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 disturbance 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, erthromycin, fulconazole, 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, Warnings, Precautions and Dosage and Administration for further information.)
Darvon-N contains propoxyphene napsylate, USP which 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.
DARVON-N (propoxyphene) is indicated for the following:
Media Articles Related to Darvon-N (Propoxyphene)
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 Darvon-N (Propoxyphene)
Characterizing the subjective, psychomotor, and physiological effects of oral propoxyphene in non-drug-abusing volunteers. [2004.02.07]
BACKGROUND: The subjective, psychomotor, and physiological effects of a widely prescribed prescription opioid, propoxyphene, have not been studied in a population of non-drug-abusing people. The drug also has potential for abuse and it was of interest in the present study to determine if the drug had any abuse liability-related subjective effects in this population... CONCLUSIONS: There was a lack of statistically significant subjective effects of propoxyphene in the group as a whole, including a propoxyphene dose that was twice as high as the typical clinically-prescribed dose of 100 mg. However, there were some subjects who did report effects, consistent with the notion that patients differ in their sensitivity to opioid effects.
The cognitive and psychomotor effects of morphine in healthy subjects: a randomized controlled trial of repeated (four) oral doses of dextropropoxyphene, morphine, lorazepam and placebo. [2000.03]
Ten healthy subjects (four male) of mean age 31 years (range 25-40) took part in a randomized double-blind four-way crossover study to examine the cognitive and psychomotor effects of repeated oral doses of dextropropoxyphene and morphine. Four treatments were compared: dextropropoxyphene napsylate 100 mg, morphine sulphate 10 mg, lorazepam 0.5 mg and placebo...
Dextropropoxyphene versus morphine in opioid-naive cancer patients with pain. [1998.02]
The role of opioids for moderate pain (so-called "weak" opioids) in the second step of the World Health Organization's analgesic ladder has been investigated in a prospective randomized study. Sixteen patients were administered dextropropoxyphene (DPP) in a dosage ranging from 120 mg to 240 mg daily (group 1), and 16 patients were administered the lowest doses (20 mg daily) of commercially available controlled-release morphine (group 2)...
Analgesia after day case laparoscopic sterilisation. A comparison of tramadol with paracetamol/dextropropoxyphene and paracetamol/codeine combinations. [1997.07]
In a prospective, double-blind trial we compared the analgesic efficacy of tramadol during the first 24 h after day case laparoscopic sterilisation with two commonly prescribed combination analgesics. Seventy-five women were allocated randomly to receive oral paracetamol 325 mg/dextropropoxyphene hydrochloride 32.5 mg, tramadol 50 mg or paracetamol 500 mg/codeine phosphate 30 mg as required after a standardised anaesthetic technique...
[Analgesic effect and clinical tolerability of the combination of paracetamol 500 mg and caffeine 50 mg versus paracetamol 400 mg and dextropropoxyphene 30 mg in back pain] [1996.09.07]
OBJECTIVES: A double-blind randomized multicentric study was performed to test the hypothesis that the analgesic effect of paracetamol-cafeine is equivalent to that of paracetamol-dextropropoxyphen in patients suffering from pain due to osteoarthritis of the spine... CONCLUSION: The potentializing action of cafeine on paracetamol-induced pain relief enables a degree of pain relief equivalent to that of a combination using an analgesic with a peripheral action, paracetamol, and another with a central action, dextropoxyphen. The fact that the paracetamol-cafeine combination does not have a central action avoids secondary effects induced by central analgesics (drowsiness, constipation) in patients with osteoarthritis back pain.
Clinical Trials Related to Darvon-N (Propoxyphene)
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.
Neuraxial Pethidine After Lumbar Surgery Trial [Recruiting]
The hypothesis is that epidural pethidine is an effective form of pain relief following
lumbar spinal surgery, resulting in significantly lower usage of concomitantly administered
(intravenous) patient-controlled analgesia (PCA) pethidine.
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.
Page last updated: 2016-10-21