Dilaudid (Hydromorphone Hydrochloride) - Summary

DILAUDID SUMMARY

DILAUDID® ORAL LIQUID and DILAUDID® 8 mg TABLETS
(hydromorphone hydrochloride)
CS-II

DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid analgesic.

DILAUDID is indicated for the relief of moderate to severe pain such as that due to:

Surgery

Cancer

Trauma (soft tissue & bone)

Biliary Colic

Myocardial Infarction

Burns

Renal Colic

See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Dilaudid (Hydromorphone)

FDA Extends NDA Review For Exalgo™ Extended-Release Tablets
Source: Health News from Medical News Today [2009.11.23]
CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months.

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.

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Published Studies Related to Dilaudid (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.

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Clinical Trials Related to Dilaudid (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.

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.

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

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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PATIENT REVIEWS / RATINGS / COMMENTS

Dilaudid review by 26 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		broken ribs
Dosage & duration:		4mg taken 4 hrs for the period of 4 weeks
Other conditions:		broken leg, torn acl
Other drugs taken:		meloxacam
		Reported Results
Benefits:		Very effective at eliminating pain.
Side effects:		Drowsiness, Constipation, Nightmares, Inability to focus.
Comments:		I had a motorcycle crash. I broke 3 ribs and my leg in two places around me knee. I also tore my acl. Given 2 dilaudid injections in ER and prescribed 4 mg tabs to be taken every 4 hrs. Did this for one week and began having the "mental" side effects (specifically nightmares and mild hallucinations) after 3 days. I started taking the 4 mg tabs every 6 hrs and eventually every 8 hrs and these side effects diminished. Constipation was a serious issue with the 4 mg tabs. Got a refill for 2 Mg tabs and were definitely less effective but experienced only light side effects (mainly inability to focus). Took 2 Mg tabs for the remainder of the occasional pain outbreaks for the remaining 2 weeks

Dilaudid review by 55 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Pain after foot surgery
Dosage & duration:		2 mg, take 1-2 tabs every 4 hours taken 1 every 4 hours for the period of 4 days
Other conditions:		sciatic nerve pain
Other drugs taken:		levoxyl, neurontin
		Reported Results
Benefits:		Successful management of post-op pain following reconstructive foot surgery including osteotomy with split tendon transfer.
Side effects:		Unexplainable behavior: Constructed the letter "P" from toilet tissue, later had no recollection and couldn't explain why I did it. Apparently told husband to consult with nurse friend about my medications, but forgot and was upset when he did so. Visual hallucinations: while looking at my friend, saw her hair rising as if being blown from below; wherever I focused strange things happened. Thought they were really happening. Soon after med discontinued, became severely nauseated and started vomiting, unable to tolerate food or liquids for 20 hours, had to take zofran.
Comments:		Was prescribed 2-4 mg dilaudid (I took 2mg, weigh 95#)with hydroxyzine pamoate 50 mg every 4 hours, because following previous surgery both percocet and vicodin caused vomiting and itching. First dose was given in recovery room and continued to take it every 4-6 hours with vistaril as prescribed until untoward symptoms appeared. I had no nausea, vomiting, or itching