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Propoxyphene Napsylate and Acetaminophen (Propoxyphene Napsylate / Acetaminophen) - Summary

 
 



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.

 

SUMMARY

PROPOXYPHENE NAPSYLATE and ACETAMINOPHEN TABLETS, USP

Each tablet of propoxyphene napsylate and acetaminophen tablets, for oral administration, contains 100 mg (176.8 μmol) propoxyphene napsylate and 650 mg (4,300 μmol) acetaminophen.

Propoxyphene is a centrally acting narcotic analgesic agent.

This product is indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever.


See all Propoxyphene Napsylate and Acetaminophen indications & dosage >>

NEWS HIGHLIGHTS

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

Why being double-jointed can be a pain in the gut
Source: Bones / Orthopedics News From Medical News Today [2014.04.17]
Scientists from Queen Mary University of London are carrying out groundbreaking research which, for the first time, investigates the link between hypermobility (double-jointedness) and gut...

Intelligent prosthetic liners could ease pain for lower limb amputees
Source: Medical Devices / Diagnostics News From Medical News Today [2014.04.16]
A new device could help to relieve the pain and discomfort experienced by thousands of amputees as a result of poorly fitting replacement lower limbs.

Safe Epidurals, Hydrocodone Rescheduling: The Pain Medicine News Report
Source: MedPage Today Emergency Medicine [2014.04.16]
(MedPage Today) -- A regular update on what's new in surgery from our friends at Pain Medicine News.

Chronic Pain
Source: MedicineNet Alternative Medicine Specialty [2014.04.15]
Title: Chronic Pain
Category: Diseases and Conditions
Created: 5/14/2002 12:00:00 AM
Last Editorial Review: 4/15/2014 12:00:00 AM

Taking Blood Thinners With Certain Painkillers May Raise Bleeding Risk
Source: MedicineNet Atrial Fibrillation Specialty [2014.04.15]
Title: Taking Blood Thinners With Certain Painkillers May Raise Bleeding Risk
Category: Health News
Created: 4/14/2014 4:36:00 PM
Last Editorial Review: 4/15/2014 12:00:00 AM

more news >>

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.

more studies >>

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.

more trials >>

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 >>


Page last updated: 2014-04-17

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