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Darvocet-N (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.

 

DARVOCET-N SUMMARY

DARVOCET-N 50
and
DARVOCET-N 100
PROPOXYPHENE NAPSYLATE
AND ACETAMINOPHEN
TABLETS, USP

Propoxyphene Napsylate, USP is an odorless, white crystalline powder with a bitter taste.

Each tablet of Darvocet-N 50 contains 50 mg (88.4 μmol) propoxyphene napsylate and 325 mg (2,150 μmol) acetaminophen.

Each tablet of Darvocet-N 100 contains 100 mg (176.8 μmol) propoxyphene napsylate and 650 mg (4,300 μmol) acetaminophen.

These products 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 Darvocet-N indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Darvocet-N (Propoxyphene / Acetaminophen)

DPP-4 Inhibitors Can Cause Severe Joint Pain, FDA Says
Source: Medscape Diabetes & Endocrinology Headlines [2015.08.28]
However, the pain associated with dipeptidyl peptidase-4 inhibitors for type 2 diabetes goes away once patients stop taking the medicine, according to the agency.
News Alerts

Group Offers Guidelines to Lessen Vaccination Pain
Source: Medscape Pediatrics Headlines [2015.08.28]
Clinicians can shuffle the order of vaccine injections, leverage the calming influence of parents and breast-feeding, and routinely apply topical anesthetic to ease vaccination pain for patients.
Medscape Medical News

DPP-4 Inhibitors Linked to Severe Joint Pain, FDA Warns
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.28]
(MedPage Today) -- The agency has identified 33 cases since 2006

Low Back Pain and GI Symptoms on the Swiss Alps
Source: Medscape Gastroenterology Headlines [2015.08.26]
Dr Paget discusses a recent patient of his who presented with a 5-year history of recurrent severe low back pain and gastrointestinal symptoms.
Medscape Rheumatology

Is There Sex After Low Back Pain?
Source: Medscape Orthopaedics Headlines [2015.08.26]
For many people with low back pain, sex is excruciating. But the recommended position for the past 25 years--'side-lying' (ie, 'spooning')--is contraindicated by two new biomechanical studies.
Medscape Orthopedics

more news >>

Published Studies Related to Darvocet-N (Propoxyphene / Acetaminophen)

Acceptability and efficacy of two associations of paracetamol with a central analgesic (dextropropoxyphene or codeine): comparison in osteoarthritis. [1992.11]
A double-blind randomized parallel group trial was undertaken to compare the acceptability and efficacy of 2 forms of analgesic treatment, DI-Antalvic (Houde Laboratories, Puteaux, France) (30 mg dextropropoxyphene and 400 mg paracetamol per capsule) and Efferalgan-Codeine (UPSA Laboratories, Rueil Malmaison, France) (30 mg codeine and 500 mg paracetamol per tablet) prescribed for 1 week at doses of 6 capsules/day and 6 tablets/day, respectively, in 141 outpatients with active osteoarthritis of the knee or hip...

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,

Hypersensitivity pneumonitis associated with co-proxamol (paracetamol + dextropropoxyphene) therapy. [1999.08]
A 61-year-old man developed hypersensitivity pneumonitis and skin rash in close association with taking co-proxamol. These problems occurred in spite of being treated with prednisolone 40 mg daily (20 mg daily at the time of presentation) for assumed cranial arteritis...

Systematic overview of co-proxamol to assess analgesic effects of addition of dextropropoxyphene to paracetamol. [1997.12.13]
OBJECTIVE: To evaluate the comparative efficacy and tolerability of paracetamol-dextropropoxyphene combination and paracetamol through a systematic overview of randomised controlled trials... CONCLUSION: On the basis of data on analgesic efficacy and acute safety in both head to head and indirect comparisons, there is little objective evidence to support prescribing a combination of paracetamol and dextropropoxyphene in preference to paracetamol alone in moderate pain such as that after surgery.

more studies >>

Clinical Trials Related to Darvocet-N (Propoxyphene / Acetaminophen)

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.

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Darvocet-N has an overall score of 5.75. The effectiveness score is 7 and the side effect score is 6.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Darvocet-N review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   arthritic joint pain/carpal tunnel
Dosage & duration:   100/650 (dosage frequency: 1 tablet 3 times daily as needed) for the period of 5 years
Other conditions:   coronary artery disease
Other drugs taken:   metropolol
  
Reported Results
Benefits:   affording daily movement and ability to continue to perform daily household duties, employment, and still afford me ability to enjoy activities with husband and grandchildren.
Side effects:   Some stomach discomfort and mild queasiness but I found taking 1/2 tablets at a time with ample fluids usually alleviated problems.
Comments:   carpal tunnel from job related injury and arthritis degeneration of my vertebrae requires daily regimine for pain and movement. Several medications tried such as ibruprofin, allieve, demoral etc caused many unpleasent and intolerable side effects. The Darvocet taken 1/2 tablet 4-6 times daily works perfectly as nearly can be expected. I also do not experience any bothersome toxicity or effectiveness problems as I generally would afford myself time-out days allowing my system a break from routines. I believe without this medication life would be greatly less enjoyable and my abilities to participate in a positive manner would be extremely limited.

 

Darvocet-N review by 50 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   pain relief after outpatient hernia surgery
Dosage & duration:   650 mg taken 1 every 4 hours for the period of 3 doses/about 12 hours
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   initial drowsiness
Side effects:   After 12 hours from the first dose, I experienced dizziness even lying down, then nausea. I threw up periodically for the subsequent 12 hours, until it was completely out of my system.
Comments:   Propoxyphene was prescribed with some hesitance by my surgeon, because I am allergic/sensitive to codeine products, and throw up with it as well. The follow-up call from the pre-op nurse advised me to discontinue (which I had already done) and try Tylenol instead. I had been able to tolerate Darvocet 14 years ago after a c-section. I am petite, at 5'4" and 104 lbs.

 

Darvocet-N review by 50 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   pain relief after outpatient hernia surgery
Dosage & duration:   650 mg taken 1 every 4 hours for the period of 3 doses/about 12 hours
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   initial drowsiness
Side effects:   After 12 hours from the first dose, I experienced dizziness even lying down, then nausea. I threw up periodically for the subsequent 12 hours, until it was completely out of my system.
Comments:   Propoxyphene was prescribed with some hesitance by my surgeon, because I am allergic/sensitive to codeine products, and throw up with it as well. The follow-up call from the pre-op nurse advised me to discontinue (which I had already done) and try Tylenol instead. I had been able to tolerate Darvocet 14 years ago after a c-section. I am petite, at 5'4" and 104 lbs.

See all Darvocet-N reviews / ratings >>

Page last updated: 2015-08-28

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