Ask your doctor before making any changes in how or when you take your medications. Participants were permitted to manipulate the tablet for as long as needed to turn it into a form suitable for snorting. There was no difference in the actual time that participants spent tampering with the tablets DCR: Do not stop using any medications without first talking to your doctor. Opana ER is not for use on an as-needed basis for pain. Since Opana is sometimes taken as needed, you may not be on a dosing schedule. Orthostatic hypotension feeling dizzy when you stand up from sitting or lying down due to a drop in your blood pressure.
Some forms of Opana are made with ingredients that are not absorbed in the body. Part of the tablet may appear in your stool. This is a normal side effect and will not make the medication less effective. Do not stop using Opana suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using this medicine. Keep track your medicine. Oxymorphone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover Opana tablets. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused tablets down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.
Dosage Information in more detail. Since Opana is sometimes taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at A oxymorphone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include extreme drowsiness, muscle weakness, confusion, cold and clammy skin, pinpoint pupils, slow heart rate, very slow breathing, or coma.
Do not drink alcohol. Dangerous side effects or death could occur when alcohol is combined with oxymorphone. This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Opana will affect you. Dizziness or severe drowsiness can cause falls or other accidents. Get emergency medical help if you have any signs of an allergic reaction to Opana: Like other narcotic medicines, oxymorphone can slow your breathing.
Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: Serious side effects may be more likely in older adults and those who are malnourished or debilitated. Long-term use of opioid medication may affect fertility ability to have children in men or women.
It is not known whether opioid effects on fertility are permanent. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Side effects in more detail. Narcotic opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:. This list is not complete. No drug was administered in these studies. The primary outcome for Study 1 was particle size distribution, and the primary outcome for Study 2 was percent yield of active drug in the extracts.
Other descriptive variables were examined to better understand potential responses to these formulations. Percent yield of active drug in extract was low and did not differ between the two formulations DCR: Although there are safety issues associated with formulations that gel, these data suggest that the oxymorphone DCR formulations may be a promising technology for reducing opioid abuse.
The abuse of opioid analgesics is a public health problem in the United States. Estimates from the National Survey on Drug Use and Health reveal that non-medical use of narcotic pain relievers among persons aged 12 years or older was second only to that of marijuana in SAMHSA, Estimates of prescription opioid related mortality have increased correspondingly Maxwell, Most nonmedical use of prescription opioids consists of ingesting the medication orally Katz et al.
And yet, prescription opioid abusers also tamper with these medications in order to achieve a more rapid and robust drug effect Budman et al. The relationship between rate of drug delivery and drug preference has been demonstrated, although not extensively modeled, across multiple drug classes Abreu et al. Administration of drugs in either manner is accompanied by increased health risks, such as overdose, or the transfer of communicable disease Green et al.
To counter medication-tampering techniques that may lead to behaviors that are accompanied by such health risks, a great deal of attention is being paid to drug formulation technologies that may deter abuse Coleman et al. It has been hypothesized that these formulations may be most likely to reduce the attractiveness of prescription opioids to abusers who snort, smoke, or inject them Budman et al. One specific strategy for abuse deterrence, as stated above, involves incorporating a physical barrier into tablets that is designed to render them crush resistant and therefore difficult to prepare for insufflation or injection Coleman et al.
Tablets incorporating this technology have been marketed for reformulated oxycodone CR, tapentadol ER, and reformulated oxymorphone ER. It is available for the relief of moderate to severe pain in patients requiring continuous opioid treatment for an extended period of time. The tablet is difficult to crush, and will turn gel-like and viscous when combined with fluid. Whether such tablets are able to withstand the efforts of experienced, intravenous and intranasal drug abusers is not known.
Thus, the goal of the present studies was to examine the mechanical stability of oxymorphone ER tablets that have been designed to be crush-resistant DCR , and to determine whether experienced abusers were able to convert the DCR tablets into forms that were amenable to intranasal or intravenous drug administration. No drug was snorted, injected, tasted, or otherwise consumed by the participants in these studies. Local newspapers and word of mouth were used to recruit healthy research volunteers between 21 and 60 years of age who were able to give informed consent.
Participants had to be actively abusing prescription opioids intranasally regardless of how the opioids were obtained to participate in the study. Exclusion criteria were a history of significant violence or a current psychopathology that would interfere with study completion. This was a 1-day outpatient study with a repeated-measures design. Tablets were referred to as Tablet A or Tablet B; the formulation of the tablets was not revealed.
Tools that had been specifically requested by the participants were provided to them. Participants were permitted to manipulate the tablet for as long as needed to turn it into a form suitable for snorting. Each session was monitored by a senior investigator and research assistant to ensure that no drug was taken, and to answer any questions that arose. After each attempt, investigators collected the tablet sample and packaged it for analysis; no drug was taken.
Research volunteers came to the laboratory and, after signing a screening consent form, completed a brief screening procedure during which psychiatric and clinical interviews were conducted to ensure appropriateness for study participation. Participants then signed study consent forms describing the aims of the study and the potential risks and benefits of participation. Participants also completed a field sobriety test to ensure that they were not intoxicated.
The field sobriety test included balancing on one foot, walking heel-to-toe in a straight line, and touching different parts of their face nose, mouth, eyes with their eyes closed. Once cleared for study participation, participants were seated at a desk in the laboratory with a large board in front of them upon which they were instructed to work. Participants were provided with test tablets OXM or DCR in a random sequence under direct supervision by the investigators.
Tablets were referred to as Tablet A or Tablet B with no further description. Approved tools that had been specifically requested by the participant prior to the onset of the session were provided to them. Participants were encouraged to use as much time as they needed to tamper with the tablets. Investigators recorded the time spent manipulating the tablets with stopwatches.
After the tampering procedures were completed, participants responded to questions concerning their impression of both formulations. Upon the completion of each tampering attempt, investigators packaged the tampered samples into Nalgene cryogenic 15 mL vials, or Low Temp 3 mL freezer vials. Vials were labeled, and stored at ambient temperatures. Horsham, PA for particle size analysis. The primary outcome of the trial was particle size distribution.
Secondary outcomes were the self-reported willingness to snort the tampered product, the actual time spent tampering with the tablets, and the self-reported maximum time participants would be willing to spend on a routine basis preparing the tablets for intranasal abuse. Additional data collected included the reasons participants gave for their decision as to whether or not they would be willing to snort the tablets, and the relative amount of money participants would be willing to pay for the DCR tablet if it contained the same amount of drug as the OXM, given what the participants had experienced during the laboratory session.
Participants were also asked how often they took measures to prevent unwanted particles from ending up in the powder when they prepared a tablet for snorting to estimate the degree of caution that exists in this population regarding insufflation of particles. The primary endpoint measure was the particle size distribution of the tampered tablets. Particle sizes were analyzed using a Sympatec Qicpic image analyzer Clausthal-Zellerfeld, Germany , and summarized with descriptive statistics.
Continuous secondary endpoint measures, namely, the actual time spent tampering with the tablets and the self-reported maximum time participants would be willing to spend tampering with tablets were analyzed with paired t-tests. Additional data were descriptively reported. Data analyses were performed with SPSS v. Twenty-five current intranasal prescription opioid abusers 17 men, 8 women: Sixty-four percent began using prescription opioids to treat pain before recreational use was initiated.
Table 1 left panel presents the tools and solvents used by participants to prepare the tablets for insufflation. Hammers were used for crushing the tablets, razors were employed for shaving or cutting the tablets, while wax paper was used to hold the tablets in place as they were being manipulated. The maximum cutoff for the Sympatec Qicpic image analyzer was 1. Of the 25 OXM samples, The theoretical tablet weight of each tablet was estimated to be Almost all of the OXM particles were small enough to be submitted for analysis The OXM mean particle size distribution for d10, d50, and d90 was Few of the DCR particles were small enough to be submitted for analysis 9.
From this set, the DCR mean particle size distribution for d10, d50, and d90 was As can be seen, OXM particles A were a fine powder, with small particles. However, DCR particles B were large and angular, with sharp edges. However, self-reported maximum time participants would be willing to spend tampering with the tablets did not differ between formulations DCR: Table 2 summarizes explanations participants provided when asked why they would or would not snort their tampered product.
Table 3 summarizes the responses to the question how much participants would be willing to pay for the DCR for snorting if it contained the same amount of drug as the OXM. Table 4 summarizes responses to the question addressing how often participants took measures to prevent unwanted particles from ending up in the powder when preparing a tablet for abuse.
Twenty-four percent of participants said they "Sometimes" removed unwanted particles, primarily because they did not have a preference, i. Participants who "Never" removed unwanted particles indicated they ground the shell up when they were preparing drug, and thought there was no point to removing them if the particles were small, or it took too much effort. Healthy research volunteers between 21 and 60 years of age who were able to give informed consent were recruited.
Participants had to be abusing prescription opioids intravenously regardless of how the opioids were obtained to participate in the study. Participants were recruited through local newspapers and word of mouth. The design and procedures were similar to those employed in Study 1. The exception was that participants were instructed to tamper with the tablets in a manner that would render them into a form suitable for injection shooting.
After each tampering attempt, investigators packaged the tampered samples into Nalgene cryogenic 15 mL vials, or Low Temp 3 mL freezer vials if extract was produced. Vials were labeled; samples that did not involve extracts were stored at ambient temperatures, while extracts were frozen. Batch orders were shipped to PMRS for volume and concentration analyses. The primary outcome of this study was the percent yield or the total percent of the 40 mg of active drug that was extracted.
Secondary outcomes were the self-reported willingness to inject the tampered product, the actual time spent tampering with the tablets, and the self-reported maximum time participants would be willing to spend on a routine basis preparing the tablets for abuse. Additional data collected included the reasons participants gave for their decision as to whether or not they would be willing to inject the solution, the relative amount of money participants would be willing to spend for the DCR if it contained the same amount of drug as the OXM formulation, and the self-reported willingness to inject the products of the tampering attempts.
Participants were also asked how often they took measures to prevent unwanted particles from ending up in the solution when they prepared a tablet for injecting. The primary endpoint measure was the percentage of active drug in the solution that had been extracted from the tampered tablets. Percent yield of active drug was summarized with descriptive statistics. Twenty-five current intravenous prescription opioid abusers 17 men, 8 women: Fifty-six percent began using prescription opioids to treat pain before recreational use was initiated.
Table 1 right panel presents the tools and solvents used by participants to prepare the tablets for injection. This reflects the standard procedure of crushing the tablets with hammers or razors , mixing particles from the crushed tablet with a solvent in a spoon, heating the solution to a boil with the lighter under the spoon , then drawing up the solution with a syringe using cotton as a filter. Table 5 presents the volume, concentration, and percent active yield data. There were no differences between the two formulations in percent yield of active drug.
Both solutions were viscous and gelled. Little difference was observed between the two formulations. There was no difference in the actual time that participants spent tampering with the tablets DCR: There was also no difference in self-reported maximum time participants would be willing to spend tampering with either tablet DCR: Table 6 summarizes the explanations provided by participants when asked why they would or would not inject the extract from their tampered product.
Table 7 summarizes the responses to the question how much participants would be willing to pay for the DCR tablet if it contained the same amount of drug as the OXM tablet. Table 8 summarizes the responses to whether participants would inject the remnants, or, what was left in the spoon, after the solution was drawn up. Others cited safety or cleanliness: Formulations that have been designed to be crush-resistant are being developed by the pharmaceutical industry as one manner by which to combat the public health problem of prescription opioid abuse Webster et al.
Deaths have been attributed to oxymorphone abuse in the academic literature Garside et al. The current studies were conducted to examine whether a formulation of oxymorphone ER that was designed to be crush-resistant DCR was able to withstand tampering efforts by experienced prescription opioid abusers. The data collected in the present studies characterize a number of tampering behaviors.
This was notable particularly because they were informed at the beginning of laboratory sessions that they could work as long as they liked. The maximum time spent preparing the OXM tablet for intranasal use was 7 minutes, whereas the maximum time manipulating DCR for intranasal use was 17 minutes. Although these studies occurred in a laboratory setting that may have influenced tampering behaviors, these data support the view that substance abusers do not spend unlimited amounts of time tampering with pills, as has been implicated in the literature Budman et al.
No particularly unique tools were requested for tampering purposes. Intranasal abusers worked primarily with a hammer, razor, and wax paper; while intravenous abusers primarily employed a razor, spoon, lighter, hammer, syringe and cotton, cookers, and water. This is consistent with observations gleaned from the internet regarding tampering, namely, complex procedures are not typically employed by substance abusers to alter medication formulations Cone, ; Katz et al.
The DCR particles were large and jagged, and most often had to be cut to size by hand, whereas OXM particles were produced quickly by crushing. In addition to the reasons cited for these choices, namely the favorable consistency of the OXM powder, and the lack of favorable powder consistency or difficulty with the DCR tablets; differences between the formulations were also captured with the particle size analyses.
Yet the estimates cannot be interpreted independently of the amount of material that was submitted for analysis. The relative value of the DCR tablets to prescription opioid intranasal abusers was clearly less than OXM, as evidenced by the finding that all participants would pay "Less" or "Nothing" for the DCR tablets. This was due to the complementary observations that either the OXM formulation was so much easier to prepare for abusers, or the DCR formulation was so much more difficult to prepare, suggesting that the majority of intranasal users are not interested in products that are difficult to prepare Katz et al.
This finding complements research being conducted with the goal of identifying factors that affect drug abusers' preferences for prescription opioids Budman et al. These studies have suggested that specific features of opioid formulations may affect the desirability or attractiveness of prescription opioids. The data herein support this notion. The solutions that were produced were viscous.