Naprosyn Drug Uses

Naprosyn is indicated for the treatment of rheumatoid arthritis, osteoarthritis, juvenile arthritis, ankylosing spondylitis, tendonitis and bursitis, and acute gout. It is also indicated in the relief of mild to moderate pain, and for the treatment of primary dysmenorrhea. Naprosyn Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.

How Taken

Naprosyn comes as a regular tablet, an extended-release tablet, and a liquid to take by mouth. It usually is taken twice a day for arthritis, every 8 hours for gout, and once a day (extended-release tablets) or every 6-8 hours (regular tablets) as needed for pain. Naprosyn may cause an upset stomach. Take Naprosyn with food or milk.

Naprosyn Warnings/Precautions

Before taking this medication, tell your doctor if you have an allergy to aspirin or any other NSAIDs, have an ulcer or bleeding in your stomach, drink more than three alcoholic beverages a day, have liver disease, Have kidney disease, have a coagulation (bleeding) disorder, have congestive heart failure, have fluid retention, have heart disease, or have high blood pressure. You may not be able to take Naprosyn or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Naprosyn is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Naprosyn should not be taken late in pregnancy (the third trimester) because a similar drug is known to affect the baby's heart. Do not take Naprosyn without first talking to your doctor if you are pregnant. Naprosyn passes into breast milk and may affect a nursing infant. Do not take this medicine without first talking to your doctor if you are breast-feeding a baby.

Naprosyn Missed Dose

If you are taking Naprosyn on a regular schedule, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose. If you are taking Naprosyn as needed, take the missed dose if it is needed, then wait the recommended or prescribed amount of time before taking another dose.

Naprosyn Possible Side Effects

Contact your doctor if you experience blood in vomit or bloody, black, or tarry stools. These symptoms could indicate damage to the stomach or intestines, which could be dangerous. If you experience any of the following serious side effects, stop taking Naprosyn and seek medical treatment or contact your doctor immediately: an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); muscle cramps, numbness, or tingling; ulcers (open sores) in the mouth; rapid weight gain (fluid retention); seizures; decreased hearing or ringing in the ears; yellowing of your skin or eyes (jaundice); or abdominal cramping, heartburn, or indigestion. Other, less serious side effects may be more likely to occur. Continue to take Naprosyn and talk to your doctor if you experience dizziness or headache; nausea, diarrhea, or constipation; depression; fatigue or weakness; dry mouth; or irregular menstrual periods. Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Naprosyn Storage

Store Naprosyn suspension at room temperature; avoid excessive heat, above 40°C (104°F). Dispense in light-resistant container. Store Naprosyn tablets at room temperature and in well-closed containers; dispense in light-resistant container.

Naprosyn Overdose

Significant over dosage may be characterized by drowsiness, heartburn, indigestion, nausea or vomiting, seizures. If you ingest a large number of tablets or a large volume of suspension, accidentally or purposefully consult a doctor, an emergency room, or a poison control left for advice.

More Information

Avoid prolonged exposure to sunlight. Naprosyn may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable. Avoid alcohol or use it with moderation. If you drink more than three alcoholic beverages a day, Naprosyn may increase the risk of dangerous stomach bleeding. Talk to your doctor before taking Naprosyn if you drink more than 3 alcoholic beverages a day. Use caution when driving, operating machinery, or performing other hazardous activities. Naprosyn may cause dizziness. If you experience dizziness, avoid these activities. Many over-the-counter cough, cold, allergy, and pain medicines contain aspirin or other medicines similar to Naprosyn. Before taking any prescription or over-the-counter medicine, talk to your doctor and pharmacist.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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Even as Evista (raloxifene) reduced the risk of invasive breast cancer by 44%, compared with placebo, it had a significantly increased relative risk of thromboembolic events -- including fatal strokes -- according to a study of more than 10,000 postmenopausal women.
Evista was associated with a 49% increase in the relative risk of fatal stroke (P=0.05), Elizabeth Barrett-Connor, M.D., of the University of California San Diego and colleagues for the RUTH (Raloxifene Use for The Heart) trial reported in the July 13 issue of the New England Journal of Medicine.
Evista was also associated with a significant increase in risks of venous thromoboembolic events (P=0.02), but as expected Evista was associated with a significant decrease in risk of clinical vertebral fractures (P=0.007).
The 44% decrease in invasive breast cancer risk (P=0.003) among women taking Evista was driven by a highly significant reduction in estrogen-positive breast cancer (P<0.001). Evista did not reduce the risk of estrogen-negative breast cancers (P=0.40).
Women taking Evista also had significantly more hot flushes, leg cramps, and peripheral edema (P<0.001 for all compared with placebo), they wrote.
The RUTH investigators randomly assigned 10,101 postmenopausal women (mean age 67.5) with established coronary heart disease or multiple risk factors for heart disease to either 60 mg of Evista daily or placebo. The women were followed for a median of 5.6 years. The primary endpoints were coronary events and invasive breast cancer.
In this group of women at high risk for coronary events, "the difference in absolute rates of events that were decreased (i.e., breast cancer and clinical vertebral fractures) was similar to the difference in the absolute rates of events that were increased (i.e., venous thromboembolic events and fatal strokes)," the authors wrote.
And that may be the sticking point for many clinicians counseling women, said Steven Nissen, M.D., acting director of cardiology at the Cleveland Clinic.
"When a drug increases cardiovascular risk, we have to take that seriously," he said adding that Dr. Barrett-Connor and colleagues did an excellent job of "laying out the risks and benefits very clearly, with no spin."
Dr. Nissen, who was an early critic of Vioxx (rofecoxib) because of its increased risk of thromboembolic events, said that results of the RUTH trial are likely to spur debate if Lilly, the maker of Evista, seeks FDA approval for Evista for breast cancer prevention.
Currently the drug is approved for treatment and prevention of osteoporosis in postmenopausal women.
Earlier this year, results of the STAR (Study of Tamoxifen and Raloxifene) trial indicated that Evista is as effective as tamoxifen for preventing breast cancer in postmenopausal women. Tamoxifen is the only FDA approved drug for prevention of breast cancer.
Lilly said in June that it plans to ask the FDA to approve Evista for cancer prevention.
Evista and tamoxifen are both selective estrogen receptor modulators, or SERMs. SERMs were originally developed as alternatives to estrogen to treat symptoms of menopause as well as osteoporosis. But unlike estrogen, SERMs do not reduce vasomotor symptoms, although they have demonstrated efficacy in osteoporosis.
When the RUTH trial began recruiting women in 1998 it was widely believed that estrogen reduced the risk of coronary events, which led Dr. Barrett-Connor and colleagues to hypothesize that Evista would also be cardio-protective. But in 2002, investigators for the Women's Health Initiative reported that estrogen increased the risk of stroke and thromboembolic events, as well as increasing the risk of breast cancer.
The RUTH results "now allow us to say that all modulators of the estrogen receptors potentially increase the risk of cardiovascular events," said Dr. Nissen.
John T. Cole, M.D., medical director of hematology and oncology services at the Ochsner Health System in New Orleans, said that the RUTH findings coming on the heels of the STAR trial confirm that Evista has a role in chemoprevention in a select population -- but defining that population may be difficult.
Even so-called high risk women only have very small absolute risk for developing breast cancer, he said. "If you look at in terms of telling a woman that she has about a 98.4% chance of [not developing breast cancer], it is difficult to imagine her wanting chemoprevention," he said.
Nonetheless, Dr. Cole said that in both the RUTH trial and the STAR trial "as risk increased, so did the potential benefit of chemoprevention."
In an NEJM editorial, Marcia L. Stefanick, Ph.D., of the Stanford Prevention Research Center in Stanford, Calif., said the RUTH study "highlights the need to consider the risk of breast cancer as well as other risks and coexisting conditions in determining whether and when [Evista] or another SERM is warranted for an individual woman."
"For women represented by the RUTH cohort of women with or at increased risk for CHD, the moderate benefits of raloxifene for breast cancer prophylaxis do not seem to justify the risks" she wrote.
"For now," Dr. Stefanick continued, "there is no magic bullet that can reduce the risks of major health problems related to estrogens and aging without introducing other potentially serious health concerns."

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