The Salina Journal from Salina, Kansas on October 27, 1996 · Page 56
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The Salina Journal from Salina, Kansas · Page 56

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Salina, Kansas
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Sunday, October 27, 1996
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Page 56
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NAPRELAN (naproxen sodium] CONTROLLED-PELEASE TABLETS BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR THE PATIENT HAPRELMP (NAPflOXEN SODIUM) CONTROUED-RELEASE TABLETS EQUIVALENT TO 375 MG AND 500 MO NAPROXEN This Summary describes when and how to use Naprelan, a formulation of naproxen sodium. Please read it 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. USESOFNAPREUN 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 HAFDELAN SHOULD NOT BE USED II you have had allergic reactions to prescription or to over-the^ounter products containing aspirin, naproxen, or other NSAIDs. It you have a history ot 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 USINO 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. I In patients observed In clinical trials with naproxen of several months to 2 years' duration, symptomatic upper Gl ulcers, gross [ bleeding, or perforation appear to occur in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 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 peptic ulceration and bleeding or any differences between various naproxen products in their likelihood to cause these events. Except for a history ol 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 bleeding 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 to offset Ihe potential increased I risk of Gl toxicity. PRECAUTIONS GENERAL NAPRELAN SHOULD NOT BE USED AT THE SAME TIME AS OTHER NAPROXEN PRODUCTS. I Kidney Effects: There have been reports of acute inflammation of the kidney tissues, blood or protein in the urine, and occasionally degen- I erative kidney changes associated with naproxen-containlng products and other NSAIDs. In patients already experiencing a decrease in I kidney blood flow, NSAIDs may result in inadequate circulation through the kidney. Patients at greatest risk are those with impaired kid- I ney function, heart failure, liver dysfunction, diuretic use, and the elderly. I Uver Effects. As with other NSAIDs, borderline elevations of liver tests may occur In up to 15% of patients. These abnormalities may I progress, may remain essentially unchanged, or may resolve with continued therapy. Severe liver reactions, including jaundice and I fatal hepatitis, have been reported with naproxen and other NSAIDs but are rare. I Fluid Retention and Edema (Swelling): Naprelan should be used with caution in patients with fluid retention, high blood pressure, or I heart failure. I INFORMATION FOR PATIENTS Naprelan, like other drugs of its class, is not free of side effects. This formulation of naproxen can cause I discomfort and, rarely, there are more serious side effects, such as Gl bleeding, which may result in hospitalization and even fatal out- I comes. I Caution should be exercised when engaged in activities requiring alertness if you experience drowsiness, dizziness, depression, or I a sensation of moving or moving objects during therapy with naproxen. I DRUG INTERACTIONS: The use ol NSAIDs in patients who are receiving ACE inhibitors (eg, captopril, enalapril, lisinopril) may potent!I ate kidney disease slates. Caution is advised when individuals receive the drug and a coumarin-type anticoagulant (eg, warfarin), I hydantoin (eg, phenytoin), sullonamide (eg, sullisoxazole), or sulfonylurea (some diabetic agents), because interactions have been I seen with other nonsteroidal agents of this class. I Naproxen and aspirin should not be taken together because the naproxen blood levels may be affected. Interactions with I furosemide. lithium, probenecid, propranolol, and other drugs of Ihe same class (ie, bela-blockers) may also occur. Caution should I be used if naproxen is administered with melholrexate. I DRUG/LABORATORY TEST INTERACTIONS: If you are scheduled for any laboratory tests, tell your health care provider that you are tak- I ing Naprelan. Certain laboratory tests may be affected by Naprelan. I CAHCINOGENESIS: Naprelan, like most prescription drugs, was required to be tested in animals before it was marketed for human I use. Often these tests are conducted with higher drug concentrations than recommended lor humans. No evidence of cancer was I demonstrated in any ol these tests. Your doctor can tell you more about what the results of these tests mean. I DURING PREGNANCY: There are no adequate and well-controlled studies in pregnant women. Therefore, Naprelan should be used I during pregnancy only if clearly needed. I NURSING MOTHERS: Naprelan should be avoided if you are breast-feeding. I PEDIATRIC USE: No pediatric studies have been performed with Naprelan, thus safety of Naprelan in pedlatric populations I has not been established I SIDE EFFECTS I As with all drugs in this class, the frequency and severity of adverse events depends on several factors: the dose ol the drug and dura- I tion of treatment: your age. sex, physical condition, and any concurrent medical diagnoses or individual risk factors. The most frequent I side effects experienced in the Naprelan clinical trials were headache, indigestion, and flu syndrome. Side effects that occurred in more I man 1% of the patients studied are listed below. Body a* • Whoto — Back pain, pain, infection, fever, accidental injury, weakness, I chest pain, headache, flu syndrome. Ga«trolnt**tln*l — Nausea, diarrhea, constipation, abdominal pain, flatulence. Inflammation of I stomach membranes, vomiting, difficulty swallowing, indigestion. Hwiwtotogip — Anemia, small hamorrhaglc spots in the skin. I RMplntoiy — Inflammation ol the throat, nasal congestion, sinusitis, bronchitis, cough increased. FUntl — Urinary tract infection, I inflammation of the bladder. Of mwtologlc —Skin rash. IfMjtfwUc »nd Nutrition —Swelling of the extremities, increased blood I Cwrtral N«rvou» 8y«t»m — Dizziness, tingling sensation of the skin, insomnia. CardtoVMCuUr — Hypertension. Mm I Leg cramps, muscle pain, joint pain, joint disorder, tendon disorder. I Additional side effects, some of which may be considered serious, were reported; however, they occurred in less than 1% ol the • patients studied. These events are listed in the full prescribing information. Also see Warnings for information about gastrointestinal I toxicily such as bleeding, ulcerallon, and perforation. I OTHER INFORMATION I Your doctor has prescribed this drug lor you and you alone. Do not give the drug to anyone else. I Keep this drug and all drugs out of the reach of children. In case of overdose, call your doctor, hospital, or poison control center I immediately. I This Summary provides the most important information about NAPRELAN. It you want to read more, ask your doctor or pharmacist I to let you read the professional labeling. I This Brief Summary for Direct-to-Consumer Advertising is based on the current NAPHEUAN Physician Insert Cl 4685-2. Revised I February 15.1996. WAN A-1628 W WYETH-AYEBST LABORATORIES >hilad«lphta, PA 19101 © 1996. Wyeth-Ayerst Laboratories THE books This week's diverse crop of photo books: • The Table (RANDOM HOUSE, $40), by Diane Von Furstenberg. The Vanity Fair contributing editor, whose previous books were on beds and baths, examines her friends' tables: how they're set, their location and their meaning in creating community. Of course, the handsome book looks good on the table. • Naked Babies (PENGUIN STUDIO, $24.95), by writer Anna Quindlen and photographer Nick Kelsh. That's right, naked babies. Kelsh's photography is stunning; Quindlen writes about •n i naKca babies AnruQuinjk-n 6-NirkKash New photo books the miracle and development of the littlest people. • Tlie Cats' House (ANDREWS AND MCMEEL, $19.95), by Bob Walker. A husband and wife design their house to accommodate their nine felines. For instance, there is an overhead cat walkway held up by a scratching post. • The White T (HARPERCOLLINS, $45), by Alice Harris. The history of a U.S. original now worn by billions, from the first Hanes shirt sold for 24 cents in the 1930s. Full of photos of famous people wearing theirs. Hallow • Showman Harry Houdini died 70 Halloweens ago, and the occasion is marked by a new video, Houdini, and book, Houdini.'.' The Career of Ehrich Weiss (HARPER- COLLINS, $35). A bad appendix killed him, but some fans hold seances, believing death is one more trap he'll escape. • In case you're turned down for treats, pick up some tricks from Satan's Little Instruction Book (MAIN STREET, $6.95), a new spoof. Among other "devilisms," Carmine DeSena advises parents to "tell each sibling the other is your favorite" and teachers to "place short students in the back." tv Would you kiss a pig? Sing Amazing Grace to a crowd of strangers? Well, if you were running for public office you might, and that's just what some local candidates do in Vote for Me: Politics in America, airing on PBS stations Monday and Tuesday (9 p.m. ET). The packaging of candidates from sea to shining sea is the subject of the series, and in case you aren't cynical enough about politics, you'll thrill to statements like this one from a New York media consultant: "Negative advertising is like pornography. People say they hate it, but they look." aliens wild action with e 71770 By Myron B. Pitt* Send comments to "The Week,' 1000 Wilson Blvd., Arlington, \fe. 22229-0012; e-mail: Umr8ek@usaweekend.com I USA WEEKEND • Oct. 25-27. 1996

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