BOX WARNING WARNINGS
- 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 Napsylate and Acetaminophen (Propoxyphene / Acetaminophen)
NSAID Prescriptions for Pain 'Out of Control' Source: Medscape Medical News Headlines [2013.06.15] An increasing number of patients with heart disease and cardiovascular risk factors are prescribed nonsteroidal anti-inflammatory drugs rather than safer alternatives, warn researchers. Medscape Medical News
EU regulator advises caution on painkiller diclofenac Source: Yahoo! Health News [2013.06.14] LONDON (Reuters) - Europe's drugs agency warned on Friday that use of the common painkiller diclofenac, especially in high doses, carries extra heart attack risks which should be taken into consideration by doctors prescribing the drug. While ...
Steroid Injections for Back Pain Linked to Spinal Fracture Risk Source: MedicineNet Low Back Pain Specialty [2013.06.14] Title: Steroid Injections for Back Pain Linked to Spinal Fracture Risk Category: Health News Created: 6/14/2013 10:35:00 AM Last Editorial Review: 6/14/2013 12:00:00 AM
Cardiac MRI Use Reduces Adverse Events For Patients With Acute Chest Pain Source: Cardiovascular / Cardiology News From Medical News Today [2013.06.13] Wake Forest Baptist Medical Center doctors have found that using stress cardiac magnetic resonance (CMR) imaging in an Emergency Department observation unit to care for patients with acute chest pain is a win-win - for the patient and the institution. In a small, single-center clinical trial, Chadwick Miller, M.D., M.S...
Scant data on seizure drugs for women's genital pain Source: Yahoo! Health News [2013.06.13] By Kerry Grens NEW YORK (Reuters Health) - Although doctors sometimes prescribe anti-seizure drugs to treat chronic pain in the vulva, just a handful of low-quality studies have examined the drugs' effects, according to a new review. Based on ...
Published Studies Related to Propoxyphene Napsylate and Acetaminophen (Propoxyphene / Acetaminophen)
Analgesic efficacy of tramadol/acetaminophen and propoxyphene/acetaminophen for
relief of postoperative wound pain. [2012] Depain-X in acute postoperative pain... CONCLUSION: Among patients with mild to moderate postoperative wound pain,
Propoxyphene and pain management in the elderly. [2009.11] Pain is frequently reported and often undertreated in the elderly population.Therefore, it is very important to consider alternatives to propoxyphene such as APAP, nonsteroidal anti-inflammatory drugs (rare use due to adverse effects) and other opioids, when managing elderly patients with pain.
Clinical Trials Related to Propoxyphene Napsylate and Acetaminophen (Propoxyphene / Acetaminophen)
Multiple-Ascending-Dose Study to Evaluate the Safety of Propoxyphene Napsylate In Healthy Adult Subjects [Recruiting]
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.
Reports of Suspected Propoxyphene Napsylate and Acetaminophen (Propoxyphene / Acetaminophen) Side Effects
Myocardial Infarction (9),
Atrial Fibrillation (8),
Palpitations (5),
Arrhythmia (4),
Blood Pressure Inadequately Controlled (3),
Transient Ischaemic Attack (3),
Blindness (3),
Cardiac Arrest (3),
Sudden Death (2),
Disorientation (2), more >>
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