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Dilaudid-HP (Hydromorphone Hydrochloride) - Summary



(hydromorphone hydrochloride)

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

DILAUDID-HP is indicated for the relief of moderate-to-severe pain in opioid-tolerant patients who require larger than usual doses of opioids to provide adequate pain relief. Because DILAUDID-HP contains 10 mg of hydromorphone hydrochloride per mL, a smaller injection volume can be used than with other parenteral opioid formulations. Discomfort associated with the intramuscular or subcutaneous injection of an unusually large volume of solution can therefore be avoided.

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Published Studies Related to Dilaudid-HP (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.

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Clinical Trials Related to Dilaudid-HP (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 OROSŪ 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

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.

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Reports of Suspected Dilaudid-HP (Hydromorphone) Side Effects

Unresponsive TO Stimuli (2)Sudden Death (2)Throat Tightness (2)Loss of Consciousness (2)Neck Pain (2)Chest Pain (2)Dyspnoea (2)Chest Discomfort (2)Vomiting (2)Retching (2)more >>

Page last updated: 2013-02-10

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