WARNING:
Palladone™ (hydromorphone hydrochloride extended-release) Capsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time (weeks to months) or longer. Palladone™ Capsules should only be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a minimum total daily dose of opiate medication equivalent to 12 mg of oral hydromorphone. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, or at least 30 mg of oral oxycodone/day, or at least 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid, for a week or longer. Palladone™ Capsules should be administered once every 24 hours.
Appropriate patients for treatment with Palladone Capsules include patients who require high doses of potent opioids on an around-the-clock basis to improve pain control and patients who have difficulty attaining adequate analgesia with immediate-release opioid formulations.
Palladone Capsules are contraindicated for use on an as needed basis (i.e., prn).
Palladone™ Capsules are NOT intended to be used as the first opioid product prescribed for a patient, or in patients who require opioid analgesia for a short period of time.
Palladone™ Capsules are for use in OPIOID-TOLERANT patients ONLY. Use in non-opioid-tolerant patients may lead to FATAL RESPIRATORY DEPRESSION. Overestimating the Palladone dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Due to the mean apparent 18-hour elimination half-life of Palladone, patients who receive an overdose will require an extended period of monitoring and treatment that may go beyond 18 hours. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects.
Palladone™ Capsules contain the potent Schedule II opioid agonist, hydromorphone. Schedule II opioid agonists (which include hydromorphone, fentanyl, methadone, morphine, oxycodone, and oxymorphone), have the highest risk of fatal overdoses due to respiratory depression, as well as the highest potential for abuse. Palladone can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Palladone in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.
Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.
Palladone capsules are to be swallowed whole and are not to be broken, chewed, opened, dissolved or crushed. Consuming alcohol while taking palladone™ capsules or taking broken, chewed, dissolved, or crushed palladone™ capsules or its contents can lead to the rapid release and absorption of a potentially fatal dose of hydromorphone. Overestimating the palladone dose when converting the patient from another opioid medication can result in fatal overdose with the first dose. With the long half-life of palladone (18 hours), patients who receive the wrong dose will require an extended period of monitoring and treatment that may go beyond 18 hours. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects.
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PALLADONE SUMMARY
PALLADONE
CII
(hydromorphone hydrochloride extended-release) Capsules
12 mg, 16 mg, 24 mg, 32 mg
Palladone™ (hydromorphone hydrochloride extended-release) Capsules are an opioid analgesic supplied in 12 mg, 16 mg, 24 mg, and 32 mg capsule strengths for oral administration. The pellet formulation is the same for all capsule strengths. The strength designation of each capsule indicates the amount of hydromorphone hydrochloride salt.
Palladone™ Capsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time generally weeks to months or longer. Palladone™ Capsules should only be used in patients who are already receiving opioid therapy, have demonstrated opioid tolerance, and who require a minimum total daily dose of opiate medication equivalent to 12 mg of oral hydromorphone. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, or at least 30 mg oral oxycodone/day, or at least 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid, for a week or longer. Appropriate patients for treatment with Palladone include patients who require high doses of potent opioids on an around-the-clock basis to improve pain control, and patients who have difficulty attaining adequate analgesia with immediate-release opioid formulations.
Palladone™ Capsules are NOT intended to be used:
- as the first opioid product prescribed for a patient.
- in patients who require opioid analgesia for a short period of time.
- on an as needed basis (i.e., prn).
An evaluation of the appropriateness and adequacy of immediate-release opioids is advisable prior to initiating therapy with any modified-release opioid. Prescribers should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen, to opioids, in a plan of pain management such as outlined by the World Health Organization, the Agency for Health Research and Quality, the Federation of State Medical Boards Model Policy, or the American Pain Society.
Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.
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NEWS HIGHLIGHTSMedia Articles Related to Palladone (Hydromorphone)
FDA Discusses Neuromed NDA Application For Exalgo
Source: Pain / Anesthetics News From Medical News Today [2009.11.18]
Covidien (NYSE: COV) announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA). Mallinckrodt Inc., a Covidien company, obtained the commercial rights to Exalgo in the United States from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd., in June 2009.
Published Studies Related to Palladone (Hydromorphone)
Randomized clinical trial comparing a patient-driven titration protocol of intravenous hydromorphone with traditional physician-driven management of emergency department patients with acute severe pain. [2009.10]
STUDY OBJECTIVE: We test the null hypothesis that the "1+1" hydromorphone patient-driven protocol is clinically and statistically equivalent in safety and efficacy to that of traditional physician-driven administration of opioids for emergency department (ED) treatment of acute severe pain... CONCLUSION: The 1+1 hydromorphone patient-driven protocol is statistically superior and at least as clinically efficacious and safe as traditional physician-driven treatment of ED patients with acute severe pain. More than 9 of 10 patients randomized to the study protocol achieved satisfactory pain control, as defined by the patient, within an hour or less.
Gastrointestinal symptoms under opioid therapy: a prospective comparison of oral sustained-release hydromorphone, transdermal fentanyl, and transdermal buprenorphine. [2009.08]
INTRODUCTION: The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release hydromorphone, transdermal fentanyl, and transdermal buprenorphine on nausea, emesis and constipation... CONCLUSIONS: Gastrointestinal symptoms of cancer pain patients undergoing an opioid therapy are related to multifactorial causes. Transdermal opioids showed no benefit over oral controlled-release hydromorphone with regard to gastrointestinal symptoms. The conversion ratios for transdermal fentanyl, transdermal buprenorphine, and oral hydromorphone did not accord to the literature, because of differing occurrences of opioid tolerance after long-term therapy.
Efficacy and safety profile of a single dose of hydromorphone compared with morphine in older adults with acute, severe pain: a prospective, randomized, double-blind clinical trial. [2009.02]
BACKGROUND: Older adults (ie, those aged > or =65 years) are the fastest growing segment of the US population, with an estimated approximately 71 million expected by 2030. Over the past 10 years, there has been an 11% increase in the number of emergency department (ED) visits by older adults, and pain is their most common chief complaint. OBJECTIVE: The goal of this study was to compare weight-based IV hydromorphone and IV morphine in adults aged > or =65 years presenting to the ED with acute, severe pain... CONCLUSIONS: A single dose of IV hydromorphone at 0.0075 mg/kg was neither clinically nor statistically different from IV morphine at 0.05 mg/kg for the treatment of acute, severe pain at 30 minutes postbaseline in these older adults in the ED. The incidence of adverse effects was not statistically different. Our data suggest that hydromorphone and morphine in the doses given had similar efficacy and safety profiles in these older adults. Neither regimen provided > or =50% pain relief for the majority of patients. Future investigations of acute pain management in older adults should examine the efficacy and safety of higher initial (loading) doses of opioids titrated at frequent intervals until adequate analgesia is achieved.
A randomized, double-blind comparison of OROS(R) hydromorphone and controlled-release morphine for the control of chronic cancer pain. [2008.10.31]
ABSTRACT: BACKGROUND: Long-acting opioid formulations are advocated for maintaining pain control in chronic cancer pain. OROS(R) hydromorphone is a sustained-release formulation of hydromorphone that requires dosing once daily to maintain therapeutic concentrations. The objective of this study was to demonstrate the clinical equivalence of immediate-release and sustained-release formulations of hydromorphone and morphine for chronic cancer pain... CONCLUSION: Equivalence was demonstrated for immediate-release formulations of hydromorphone and morphine, but not for the sustained-release formulations of OROS(R) hydromorphone and controlled-release morphine. The direction of the mean difference between the treatments (-0.8) and the out-of-range lower limit of the 95% CI (-1.6) were in favor of OROS(R) hydromorphone. TRIAL REGISTRATION: ClinicalTrials.gov: NCT0041054.
The side effects of morphine and hydromorphone patient-controlled analgesia. [2008.10]
BACKGROUND: Despite "clinical lore" among health care providers that treatment with hydromorphone results in improved pain control and fewer adverse side effects, morphine continues to be the first-line medication for postoperative patient-controlled analgesia (PCA). In this study, we compared the efficacy and side-effect profiles of morphine and hydromorphone at concentrations producing equivalent drug effect measured by pain score and miosis... CONCLUSIONS: We found no systematic difference between morphine and hydromorphone in opioid-related side effects. Neither was there any difference in efficacy of pain control or patient satisfaction when patients self-titrated to equal drug effect as measured by equianalgesia and pupillary miosis. The choice between morphine and hydromorphone for use in PCA should be guided by patient history, as there may be idiosyncratic reactions to either drug.
Clinical Trials Related to Palladone (Hydromorphone)
Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-Release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain [Completed]
The purpose of this study was to characterize a safe and effective means of conversion and
titration to an appropriate dose of hydromorphone HCI, to demonstrate comparable efficacy of
OROS hydromorphone HCI SR (slow release) and hydromorphone HCI IR (immediate release)
following administration of approximately equivalent total daily doses and demonstrate a
significant dose-response relationship between OROS hydromorphone HCI SR (slow release) for
breakthrough pain medication use or alternatively, diary-based analgesic scores
An Open-Label Evaluation of the Independent Effects of Coadministration of a High-Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCI) 16mg [Completed]
The purpose of this study was to compare the pharmacokinetic (the way a drug enters and
leaves the blood and tissues over time) profile of Dilaudid OROS 16mg (Dilaudid Slow Release;
hydromorphone HCL) administered under fasting conditions, following a high-fat breakfast
meal. The study also examined the effect of naltrexone blockade on the pharmacokinetic
profile of Dilaudid SR.
Comparison of Side Effects of Morphine and Hydromorphone PCA [Completed]
Both morphine and hydromorphone are pain medications commonly used after surgery. It is
thought at our institution that hydromorphone causes less side effects but this has not been
studied. We propose to treat our patients with either morphine or hydromorphone and
determine how much nausea, vomiting, and itching they have with each drug
A Study on Efficacy (Effectiveness), Safety, and Impact on Quality of Life Measures of Dilaudid CR (Controlled Release);, Hydromorphone HCl in Patients With Chronic Low Back Pain [Completed]
The purpose of the study was to characterize the safety, effectiveness, and impact on quality
of life (QOL) measures of OROS® hydromorphone HCL in patients with chronic low back pain.
Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients [Active, not recruiting]
We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone
followed by an additional 1mg. Eligible patients will be given 1 mg IV hydromorphone. At 15
minutes, these patients will be asked the question, "Do you need more pain medication?"
Those that answer "yes" will receive an additional 1mg IV hydromorphone. Those that answer
"no" will not receive additional pain medications at that time period (15 minutes). Thus, we
wish to give up to 2 mg IV hydromorphone titrated to patients' pain, which we believe will
result in less incidence of oxygen desaturation.
If our study shows that this regimen is safe, its efficacy can be assessed in future trials.
Positive results of those trials may lead to the use of this regimen to improve pain
management in the emergency department.
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Page last updated: 2009-11-18
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