BOX WARNING
Do not prescribe propoxyphene for patients who are suicidal or addiction prone.
Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess.
Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.
Propoxyphene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon. In a survey of deaths due to overdosage conducted in 1975, in approximately 20% of the fatal cases, death occurred within the first hour (5% occurred within 15 minutes). Propoxyphene should not be taken in doses higher than those recommended by the physician. The judicious prescribing of propoxyphene is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, propoxyphene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations.
Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of propoxyphene alone or in combination with other drugs. Patients taking propoxyphene should be warned not to exceed the dosage recommended by the physician.
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NEWS HIGHLIGHTSMedia Articles Related to Propoxyphene and Acetaminophen (Propoxyphene / Acetaminophen)
62-Year-Old Man Becomes First Patient In China Implanted With Rechargeable Neurostimulator For Chronic Pain
Source: Health News from Medical News Today [2009.11.19]
St. Jude Medical, Inc. (NYSE:STJ) announced that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.
Common Pain Relief Medication May Encourage Cancer Growth
Source: Cancer / Oncology News From Medical News Today [2009.11.19]
Although morphine has been the gold-standard treatment for postoperative and chronic cancer pain for two centuries, a growing body of evidence is showing that opiate-based painkillers can stimulate the growth and spread of cancer cells. Two new studies advance that argument and demonstrate how shielding lung cancer cells from opiates reduces cell proliferation, invasion and migration in both cell-culture and mouse models.
CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.
Transplanting People's Own Stem Cells Into Heart Lessens Pain, Improves Ability To Walk
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.
FDA Approves New Drug For Pain That Persists After Shingles
Source: Dermatology News From Medical News Today [2009.11.18]
The US Food and Drug Administration (FDA) announced yesterday that it has approved Qutenza (capsaicin) 8% patch for the treatment of post-herpetic neuralgia (PHN), an often excruciating pain that can persist for weeks, months and even years in 10 to 15 per cent of people who get shingles. The medicated skin patch, which is made by Lohmann Therapie-Systems AD of Andernach, Germany and distributed in the US by NeurogesX Inc.
Published Studies Related to Propoxyphene and Acetaminophen (Propoxyphene / Acetaminophen)
Retrospective diagnosis of an adverse drug reaction in a breastfed neonate: liquid chromatography-tandem mass spectrometry quantification of dextropropoxyphene and norpropoxyphene in newborn and maternal hair. [2008.11]
Dextropropoxyphene (DP) and norpropoxyphene (NP) are commonly used in the treatment of postpartum pain. The drug is widely prescribed in Europe and Canada and has been recently approved for use in the U.S... Breastfeeding should be encouraged under most circumstances, and if the mother takes any treatment for pain, a commonly prescribed drug with pharmacologic data available must be used.
Propoxyphene prescribing among populations older and younger than age 65 in a tertiary care hospital. [2007.02]
OBJECTIVE: To evaluate the proportion of patients aged 65 years and older who are prescribed propoxyphene (PP) versus those aged 65 and younger... CONCLUSIONS: Compared with nationally reported data, the rate of PP prescribing is relatively low. However, despite the recommendation to avoid the use of PP in elderly patients, its use occurs in a higher proportion of patients age 65 years or older than in younger patients. Studies evaluating the prescribing rates of potentially inappropriate medications should be put in context by comparing reported data with that of a younger cohort.
Propoxyphene (dextropropoxyphene): a critical review of a weak opioid analgesic that should remain in antiquity. [2006.11]
Propoxyphene (dextropropoxyphene) is a synthetic weak opioid introduced into the United States in 1957. It is most frequently prescribed in combination with acetaminophen and/or aspirin... The mere warnings of fatalities within the package insert should alert any cautious prescriber on the dangers of this agent and dampen its prescribing potential.
Propoxyphene use and risk for hip fractures in older adults. [2006.09]
BACKGROUND: Published guidelines have identified propoxyphene as an inappropriate medication for use in aged patients. It is no more effective than acetaminophen, yet has been associated with the same adverse effects (AEs) associated with other opioid drugs. In particular, its central nervous system-related AEs, dizziness and sedation, may increase the risk for fracture resulting from falls in older adults. Nonetheless, US studies have reported widespread use of propoxyphene in the elderly US population. OBJECTIVE: The aim of this study was to examine the risk for fracture associated with propoxyphene use in older adults... CONCLUSIONS: The results of this cohort database study suggest that propoxyphene use among adults aged > or =65 years is associated with increased risk for hip fracture and suggest a need for interventions to reduce propoxyphene use in older adults. Clinicians should be aware of the risk for hip fracture with other opioids as well and weigh them against potential benefits when prescribing for older adults.
Profound metoprolol-induced bradycardia precipitated by acetaminophen-propoxyphene. [2006.03]
Pharmacokinetic studies demonstrate that propoxyphene is a potent inhibitor of cytochrome P450 (CYP) 2D6...
Clinical Trials Related to Propoxyphene and Acetaminophen (Propoxyphene / Acetaminophen)
Lumbar Stenosis Outcomes Research II [Recruiting]
The primary objective of the proposed pilot study is to determine the efficacy of
oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time
to onset of pain and reducing the severity of pain associated with walking in patients with
neurogenic intermittent claudication. The secondary objective is to examine the functional
benefit of oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect
to improvement in duration and distance of walking tolerance.
The proposed study will also provide the foundation for a treadmill-based methodology for
assessing the analgesic efficacy of drugs for low back pain provoked by standing and walking
associated with lumbar spinal stenosis.
Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain [Active, not recruiting]
RATIONALE: Oxycodone helps lessen pain caused by cancer and may improve quality of life. It
is not yet known whether oxycodone works better and is more cost effective than standard
therapy in treating patients with cancer pain.
PURPOSE: This randomized phase IV trial is studying oxycodone to see how well it works
compared with standard pain therapy in treating patients with cancer pain and if it is more
cost effective than standard pain therapy.
An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee [Completed]
The purpose of this study is to determine the safety and effectiveness of 650 mg and 1300 mg
acetaminophen extended release given three times a day for the relief of signs and symptoms
of osteoarthritis of the hip or knee for a period of 12 weeks.
Effect Of Celecoxib On Hip Osteoarthritis (OA) Progression [Terminated]
Objectives of the study:
Primary: Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo
administered once daily (QD) for 24 months in slowing disease progression as assessed
radiographically in subjects with osteoarthritis (OA) of the hipSecondary: Assess the ability
of a continuous treatment of celecoxib 200 mg versus placebo administered QD for 24 months in
treating disease signs and symptoms in subjects with OA of the hip. Evaluate the ability of a
continuous 24-month intake of celecoxib 200 mg QD versus placebo to reduce number of subjects
eligible for hip replacement according to the investigator. Evaluate the tolerability and
safety of a continuous 24-month intake of celecoxib 200 mg QD versus placebo in subjects with
OA of the hip.
Neuraxial Pethidine After Lumbar Surgery Trial [Recruiting]
The hypothesis is that epidural pethidine is an effective form of pain relief following
lumbar spinal surgery, resulting in significantly lower usage of concomitantly administered
(intravenous) patient-controlled analgesia (PCA) pethidine.
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