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.
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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. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (α S,1 R) - α-[2-(Dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.74.
Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride.
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.
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NEWS HIGHLIGHTSMedia Articles Related to Darvocet-N (Propoxyphene / Acetaminophen)
propoxyphene and acetaminophen, Darvocet A500; Darvocet-N (Darvocet, Wygesic)
Source: MedicineNet Tylenol Liver Damage Specialty [2009.09.10]
Title: propoxyphene and acetaminophen, Darvocet A500; Darvocet-N (Darvocet, Wygesic)
Category: Medications
Created: 3/26/1998 2:30:00 PM
Last Editorial Review: 9/10/2009
Addex: ADX71943 Demonstrates Analgesic Effects In Pain Models
Source: Health News from Medical News Today [2010.02.08]
Addex Pharmaceuticals / Addex: ADX71943 Demonstrates Analgesic Effects in Pain Models processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement. Addex Pharmaceuticals (SWISS: ADXN), the allosteric modulation company, announced today that ADX71943 has demonstrated statistically significant analgesic-like effects in three preclinical models of pain...
AAPM: Spine Stimulation Leads to Durable Pain Relief (CME/CE)
Source: MedPage Today Neurology [2010.02.07]
SAN ANTONIO (MedPage Today) -- Spinal cord stimulation provided durable pain relief for patients with complex regional pain syndrome but did not halt progression, a retrospective analysis of a small clinical series showed.
AAPM: Facet Graft Quells Refractory Back Pain (CME/CE)
Source: MedPage Today Neurology [2010.02.07]
SAN ANTONIO (MedPage Today) -- Minimally invasive facet arthrodesis significantly reduced pain and improved physical function for one year in patients with medically refractory facet arthropathy, according to data from a prospective clinical series.
Minimally Invasive Spine Surgery And Spinal Cord Stimulation Show Promise In Alleviating Back Pain
Source: Clinical Trials / Drug Trials News From Medical News Today [2010.02.05]
Results from the first prospective study of minimally invasive facet arthrodesis and long-term data on spinal cord stimulation demonstrate the viability of these options to achieve pain relief in patients with various back pain conditions. The studies were presented at the American Academy of Pain Medicine's 26th Annual Meeting in San Antonio, TX...
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...
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.
Clinical Trials Related to Darvocet-N (Propoxyphene / Acetaminophen)
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Darvocet-N has an overall score of 6. The effectiveness score is 6 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Darvocet-N review by 28 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | pain |
| Dosage & duration: | | 1-2 tablets every 4-6 hours taken 1 tablet every 6-8 hours for the period of 1-2 days |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Treatment benefits were to address pain and discomfort. It was perscribed to me after I was in the hospital instead of Vicaden (spelling?), as Vicaden does not suite me well. The medication began working after about 45 minutes of taking it and (for me) lasted over 6 hours. |
| Side effects: | | Treatment side effects for me were nausea and feeling unclear or 'loopy'. I found that if I took more than one pill within six hours, I became very nauseated. In addition, I would not have been able to function properly or drive a car comfortably because of the side effects with my clarity. |
| Comments: | | The treatment was for pain and was taken by myself for a situation that could not have been allieviated by medical attention. I had an ovarian cyst rupture. My doctor and the ER told me there was really nothing for them to do other than wait for it to be reabsorbed. So, pain medication was my last resort. I took a few of these pills over two days to help alleviate my extreme pain. |
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Page last updated: 2010-02-08
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