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

elite laboratories, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]      •  have not been tolerated, or are not expected to be tolerated,      •  have not provided adequate analgesia, or are not expected to provide adequate analgesia oxycodone and acetaminophen tablets is contraindicated in patients with:      •  significant respiratory depression [see warnings]      •  acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings]      •  known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings]     •  hypersensitivity to oxycodone, acetaminophen, or any other

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

elite laboratories, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use   because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: - significant respiratory depression [see warnings] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings] - hypersensitivity to hydrocodone or acetaminophen (e

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

elite laboratories, inc. - trimipramine maleate (unii: 269k6498ld) (trimipramine - unii:6s082c9ndt) - trimipramine maleate capsules are indicated for the relief of symptoms of depression. endogenous depression is more likely to be alleviated than other depressive states. in studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. in hospitalized depressed patients, trimipramine and imipramine were equally effective in relieving depression. the use of maois intended to treat psychiatric disorders with trimipramine maleate or within 14 days of stopping treatment with trimipramine maleate is contraindicated because of an increased risk of serotonin syndrome. the use of trimipramine maleate within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration ). starting trimipramine maleate in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also co

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

elite laboratories, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see warnings) , reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated. - have not provided adequate analgesia, or are not expected to provide adequate analgesia acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age (see warnings). - post-operative

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

elite laboratories, inc. - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is 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; fo

Philippines - English - FDA (Food And Drug Administration)

gold life distribution phils. inc. - ascorbic acid , zinc ,cholecalciferol (vitamin d3) - capsule - 500 mg (equivalent to 562.43 mg sodium ascorbate)/ 10 mg (equivalent to 70 mg zinc gluconate)/1,000 iu

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

elite laboratories, inc. - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - 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 capsules administration is contraindicated in patients: - known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see adverse reactions (6.2)] - taking monoamine oxidase inhibitors (maois), or within 14 days of stopping maois (including maois such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see warnings and precautions (5.8) and drug interactions (7.1) ] 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/othermediciations/. risk summary available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified a drug-associated risk of major birth defects and miscarriage (see data ). adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers taking amphetamines during pregnancy (see clinical considerations ). no apparent effects on morphological development were observed in embryo-fetal development studies, with oral administration of amphetamine to rats and rabbits during organogenesis at doses 2 and 12 times, respectively, the maximum recommended human dose (mrhd) of 20 mg/day given to adolescents, on a mg/m2 basis. however, in a pre- and post-natal development study, amphetamine (d- to l- ratio of 3:1) administered orally 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 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions amphetamines, such as dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release 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 mothers taking amphetamines during pregnancy 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 amphetamine (d- to l- enantiomer ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. these doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (mrhd) of 20 mg/day given to adolescents, on a mg/m2 basis. fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the mrhd given to adolescents on a mg/m2 basis) or greater to pregnant animals. administration of these doses was also associated with severe maternal toxicity. a study was conducted in which pregnant rats received daily oral doses of amphetamine (d- to l- enantiomer ratio of 3:1) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. these doses are approximately 0.8, 2, and 4 times the mrhd of 20 mg/day given to adolescents, on a mg/m2 basis. 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 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 amphetamine 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, advise patients that breastfeeding is not recommended during treatment with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. the safety and effectiveness of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules have been established in pediatric patients with adhd 6 years of age and older. the safety and efficacy of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in pediatric patients less than 6 years of age have not been established. long-term effects of amphetamines in pediatric patients has not been well established. long-term growth suppression growth should be monitored during treatment with stimulants, including dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, and pediatric patients aged 6 to 17 years who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.5)]. juvenile animal toxicity data juvenile rats treated with mixed amphetamine salts early in the postnatal period through sexual maturation demonstrated transient changes in motor activity. learning and memory was impaired at approximately 6 times the maximum recommended human dose (mrhd) given to children on a mg/m2 basis. no recovery was seen following a drug-free period. a delay in sexual maturation was observed at a dose approximately 6 times the mrhd given to children on a mg/m2 basis, although there was no effect on fertility. in a juvenile developmental study, rats received daily oral doses of amphetamine (d to l enantiomer ratio of 3:1) of 2, 6, or 20 mg/kg on days 7-13 of age; from day 14 to approximately day 60 of age these doses were given b.i.d. for total daily doses of 4, 12, or 40 mg/kg. the latter doses are approximately 0.6, 2, and 6 times the mrhd of 30 mg/day, given to children on a mg/m2 basis. post dosing hyperactivity was seen at all doses; motor activity measured prior to the daily dose was decreased during the dosing period but the decreased motor activity was largely absent after an 18 day drug-free recovery period. performance in the morris water maze test for learning and memory was impaired at the 40 mg/kg dose, and sporadically at the lower doses, when measured prior to the daily dose during the treatment period; no recovery was seen after a 19 day drug-free period. a delay in the developmental milestones of vaginal opening and preputial separation was seen at 40 mg/kg but there was no effect on fertility. dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules has not been studied in the geriatric population. due to reduced clearance of amphetamines in patients with severe renal impairment (gfr 15 to < 30 ml/min/1.73m2 ), the recommended dose should be reduced.  dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are not recommended in patients with esrd (gfr < 15 ml/min/1.73m2 ) [see dosage and administration (2.6), clinical pharmacology (12.3)]. d-amphetamine is not dialyzable. dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain amphetamine, a schedule ii controlled substance. dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 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)] . dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release 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 healthcare 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 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release 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. physical dependence dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance   dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 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).

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

elite laboratories, inc. - vigabatrin (unii: gr120krt6k) (vigabatrin - unii:gr120krt6k) - vigabatrin is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see warnings and precautions (5.1)] . vigabatrin is not indicated as a first line agent for complex partial seizures. vigabatrin is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see warnings and precautions (5.1) ]. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, including vigabatrin, during pregnancy. encourage women who are taking vigabatrin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334 or visiting the website,

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

elite laboratories, inc. - hydromorphone hydrochloride (unii: l960up2krw) (hydromorphone - unii:q812464r06) - hydromorphone hydrochloride tablets, usp are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use   because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve hydromorphone hydrochloride tablets, usp for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: •  have not been tolerated, or are not expected to be tolerated, • have not provided adequate analgesia, or are not expected to provide adequate analgesia hydromorphone hydrochloride tablets, usp are contraindicated in patients with: •  significant respiratory depression [see warnings and precautions (5.6)] • acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.6)] • known or suspected gastrointestinal obstruction, including paralyti

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

elite laboratories, inc - phendimetrazine tartrate (unii: 6985ip0t80) (phendimetrazine - unii:ab2794w8kv) - phendimetrazine tartrate is 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/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. below is a chart of body mass index (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 follow: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.   phendimetrazine tartrate is indicated for the use as monotherapy only known hypersensitivity or idiosyncratic reactions to sympathomimetics. advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, and glaucoma. highly nervous or agitated patients. patients with a history of drug abuse. patients taking other cns stimulants, including mon