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
62-Year-Old Man Becomes First Patient In China Implanted With Rechargeable Neurostimulator For Chronic Pain
Source: Health News from Medical News Today [2009.11.19]
St. Jude Medical, Inc. (NYSE:STJ) announced that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.
Common Pain Relief Medication May Encourage Cancer Growth
Source: Cancer / Oncology News From Medical News Today [2009.11.19]
Although morphine has been the gold-standard treatment for postoperative and chronic cancer pain for two centuries, a growing body of evidence is showing that opiate-based painkillers can stimulate the growth and spread of cancer cells. Two new studies advance that argument and demonstrate how shielding lung cancer cells from opiates reduces cell proliferation, invasion and migration in both cell-culture and mouse models.
CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.
Transplanting People's Own Stem Cells Into Heart Lessens Pain, Improves Ability To Walk
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.
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: 2009-11-19
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