There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol. Fatalities within the first hour of overdosage are not uncommon. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation/attempts and/or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation.
- The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) leading to enhanced propoxyphene plasma levels. Patients receiving propoxyphene and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (see
CLINICAL PHARMACOLOGY – Drug Interactions, and
, PRECAUTIONS and DOSAGE AND ADMINISTRATION for further information).
Propoxyphene napsylate is a centrally acting narcotic analgesic agent.
Propoxyphene napsylate, USP is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone.
Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations.
Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.
Propoxyphene napsylate and acetaminophen tablets, USP are indicated for the relief of mild to moderate pain.
Media Articles Related to Propoxyphene and Acetaminophen (Propoxyphene / Acetaminophen)
A Man With Fever and Leg Pain: Osmosis Question of the Week
Source: Medscape Emergency Medicine Headlines [2016.10.21]
A 67-year-old man presents to the urgent care clinic following several days of fever and dull pain in his left leg. Do you know the diagnosis?
Positive pivotal Phase 3 data announced demonstrating investigational Elagolix reduced endometriosis-associated pain
Source: Clinical Trials / Drug Trials News From Medical News Today [2016.10.20]
AbbVie, a global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc.
'Fake Pills' May Help Ease Back Pain
Source: MedicineNet Chronic Pain Specialty [2016.10.20]
Title: 'Fake Pills' May Help Ease Back Pain
Category: Health News
Created: 10/19/2016 12:00:00 AM
Last Editorial Review: 10/20/2016 12:00:00 AM
Pregabalin may lessen pain from irritable bowel syndrome, Mayo Clinic study finds
Source: Irritable Bowel Syndrome News From Medical News Today [2016.10.19]
A pilot study by researchers at Mayo Clinic has found that patients suffering from pain related to irritable bowel syndrome (IBS) may benefit from taking pregabalin, a neuro-pain inhibitor commonly...
FDA Places Regeneron and Teva's Pain-Drug Study on Hold
Source: Medscape Orthopaedics Headlines [2016.10.18]
Regeneron Pharmaceuticals Inc and partner Teva Pharmaceutical Industries Ltd said the U.S. health regulator placed a clinical hold on a mid-stage study of their experimental drug for chronic lower back pain.
Reuters Health Information
Published Studies Related to Propoxyphene and Acetaminophen (Propoxyphene / Acetaminophen)
Analgesic efficacy of tramadol/acetaminophen and propoxyphene/acetaminophen for
relief of postoperative wound pain. 
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.
Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol). [2009.09]
AIMS: Three 'weak' opioid analgesics in association with paracetamol are marketed in France as step 2 analgesics: dextropropoxyphene, tramadol and codeine. These combinations are involved in several adverse drug reactions (ADRs), but no data are available about their comparative reporting rate. The aim was to compare the reporting rate of ADRs between tramadol/paracetamol (TRM+P), codeine/paracetamol (COD+P) and dextropropoxyphene/paracetamol (DXP+P)... CONCLUSIONS: Among the three step 2 analgesic combinations, reporting rate and 'seriousness' of ADRs are the highest with TRM+P and the lowest with COD+P. Our study suggests that the safety profile of DXP+P is worst than that of COD+P.
Use of dextropropoxyphene + acetaminophen fixed-dose combination in psychiatric hospital in Bahrain: is there a cause for concern? [2009.04]
There are concerns about the safety of the dextropropoxyphene and acetaminophen fixed-dose combination, particularly in patients with psychiatric morbidity, which has led to a phased withdrawal of this fixed-dose combination in many countries. A retrospective prescription audit was conducted to evaluate the dextropropoxyphene + acetaminophen fixed-dose combination prescribing pattern in the major psychiatric hospital of Bahrain...
Dextropropoxyphene withdrawal from a French university hospital: impact on analgesic drug consumption. [2009.04]
Dextropropoxyphene is a weak opioid analgesic, widely used as a step 2 analgesic (according to WHO classification) in combination with peripheral analgesics, mainly paracetamol. Recent data have underlined its poor analgesic efficacy (in comparison with paracetamol), risks of serious adverse drug reactions (i.e.
Clinical Trials Related to Propoxyphene and Acetaminophen (Propoxyphene / Acetaminophen)
Multiple-Ascending-Dose Study to Evaluate the Safety of Propoxyphene Napsylate In Healthy Adult Subjects [Terminated]
Lumbar Stenosis Outcomes Research II [Completed]
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 [Completed]
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.
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.
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.
Page last updated: 2016-10-21