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Propoxyphene and Acetaminophen (Propoxyphene Hydrochloride / Acetaminophen) - Summary

 
 



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.

 

SUMMARY

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP

Propoxyphene hydrochloride is an odorless white crystalline powder with a bitter taste. It is freely soluble in water.

Propoxyphene hydrochloride and acetaminophen tablets are 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 and Acetaminophen indications & dosage >>

NEWS HIGHLIGHTS

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

Temple study suggests a novel approach for treating non-cardiac chest pain
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2014.10.24]
Chest pain doesn't necessarily come from the heart. An estimated 200,000 Americans each year experience non-cardiac chest pain, which in addition to pain can involve painful swallowing, discomfort...

Extra-Depth Shoes May Help Ease Foot Pain in Elderly
Source: Medscape NeurologyHeadlines [2014.10.23]
For seniors with disabling foot pain, off-the-shelf extra-depth footwear reduced pain and improved function in a new study.
Reuters Health Information

Changing how primary-care doctors treat pain, fatigue and other common symptoms
Source: Pain / Anesthetics News From Medical News Today [2014.10.23]
Common symptoms such as pain or fatigue account for over half of all doctor's office appointments in the United States, translating into more than 400 million visits annually.

Health Tip: Coping With Chronic Pain
Source: MedicineNet Chronic Pain Specialty [2014.10.23]
Title: Health Tip: Coping With Chronic Pain
Category: Health News
Created: 10/23/2014 12:00:00 AM
Last Editorial Review: 10/23/2014 12:00:00 AM

Tear duct implant effective at reducing pain and inflammation in cataract surgery patients
Source: Eye Health / Blindness News From Medical News Today [2014.10.21]
The first tear duct implant developed to treat inflammation and pain following cataract surgery has been shown to be a reliable alternative to medicated eye drops, which are the current standard of...

more news >>

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.

more studies >>

Clinical Trials Related to Propoxyphene 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 >>


Page last updated: 2014-10-24

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