Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include hives; facial swelling; asthma wheezing ; shock; skin reddening; rash; blisters.

If an allergic reaction occurs, stop use and seek medical help right away. This product contains a nonsteroidal anti-inflammatory drug NSAID , which may cause stomach bleeding. The chance is higher if you: Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers; stomach problems that last or come back, such as heartburn, upset stomach or stomach pain; ulcers; high blood pressure; taken a diuretic; bleeding problems; heart or kidney disease; reached age 60 or older.

Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID prescription or nonprescription ; taking a blood thinning anticoagulant or steroid drug; under a doctor's care for any serious condition; taking any other drug. Elimination of naproxen is decreased in patients with severe renal impairment.

Drug Interaction Studies Aspirin: The clinical significance of this interaction is not known. No evidence of tumorigenicity was found.

Mutagenesis Naproxen tested positive in the in vivo sister chromatid exchange assay for but was not mutagenic in the in vitro bacterial reverse mutation assay Ames test. There were no adverse effects on fertility noted up to 0. Clinical Studies Naproxen has been studied in patients with rheumatoid arthritis, osteoarthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, tendonitis and bursitis, and acute gout.

Improvement in patients treated for rheumatoid arthritis was demonstrated by a reduction in joint swelling, a reduction in duration of morning stiffness, a reduction in disease activity as assessed by both the investigator and patient, and by increased mobility as demonstrated by a reduction in walking time. Generally, response to naproxen has not been found to be dependent on age, sex, severity or duration of rheumatoid arthritis.

In patients with osteoarthritis, the therapeutic action of naproxen has been shown by a reduction in joint pain or tenderness, an increase in range of motion in knee joints, increased mobility as demonstrated by a reduction in walking time, and improvement in capacity to perform activities of daily living impaired by the disease.

Nineteen patients in the mg group terminated prematurely because of adverse events. Most of these adverse events were gastrointestinal events. In clinical studies in patients with rheumatoid arthritis, osteoarthritis, and polyarticular juvenile idiopathic arthritis, naproxen has been shown to be comparable to aspirin and indomethacin in controlling the aforementioned measures of disease activity, but the frequency and severity of the milder gastrointestinal adverse effects nausea, dyspepsia, heartburn and nervous system adverse effects tinnitus, dizziness, lightheadedness were less in naproxen-treated patients than in those treated with aspirin or indomethacin.

In patients with ankylosing spondylitis, naproxen has been shown to decrease night pain, morning stiffness and pain at rest. In double-blind studies the drug was shown to be as effective as aspirin, but with fewer side effects. In patients with acute gout, a favorable response to naproxen was shown by significant clearing of inflammatory changes e.

Naproxen has been studied in patients with mild to moderate pain secondary to postoperative, orthopedic, postpartum episiotomy and uterine contraction pain and dysmenorrhea. Onset of pain relief can begin within 1 hour in patients taking naproxen and within 30 minutes in patients taking naproxen sodium. Analgesic effect was shown by such measures as reduction of pain intensity scores, increase in pain relief scores, decrease in numbers of patients requiring additional analgesic medication, and delay in time to remedication.

The analgesic effect has been found to last for up to 12 hours. When added to the regimen of patients receiving gold salts, naproxen did result in greater improvement. Its use in combination with salicylates is not recommended because there is evidence that aspirin increases the rate of excretion of naproxen and data are inadequate to demonstrate that naproxen and aspirin produce greater improvement over that achieved with aspirin alone.

In addition, as with other NSAIDs, the combination may result in higher frequency of adverse events than demonstrated for either product alone. In 51Cr blood loss and gastroscopy studies with normal volunteers, daily administration of mg of naproxen sodium has been demonstrated to cause statistically significantly less gastric bleeding and erosion than mg of aspirin.

In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state. Seek emergency help if an anaphylactic reaction occurs. When NAPRELAN is used in patients with preexisting asthma without known aspirin sensitivity , monitor patients for changes in the signs and symptoms of asthma.

These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of NAPRELAN at the first appearance of skin rash or any other sign of hypersensitivity. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis.

Co-morbid conditions such as coagulation disorders, concomitant use of warfarin, other anticoagulants, antiplatelet agents e. Laboratory Monitoring Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically.

Patient Counseling Information Advise the patient to read the FDA-approved patient labeling Medication Guide that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with NAPRELAN and periodically during the course of ongoing therapy. Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia , melena , and hematemesis to their health care provider.

Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity e. Your doctor may give you a lower dose if you are older or have certain health problems. The usual dose for adults is from mg to mg per day. The usual dose for children over 5 years of age for juvenile arthritis is 11mg per kg bodyweight per day. Taking your medicine at the same time each day will have the best effect.

It will also help you remember when to take the tablets. Otherwise, take it as soon as you remember and then continue taking it as you would normally. Do not double a dose to make up for one you have missed. If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

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Therefore, 275mg with naproxen sodium is not recommended in these patients with advanced renal disease. Major Due to the thrombocytopenic effects of carmustine, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants, NSAIDs, naproxen sodium 275mg tablets, platelet inhibitors, including aspirin, naproxen sodium 275mg tablets, ASA, strontium chloride, and thrombolytic agents. This drug may make you dizzy or drowsy. Nonteratogenic Effects There is some evidence to suggest that tablet inhibitors of prostaglandin naproxen are used to delay preterm labor there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus and intracranial hemorrhage. Major Substantial increases in the plasma concentration of naproxen naproxen have been observed following concomitant tablet sodium probenecid. Major Mechlorethamine, nitrogen mustard is highly toxic and is associated with lymphocytopenia, granulocytopenia, and 275mg. Caution is naproxen sodium high doses are required and some adjustment of dosage may be required in elderly patients. Because elderly patients are more likely to have decreased renal tablet, care should be taken in dose selection, 275mg it may be useful to monitor renal function. Patients should be monitored for toxicity.

How Does Naproxen Work In The Body?

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