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Naprosyn (Naproxen Sodium) - Summary

 



Cardiovascular Risk

  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
  • Naproxen as NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
 

NAPROSYN SUMMARY

EC-NAPROSYN® (naproxen delayed-release tablets)
NAPROSYN® (naproxen tablets)
ANAPROX®/ANAPROX® DS (naproxen sodium tablets)
NAPROSYN® (naproxen suspension)

Naproxen is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs.

Naproxen as NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis.

Naproxen as NAPROSYN Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.

Naproxen as NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension are also indicated for the treatment of tendonitis, bursitis, acute gout, and for the management of pain and primary dysmenorrhea. EC-NAPROSYN is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).


See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Naprosyn (Naproxen)

Naproxen May Help Prevent Alzheimer's
Source: MedicineNet celecoxib Specialty [2009.07.17]
Title: Naproxen May Help Prevent Alzheimer's
Category: Health News
Created: 7/17/2009
Last Editorial Review: 7/17/2009

NSAIDs Prevent Early Sign Of Alzheimer Disease In Mice
Source: Pain / Anesthetics News From Medical News Today [2009.11.10]
If taking nonsteroidal antiinflammatory drugs (NSAIDs) such as ibuprofen or naproxen is to protect you from developing Alzheimer disease then you will have to start taking them at a very early age according to research in a mouse model of the disease. Emerging data indicate that an early molecular event in the development of Alzheimer disease is the induction of neuronal cell cycle events (CCEs).

more news >>

Published Studies Related to Naprosyn (Naproxen)

Platelet inhibitory effects of OTC doses of naproxen sodium compared with prescription dose naproxen sodium and low-dose aspirin. [2009.10]
CONCLUSIONS: These data suggest that OTC doses of NAPSO (220 mg two or three times daily) have an antiplatelet effect similar to EC-ASA 81 mg and to prescription dose NAPSO (550 mg twice daily).

Effects of the cyclooxygenase inhibiting nitric oxide donator naproxcinod versus naproxen on systemic blood pressure in patients with osteoarthritis. [2009.09.15]
Traditional nonsteroidal anti-inflammatory drugs are associated with the destabilization of blood pressure (BP) control, particularly in hypertensive patients treated with blockers of the renin-angiotensin system. To assess the potential impact of nitric oxide donation, the effects of naproxcinod with naproxen and placebo on changes in BP were compared in a randomized clinical trial of 916 patients with osteoarthritis after 13 weeks of therapy...

Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled, crossover study. [2009.08]
Two identical randomized, placebo-controlled, crossover studies were conducted to evaluate consistency of response to sumatriptan/naproxen sodium 85/500 mg (S/NS) over four attacks in adults with migraine. Patients were instructed to treat within 1 h of pain onset while pain was mild... The incidences of any adverse event and of specific adverse events were low and generally similar between S/NS and placebo.

Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. [2009.07]
OBJECTIVE: To evaluate the efficacy and tolerability of sumatriptan-naproxen during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea... CONCLUSION: Sumatriptan-naproxen provided an effective pain-free response at 2 hours, which was maintained up to 48 hours in menstrual migraineurs with dysmenorrhea. Sumatriptan-naproxen was well-tolerated and resulted in decreased rescue medication use and relief of nonpainful menstrual symptoms. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00329459 and NCT00329355 LEVEL OF EVIDENCE: I.

Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. [2009.07]
OBJECTIVE: To evaluate efficacy and tolerability of a single, fixed-dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg (sumatriptan/naproxen sodium) vs placebo in migraineurs who had discontinued treatment with a short-acting triptan because of poor response or intolerance. BACKGROUND: Triptan monotherapy is ineffective or poorly tolerated in 1 of 3 migraineurs and in 2 of 5 migraine attacks. In April, 2008, the Food and Drug Administration approved the combination therapy sumatriptan/naproxen sodium, developed specifically to target multiple migraine mechanisms. This combination product offers an alternative migraine therapy for patients who have reported poor response or intolerance to short-acting triptans... CONCLUSION: In migraineurs who reported poor response to a short-acting triptan, sumatriptan/naproxen sodium was generally well tolerated and significantly more effective than placebo in conferring initial, intermediate, and sustained efficacy for pain and migraine-associated symptoms of photophobia and phonophobia.

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Clinical Trials Related to Naprosyn (Naproxen)

Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations [Completed]
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E [Recruiting]
The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.

Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone [Recruiting]
The purpose of this study is to determine whether the absorption of naproxen from the PN 400 combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets (Naprosyn®), which are currently sold in Australia.

A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer [Suspended]
To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.

A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-Month Period [Not yet recruiting]
The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets containing only naproxen sodium when these drugs are taken to treat migraine headaches that occur during a 6-month period.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Naprosyn has an overall score of 5.25. The effectiveness score is 6 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Naprosyn review by 46 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   ankylosing spondylitis
Dosage & duration:   500mg taken 2 per day for the period of 24 years
Other conditions:   none
Other drugs taken:   painkillers
  
Reported Results
Benefits:   enables me to get on with my life and be mobile. without it my back and neck become "stiff" so I also combine taking the drug with daily exercise to keep myself as fit as is possible. my condition was inherited from my father.
Side effects:   none that I know of.
Comments:   twice per day, with meals (morning and night).

 

Naprosyn review by 50 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   muscle inflammation
Dosage & duration:   500 mg taken 2 times a day for the period of 6 weeks
Other conditions:   whiplash
Other drugs taken:   none
  
Reported Results
Benefits:   None. I was told it would take 6 weeks for the medicine to accumulate and become completely effective. It did not produce any results that were apparent. Not in inflammation reduction or in pain reduction due to the inflammation were any results ascertainable. I suffered while waiting for this medication to do anything. Further, you are told to consume food to protect the lining of your stomach from this medication. Not always something you want to do when you are experiencing a lot of pain because pain can make you feel like vomiting.
Side effects:   Stomach issues, burning The more adverse affect was the constant pain due to the continuing inflammation with the added and increasing reduction in movement, and muscle usage. Worst, was the waste of time. Another med could have been prescribed in the time I used this medicine that would have been more effective and time healing would not have been wasted. In fact, another anti-inflammatory was prescribed that provided immediate benefits (30 minutes) without the build-up in your system that the M.D. and pharmacist said Naprosyn requires before it becomes effective.
Comments:   Tried various dosages from the lowest, to more frequency. It simply had little affect on inflammation or pain. No other pain medication was added to this treatment and no other medication was given. I had a car accident and suffered whiplash, thoracic muscle strain, herniation of entire lumbar region, etc. Inflammation was rampant from hip level up. Any relief would have been noted and appreciated. Another drug was later prescribed, another anti-inflammatory, which proved just how much the naprosyn did not work. I had immediate pain relief in 30 minutes and notable inflammation reduction very quickly. In fact, after a 3 week loading of this drug, I was able to get out of bed, move around, and be functional! The Doctor insisted on trying this level, Naprosyn, first and then changed after 6 weeks, to supposedly stronger medication in some kind of protocol progression. I now tell my doctors which medication works and refuse anything else. They waste time on ineffective medications allowing suffering. I saw the doctors within the 6 week period declaring and their noting how ineffective this medication was.

 

Naprosyn review by 50 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   muscle inflammation
Dosage & duration:   500 mg taken 2 times a day for the period of 6 weeks
Other conditions:   whiplash
Other drugs taken:   none
  
Reported Results
Benefits:   None. I was told it would take 6 weeks for the medicine to accumulate and become completely effective. It did not produce any results that were apparent. Not in inflammation reduction or in pain reduction due to the inflammation were any results ascertainable. I suffered while waiting for this medication to do anything. Further, you are told to consume food to protect the lining of your stomach from this medication. Not always something you want to do when you are experiencing a lot of pain because pain can make you feel like vomiting.
Side effects:   Stomach issues, burning The more adverse affect was the constant pain due to the continuing inflammation with the added and increasing reduction in movement, and muscle usage. Worst, was the waste of time. Another med could have been prescribed in the time I used this medicine that would have been more effective and time healing would not have been wasted. In fact, another anti-inflammatory was prescribed that provided immediate benefits (30 minutes) without the build-up in your system that the M.D. and pharmacist said Naprosyn requires before it becomes effective.
Comments:   Tried various dosages from the lowest, to more frequency. It simply had little affect on inflammation or pain. No other pain medication was added to this treatment and no other medication was given. I had a car accident and suffered whiplash, thoracic muscle strain, herniation of entire lumbar region, etc. Inflammation was rampant from hip level up. Any relief would have been noted and appreciated. Another drug was later prescribed, another anti-inflammatory, which proved just how much the naprosyn did not work. I had immediate pain relief in 30 minutes and notable inflammation reduction very quickly. In fact, after a 3 week loading of this drug, I was able to get out of bed, move around, and be functional! The Doctor insisted on trying this level, Naprosyn, first and then changed after 6 weeks, to supposedly stronger medication in some kind of protocol progression. I now tell my doctors which medication works and refuse anything else. They waste time on ineffective medications allowing suffering. I saw the doctors within the 6 week period declaring and their noting how ineffective this medication was.

See all reviews / ratings >>

Page last updated: 2009-11-10

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