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Darvon (Propoxyphene Hydrochloride) - 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.

 

DARVON SUMMARY

PULVULES®
DARVON®
PROPOXYPHENE
HYDROCHLORIDE
CAPSULES, USP

Each 300-mg Tigan capsule for oral use contains trimethobenzamide hydrochloride equivalent to 300 mg.

Tigan is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.


See all Darvon indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Darvon (Propoxyphene)

American Academy of Pain Management (AAPM) 25th Annual Clinical Meeting
Source: Medscape Family Medicine Headlines [2014.09.17]
Read clinically focused news coverage of key developments from AAPM 2014.
Medscape Neurology

Morphine-epilepsy drug combo can result in less pain, lower opioid doses
Source: Epilepsy News From Medical News Today [2014.09.17]
Adding a common epilepsy drug to a morphine regimen can result in better pain control with fewer side effects.

Deaths From Narcotic Painkillers Quadrupled in Past Decade: CDC
Source: MedicineNet Chronic Pain Specialty [2014.09.17]
Title: Deaths From Narcotic Painkillers Quadrupled in Past Decade: CDC
Category: Health News
Created: 9/16/2014 4:36:00 PM
Last Editorial Review: 9/17/2014 12:00:00 AM

Back-Related Leg Pain: Spine Manipulation Helps
Source: Medscape Orthopaedics Headlines [2014.09.16]
Spine manipulation plus exercise and home advice provided more short-term relief for patients with back-related leg pain than exercise and home advice alone, according to a recent study.
Medscape Medical News

Chiropractic care and exercise provide short-term relief of back-related leg pain
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2014.09.15]
In the short term, patients who received chiropractic care coupled with home exercise and advice reported greater reductions in back-related leg pain (BRLP) than those who received home exercise...

more news >>

Published Studies Related to Darvon (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.

more studies >>

Clinical Trials Related to Darvon (Propoxyphene)

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.

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.

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.

more trials >>

Reports of Suspected Darvon (Propoxyphene) Side Effects

Cardiac Disorder (395)Cardiovascular Disorder (385)Arrhythmia (376)Myocardial Infarction (371)Cardio-Respiratory Arrest (366)Injury (75)Drug Ineffective (17)Drug Hypersensitivity (13)Sudden Cardiac Death (9)Cardiac Failure Congestive (8)more >>


Page last updated: 2014-09-17

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