The Baytown Sun (Baytown, Tex.), Vol. 75, No. 55, Ed. 1 Sunday, January 5, 1997 Page: 35 of 54
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YOUR QUESTIONS
(naproxen sodium]
C O SITAOLLEn-IIE LEASE TABLETS
wsiiHumw^»Mtw<MHmoaFainEMnaT
umbjw* (Mno» neut) cam«iHwaH« resins
aunKar to sn k mo hm ng mhtoxbi
This Summary describes when and how to use Naprelan, a formulation of naproxen sodium. Please read it carefuSy. Contact your
doctor if you haw any questions. Only your doctor has the training necessary to weigh the benefits and risks of a prescription drug
lor you.
osireraM
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.
OHB MfflHM SHOULD GOT K WHI
If you have had allergic reactions to prescription or to over-the-counter products containing aspirin, naproxen, or other NSAIDs
If you have a history of angtoedema 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.
ana COO&KMnM l&ORE ilMG OIIHiaM
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, a 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 prodxts 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 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 debkitated patients seem to tolerate ulceration or Heed-
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 to offset the potential increased
risk of Gl toxicity.
FttEotmaB
GENERAL
IMNBM MHU M>T K UEOIR THE (ME TIC M 9TIB fUHKBB HVMCn.
Kxtoey Btects There have been reports of acute inflammation of the kidney tissues, blood a protein in the urine, and occasionally degen-
erative kidney changes associated with naproxen-contarmg products and other NSAIDs. In patients already experiencing a decrease in
kidney blood low. NSAIDs may result in inadequate circUabon through the kidney. Patients at greatest risk are those with impaired kid-
ney function, heart failure, liver dysfunction, diuretic use. and the elderly
Dver Elfeds. As with other NSAIDs. borderimeeleva'jons of liver tests may occur in up to 15% of patents 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.
Raid Retention and Edema (Swelling): Naprelan should be used with caution in patients with fluid retention, high Mood pressure, or
heart failure.
INFORMATION FOR PATIENTS: Naprelan. like other drugs of its dass is not free of Side effects This formulation of naproxen can cause
discomfort and. rarely, there are more serious side effects, such as Gl breeding, whfoh may result in hospitalization and even faal out-
comes.
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 NSAIDs in patens who are receiving ACE inhibitors (eg, captopril, enalapril, lisinopril) may potent-
ate kidney disease states. Caulion is advised when individuals receive the drug and a coumarin-type anticoagulant (eg, warfarin),
hydantoin (eg. phenytoin), sulfonamide (eg. sulfisoxazole), or sulfonylurea (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
iurosemde. 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 methotrexate.
DRUGLABORATORY TEST INTERACTIONS: If you are scheduled for any laboratory tests, tell your health care provider that you are lak-
ing Naprelan Certain laboratory tests may be aflecled by Naprelan
CARCINOGENESIS: Naprelan, like most prescription drugs, was required to be rested 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 rests. Tour doctor can M you more about what the results of these tests mean.
DURING pregnancy There are no adequate and wek-controBed studies in pregnant women. Therefore. Naprelan should be used
during pregnancy only it dearly 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 estabtshed.
As wHi al drugs h this dass. the frequency and severity of adverse events depends on several factors: the dose of tie drug and An-
Son of leatment yore age, sex. physical condition, and any concurent medical diagnoses or individual risk factors. The most frequent
side effects experienced in the Naprelan ctefaal trials were headache, indigestion, and flu syndrome. Side effects that occurred in more
than 1% of Pie patients sluded are Ssled below. Body « a Whde - Back pain, pam. rtection, fever acodertal iryury, weakness,
chest pan. headache. Hu syndrome. teNMM - Nausea, darrhee. constipation, abdominal pain. MMance. inflammation of
saxnach membranes, vomiting. dfficdty swafcwnq. indigestion. IlisalaUglr - Anemia, smal hemonhagfo spots n the akm.
Raedratory — Wamfrsaon of Vb trvoat nasal congest™, snusits. Wontiiitis. cough increased Renaf - Urxrery tract infection,
■nftarmafonofthebladde' Denweldngfc-Skin rate. MaMcandMMIon-Swelling of the exSemites, increased blood sugar.
CcaMMneaSydM-Deznesstingingsensationoflheskin,raom-u Casdreuoeoter-Hypertension Muii'uxiiWste -
Lag cramps, muscle pein, font pain, join disorder, tendon teortw.
Addlionai ade effects, some of whtch may be oonstderad aerious, were reported: Ixwever. they occurred in less than 1% of the
paw* texted These events are kstedxi me lull prescrforg information. Also see Wirings for Womeson about gaatoHestinal
toxicity such as breeding, iteration and perforation.
ytxrdocscrrw prescribed ns dug far you and you atone. Do not gw the drug to anyone ese
Keep fore drug ted aidrugs out ol the reach of cMdren In case of overdose cM yow doctor, hospital, or poaon consol carter
"’nSsumrrwy provides tie most important riormeOon about NAPRELAN « you want to read more, ask yxxz doctor a pharmacat
® ?^B5f&Ate^to0iaa»Cmeinw Adverasmg is baaed on lhe current NAPRELAN Physcan Insert 0 4685-2 Revised
February >5-19®
WANA-1628
717TOO1
ARE BODY CLOCKS SET FROM
BIRTH? I’m a morning person. Are
biological clocks determined from birth?
Richard LKissick
TrvwrviA lilvudv
lacoma, wash.
There really are
“night people”
(owls) and “morn-
ing people” (larks),
and they’re that
way most of their
lives. The Owi/Lark Questionnaire,
created about 10 years ago, tries to
identify larks and owls and predict
who might function better at certain
times. Also, our circadian rhythm
affects our alertness throughout the
day. Finally, as we age we become
more morning people and less night
people because we “phase advance,”
which means we go to bed earlier and
wake up earlier as our internal clock
increases speed. Expert Thomas Roth
HOW CAN TEENS
CURE BISOMMA?
I'm 15 and cart sleep,
no matter how tired I
am. Is it because I'm
a teenager? Is there a
safe drug I could take?
Barbara McManus Dublin, Calif.
It’s important to figure out why you
can’t sleep. Any emotional arousal,
worry or fear can interfere with fall-
ing asleep. Also, many teenagers
get more caffeine than they realize,
in sodas, tea and coffee; caffeine
can keep you awake. Medications
often help in the short run but can
cause problems later on. If insom-
nia really interferes with your life,
see a doctor. Fatigue causes prob-
lems with learning, memory and
handling emotions — critical stuff
fora 15-year-old. Expert Bonaid Dart
DO YOU LIVE LONGER HF YOU
SLEEP MORE? I'm 59, married and
have a high-stress job. I’ve always been a
poor sleeper, averaging three to four hours
a night Otherwise fm healthy. Does lack
of steep shorten life?
Joyce A Rhinehart, Chillicothe, Ohio
Some studies indicate that people
who sleep either a very long or very
short time have a higher mortality
rate. But those
studies didn’t eval- |
uate the presence By*' ■-'ji
of other conditions,
such as chronic ill-
nesses. Increasing WggFgMM
amounts of evi- 9
deuce suggest that
there are long-term health conse-
quences to sleep disorders. Right
now, the duration of your life
should not be your only concern.
Quality of life is important If you
believe the kind of sleep you’re get-
ting is poor, you should see a spe-
cialist Expat David Din&s
CAN YOU WORK THE
NIGHT SHIFT ALL WEEK AND
HAVE NORMAL WEEKENDS?
How should I mate the transition from
sleeping during the day to sleeping at nigit
on my days off?
Janice Woodruff, Redfield, S.D.
Change your bedtime by just five
or six hours, rather than nine or
10. If, for example, you go to bed
at 8 a.m. and get up at 3 p.m. dur-
ing the workweek, don’t make an
abrupt transition and go to bed at
10 p.m. and get up at 5 or 6 a.m. on
weekends. After the last night shift,
you should go home, sleep two or
three hours, get up by noon and
then begin your day-oriented life.
Expert James Mfelsh
RJchardP.AAcn, assistant professor of neu- staff physician and senior research associate,
robgy, Johns Hopkins University, Baltimore; Stanford University Sleep Disorder Center,
David Binges, chief, division of Sleep and Stanford, Calif.; Mark MahowaH, director.
Chronobiology, University of Pennsylvania, Minnesota Regional Steep Disorder Center
Philadelphia; Ronald DtN, associate pro- at Hennepin County Medical Center, Minne-
fesorof psychiatry and pediatrics, University apolis; ttavW N. Neubauw, associate direc-
of Pittsbutfi Medical Center; Rfta Dwyer, tor, Johns Hopkins Sleep Disorders Center,
eieafove officer, Internationa! Association Baltimore; Rafael Pelayo, head of the pedi-
forthe Study of Dreams, Vienna, Va.; Ernest atrc steep service, Stanford University Sleep
Hartmann, director, Sleep Disorders Center Disorder Center, Stanford, Calif.; Thomas
at Newton Wefresiey Hospital, Newton, Mass., Roth, chief of Sleep Medicine, Henry Ford
and professor of Psychiatry at Tufts University Hospital, Detroit; Arthur Strauss, former
School of Medicine, Boston; Gary Kaplan, president, Steep Disorders Dental Society,
president, Medical Acupuncture Research Fate Church, Va.; Mrchaei Thorjy, director,
Foundation, UsAngetes; Ned Kavey.dtrectix, Sleep Disorder Center, Montefiore Hospital,
SeepDtsordere Center; Cokjn*e4>restjytenan Bronx, N.Y; James Walsh, director of Sleep
Medial Center, New fork Qty; CMeKushida, Medicine and Research Center, St Louts.
S USA WEEKEND • Am. 3-J,/W7
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Dobbs, Gary. The Baytown Sun (Baytown, Tex.), Vol. 75, No. 55, Ed. 1 Sunday, January 5, 1997, newspaper, January 5, 1997; Baytown, Texas. (https://texashistory.unt.edu/ark:/67531/metapth1176791/m1/35/: accessed July 18, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu.; crediting Sterling Municipal Library.