Naprosyn (Naproxen Sodium) - Summary

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 Naprosyn indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Naprosyn (Naproxen)

Comparison of the analgesic effects of oral tramadol and naproxen sodium on pain relief during IUD insertion. [2012]
on pain during insertion of an intrauterine device (IUD)... CONCLUSION: Prophylactic analgesia using 50 mg tramadol and 550 mg naproxen,

Impact of a Fixed-Dose Combination of Naproxen and Esomeprazole Magnesium on Serum Thromboxane B(2) Inhibition by Low-Dose Aspirin Over 5 Days in Healthy Adults: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Noninferiority Trial. [2011.11.09]
Background: Low-dose aspirin (LDA) and nonsteroidal anti-inflammatory drugs (NSAIDs) are often used concomitantly; however, some NSAIDs may interfere with LDA antiplatelet activity. OBJECTIVE: We evaluated the impact of coadministered enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg (fixed-dose combination) on LDA-mediated platelet cyclooxygenase (COX)-1 inhibition... CONCLUSIONS: This pilot investigation suggests that LDA coadministered with naproxen/esomeprazole magnesium is noninferior to LDA alone for platelet COX-1 inhibition, as measured by serum TXB(2) concentration, in healthy volunteers. ClinicalTrials.gov identifier: NCT01094483. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

Naproxen as prophylaxis against atrial fibrillation after cardiac surgery: the NAFARM randomized trial. [2011.11]
PURPOSE: We sought to assess the effect of naproxen versus placebo on prevention of atrial fibrillation after coronary artery bypass graft (CABG) surgery... CONCLUSIONS: Postoperative use of naproxen did not reduce the incidence of atrial fibrillation but decreased its duration, in a limited sample of patients after CABG surgery. There was a significant increase in acute renal failure in patients receiving naproxen 275 mg twice daily. Our study does not support the routine use of naproxen after CABG surgery for the prevention of atrial fibrillation. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial. [2011.09.24]
OBJECTIVE: The purpose of this study was to evaluate whether oral naproxen or transdermal estradiol decreases bleeding and spotting in women who are initiating the levonorgestrel-releasing intrauterine system... CONCLUSION: The administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo. Copyright A(c) 2011 Mosby, Inc. All rights reserved.

Celecoxib or Naproxen Treatment Does Not Benefit Depressive Symptoms in Persons Age 70 and Older: Findings From a Randomized Controlled Trial. [2011.07.19]
BACKGROUND:: Several lines of evidence suggest that inflammatory mechanisms may be involved in the severity and progression of depression. One pathway implicated is the production of prostaglandins via the enzyme cyclooxygenase (COX). Although late-life depression in particular has been associated with inflammation, we know of no published studies using COX inhibitors, such as nonsteroidal anti-inflammatory drugs (NSAIDs), in the treatment of depressive syndromes in this population. OBJECTIVE:: To evaluate the effect of the NSAIDs celecoxib and naproxen on depressive symptoms in older adults... CONCLUSION:: Treatment with celecoxib or naproxen did not improve depressive symptoms over time compared with placebo. While inflammation has been implicated in late-life depression, these results do not support the hypothesis that inhibition of the COX pathway with these NSAIDs at these doses alleviates depressive symptoms in older adults.

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Clinical Trials Related to Naprosyn (Naproxen)

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as 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.

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.

Naproxen for the Prevention of HO After Complex Elbow Trauma [Recruiting]
Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification). This new bone is unwanted and it can restrict motion. This research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs which stands for non-steroidal anti-inflammatory drugs.

Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted formation of new bone around the hip. The effect of NSAIDS on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip.

The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot specifically for the treatment of heterotopic ossification.

A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee [Recruiting]
PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.

Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee [Recruiting]
This study aims to evaluate various methods of measuring pain relief in subjects who have chronic OA of the knee. After a 1 week of wash-out from existing therapy, subjects will be treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment, subjects will have another week of wash-out followed by a second period of 1 week of the alternate treatment. Subjects will not be allowed to use oral non-steroidal anti-inflammatory drugs (NSAIDs) or other oral analgesics, or topical medications on their target knees during the study. Acetaminophen will be allowed as a rescue medication.

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Reports of Suspected Naprosyn (Naproxen) Side Effects

Abdominal Discomfort (10),  Abdominal Pain (8),  Drug Ineffective (8),  Pain (8),  Nausea (8),  Drug Hypersensitivity (8),  Pain in Extremity (7),  Abdominal Pain Upper (6),  Malaise (5),  Oedema Peripheral (5), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

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 31 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Rheumatoid Arthritis
Dosage & duration:		Twice Daily (dosage frequency: once a month) for the period of 4 month
Other conditions:		none
Other drugs taken:		celebrex
		Reported Results
Benefits:		join pain and swelling
Side effects:		nausea, vomit, gastrointestial disorders
Comments:		The medicine woks but I still can feel the pain, so for me is not working because of the side effects, I have to take the medicine with food and milk and still have this severe stomach pain, nausea and some times vomits. My doctors are working on put me on something else that could work better for me

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.