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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Many of us have been jaded by the constant onslaught of “the latest” medical news, much of which seems to contradict what we just heard or read about the week before.
But on July 9, millions of us – patients and health care providers alike – paid rapt attention when the federal government’s National Institutes of Health released findings from a major clinical trial, warning of the risks associated with a widely used type of hormone replacement therapy (HRT) that combines two female hormones, estrogen and progestin.
It’s estimated that 6 million postmenopausal American women currently take Prempro or similar combined estrogen-progestin drugs to ease menopause symptoms and to improve their health and well-being.
Risks Outweigh Benefit, Study Found
The study, called the Women’s Health Initiative (WHI), found that the combined drugs caused increases in breast cancer, heart attacks, strokes and blood clots. Although the risk to an individual woman may be small, the number of cases occurring in the population at large can be great, researchers said. And those risks outweigh the drugs' actual benefits – a small decrease in hip fractures and a decrease in cases of colorectal cancer. The study was released four years earlier than expected because of researchers’ concerns.
The WHI study is the first-ever long-term randomized controlled clinical trial – considered the gold standard by medical researchers – of hormone replacement therapy. The WHI was established in 1991 by the government to address the most common causes of death, disability and impaired quality of life in postmenopausal women. The Medical College of Wisconsin is one of 40 WHI clinical sites nationwide where study participants are seen and monitored.
The Women’s Health Initiative is a 15-year multimillion-dollar endeavor, and one of the largest US prevention studies of its kind. The study was designed to look at the effects not only of HRT, but also diet modification and vitamin and mineral supplements. Some 67,000 women from across the country, ranging in age from 50 to 79, are participating in the WHI clinical trials. In addition to those women, the study is also following the medical history and health habits of an additional 100,000 women to examine the relationship between lifestyle, health and risk factors with specific disease outcomes. Final results are due out in 2006.
More than 16,600 US women are participating in the combined estrogen-progestin portion of the trial, among them 438 women who are in the Medical College of Wisconsin group. They were sent letters telling them to discontinue taking those drugs. The WHI is continuing to study the effects of ERT, or estrogen-alone drugs, used by women who have had a hysterectomy. WHI has not stopped that portion of the study.
Jane Morley Kotchen, MD, Professor and Director of Epidemiology at MCW, is the principal investigator for MCW’s portion of the study. She admits she was caught by surprise by the early release.
"The breast cancer risks for women on the combined estrogen-progestin therapy are similar to risks that have been found in other studies,” she notes, although she says the cardiovascular findings were not anticipated. “A decreased risk of coronary heart disease had been hypothesized for women on active hormone therapy, so the finding of slightly greater risks for women on the active hormone therapy was unexpected. Overall, the health risks for women taking combined estrogen plus progestin therapy were found to outweigh the benefits. The trial was stopped because the risk-benefit balance, as indicated by a global indicator of overall risk, was unfavorable and the breast cancer risks crossed the predetermined safety boundaries."
The WHI’s Data and Safety Monitoring Board – an independent advisory committee charged with reviewing results and ensuring participant safety – set the limits of acceptable risk for breast cancer at an unusually low level of cases per thousand. When that level was reached, the trial was stopped and results were released early.
Another Medical College faculty member who served as a WHI investigator agreed that the early release of the findings was surprising. For Vanessa Barnabei, MD, PhD, the medical risks and benefits that caused such a national media furor when the WHI released its combined estrogen-progestin study results had been indicated by earlier patient studies, although earlier studies were regarded as “observational,” and had not met the strict standards of the WHI. Dr. Barnabei is an Associate Professor of Obstetrics and Gynecology at MCW and Director of MCW Physicians’ Division of General Obstetrics and Gynecology.
"Early harm from heart disease and stroke were suggested several years ago, and women in the study were informed about it at that time,” Dr. Barnabei says. “And the breast cancer risks have been suspected. The numbers and magnitude of risk are no different today than they were then.
Risk ‘Relatively Small’ for Individual Women
In a news release from the NIH on July 9, Jacques Rossouw, MD, acting director of the WHI, summarized the risk findings:
"The WHI results tell us that during one year, among 10,000 postmenopausal women with a uterus [as opposed to those who have had their uterus removed] who are taking estrogen plus progestin, eight more will have invasive breast cancer, seven more will have a heart attack, eight more will have a stroke, and 18 more will have blood clots, including eight with blood clots in the lungs, than will a similar group of 10,000 women not taking these hormones. This is a relatively small annual increase in risk for an individual woman,” he said.
Dr. Barnabei said that she found it interesting that the WHI has continued with the estrogen-only portion of the study. She says scientists have known that progestin can act to influence breast growth and development while reducing the risk of uterine cancer. And an article in the January 26, 2000, Journal of the American Medical Association reported that researchers at the National Cancer Institute had found that women who are current or recent users of combined estrogen and progestin had a higher relative risk of breast cancer than women who only take estrogen.
What Patients Should Know
Dr. Rossouw, the acting WHI director, offered this advice: “Women with a uterus who are currently taking estrogen plus progestin should have a serious talk with their doctors to see if they should continue it. If they are taking this hormone combination for short-term relief of symptoms, it may be reasonable to continue, since the benefits are likely to outweigh the risks. Longer term use or use for disease prevention must be re-evaluated, given the multiple adverse effects noted in WHI."
Dr. Barnabei says she always cautions patients about the potential for increased breast cancer risks. First, she rules out women who are not candidates for HRT– those with vaginal bleeding of an unknown cause, suspected breast cancer or history of breast cancer, history of endometrial cancer or certain cancers of the uterus, chronic liver disease such as cirrhosis or a history of blood clots.
For women who are eligible for HRT, the primary reason for HRT is symptom relief, she says, with less emphasis on using hormone therapy for disease prevention: “I explain the known risks and benefits. And I do remind them that the risk for breast cancer does increase naturally for all women as they age, along with heart disease and osteoporosis."
Dr. Barnabei tells her patients who want to stop HRT that they can certainly quit anytime. “First of all, with menopause, we’re not treating a disease,” she says. “Stopping HRT has no major consequences except perhaps a return of menopausal symptoms.”

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