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Propoxyphene and Acetaminophen (Propoxyphene Hydrochloride / Acetaminophen) - Summary



  • 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 WARNINGS ,  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.

See all Propoxyphene and Acetaminophen indications & dosage >>


Media Articles Related to Propoxyphene and Acetaminophen (Propoxyphene / Acetaminophen)

Newly Insured Treasure Medicaid, But Growing Pains Felt
Source: Medscape Medical News Headlines [2015.10.02]
The Affordable Care Act unleashed a building boom of community health centers across the country. At a cost of $11 billion, more than 950 health centers have opened and thousands have expanded or modernized.
Kaiser Health News

Pneumothorax treatment gets less painful
Source: Respiratory / Asthma News From Medical News Today [2015.10.02]
Scientists working in Tianjin Chest Hospital, China, have developed a less painful treatment strategy for Pneumothorax treatment.

Menopausal women experiencing distressing pain during sex
Source: Psychology / Psychiatry News From Medical News Today [2015.10.01]
Results from qualitative research of postmenopausal women with vulvar and vaginal atrophy (VVA) show that they recognize the significant physical, emotional and psychological consequences of...

Canadian multicentre study examines safety of medical cannabis in the treatment of chronic pain
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2015.09.30]
A Canadian research team led by Dr. Mark Ware from the Research Institute of the McGill University Health Centre (RI-MUHC) in Montréal has completed a national multicentre study looking at the...

New drug trial could help relieve the pain of diabetes
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.09.25]
UK patients with diabetic neuropathy are being recruited for a phase II clinical trial which will evaluate the safety, tolerability and efficacy of a novel class of analgesicThe trial will be...

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Published Studies Related to Propoxyphene 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.

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.

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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.

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Page last updated: 2015-10-02

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