TABLETS CONTAIN HYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLED OPIOID AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE, OXYMORPHONE, OXYCODONE, FENTANYL, AND METHADONE, HAVE THE HIGHEST POTENTIAL FOR ABUSE AND RISK OF PRODUCING RESPIRATORY DEPRESSION. ALCOHOL, OTHER OPIOIDS AND CENTRAL NERVOUS SYSTEM DEPRESSANTS (SEDATIVE-HYPNOTICS) POTENTIATE THE RESPIRATORY DEPRESSANT EFFECTS OF HYDROMORPHONE, INCREASING THE RISK OF RESPIRATORY DEPRESSION THAT MIGHT RESULT IN DEATH.
Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic.
Hydromorphone hydrochloride tablets USP are indicated for the management of pain in patients where an opioid analgesic is appropriate.
Published Studies Related to Hydromorphone
Potency ratio of hydromorphone and diacetylmorphine in substitution treatment for
long-term opioid dependency. 
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.
Clinical Trials Related to 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
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.
Safety and Tolerability of Long-Term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain [Completed]
The primary purpose of this study was to characterize the pain control achieved with
long-term repeated dosing of OROS hydromorphone (slow release) in patients with chronic
cancer pain and the secondary purpose was to characterize the effects of pain on the
patients' quality of life with long-term, repeated dosing of OROS hydromorphone (slow
release) taken by patients with chronic cancer pain.
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.
Reports of Suspected Hydromorphone Side Effects
Completed Suicide (3),
Intentional Overdose (1),
Toxicity TO Various Agents (1),
Sinus Tachycardia (1)
Page last updated: 2013-02-10