Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical - oxymorphone hydrochloride (unii: 5y2ei94nbc) (oxymorphone - unii:9vxa968e0c) - oxymorphone hydrochloride 5 mg - oxymorphone hydrochloride tablets are indicated for the management of acute 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 oxymorphone hydrochloride tablets 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 oxymorphone hydrochloride tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.2)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.5)] - known or suspected gastrointestinal obstruction, including paralytic ileus [see war

Yhdysvallat - englanti - NLM (National Library of Medicine)

redpharm drug, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride 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 and precautions (5.1)], reserve oxycodone hydrochloride tablets 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. oxycodone hydrochloride tablets are contraindicated in patients with: • significant respiratory depression [see warnings and precautions (5.2)] • acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see warnings and precautions (5.6)] • known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.10)] known hypersensitivity (e.g., anaphylaxis) to oxycodone [see adverse reactions (6.2)] 8.1 pregnancy risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.3)]. available data with oxycodone hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. animal reproduction studies with oral administrations of oxycodone hcl in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity. in several published studies, treatment of pregnant rats with oxycodone at clinically relevant doses and below, resulted in neurobehavioral effects in offspring [see data]. based on animal data, advise pregnant women of the potential risk to a fetus. 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 prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents irritability, hyperactivity, and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid use, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly[see warnings and precautions (5.3)]. labor or delivery opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. oxycodone hydrochloride tablets are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including oxycodone hydrochloride tablets, can prolong labor through actions which temporarily reduce the strength, duration and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of oxycodone hcl administered during the period of organogenesis up to 16 mg/kg/day and up to 25 mg/kg/day, respectively. these studies revealed no evidence of teratogenicity or embryo-fetal toxicity due to oxycodone. the highest doses tested in rats and rabbits were equivalent to approximately 2.6 and 8.1 times an adult human dose of 60 mg/day, respectively, on a mg/m2 basis. in published studies, offspring of pregnant rats administered oxycodone during gestation have been reported to exhibit neurobehavioral effects including altered stress responses, increased anxiety-like behavior (2 mg/kg/day iv from gestation day 8 to 21 and postnatal day 1, 3, and 5; 0.3-times an adult human dose of 60 mg/day, on a mg/m2 basis) and altered learning and memory (15 mg/kg/day orally from breeding through parturition; 2.4 times an adult human dose of 60 mg/day, on a mg/m2 basis). 8.2 lactation risk summary oxycodone is present in breast milk. published lactation studies report variable concentrations of oxycodone in breast milk with administration of immediate-release oxycodone to nursing mothers in the early postpartum period. the lactation studies did not assess breastfed infants for potential adverse reactions. lactation studies have not been conducted with oxycodone hydrochloride tablets, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for oxycodone hydrochloride tablets and any potential adverse effects on the breastfed infant from oxycodone hydrochloride tablets or from the underlying maternal condition. clinical considerations infants exposed to oxycodone hydrochloride tablets through breast milk should be monitored for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped or when breast-feeding is stopped. 8.3 females and males of reproductive potential infertility chronic use of opioids may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6.2), clinical pharmacology (12.2)]. 8.4 pediatric use the safety and efficacy of oxycodone hydrochloride tablets in pediatric patients have not been evaluated. 8.5 geriatric use of the total number of subjects in clinical studies of oxycodone hydrochloride tablets, 20.8% (112/538) were 65 and over, while 7.2% (39/538) were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone. in general, use caution when selecting a dosage for an elderly patient, 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. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of oxycodone hydrochloride tablets slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see warnings and precautions (5.6)]. oxycodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 hepatic impairment because oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. initiate therapy in these patients with a lower than usual dosage of oxycodone hydrochloride tablets and titrate carefully. monitor closely for adverse events such as respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)]. 8.7 renal impairment because oxycodone is known to be substantially excreted by the kidney, its clearance may decrease in patients with renal impairment. initiate therapy with a lower than usual dosage of oxycodone hydrochloride tablets and titrate carefully. monitor closely for adverse events such as respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)]. 9.1 controlled substance oxycodone hydrochloride tablets contain oxycodone, a schedule ii controlled substance. 9.2 abuse oxycodone hydrochloride tablets contain oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone hydromorphone, methadone, morphine, oxymorphone, and tapentadol. oxycodone hydrochloride tablets can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1)]. all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. oxycodone hydrochloride tablets, like other opioids, can be diverted for non-medical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of oxycodone hydrochloride tablets oxycodone hydrochloride tablets are for oral use only. abuse of oxycodone hydrochloride tablets poses a risk of overdose and death. the risk is increased with concurrent abuse of oxycodone hydrochloride tablets with alcohol and other central nervous system depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. 9.3 dependence both tolerance and physical dependence can develop during chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. oxycodone hydrochloride tablets should not be abruptly discontinued in a physically-dependent patient [see dosage and administration (2.4)]. if oxycodone hydrochloride tablets are abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)].

Yhdysvallat - englanti - NLM (National Library of Medicine)

novel laboratories, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride capsules are an opioid agonist indicated in adults 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 oxycodone hydrochloride capsules 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 oxycodone hydrochloride capsules are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3) ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.7) ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.11)] - hypersensitivity to oxycodone (e.g., angioedema) [see adverse reactions (6) ] risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)] . available data with oxycodone hydrochloride capsules are insufficient to inform a drug-associated risk for major birth defects and miscarriage. animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity. in several published studies, treatment of pregnant rats with oxycodone at clinically relevant doses and below, resulted in neurobehavioral effects in offspring [see data]. based on animal data, advise pregnant women of the potential risk to a fetus. the 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 prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.4)]. labor or delivery opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. oxycodone hydrochloride capsules are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including oxycodone hydrochloride capsules, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of oxycodone hydrochloride administered during the period of organogenesis up to 16 mg/kg/day and up 25 mg/kg/day, respectively. these studies revealed no evidence of teratogenicity or embryo-fetal toxicity due to oxycodone. the highest doses tested in rats and rabbits were equivalent to approximately 2.6 and 8.1 times an adult human dose of 60 mg/day, respectively, on a mg/m2 basis. in published studies, offspring of pregnant rats administered oxycodone during gestation have been reported to exhibit neurobehavioral effects including altered stress responses, increased anxiety-like behavior (2 mg/kg/day iv from gestation day 8 to 21 and postnatal day 1, 3, and 5; 0.3-times an adult human dose of 60 mg/day, on a mg/m2 basis) and altered learning and memory (15 mg/kg/day orally from breeding through parturition; 2.4 times an adult human dose of 60 mg/day, on a mg/m2 basis). risk summary oxycodone is present in breast milk. published lactation studies report variable concentrations of oxycodone in breast milk with administration of immediate-release oxycodone to nursing mothers in the early postpartum period. the lactation studies did not assess breastfed infants for potential adverse reactions. lactation studies have not been conducted with oxycodone hydrochloride capsules, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for oxycodone hydrochloride capsules and any potential adverse effects on the breastfed infant from oxycodone hydrochloride capsules or from the underlying maternal condition. clinical considerations monitor infants exposed to oxycodone hydrochloride capsules through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast- feeding is stopped. infertility chronic use of opioids may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6), clinical pharmacology (12.2)]. the safety and effectiveness of oxycodone hydrochloride capsules have not been established in pediatric patients. the safety and pharmacokinetics of a single-dose of an oxycodone hydrochloride oral solution were evaluated in an open-label clinical trial in 89 pediatric patients 2 years to less than 17 years of age with postoperative pain. however, definitive conclusions are not possible because of insufficient information. elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone. in general, use caution when selecting a dose for an elderly patient, 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. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of oxycodone hydrochloride capsules slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see warnings and precautions (5.7)]. oxycodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. since oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. initiate therapy in these patients with a lower than usual dosage of oxycodone hydrochloride capsules and titrate carefully. monitor closely for adverse events such as respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)] . information from oxycodone tablets indicate that patients with renal impairment had higher plasma concentrations of oxycodone than subjects with normal renal function. initiate therapy with a lower than usual dosage of oxycodone hydrochloride capsules and titrate carefully. monitor closely for adverse events such as respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)]. oxycodone hydrochloride capsules contains oxycodone, a schedule ii controlled substance oxycodone hydrochloride capsules contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. oxycodone hydrochloride capsules can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1)] . all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. "drug-seeking" behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s). "doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. oxycodone hydrochloride capsules, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of oxycodone hydrochloride capsules oxycodone hydrochloride capsules are for oral use only. abuse of oxycodone poses a risk of overdose and death. the risk is increased with concurrent use of alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. do not abruptly discontinue oxycodone hydrochloride capsules in a patient physically dependent on opioids. rapid tapering of oxycodone hydrochloride capsules in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing oxycodone hydrochloride capsules, gradually taper the dosage using a patient-specific plan that considers the following: the dose of oxycodone hydrochloride capsules the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper,  [see dosage and administration(2.5) warnings and precautions (5.13)]. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)] .

Yhdysvallat - englanti - NLM (National Library of Medicine)

northstar rx llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets are indicated in adults 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 tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: tramadol hydrochloride tablets are contraindicated for: tramadol hydrochloride tablets are also contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. available data with tramadol hydrochloride tablets in pregnant women are insufficient to inform a drug- associated risk for major birth defects and miscarriage. in animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4,

Yhdysvallat - englanti - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - meperidine hydrochloride 50 mg - meperidine hydrochloride tablets are indicated for the management of acute 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 (5.2)] , reserve meperidine hydrochloride tablets 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. meperidine hydrochloride tablets should not be used for treatment of chronic pain. prolonged meperidine hydrochloride tablets use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine. meperidine hydrochloride tablets are contraindicated in patients with: - significant respiratory depression [see warnings and preca

Yhdysvallat - englanti - NLM (National Library of Medicine)

bryant ranch prepack - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride capsule is an opioid analgesic, indicated for the management of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. oxycodone hydrochloride is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. oxycodone hydrochloride is contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone hydrochloride is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. oxycodone hydrochloride is contraindicated in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product. pregnancy category b: there are no adequate and well-controlled studies of oxycodone use during pregnancy. based on limited human data in the literature, oxycodone does not appear to increase the risk of congenital malformations. because animal reproduction studies are not always predictive of human response, oxycodone should be used during pregnancy

Yhdysvallat - englanti - NLM (National Library of Medicine)

actavis pharma, inc. - hydromorphone hydrochloride (unii: l960up2krw) (hydromorphone - unii:q812464r06) - hydromorphone hydrochloride 8 mg - hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in o p i o i d - t o l e r a n t  patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. l i m i tat i o ns   of   u s e - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom  alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are inef

Yhdysvallat - englanti - NLM (National Library of Medicine)

physicians total care, inc. - oxymorphone hydrochloride (unii: 5y2ei94nbc) (oxymorphone - unii:9vxa968e0c) - oxymorphone hydrochloride 10 mg - oxymorphone hydrochloride tablets are indicated for the relief of moderate to severe acute pain where the use of an opioid is appropriate. - oxymorphone hydrochloride tablets are contraindicated in patients with a known hypersensitivity to oxymorphone or to any of the other ingredients in oxymorphone hydrochloride tablets, or with known hypersensitivity to morphine analogs such as codeine. - oxymorphone hydrochloride tablets are contraindicated in patients with respiratory depression, except in monitored settings and in the presence of resuscitative equipment. - oxymorphone hydrochloride tablets are contraindicated in patients with acute or severe bronchial asthma or hypercarbia. - oxymorphone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus [see warning and precautions (5.8)] . - oxymorphone hydrochloride tablets are contraindicated in patients with moderate or severe hepatic impairment [see warnings and precautions (5.6)] . the safety of using oxymor

Yhdysvallat - englanti - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - oxymorphone hydrochloride (unii: 5y2ei94nbc) (oxymorphone - unii:9vxa968e0c) - oxymorphone hydrochloride 5 mg - oxymorphone hydrochloride tablets are indicated for the relief of moderate to severe acute pain where the use of an opioid is appropriate. - oxymorphone hydrochloride tablets are contraindicated in patients with a known hypersensitivity to oxymorphone or to any of the other ingredients in oxymorphone hydrochloride tablets, or with known hypersensitivity to morphine analogs such as codeine. - oxymorphone hydrochloride tablets are contraindicated in patients with respiratory depression, except in monitored settings and in the presence of resuscitative equipment. - oxymorphone hydrochloride tablets are contraindicated in patients with acute or severe bronchial asthma or hypercarbia. - oxymorphone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus [see warning and precautions (5.8)] . - oxymorphone hydrochloride tablets are contraindicated in patients with moderate or severe hepatic impairment [see warnings and precautions (5.6)] . the safety of using oxymorphone in pregnancy has not been established with regard to possible adverse effects on fetal development. the use of oxymorphone hydrochloride tablets in pregnancy, in nursing mothers, or in women of child-bearing potential requires that the possible benefits of the drug be weighted against the possible hazards to the mother and the child. teratogenic effects pregnancy category c there are no adequate and well-controlled studies of oxymorphone in pregnant women. in animal studies, oxymorphone caused decreased fetal and pup weights, an increase in stillbirth, and a decrease in postnatal pup survival at maternal oxymorphone doses equivalent to 0.4 to 4 times the human daily dose of 120 mg (based on body surface area). oxymorphone hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in embryo-fetal developmental toxicity studies, pregnant rats and rabbits received oxymorphone hydrochloride at doses up to about 2 times (rats) and 8 times (rabbits) total human daily dose of 120 mg (based on body surface area). no malformations occurred, but reduced fetal weights occurred at maternal doses of 0.8 (rat) and 4 (rabbit) times the total human daily dose of 120 mg (based on body surface area). there were no adverse developmental effects in rats that received 0.4 times or rabbits that received less than 4 times the total human dose. there were no effects of oxymorphone hydrochloride on intrauterine survival at doses in rats ≤2 times, or in rabbits at ≤8 times the human dose (see non-teratogenic effects, below). in a study conducted prior to the establishment of good laboratory practices (glp) and not according to current recommended methodology, a single subcutaneous injection of oxymorphone hydrochloride on gestation day 8 produced malformations in offspring of hamsters that received a dose equivalent to 10 times the total human daily dose of 120 mg (based on body surface area). this dose also produced 83% maternal lethality. non-teratogenic effects oxymorphone hydrochloride administration to female rats during gestation in a pre- and postnatal developmental toxicity study reduced mean litter size (18%) at a dose of 25 mg/kg/day, attributed to an increase in the incidence of stillborn pups. an increase in neonatal death occurred at doses ≥5 mg/kg/day (0.4 times a total human daily dose of 120 mg, based on body surface area). low pup birth weight, decreased post-natal weight gain, and reduced post-natal survival of pups occurred following treatment of the dams with 25 mg/kg/day (about 2 times a total human daily dose of 120 mg, based on body surface area). prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal physical dependence. neonatal withdrawal may occur. symptoms usually appear during the first days of life and may include convulsions, irritability, excessive crying, tremors, hyperactive reflexes, fever, vomiting, diarrhea, sneezing, yawning, and increased respiratory rate. opioids cross the placenta and may produce respiratory depression in neonates. oxymorphone hydrochloride tablets are not recommended for use in women during and immediately prior to labor, when use of shorter acting analgesics or other analgesic techniques are more appropriate. occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. neonates whose mothers received opioid analgesics during labor should be observed closely for signs of respiratory depression. a specific opioid antagonist, such as naloxone or nalmefene, should be available for reversal of opioid-induced respiratory depression in the neonate. it is not known whether oxymorphone is excreted in human milk. because many drugs, including some opioids, are excreted in human milk, caution should be exercised when oxymorphone hydrochloride tablets are administered to a nursing woman. infants exposed to oxymorphone hydrochloride tablets through breast milk should be monitored for excess sedation and respiratory depression. withdrawal symptoms can occur in breast-fed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. safety and effectiveness of oxymorphone hydrochloride tablets in pediatric patients below the age of 18 years have not been established. oxymorphone hydrochloride tablets should be used with caution in elderly patients [see clinical pharmacology ( 12.3 )] . of the total number of subjects in clinical studies of oxymorphone hydrochloride tablets, 31% were 65 and over, while 7% were 75 and over. no overall differences in effectiveness were observed between these subjects and younger subjects. there were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects. these adverse events included dizziness, somnolence, confusion, and nausea. in general, dose selection for elderly patients 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 a study of extended-release oxymorphone tablets, patients with mild hepatic impairment were shown to have an increase in bioavailability of 1.6 fold. oxymorphone hydrochloride tablets should be used with caution in patients with mild impairment. these patients should be started with the lowest dose and titrated slowly while carefully monitoring for side effects. oxymorphone hydrochloride tablets are contraindicated for patients with moderate and severe hepatic impairment [see contraindications ( 4 ), warnings and precautions ( 5.6 ), and dosage and administration ( 2.5 )] . in a study of extended-release oxymorphone tablets, patients with moderate to severe renal impairment were shown to have an increase in bioavailability ranging from 57-65% [see clinical pharmacology ( 12.3 )] . such patients should be started cautiously with lower doses of oxymorphone hydrochloride tablets and titrated slowly while monitoring for side effects [see dosage and administration ( 2.6 )] . oxymorphone hydrochloride tablets contain oxymorphone, a mu opioid agonist and a schedule ii controlled substance with an abuse liability similar to morphine and other opioids. oxymorphone can be abused and is subject to criminal diversion [see warnings and precautions ( 5.2 )]. all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. addiction is characterized by one or more of the following: impaired control over drug use, compulsive use, use for non-medical purposes, and continued use despite harm. drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. “drug-seeking” behavior is very common to addicts and drug abusers. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated claims of loss of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating physician(s). “doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. oxymorphone hydrochloride tablets, like other opioids, may be diverted for non-medical use. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. oxymorphone hydrochloride tablets are intended for oral use only. abuse of oxymorphone hydrochloride tablets poses a risk of overdose and death. this risk is increased with concurrent abuse of oxymorphone hydrochloride tablets with alcohol and other substances. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. opioid analgesics may cause physical dependence. physical dependence results in withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an opioid antagonist or mixed opioid agonist/antagonist agent. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, e.g., naloxone, nalmefene, or mixed agonist/antagonist analgesics (pentazocine, butorphanol, buprenorphine, nalbuphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). the development of physical dependence and/or tolerance is not unusual during chronic opioid therapy. oxymorphone hydrochloride tablets should not be abruptly discontinued [see dosage and administration ( 2.4 )] . if oxymorphone hydrochloride tablets are abruptly discontinued in a physically-dependent patient, an abstinence syndrome may occur. some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms [see use in specific populations ( 8.1 , 8.2 )] .

Yhdysvallat - englanti - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 100 mg in 5 ml - oxycodone hydrochloride oral solution 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 and precautions (5.2)] , reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: oxycodone hydrochloride oral solution is contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)] . available data with oxycodone hydrochloride oral solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.