WARNING
HYDROMORPHONE HYDROCHLORIDE
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.
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HYDROMORPHONE SUMMARY
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.
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NEWS HIGHLIGHTS
Published Studies Related to Hydromorphone
Hydromorphone extended release for neuropathic and non-neuropathic/nociceptive
chronic low back pain: a post hoc analysis of data from a randomized,
multicenter, double-blind, placebo-controlled clinical trial. [2014] (LBP) with or without a neuropathic component... CONCLUSIONS: The results of this study indicate that hydromorphone ER is
Safety and efficacy of once-daily hydromorphone extended-release versus
twice-daily oxycodone hydrochloride controlled-release in chinese patients with
cancer pain: a phase 3, randomized, double-blind, multicenter study. [2014] Noninferiority of the efficacy of once-daily hydromorphone hydrochloride
extended-release (hydromorphone ER) compared with twice-daily oxycodone
hydrochloride controlled-release (oxycodone CR) was investigated in this
randomized, double-blind study in Chinese patients with moderate to severe cancer
pain requiring strong oral opioid analgesics.
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...
Clinical Trials Related to Hydromorphone
Methadone and Hydromorphone For Spinal Surgery [Recruiting]
Patients undergoing major spinal surgery continue to experience moderate-to-severe pain
during the first 2-3 days following the operative procedure. Pain complicates the recovery
process, despite the routine practice of using potent opioid analgesics. The primary reason
that pain is poorly controlled in patients undergoing major surgery is that most
commonly-used opioids only produce analgesia for 2-4 hours. The intermittent use of these
drugs results in periods of time when a patient will experience discomfort (at which time a
nurse administers more drug or the button on a patient-controlled analgesic (PCA) system is
pressed to deliver more medication). The use of a long-acting opioid may be advantageous in
the perioperative setting. Methadone is an opioid that has a median duration of analgesia
of 24-36 hours. Therefore, a single dose administered in the operating room may reduce the
need for pain medication and improve pain control for the first few postoperative days. The
aim of this randomized clinical trial is to examine the effect of methadone (compared to
hydromorphone) on postoperative pain management in patients undergoing major spine surgery
An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain [Completed]
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.
Single-arm Study to Assess the Safety of Hydromorphone HCl by Intrathecal Administration [Recruiting]
Fixed Dose of Intravenous Hydromorphone in the Treatment of Acute Pain [Completed]
Research question: In adult emergency department (ED) patients to whom the attending ED
physician has decided to administer intravenous opioid pain control:
1. What is the incidence of serious adverse events, defined as the use of naloxone, up to
a total of 2 hours after infusion of 2 mg IV hydromorphone?
2. What is the incidence of other side effects (respiratory depression, hypotension,
oxygen desaturation, nausea, vomiting, and pruritus) at 5, 15, 30 and 120 minutes post
infusion of 2mg IV hydromorphone?
3. What is the speed of onset of 2 mg IV hydromorphone? This will be measured by asking
the patient for his NRS pain score at 1, 2, 3, 4, and 5 minutes post infusion of 2 mg
IV hydromorphone.
4. What is the incidence of administration of rescue medications?
5. For those patients who decline to enter the study, what are their reasons for refusal
(e. g. fear of becoming addicted)? The investigators believe this is yet another barrier
to providing adequate pain relief for patients with acute severe pain.
Reports of Suspected Hydromorphone Side Effects
Completed Suicide (3),
Atelectasis (1),
Intentional Overdose (1),
Death (1),
Hypoxia (1),
Thrombocytopenia (1),
Anaemia (1),
Toxicity TO Various Agents (1),
Delirium (1),
Sinus Tachycardia (1)
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Page last updated: 2015-08-10
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