Amerika Syarikat - Inggeris - 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)] .

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

bryant ranch prepack - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 30 mg - oxycodone hydrochloride tablets is contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. this includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. oxycodone hydrochloride tablets is contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone hydrochloride tablets, a mu-agonist opioid of the morphine type and is a schedule ii controlled substance. oxycodone hydrochloride tablets, like other opioids used in analgesia, can be abused and is subject to criminal diversion. drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common. “drug-seeking” behavior is very common in addicts and drug abuser

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

aurolife pharma, llc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride 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 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 is 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 or hypercarbia [see warnings and precautions (5.7)]. • known or suspected gastrointestinal obstruction, in

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

mckesson corporation - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride (hcl) 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 hcl 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 hcl is 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

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

bryant ranch prepack - 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

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

dispensing solutions, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 15 mg - oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. oxycodone hydrochloride tablets are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. this includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. oxycodone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone hydrochloride tablets contain oxycodone, a mu-agonist opioid of the morphine type and is a schedule ii controlled substance. oxycodone hydrochloride tablets, like other opioids used in analgesia, can be abused and is subject to criminal diversion. drug addiction is characterized by compulsive use, use for nonmedical purposes,

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

blenheim pharmacal, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 15 mg - oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. oxycodone hydrochloride tablets are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. this includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. oxycodone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone hydrochloride tablets contain oxycodone, a mu-agonist opioid of the morphine type and is a schedule ii controlled substance. oxycodone hydrochloride tablets, like other opioids used in analgesia, can be abused and is subject to criminal diversion. drug addiction is characterized by compulsive use, use for nonmedical purposes,

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

mayne pharma inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - oxycodone hydrochloride 4.8355 mg - oxycodone and aspirin tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see warnings), reserve oxycodone and aspirin 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 aspirin 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 oxycodone or aspirin, (e.g. angioedema) (see warnings) - patients with hemophilia. - aspirin should not be us

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

stat rx llc usa - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. oxycodone hydrochloride tablets are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. this includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. oxycodone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone hydrochloride tablets contain oxycodone, a mu-agonist opioid of the morphine type and is a schedule ii controlled substance. oxycodone hydrochloride tablets, like other opioids used in analgesia, can be abused and is subject to criminal diversion. drug addiction is characterized by compulsive use, use for nonmedic

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

bryant ranch prepack - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg - for the relief of moderate to moderately severe pain. oxycodone hydrochloride capsules are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. this includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma or hypercarbia. oxycodone hydrochloride capsules are contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone products are common targets for both drug abusers and drug addicts. drug addiction (drug dependence, psychological dependence) is characterized by a preoccupation with the procurement, hoarding, and abuse of drugs for non-medicinal purposes. drug dependence is treatable, utilizing a multi-disciplinary approach, but relapse is common. iatrogenic “addiction” to opioids legitimately used in the management of pain is very rare. “drug seeking” behavior is very common t