 to day 63 of age. these doses are approximately 0.3, 0.7, and 3 times the maximum recommended human daily dose of 70 mg on a mg/m2 basis for a child. dose-related decreases in food consumption, bodyweight gain, and crown-rump length were seen; after a four-week drug-free recovery period, bodyweights and crown-rump lengths had significantly recovered in females but were still substantially reduced in males. time to vaginal opening was delayed in females at the highest dose, but there were no drug effects on fertility when the animals were mated beginning on day 85 of age. in a study in which juvenile dogs received lisdexamfetamine dimesylate for 6 months beginning at 10 weeks of age, decreased bodyweight gain was seen at all doses tested (2, 5, and 12 mg/kg/day, which are approximately 0.5, 1, and 3 times the maximum recommended human daily dose on a mg/m2 basis for a child). this effect partially or fully reversed during a four- week drug-free recovery period. clinical studies of lisdexamfetamine dimesylate capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience and pharmacokinetic data [see clinical pharmacology (12.3)] have not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should start 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. due to reduced clearance in patients with severe renal impairment (gfr 15 to < 30 ml/min/1.73 m2 ), the maximum dose should not exceed 50 mg/day. the maximum recommended dose in esrd (gfr < 15 ml/min/1.73 m2 ) patients is 30 mg/day [see clinical pharmacology (12.3)] . lisdexamfetamine and d-amphetamine are not dialyzable. click here to enter drug abuse and dependence lisdexamfetamine dimesylate capsules contain lisdexamfetamine, a prodrug of amphetamine, a schedule ii controlled substance. lisdexamfetamine dimesylate capsules have 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)] . lisdexamfetamine dimesylate capsules 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 higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants including lisdexamfetamine dimesylate capsules, 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. misuse and abuse of lisdexamfetamine, a prodrug of amphetamine, 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 lisdexamfetamine dimesylate capsules, 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. studies of lisdexamfetamine dimesylate capsules in drug abusers a randomized, double-blind, placebo-control, cross-over, abuse liability study in 38 patients with a history of drug abuse was conducted with single-doses of 50, 100, or 150 mg of lisdexamfetamine dimesylate capsules, 40 mg of immediate-release d-amphetamine sulphate (a controlled ii substance), and 200 mg of diethylpropion hydrochloride (a controlled iv substance). lisdexamfetamine dimesylate capsules 100 mg produced significantly less “drug liking effects” as measured by the drug rating questionnaire-subject score, compared to d-amphetamine 40 mg; and 150 mg of lisdexamfetamine dimesylate capsules demonstrated similar “drug-liking effects” compared to 40 mg of d-amphetamine and 200 mg of diethylpropion. intravenous administration of 50 mg lisdexamfetamine dimesylate to individuals with a history of drug abuse produced positive subjective responses on scales measuring “drug liking”, “euphoria”, “amphetamine effects”, and “benzedrine effects” that were greater than placebo but less than those produced by an equivalent dose (20 mg) of intravenous d-amphetamine. physical dependence lisdexamfetamine dimesylate capsules 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 lisdexamfetamine dimesylate capsules include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance lisdexamfetamine dimesylate capsules may produce tolerance. tolerance is 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).

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

h2-pharma, llc - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - klonopin is useful alone or as an adjunct in the treatment of the lennox-gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, klonopin may be useful. some loss of effect may occur during the course of clonazepam treatment (see precautions: loss of effect). klonopin is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-v. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of klonopin was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir category of panic disorder (see clinical pharmacology: clinical trials). panic disorder (dsm-v) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. the effectiveness of klonopin in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. the physician who elects to use klonopin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). klonopin is contraindicated in patients with the following conditions: - history of sensitivity to benzodiazepines - clinical or biochemical evidence of significant liver disease - acute narrow angle glaucoma (it may be used in patients with open angle glaucoma who are receiving appropriate therapy). klonopin contains clonazepam, a schedule iv controlled substance. klonopin 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). klonopin 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) and 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 klonopin or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of klonopin 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. tolerance to klonopin 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 klonopin may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines. following the short-term treatment of patients with panic disorder in studies 1 and 2 (see clinical pharmacology: clinical trials), patients were gradually withdrawn during a 7-week downward-titration (discontinuance) period. overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon. however, there are not sufficient data from adequate and well-controlled long-term clonazepam studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be associated with such use.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

solstice neurosciences, llc - rimabotulinumtoxinb (unii: 0y70779m1f) (rimabotulinumtoxinb - unii:0y70779m1f) - rimabotulinumtoxinb 2500 [usp'u] in 0.5 ml - myobloc is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults. myobloc is indicated for the treatment of chronic sialorrhea in adults. myobloc is contraindicated in patients with: - a known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see warnings and precautions (5.3), description (11)] - infection at the proposed injection site(s) risk summary there are no adequate data on the developmental risks associated with the use of myobloc in pregnant women. no developmental toxicity was observed in pregnant rats administered myobloc by intramuscular injection during gestation and lactation, at doses producing maternal toxicity. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data when myobloc was administered by intramuscular injection to pregnant rats (0, 300, 1000, or 3000 units/kg/day) or rabbits (0, 0.03, 0.1, 0.3, or 1.0 units/kg/day) throughout gestation, no adverse effects on embryofetal development were observed. the highest dose tested in rat, which was associated with maternal toxicity, was 36 times the maximum recommended human dose (mrhd) for cervical dystonia (5000 units) on a body weight (units/kg) basis. the highest dose tested in rabbit was substantially less than the mrhd for cervical dystonia on a units/kg basis; maternal toxicity was observed at all but the lowest dose tested. risk summary there are no data on the presence of myobloc in human 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 myobloc and any potential adverse effects on the breastfed infant from myobloc or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. cervical dystonia in the controlled studies for myobloc in patients with cervical dystonia, 152 (75%) were under the age of 65, and 52 (26%) were 65 years of age or older [see clinical studies (14.1)] . for these age groups, the most frequently reported adverse reactions occurred at similar rates in both age groups. efficacy results did not suggest any large differences between these age groups. very few patients age 75 or older were enrolled; therefore, no conclusions regarding the safety and efficacy of myobloc within this age group can be determined. chronic sialorrhea of the 166 myobloc-treated patients in the placebo-controlled studies for treatment of chronic sialorrhea [see clinical studies (14.2)] , 105 (63%) were 65 years of age or older, and 43 (26%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between patients over 65 years of age and younger patients, but greater sensitivity of some older patients cannot be ruled out.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

alk-abello, inc. - dactylis glomerata pollen (unii: 83n78ida7p) (dactylis glomerata pollen - unii:83n78ida7p) - dactylis glomerata pollen 20000 [pnu] in 1 ml - hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided. a patient should not be immunized against a substance which the patient has not demonstrated symptoms and/or tissue-fixed ige antibodies as demonstrated by skin testing. immunotherapy should not be attempted in patients with active asthma, severe respiratory obstruction, or cardiovascular disease. there is some evidence, although inconclusive, that routine immunizations may exacerbate autoimmune diseases. hyposensitization should be given cautiously to patients with this predisposition. the physician must w

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

corepharma, llc - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - amphetamine sulfate 1.875 mg - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

international laboratories, llc - lovastatin (unii: 9lhu78oqfd) (lovastatin - unii:9lhu78oqfd) - lovastatin 10 mg - therapy with lovastatin tablets usp should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. lovastatin tablets usp should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-c and ldl-c to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. primary prevention of coronary heart disease in individuals without symptomatic cardiovascular disease, average to moderately elevated total-c and ldl-c, and below average hdl-c, lovastatin tablets usp are indicated to reduce the risk of: - myocardial infarction - unstable angina - coronary revascularization procedures (see clinical pharmacology , clinical studies in adults .) coronary heart disease lovastatin tablets usp are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment str

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

international laboratories, llc - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14) ]. important limitations of use pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3) ]. •   initiation in patients with established nyha class iii or iv heart failure [see boxed warning]. •   use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. teratogenic effects pregnancy category c. there are no adequate and well-controlled studies of pioglitazone hydrochloride in pregnant women. animal studies show increased rates of post-implantation loss, delayed development,