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Palladone (Hydromorphone Hydrochloride) - Summary

 
 



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.

 

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.


See all Palladone indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Palladone (Hydromorphone)

Potency ratio of hydromorphone and diacetylmorphine in substitution treatment for long-term opioid dependency. [2011]
treatment are limited... CONCLUSIONS: Studies using hydromorphone as a diacetylmorphine equivalent should

Effects of acepromazine, hydromorphone, or an acepromazine-hydromorphone combination on the degree of sedation in clinically normal dogs. [2010.11.15]
OBJECTIVE: To determine the effects of IM administration of acepromazine, hydromorphone, or the acepromazine-hydromorphone combination on degree of sedation in clinically normal dogs and to compare 2 sedation scoring techniques... The NRS was a less-reliable measure of sedation.

Steady-state pharmacokinetics of extended-release hydromorphone (OROS hydromorphone): a randomized study in healthy volunteers. [2010.09]
The steady-state pharmacokinetics of an extended-release formulation of hydromorphone, OROS hydromorphone, was investigated in a randomized, open-label, crossover study in healthy volunteers. Participants were randomly assigned to receive 16 mg of OROS hydromorphone once daily and 4 mg of immediate-release hydromorphone four times daily for five consecutive days...

A randomized study to demonstrate noninferiority of once-daily OROS((R)) hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. [2010.09]
This was a randomized, open-label, comparative, parallel group study designed to demonstrate the noninferiority of once-daily OROS((R)) hydromorphone compared with twice-daily sustained-release (SR) oxycodone in subjects with chronic noncancer pain severe enough to require continuous opioid therapy...

Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. [2010.06]
CONCLUSIONS: These results provide evidence for the efficacy and safety of hydromorphone ER in opioid-tolerant patients with chronic moderate-to-severe LBP. Potential limitations include the shortened dose-conversion/titration phase, limiting the daily allowable dose of hydromorphone ER to 64 mg, and the allowance of limited rescue medication throughout the entire double-blind phase. Other trial design elements such as the use of an enrichment phase and the inclusion of only opioid tolerant patients may limit the generalizability of these results.

more studies >>

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

Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain [Recruiting]
The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.

Study of Respiratory Depression When Using a Hydromorphone Pain Protocol [Recruiting]
This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of moderate to sever pain in the Emergency Department. Appropriate patients 60 years and older who present with a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia will be enrolled in one of two study arms, "1+1" versus usual care group. 1+1 patients will receive 1mg hydromorphone followed by another 1mg after 15 minutes if pain persists. Usual care group patients will have pain treated per the discretion of the attending physician. Respiratory status, vital signs, and pain scores will be monitor to assess the efficiency of pain control as well as the safety of pain medicine administration in terms of respiratory depression.

Association Between Body Size and Response to Hydromorphone in ED [Recruiting]
Pain is the most common complaint for patients presenting to the emergency department (ED). Inadequate pain relief is also a common problem in ED. Patients' pain perceptions and responses to intravenous opioids vary widely and are influenced by multiple factors. The objective of the current study is to examine the association between total body weight, BMI (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.

Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene [Not yet recruiting]
The purpose of this study is to investigate the pharmacokinetics of OROS hydromorphone in healthy adult Taiwanese participants after the oral administration of a single 16 mg dose.

more trials >>

Reports of Suspected Palladone (Hydromorphone) Side Effects

Night Sweats (2)Weight Decreased (2)Alpha 2 Globulin Increased (2)Somnolence (2)Hepatotoxicity (2)Chest Pain (2)Depression (2)Hallucination (2)Dyspnoea (2)Vomiting (2)more >>


Page last updated: 2013-02-10

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