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)
Erectile Dysfunction Tied To Long Term Painkiller Use
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.16]
A new study suggests that long term use of opioid prescription painkillers for back pain is tied to a higher risk of erectile dysfunction (ED). The findings are published in the 15 May online issue of the journal Spine. Lead author Richard A...
Painkillers Increase Risk of Erectile Dysfunction
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.15]
Regularly taking prescription painkillers, commonly called opioids, is linked to a greater risk of erectile dysfunction (ED) in men, according to a new study published in Spine. Over 11,000 men suffering from back pain were involved in the research...
Retooling Pain Assessment for Older Adults
Source: Medscape Emergency Medicine Headlines [2013.05.14]
Current pain assessment tools for older adults are inadequate, and education for healthcare professionals falls short in meeting the unique challenges posed by pain management for elderly patients.
Medscape Medical News
Tanezumab Makes Good in Chronic Back Pain (CME/CE)
Source: MedPage Today Neurology [2013.05.14]
NEW ORLEANS (MedPage Today) -- The controversial agent tanezumab, which was once put on an FDA regulatory hold, offered durable reduction of chronic low back pain, a long-term safety and efficacy study showed.
Persistent Pain After Sexual Assault Often Untreated
Source: Medscape Nurses Headlines [2013.05.13]
Although pain is common after sexual assault, more than 50% of women don't seek appropriate medical care 6 weeks after presenting to the ED.
Medscape Medical 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.
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 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. |
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| | 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. |
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| | 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. |
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Page last updated: 2013-05-16
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