Australia - English - Department of Health (Therapeutic Goods Administration)

rf six pty ltd - cod-liver oil, quantity: 1 g (equivalent: colecalciferol, qty 2.5 microgram; equivalent: vitamin a, qty 300 re) - capsule, soft - excipient ingredients: purified water; gelatin; soya oil; d-alpha-tocopherol; glycerol - maintain/support healthy eye function ; maintain/support eye health ; maintain/support healthy eyesight/vision ; maintain/support body mucous membrane health ; maintain/support general health and wellbeing ; maintain/support bone health ; maintain/support bone strength ; help maintain/support bone mineralisation ; maintain/support healthy cardiovascular system function ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support muscle function ; maintain/support healthy neuromuscular system/function ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; maintain/support skin health ; maintain/support skin integrity/structure

Australia - English - Department of Health (Therapeutic Goods Administration)

nature's care manufacture pty limited - cod-liver oil, quantity: 1 g (equivalent: colecalciferol, qty 2.5 microgram; equivalent: vitamin a, qty 300 re) - capsule, soft - excipient ingredients: purified water; gelatin; glycerol - antioxidant/reduce free radicals formed in the body ; maintain/support eye health ; maintain/support healthy eyesight/vision ; maintain/support general health and wellbeing ; maintain/support bone health ; vitamin d helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support healthy mucous membranes/mucous tissue of the respiratory tract ; maintain/support skin health

Australia - English - Department of Health (Therapeutic Goods Administration)

the better health company (australia) pty - cod-liver oil, quantity: 1 g (equivalent: vitamin a, qty 300 re; equivalent: colecalciferol, qty 2.5 microgram) - capsule, soft - excipient ingredients: d-alpha-tocopherol; soya oil; gelatin; glycerol; purified water - maintain/support healthy eye function ; maintain/support eye health ; maintain/support healthy eyesight/vision ; maintain/support body mucous membrane health ; maintain/support general health and wellbeing ; maintain/support bone health ; maintain/support bone strength ; help maintain/support bone mineralisation ; maintain/support healthy cardiovascular system function ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support muscle function ; maintain/support healthy neuromuscular system/function ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; maintain/support skin health ; maintain/support skin integrity/structure

Australia - English - Department of Health (Therapeutic Goods Administration)

blackmores ltd - cod-liver oil, quantity: 1 g (equivalent: colecalciferol, qty 2.5 microgram; equivalent: colecalciferol, qty 100 iu; equivalent: vitamin a, qty 300 re/microgram) - capsule, soft - excipient ingredients: purified water; glycerol; gelatin - maintain/support body mucous membrane health ; maintain/support oral mucous membrane health ; maintain/support bone health ; maintain/support (state mineral) absorption in bones ; vitamin d helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life ; maintain/support healthy mucous linings of the digestive system ; maintain/support immune system health ; helps enhance/improve/promote immune system function ; maintain/support healthy mucous membranes/mucous tissue of the respiratory tract ; maintain/support skin health

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

amneal pharmaceuticals ny llc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hcl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: - adults; and - opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. limitations of use - 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 [see warnings and precautions (5.1)] , reserve oxycodone hcl extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - oxycodone hcl extended-release tablets are not indicated as an as-needed (prn) analgesic. oxycodone hcl extended-release tablets 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 (5.12)] - hypersensitivity (e.g., anaphylaxis) to oxycodone [see  adverse reactions (6.2)] risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)] .  there are no available data with oxycodone hcl extended-release tablets in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.  in animal reproduction studies, there was no embryo-fetal toxicity when oxycodone hydrochloride was orally administered to rats and rabbits, during the period of organogenesis, at doses 1.3 to 40 times the adult human dose of 60 mg/day, respectively.  in a pre- and postnatal toxicity study, when oxycodone was orally administered to rats, there was transiently decreased pup body weight during lactation and the early post-weaning period at the dose equivalent to an adult dose of 60 mg/day.  in several published studies, treatment of pregnant rats with oxycodone hydrochloride 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 estimated background risk of major birth defects and miscarriage for the indicated population is unknown.  all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.   clinical considerations fetal/neonatal adverse reactions 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 hcl extended-release tablets is not recommended for use in women immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. opioid analgesics, including oxycodone hcl extended-release 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 dilatation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data animal data pregnant rats were treated with 0.5, 2, 4, and 8 mg/kg oxycodone hydrochloride (0.08, 0.3, 0.7, and 1.3 times the human daily dose of 60 mg/day, respectively based on a mg/m2 basis) during the period of organogenesis.  oxycodone did not cause adverse effects to the fetus at exposures up to 1.3 times the human dose of 60 mg/day.  the high dose produced maternal toxicity characterized by excessive gnawing on forelimbs and decreased body weight gain. pregnant rabbits were treated with 1, 5, 25, and 125 mg/kg oxycodone hydrochloride (0.3, 2, 8, and 40 times the human daily dose of 60 mg/day, respectively, based on a mg/m2 basis) during the period of organogenesis.  oxycodone did not cause adverse effects to the fetus at exposures up to 40 times the human dose of 60 mg/day.  the 25 mg/kg and 125 mg/kg doses high doses produced maternal toxicity characterized by decreased food consumption and body weight gain. pregnant rats were treated with 0.5, 2, and 6 mg/kg oxycodone hydrochloride (0.08, 0.32, and 1 times the human daily dose of 60 mg/kg, respective, based on a mg/m2 basis, during the period of organogenesis through lactation.  decreased body weight was found during lactation and the early post-weaning phase in pups nursed by mothers given the highest dose used (6 mg/kg/day, equivalent to an adult human dose of 60 mg/day, on a mg/m2 basis).  however, body weight of these pups recovered.  in published studies, offspring of pregnant rats administered oxycodone hydrochloride during gestation have been reported to exhibit neurobehavioral effects including altered stress responses and 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 oral 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 oral dose of 60 mg/day on a mg/m2 basis). 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 extended–release oxycodone, including oxycodone hcl extended-release 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.  because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with oxycodone hcl extended-release tablets. clinical considerations infants exposed to oxycodone hcl extended-release 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.  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)] . the safety and efficacy of oxycodone hcl extended-release tablets have been established in pediatric patients ages 11 to 16 years.  use of oxycodone hcl extended-release tablets are supported by evidence from adequate and well-controlled trials with oxycodone hcl extended-release tablets in adults as well as an open-label study in pediatric patients ages 6 to 16 years. however, there were insufficient numbers of patients less than 11 years of age enrolled in this study to establish the safety of the product in this age group.  the safety of oxycodone hcl extended-release tablets in pediatric patients was evaluated in 155 patients previously receiving and tolerating opioids for at least 5 consecutive days with a minimum of 20 mg per day of oxycodone or its equivalent on the two days immediately preceding dosing with oxycodone hcl extended-release tablets.  patients were started on a total daily dose ranging between 20 mg and 100 mg depending on prior opioid dose. the most frequent adverse events observed in pediatric patients were vomiting, nausea, headache, pyrexia, and constipation [see dosage and administration (2.5), adverse reactions (6.1), clinical pharmacology (12.3) and clinical studies (14)] . in controlled pharmacokinetic studies in elderly subjects (greater than 65 years) the clearance of oxycodone was slightly reduced.  compared to young adults, the plasma concentrations of oxycodone were increased approximately 15% [see clinical pharmacology (12.3)] .  of the total number of subjects (445) in clinical studies of oxycodone hydrochloride controlled-release tablets, 148 (33.3%) were age 65 and older (including those age 75 and older) while 40 (9.0%) were age 75 and older.  in clinical trials with appropriate initiation of therapy and dose titration, no untoward or unexpected adverse reactions were seen in the elderly patients who received oxycodone hydrochloride controlled-release tablets.  thus, the usual doses and dosing intervals may be appropriate for elderly patients. however, a dosage reduction in debilitated, non-opioid-tolerant patients is recommended [see dosage and administration (2.8)] .  respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who are not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of oxycodone hcl extended-release tablets slowly in these 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. a study of oxycodone hcl extended-release tablets in patients with hepatic impairment demonstrated greater plasma concentrations than those seen at equivalent doses in persons with normal hepatic function [see clinical pharmacology (12.3)] .  therefore, a dosage reduction is recommended for these patients [see dosage and administration (2..9)]. monitor closely for signs of respiratory depression, sedation, and hypotension.   in patients with renal impairment, as evidenced by decreased creatinine clearance (<60 ml/min), the concentrations of oxycodone in the plasma are approximately 50% higher than in subjects with normal renal function [see clinical pharmacology (12.3)] .  follow a conservative approach to dose initiation and adjust according to the clinical situation. in pharmacokinetic studies with oxycodone hcl extended-release tablets, opioid-naïve females demonstrate up to 25% higher average plasma concentrations and greater frequency of typical opioid adverse events than males, even after adjustment for body weight.  the clinical relevance of a difference of this magnitude is low for a drug intended for chronic usage at individualized dosages, and there was no male/female difference detected for efficacy or adverse events in clinical trials. oxycodone hcl extended-release tablets contains oxycodone, a schedule ii controlled substance. oxycodone hcl extended-release tablets contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol.  oxycodone hcl extended-release tablets can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1)]. the high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse. 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 hcl extended release 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 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 hcl extended-release tablets oxycodone hcl extended-release tablets are for oral use only. abuse of oxycodone hcl extended-release tablets poses a risk of overdose and death. the risk is increased with concurrent use of oxycodone hcl extended-release tablets with alcohol and other central nervous system depressants.  taking cut, broken, chewed, crushed, or dissolved oxycodone hcl extended-release tablets enhances drug release and increases the risk of overdose and death. with parenteral abuse, the inactive ingredients in oxycodone hcl extended-release tablets can be expected to result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, valvular heart injury, embolism, and death. cases of thrombotic microangiopathy (a condition characterized clinically by thrombocytopenia and microangiopathic hemolytic anemia) associated with parenteral abuse have been reported. parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and hiv. abuse deterrence studies oxycodone hcl extended-release tablets are formulated with inactive ingredients intended to make the tablet more difficult to manipulate for misuse and abuse. for the purposes of describing the results of studies of the abuse-deterrent characteristics of oxycodone hcl extended-release tablets resulting from a change in formulation, in this section, the original formulation of oxycodone hcl extended-release tablets, which is no longer marketed, will be referred to as “original oxycodone hcl extended-release tablets” and the reformulated, currently marketed product will be referred to as “oxycodone hcl extended-release tablets ".  in vitro testing in vitro physical and chemical tablet manipulation studies were performed to evaluate the success of different extraction methods in defeating the extended-release formulation.  results support that, relative to original oxycodone hcl extended-release tablets, there is an increase in the ability of oxycodone hcl extended-release tablets to resist crushing, breaking, and dissolution using a variety of tools and solvents.  the results of these studies also support this finding for oxycodone hcl extended-release tablets relative to an immediate-release oxycodone. when subjected to an aqueous environment, oxycodone hcl extended-release tablets gradually forms a viscous hydrogel (i.e., a gelatinous mass) that resists passage through a needle.  clinical studies in a randomized, double-blind, placebo-controlled 5-period crossover pharmacodynamic study, 30 recreational opioid users with a history of intranasal drug abuse received intranasally administered active and placebo drug treatments.  the five treatment arms were finely crushed oxycodone hcl extended-release tablets 30 mg tablets, coarsely crushed oxycodone hcl extended-release tablets 30 mg tablets, finely crushed original oxycodone hcl extended-release tablets 30 mg tablets, powdered oxycodone hcl 30 mg, and placebo. data for finely crushed oxycodone hcl extended-release tablets, finely crushed original oxycodone hcl extended-release tablets, and powdered oxycodone hcl are described below. drug liking was measured on a bipolar drug liking scale of 0 to 100 where 50 represents a neutral response of neither liking nor disliking, 0 represents maximum disliking and 100 represents maximum liking.  response to whether the subject would take the study drug again was also measured on a bipolar scale of 0 to 100 where 50 represents a neutral response, 0 represents the strongest negative response (“definitely would not take drug again”) and 100 represents the strongest positive response (“definitely would take drug again”).  twenty-seven of the subjects completed the study.  incomplete dosing due to granules falling from the subjects’ nostrils occurred in 34% (n = 10) of subjects with finely crushed oxycodone hcl extended-release tablets, compared with 7% (n = 2) of subjects with finely crushed original oxycodone hcl extended-release tablets and no subjects with powdered oxycodone hcl. the intranasal administration of finely crushed oxycodone hcl extended-release tablets was associated with a numerically lower mean and median drug liking score and a lower mean and median score for take drug again, compared to finely crushed original oxycodone hcl extended-release tablets or powdered oxycodone hcl as summarized in table 5.   table 5:  summary of maximum drug liking (emax ) data following intranasal administration vas scale (100 mm)* oxycodone hcl extended-release tablets (finely crushed) original oxycodone hcl extended-release tablets (finely crushed) oxycodone hcl (powdered) drug liking mean (se) 80.4 (3.9) 94.0 (2.7) 89.3 (3.1) median (range) 88 (36-100) 100 (51-100) 100 (50-100) take drug again mean (se) 64.0 (7.1) 89.6 (3.9) 86.6 (4.4) median (range) 78 (0-100) 100 (20-100) 100 (0-100) * bipolar scales (0 = maximum negative response, 50 = neutral response, 100 = maximum positive response)   figure 1 demonstrates a comparison of drug liking for finely crushed oxycodone hcl extended-release tablets compared to powdered oxycodone hcl in subjects who received both treatments.  the y-axis represents the percent of subjects attaining a percent reduction in drug liking for oxycodone hcl extended-release tablets vs. oxycodone hcl powder greater than or equal to the value on the x-axis.  approximately 44% (n = 12) had no reduction in liking with oxycodone hcl extended-release tablets relative to oxycodone hcl.  approximately 56% (n = 15) of subjects had some reduction in drug liking with oxycodone hcl extended-release tablets relative to oxycodone hcl. thirty-three percent (n = 9) of subjects had a reduction of at least 30% in drug liking with oxycodone hcl extended-release tablets compared to oxycodone hcl, and approximately 22% (n = 6) of subjects had a reduction of at least 50% in drug liking with oxycodone hcl extended-release tablets compared to oxycodone hcl. figure 1: percent reduction profiles for emax of drug liking vas for oxycodone hcl extended-release tablets vs. oxycodone hcl, n=27 following intranasal administration the results of a similar analysis of drug liking for finely crushed oxycodone hcl extended-release tablets relative to finely crushed original oxycodone hcl extended-release tablets were comparable to the results of finely crushed oxycodone hcl extended-release tablets relative to powdered oxycodone hcl.  approximately 43% (n = 12) of subjects had no reduction in liking with oxycodone hcl extended-release tablets relative to original oxycodone hcl extended-release tablets.  approximately 57% (n = 16) of subjects had some reduction in drug liking, 36% (n = 10) of subjects had a reduction of at least 30% in drug liking, and approximately 29% (n = 8) of subjects had a reduction of at least 50% in drug liking with oxycodone hcl extended-release tablets compared to original oxycodone hcl extended-release tablets. summary the in vitro data demonstrate that oxycodone hcl extended-release tablets have physicochemical properties expected to make abuse via injection difficult. the data from the clinical study, along with support from the in vitro data, also indicate that oxycodone hcl extended-release tablets has physicochemical properties that are expected to reduce abuse via the intranasal route. however, abuse of oxycodone hcl extended-release tablets by these routes, as well as by the oral route, is still possible. additional data, including epidemiological data, when available, may provide further information on the impact of the current formulation of oxycodone hcl extended-release tablets on the abuse liability of the drug. accordingly, this section may be updated in the future as appropriate. oxycodone hcl extended-release tablets contains oxycodone, an opioid agonist and schedule ii controlled substance with an abuse liability similar to other opioid agonists, legal or illicit, including fentanyl, hydromorphone, methadone, morphine, and oxymorphone. oxycodone hcl extended-release tablets can be abused and is subject to misuse, addiction, and criminal diversion [ see warnings and precautions (5.1) and drug abuse and dependence (9.1)].   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 hcl extended-release tablets in a patient physically dependent on opioids. rapid tapering of oxycodone hcl extended-release tablets 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 hcl extended-release tablets, gradually taper the dosage using a patient specific plan that considers the following: the dose of oxycodone hcl extended-release tablets 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 (2.6), warnings and precautions (5.14)] . 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)] .  

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

mikart, llc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 2.5 mg - oxycodone 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 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 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 oxycodo

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

actavis 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. limitations of use 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. - aspi

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

redpharm drug, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 5 mg - oxycodone 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 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 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, acetaminophen, or any other component of the pr

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

proficient rx lp - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 10 mg - hydrocodone bitartrate and acetaminophentablets are indicated for the management of relief of moderate to moderatelysevere pain, pain severe enough to require an opioid analgesic and for whichalternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, andmisuse, with opioids, even at recommended doses [see warnings ], reserve hydrocodonebitartrate and acetaminophen tablets for use in patients for whom alternativetreatment options [e.g., non-opioid analgesics] hydrocodonebitartrate and acetaminophen tablets are contraindicated in patients with: controlled  substance hydrocodone  bitartrate and acetaminophen tablets contains hydrocodone and acetaminophen, aschedule cii controlled substance. abuse hydrocodone  bitartrate and acetaminophen tablets contains hydrocodone and acetaminophen, asubstance with a high potential for abuse similar to other opioids including  withdrawal also may be precipitated through the administration of drugs withopioid antagonist activity

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

proficient rx lp - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 10 mg - oxycodone 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 oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics ] oxycodone  and acetaminophen tablets are contraindicated in patients with:  controlled substance oxycodone  and acetaminophen tablet contains oxycodone and acetaminophen, a schedule cii controlled substance. abuse oxycodone and acetaminophen tablets contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. oxycodone  and acetaminophen tablets can be abused and is   subject to misuse, addiction, and criminal diversion [see warnings ].  all patients tr