BOX WARNING
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 maybe at greater risk (see WARNINGS).
- Naproxen 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).
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NAPROXEN SUMMARY
NAPROXEN DELAYED-RELEASE TABLETS
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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NAPROXEN NEWS HIGHLIGHTS Media Articles Related to Naproxen
NicOx' Naproxcinod Shows Highly Significant Reduction In Daytime Blood Pressure Versus Naproxen Source: Hypertension News From Medical News Today [2008.11.13]
Celebrex, Naproxen Won't Prevent Mental Decline Source: MedicineNet celecoxib Specialty [2008.05.13]
Published Studies Related to Naproxen
Comparison of naproxen with placebo for the management of noncyclical breast pain: a randomized, double-blind, controlled trial. [2008.11]
A comparison of the blood pressure changes of lumiracoxib with those of ibuprofen and naproxen. [2008.08]
Multimechanistic (sumatriptan-naproxen) early intervention for the acute treatment of migraine. [2008.07.08]
Naproxen suppository for perineal pain after vaginal delivery. [2008.07]
Cognitive Function Over Time in the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT): Results of a Randomized, Controlled Trial of Naproxen and Celecoxib. [2008.05.12]
Clinical Trials Related to Naproxen
Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations [Completed]
Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control [Completed]
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]
A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer [Suspended]
Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen [Completed]
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NAPROXEN PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Naproxen has an overall score of 5.83. The effectiveness score is 7.33 and the side effect score is 7. 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 36 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Mild Side Effects | | | Treatment Info |
| Condition / reason: | | auto accident, severe whiplash |
| Dosage & duration: | | 1 tablet 3 times a day taken 1 tablet 3 times a day for the period of 10 days |
| Other conditions: | | pinched nerve, headaches |
| Other drugs taken: | | cyclobenzaprine | | | Reported Results |
| Benefits: | | helped aleviate whip lash symptoms |
| Side effects: | | none that i noticed |
| Comments: | | i took the medications for the prescribed time and symptoms improved, however, I still have some symptoms which are being treated through physical therapy since the accident was only in December |
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| | Naproxen review by 16 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Ineffective |
| Side effects: | | Moderate Side Effects | | | Treatment Info |
| Condition / reason: | | Juvenile Idiopathic Arthritis |
| Dosage & duration: | | 500mg taken twice a day/at 12 hour intervals for the period of Four weeks |
| Other conditions: | | None |
| Other drugs taken: | | None | | | Reported Results |
| Benefits: | | The treatment did not affect the level of joint pain that I experienced, nor did it improve joint stiffness. I cannot comment on it's effect on inflammation as my inflammation tends not to be visible anyway. This may be the reason that Naproxen did not benefit me |
| Side effects: | | Caused nausea and stomach pain. The nausea would alleviate a couple of hours before the next dose was due, and start within an hour of the dose. It did not cause actual vomitting, but there were a few occasions on which I felt so nauseous I was convinced I would be sick at any moment. |
| Comments: | | I would never take Naproxen again without having a LONG discussion with both a doctor and pharmacist. |
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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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Page last updated: 2008-11-13
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