The Salina Journal from Salina, Kansas on October 20, 1996 · Page 56
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The Salina Journal from Salina, Kansas · Page 56

Salina, Kansas
Issue Date:
Sunday, October 20, 1996
Page 56
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NAPRELAN (naproxen sodium] COHTPOLLED-RELEABE TABLETS BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR THE PATIENT NAPREUN* (NAPflOXEN SODIUM) COHTHOUED-RELEASE TABLETS EQUIVALENT TO 375 MS AND 500 Mfi NAPROXEN This Summary describes when and how lo use Naprelan, a formulation of naproxen sodium. Please read il carefully. Contact your doctor if you have any questions. Only your doctor has the training necessary to weigh the benefits and risks of a prescription drug for you. USES OF NAPRELAN Naprelan is a nonsteroidal anti-inflammatory drug (NSAID) that is indicated for the treatment of rheumatoid arthritis, osteoarthritis, anky- losing spondylitis. tendinitis, bursitis, acute gout, and the management of mild to moderate pain and primary dysmenorrhea. WHEN NAPRELAN SHOULD NOT BE USED II you have had allergic reactions to prescription or to over-the-counter products containing aspirin, naproxen, or other NSAIDs. II you have a history ol angioedema, hives, bronchospastic reactivity (eg, asthma), hypotension, or nasal polyps associated with NSAIDs. Notify your doctor immediately if such symptoms occur during therapy and discontinue Naprelan. OTHER CONSIDERATIONS BEFORE USINQ NAPRELAN As with all NSAIDs. serious gastrointestinal (Gl) toxicity such as bleeding, ulceration, and perforation, can occur at any time, with or without warning symptoms. In patients observed in clinical trials with naproxen of several months to 2 years' duration, symptomatic upper Gl ulcers, gross bleeding, or perforation appear lo occur in approximately 1% of patients treated for 3 lo 6 months, and In about 2% lo 4% of patients treated for 1 year. Studies to date with all naproxen products failed to identify any subset of patients not at'risk of developing peplic ulceration and bleeding or any differences between various naproxen products in their likelihood to cause these events. Except for a history of serious Gl events and other risk factors associated with peptic ulcer disease, such as alcoholism, smoking, etc., no risk factors (eg, age, sex) have been associated with increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleed- Ing less well than other individuals and most spontaneous reports of fatal Gl events are In this population. In considering the use of relatively large doses (within the recommended dosage range), sufficient benefit should be anticipated lo offset the potential increased risk of Gl toxicity. PRECAUTIONS GENERAL NAPRELAN SHOULD NOT BE USED AT THE SAME TIME AS OTHER NAPROXEN PRODUCTS. Kidney Effects: There have been reports of acute inflammation of the kidney tissues, blood or protein in the urine, and occasionally degenerative kidney changes associated with naproxen-containing products and other NSAIDs. In patients already experiencing a decrease in kidney blood flow. NSAIDs may result in inadequate circulation through the kidney. Patients at greatest risk are those with impaired kidney function, heart failure, liver dysfunction, diuretic use, and the elderly. Liver Effects: As with other NSAIDs, borderline elevations of liver tests may occur in up to 15% of patients. These abnormalities may progress, may remain essentially unchanged, or may resolve with continued therapy. Severe liver reactions, including jaundice and fatal hepatitis, have been reported with naproxen and other NSAIDs but are rare. Fluid Retention and Edema (Swelling): Naprelan should be used with caution in patients with fluid retention, high blood pressure, or heart failure. INFORMATION FOR PATIENTS: Naprelan, like other drugs of its class, is not free of side effects. This formulation ol naproxen can cause discomfort and, rarely, there are more serious side effects, such as Gl bleeding, which may result in nospitalization and even fatal outcomes. Caution should be exercised when engaged in activities requiring alertness if you experience drowsiness, dizziness, depression, or a sensation of moving or moving objects during therapy with naproxen. DRUG INTERACTIONS: The use of NSAIOs in patients who are receiving ACE inhibitors (eg. caploprll, enalapril, lisinopril) may potenti- ate kidney disease states. Caution is advised when individuals receive the drug and a coumarln-type anticoagulant (eg, warfarin), hydantoin (eg, phenytoin), sulfonamida (eg, sulfisoxazole), or sullonylurea (some diabetic agents), because interactions have been seen with other nonsteroidal agents of this class. Naproxen and aspirin should not be taken together because the naproxen blood levels may be affected. Interactions with furosemlde, lithium, probenecid, propranolol, and other drugs of the same class (ie. beta-blockers) may also occur. Caution should be used if naproxen is administered with methotrexale. DRUG/LABORATORY TEST INTERACTIONS: If you are scheduled for any laboratory tests, tell your health care provider that you are taking Naprelan. Certain laboratory tests may be affected by Naprelan. CARCINOGENESIS: Naprelan, like most prescription drugs, was required to be tested in animals before it was marketed for human use. Often these tests are conducted with higher drug concentrations than recommended for humans. No evidence of cancer was demonstrated in any of these tests. Your doctor can tell you more about what the results of these tests mean. DURING PREGNANCY: There are no adequate and well-controlled studies in pregnant women. Therelore, Naprelan should be used during pregnancy only if clearly needed. NURSING MOTHERS: Naprelan should be avoided if you are breast-feeding. PEDIATRIC USE: No pediatric studies have been performed with Naprelan, thus safety of Naprelan in pediatric populations has not been established. SUE EFFECTS As with all drugs in this class, the frequency and severity of adverse events depends on several factors: the dose of the drug and duration of treatment; your age, sex, physical condition, and any concurrent medical diagnoses or individual risk factors. The most frequent side effects experienced in the Naprelan clinical trials were headache, Indigestion, and flu syndrome. Side effects that occurred in more than 1% of the patients studied are listed below. Body « • Whole — Back pain, pain, infection, fever, accidental Injury, weakness, chest pain, headache, flu syndrome. QMUoinUrtlnal — Nausea, diarrhea, constipation, abdominal pain, flatulence, inflammation of stomach membranes, vomiting, difficulty swallowing, indigestion. Htnwtotofllc — Anemia, small hemorrhagic spots in the skin. RMpbutory — Inflammation of the throat, nasal congestion, sinusitis, bronchitis, cough increased. Rwi*l — Urinary tract infection, inflammation of the bladder. D»rm«totoglc —Skin rash. Metabolic ind Nutrition — Swelling of the extremities, Increased blood sugar. Central Nervout 6y«t»m — Dizziness, tingling sensation of the skin, insomnia. CwflovMcuuir— Hypertension. MuwuloftoMal — leg cramps, muscle pain, joint pain, joint disorder, tendon disorder. Additional side effects, some of which may be considered serious, were reported: however, they occurred in less than 1% of the patients studied. These events are listed In the full prescribing information. Also see Warning* for information about gastrointestinal toxicity such as bleeding, ulceration, and perforation. OTHER INFORMATION Your doctor has prescribed this drug lor you and you alone. Do not give the drug to anyone else. Keep this drug and all drugs out of the reach of children. In case of overdose, call your doctor, hospital, or poison control center immediately. This Summary provides the most important information about NAPRELAN. If you want to read more, ask your doctor or pharmacist lo let you read the professional labeling. This Brief Summary for Olrect-to-Consumer Advertising is based on the current NAPRELAN Physician Insert Cl 4685-2. Revised February 15, 1996. WANA-1628 W WYETH-AYERST LABORATORIES 'hlladelphla, PA 19101 $ 1996. Wyeth-Ayergt Laboratories 71770 Continued from previous page racial harmony," explains Loren late, executive sports editor of the local daily, The News-Gazette, but "I don't think some fans care. They want to see points on the board." The Big Ten team's overall record under Tepper was a modest 2425-2 at press time. "We're going to be hired or fired" because of the record, he says. "I understand the ground rules." But that doesn't mean he's going to change. For Tepper, teaching young men to be tolerant, well-behaved, law-abiding citizens is a top priority. "What is far more important than won-loss records is what each individual takes away from the program," says former University of Colorado coach Bill McCartney, for whom Tepper was assistant head coach in the mid-'80s. "That's where Lou Tepper will score very high." Seniors on Topper's teams have an impressive graduation rate of 94 percent. Racial cliques are not evident, and the team has a low arrest record, compared to increasing numbers of players elsewhere. Tepper sends a "mission" statement to every athlete Illinois recruits for football. It details his objectives for his players, which include winning a championship, achieving "lofty academic goals," honoring the university with "exemplary behavior" and fostering a "family concept, where each member is treated with love and discipline." Players must sign the statement before they can join the team. At least four prospects (all white) have refused to sign and have not joined the team. That's not to say everyone buys into the concept initially. "I thought it was a line of crap," admits linebacker David James, from East St. Louis, 111. "But when I got here, I was surprised. He really meant it." "It brings the team closer together," says Chris Koerwitz, an offensive guard from Oshkosh, Wis. "It's not black people over here, white people over there," "I've learned to choke up on my golf swing and to appreciate Van Halen — a little," laughs James, who is black with a white roommate. "I taught him a little rap." Interracial parties, once a rarity, In school, Tepper felt like an outsider, a 'country bumpkin.' He vowed to make a professional statement'about how people should be treated/ are commonplace. And a few year- round black-white roommate bonds have formed. But is Tepper's program too high-minded to compete against today's "successful" teams? Tepper adamantly believes winners off the field can be winners on it, noting, "I don't see the conflict." "Lou Tepper stands for all the right things in college sports," says Illinois athletic director Ron Guenther, who has said Tepper will stay on as head coach at least through '97, when his contract expires. Battling prejudice has been a long-term goal for Tepper, who grew up in rural western Pennsylvania, outside Keystone, a community of 61 people, 31 of whom were kin. His dad was a janitor; his family lived on a pig and chicken farm. Because of his "corncob-rough" ways, students at the high school in town initially made him feel like an outsider. "It wasn't anything like what minorities go through every day," Tepper recalls. "It was more a feeling that I looked and dressed different, had a different culture. We were country bumpkins." He felt that way again at Rutgers University, until he met a young black woman, one of the few nonwhites at the New Jersey school. The isolation and racism she was subjected to "pulled at my heartstrings." A resolve to do something about it grew over the next 24 years as he climbed the ranks as an assistant coach for six different schools. "My wife and I told ourselves that if I ever got a top job, we'd make it reflect our views about how people should be treated," Tepper has said. The chance came in 1991 when he was named head coach. Shortly afterward, he unveiled his anti-prejudice game plan. These days, Tepper virtually lives at the university's football complex beneath stately Memorial Stadium. His days start before dawn and end around 10 p.m. Assistants say he works harder and longer than anybody else. Of course, he has to. That sign in the locker room reminds him daily of what he's up against. C3 Joe Bower last wrote tor USA WEEKEND about proper technique; for canoeing. 16 USA WEEKEND • Oct. 18-20, 1W6

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