Cardiovascular Risk
- NSAIDs1 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 delayed-release tablets are 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).
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NAPROXEN SUMMARY
NAPROXEN DELAYED-RELEASE TABLETS
Rx only
Naproxen is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (+)-6-Methoxy-a-methyl-2-naphthaleneacetic acid. Naproxen has the following structural formula.
Carefully consider the potential benefits and risks of naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen delayed-release tablets are indicated:
- For the relief of the signs and symptoms of rheumatoid arthritis
- For the relief of the signs and symptoms of osteoarthritis
- For the relief of the signs and symptoms of ankylosing spondylitis
- For the relief of the signs and symptoms of juvenile arthritis
Naproxen delayed-release tablets are 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).
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NEWS HIGHLIGHTSMedia Articles Related to 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
Published Studies Related to 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.
Clinical Trials Related to 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.
Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control [Completed]
The primary objective of this study is to determine whether the route of administration of
naproxen (either by mouth or rectally) influences post-vaginal delivery perineal pain
control.
Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Population [Completed]
The objectives of the study were to evaluate the efficacy, safety, and tolerability of
valdecoxib 10 mg once daily (QD) or naproxen 500 mg twice daily (BID) versus placebo, and to
assess the efficacy of valdecoxib 10 mg QD versus naproxen 500 mg BID, in treating the signs
and symptoms of rheumatoid arthritis (RA) in a severe Rheumatoid Arthritis population.
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.
Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen [Completed]
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 7 ratings/reviews, Naproxen has an overall score of 5.14. The effectiveness score is 6.57 and the side effect score is 6.86. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Naproxen review by 25 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | period cramps |
| Dosage & duration: | | 500 mg taken 3 days per month for the period of almost 6 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I was able to do normal daily activities again |
| Side effects: | | I had no side effects. |
| Comments: | | I always have had really bad cramps. I have tried many different prescription pain killers over the years and none have really made the pain any better. I first started taking Naproxen in 200mg as you can get this over the counter as Aleve in the States. Canada has no such product available. I found that even in 200 mg strength sometimes was enough to make my day bearable. I now get it from my Dr. in 500 mg strength and am able to carry out my normal daily activities as I was unable to even go to work some days before. |
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| | Naproxen review by 52 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | arthritis |
| Dosage & duration: | | 3 x 10mg / day taken daily for the period of 2 years |
| Other conditions: | | nil |
| Other drugs taken: | | paracetamol | | |
Reported Results |
| Benefits: | | reduced the pain and swelling |
| Side effects: | | caused severe abdominal cramps and bouts of diarrhoea and constipation |
| Comments: | | given over a period of 3 years... at first daily and then, due to stomache irritation, reduced to use only when needed. Stomache problems evident when taking 3 a day for 2 or more days. Given tab for coating the stomache. |
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| | Naproxen review by 54 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | frozen shoulder |
| Dosage & duration: | | 500 mg taken 2xday for the period of 3 weeks |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | the medication did not benefit my shoulder pain at all. The orthopedic doctor felt it would eventually kick in, but for me, it never did and didn't do anything to help. It had adverse affects. He was a very caring doctor who was trying to lessen the severe pain I experienced. |
| Side effects: | | the treatment caused my blood pressure to increase quickly - within a week or so - to very high blood pressure. I found that I was very nervous and felt horrid, dizzy. I went to a GP who took me off of it. |
| Comments: | | the treatment was for a frozen shoulder. I had a lot of pain and could not sleep at night on my back or side. I could only sleep sitting up for a few hours at a time. It was hard to move. Physical therapy eventually helped and taking Tylenol products. I had many sleepless nights. I went off the medication after three weeks since the effects for me were not helpful and had terrible side effects. |
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Page last updated: 2009-10-20
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