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.

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.

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.

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.

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.

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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July 24, 2007 -- An expert panel gave its OK for expanded use of the osteoporosis drug Evista Tuesday, telling the FDA that the drug appears effective in preventing some breast cancer.
If the agency follows the panel's advice, it would clear the way for the drug, also called raloxifene, to be legally sold as a cancer prevention agent to millions of women.
It would also position the drug as an alternative to the anti-estrogen drug tamoxifen, which has long been used to help fight breast cancer's return. In 1998, the FDA approved tamoxifen for use by women who hadn't had breast cancer but were at high risk of developing the disease.
Breast cancer is the second leading cause of cancer death among women, and about 40,500 American women will die from breast cancer in 2007, according to the American Cancer Society. About 13% of women are estimated to develop breast cancer in their lifetime, according to the National Cancer Institute.
"Postmenopausal women at high risk for invasive breast cancer, I think now should have a choice," says George Sledge, MD, a professor of medicine at Indiana University. Sledge is also a consultant for Eli Lilly & Co, the maker of Evista.
Experts voted 10-4, with one abstaining, to recommend that Lilly be allowed to market Evista's ability to cut the likelihood of breast cancer in postmenopausal women at high risk for tumors. A company study showed that raloxifene and tamoxifen are equally effective at reducing the risk of cancer in those women.
"I do believe raloxifene is effective in reducing breast cancer," says panelist Otis Brawley, MD, a professor of oncology at Emory University School of Medicine.
Close Decision
The panel voted 8 to 6, with one abstention, on whether Lilly should be allowed to promote Evista's possible cancer-fighting abilities to all postmenopausal women with osteoporosis.
Three studies filed by the company all showed that women who took Evista for up to five years developed fewer invasive breast cancers than women who took a placebo. But women who took the drug also had a higher risk of serious blood clots and fatal stroke.
An FDA analysis of the three studies was inconclusive as to whether Evista's potential benefits outweighed its risks. Agency officials said they were troubled because Lilly had not submitted any data showing whether women who take Evista actually live longer than those who don't.
"It is uncertain if the balance of benefits and risk factors for women at high risk is favorable because the magnitude of benefits is unknown," says Patricia Cortazar, MD, an FDA safety official.
Potential Risks
Several breast cancer advocacy groups opposed the approval. Carolina Hinestrosa, executive vice president of the Breast Cancer Coalition, says the government should boost efforts to find causes of breast cancer rather than approving drugs with relatively small benefits.
"Considering that most women will not develop breast cancer in their lifetimes ... taking raloxifene and tamoxifen as a risk reduction measure will be unnecessary for most," she says.
Some panelists urged the FDA to restrict the drug's marketing, particularly to keep it out of the hands of women at risk for cardiovascular disease. One panelist even suggested issuing a "black box" warning for Evista.
"There should be a strong effort to limit potential harm," says Curt D. Furburg, MD, a Wake Forest University professor of public health who voted to approve the new use for Evista.
Lilly paid $36 million in fines in 2005 after pleading guilty to illegally promoting Evista as a cancer-fighting drug. Critics said approving the new use for the drug would clear the way for the company to promote the drug with direct-to-consumer advertising.
Gwen Krivi, PhD, vice president of Lilly Research Laboratories, says the company will "continue working with the FDA to make this important option a reality for patients."

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