6
TUESDAY, NOVEMBER 23, 2004
UNC falls despite Beaver’s play
Team unlikely to
make postseason
BY ANDY WALES
STAFF WRITER
The postseason hopes of the
North Carolina volleyball team
likely ended in the ACC champi
onship match Sunday.
In that match, the Thr Heels fell
to seventh-seeded Maryland in
three games 30-24,30-24,30-17.
The team was unable to con
tinue the excellent play it used to
dispatch Florida State on Friday
and Clemson on Saturday, both in
THE Daily Crossword By Gerald R. Ferguson
65 Merit
66 Pop up
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68 Bus. sch. course
69 Adhesive mixture
70 Highland loch
71 Ownership document
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ORTHO EVRA®
(NORELGESTROMIN / ETHINYL ESTRADIOL
TRANSDERMAL SYSTEM)
PtfMsshotrid bo counseled ttwt this product doot not protect agorot HlVinfec-
Son (AIDS) id oiier aocuxßy tiansnwttod Ikiki,
only
ORTHO EVRA* Is a combination transdermal contraceptive patch with a contact sulace area
ot 20 cm 2. It contorts 6.00 mg norelgestromrt and 0.75 mg ethinyl estradiol (EE), and releases
150 micrograms ot notelgestromin and 20 mbrograms of E£ to the bloodstream per 24hours.
IMPORTANT NOTE - This Information la a BRIEF SUMMARY ot the complete prescribing
Information prodded wHh the product and therefore should not be used ae tie bans (of
prescribing the product This summary wa a prepared by deleting Iran the complete pre
ecriblnßlnfarmatlon certain text tables and retorenoee. The phyeWan shouldbe thorougWy
temllliriiibh the complete presatimßmionmtlonbeoce prescribing the product
NOKXTtONS AND USAGE ORTHO EVRA* is indicated tor the prevention ot pregnancy.
Lke oral contraceptives, ORTHO EWA* s higtity effective I used as recommended in this label.
ORTHO £WA* beeneOeen Netted Air tnik net mmuM Her nee bi swan-cy
CONTRAMHCADONSc ORTHO EVRA* should not be used it women who currently have the
folowtig conditions: 1. Thrombophlebitis, thromboembolic disorders 2. A pest history ot deep
veil thrombophlebitis or thromboembolic disorders 3. Cerebrovascular or coronary artary
disease (airent or pest history) 4. Valvular heart dbease wtti complications 5. Severs hyper
tension 6. Diabetes with vascular hvobement 7. Headaches with focal necrological symptoms
3 Major sirgety wlh prolonged immabillzaticn 9. Known or suspected carctwma of the breast
or pereoral history of bresst cancer 10. Carciioma of the endometrium or other known or
abnormal genial ljteedrtgl2.Choteetetic
jaundice ot prepiancy or jaundice with prior hormonal contraceptive use 13 Acute or chronic
hepatocellular disease with abnormal liver function 14. Hepatic adenomas or carcinomas
15. known or suspected pregnancy 16. Hyperssnstvty to any component ot this predict
WARNiWS
Cigarette smoking Ineiwases the risk or
smoking (15 or more cigarettes per day) and Is quits merited In women
osar 36 vents of ege. Women who um hormonal contraceplvee, Including
ORTHO EVRA*, shook! be atronjly advised not to smoke.
ORTHO EVRA* and other contraceptives that contaii both an estrogen and a progestin are
called combination hormonal contraceptives. There is no epidemiologic data available to
determine whether safety and efficacy wih the transdermal route ot admhtelration would be
different than the oral route. Practitkrors prescribiig ORTHO EVRA* should be famiiar with
the followiig information relating to risks.
The use ot combination hormonal contraceptives Is assockted wiltt increased risks ot several
serious conditions including myocardial infarction, thromboembolism, stroke, hepatic
neoplasia, and galUadder disease, althatfi the risk ot serious morbidity or mortally Is very
small b healthy women without underlying risk factors. The risk ot mutiny and mortality
Increases significantly In the presence ot ether undertyng risk factors such as hypertension,
hyperlpidemias. obesity and diabetes
The Herniation contahed In the package Insert is principally based on studies carried out in
women who used combination oral contraceptives with higher formulations of estrogens and
progestine than those In common use today. The effect of long-tetm use ot combination
hormonal contraceptives wilh lower doses ot both estrogen and progestin adm h stared by any
route remans to be determined.
ThroutfHut this labeing, epidemiological studies reported are ot two types: retrospective or
case control studies and prospective or cohort studies. Case control studies provide a meas
les of the relative risk ot a disease, namely, a ratio of the Incidence ot a disease among oral
contraceptive users to that among nonusers. The relative risk does not provide information
on the actual dnical occurence ot a disease. Cohort studies provide a measure ot attributa
ble risk, vWtlch is the cNTerence n the incidence ot disease between hormonal contraceptive
users and nonusers. The attributable risk does pro/ide information about the actual occu
rence ot a disease in the population (adapted !romrefs.2and3withthe author’s permission).
For kflher information, the reader Is referred to a text on epidemiological methods.
1. Thrombosmbolc Disorders And Other Vaecular Problem* a. Thromboamtxtitm: An
increased risk ot thromboembolic and thrombotic disease associated with the use of humoral
contraceptives Is well established. Case control studies have faind the relative risk of users
compered to nonusers to be 3 for the first episode of superficial venous thrombosis, 4 to 11
for deep vest thrombosis or pulmonary embolism, and 1.5 to 6 tor women wth predisposing
conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to
be somewhat lower, about 3 for new cases and about 4.5 for new cases requtttg hosptaltza
tkm. The risk of thromboembolic disease associated wih hormonal contraceptives Is not
retried to length ot use and disappears after hormonal contraceptive use Is stopped. Atwo- to
tour-fold increase h relative risk of post-operative thromboembolic complications has been
reported with (he use of hormonal contraceptsres. The relative risk of venous thrombosis In
women who have predisposing cond lions is twice that of women without such medical con
ditions. It feasible, hormonal contraceptives should be discontinued at least fou weeks prior
to and for two weeks after elective surgery of a type associated wHh an no ease h risk (X
thromboembolism and dung and following prolonged immobiiarikn. Since the Immediate
postpartum period Is also associated wih an naeased risk of thromboembolism, hormonal
contraceptives should be started no earlier than tou weeks after dslkmy h women who elect
not to breest-teed. In the large clinical triak(N= 3,330 with 1,704 women-years of e*eue),
one case of non-fatal puknenary embolism occured duing ORTHO EVRA® use, and one case
of post-operative non-fatal pulmonary embolism was reported following ORTHO EVRA® use. I
Is unknown If the risk ot venous thromboembolism with ORTHO EVRA® use Is dilerent than
win use ot combrtation oral contraceptives. As with any combination humeral contracep
tives, the clinician should be alert to the eariest manifestations ot thrombotic disorders (throm
bophlebitis, pulmonary embolism, ceretrovascular disorders, and retrial thrombosis). Should
any of those occur or be suspected, ORTHO EVRA® should be discontinued immediately,
b. Myocartflal Infarction: An hcreased risk of myocardial Infarction has bsan attributed to
hormonal contraceptive use. This risk Is primarily h smokers or women wlh <4her undertyng
risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid
obesity, and diabetes. The relatNe risk of heart attack fu curent hormonal contraceptive usets
has been estimated to be two to sk compared to non-usere. The risk k very low utder the age
ot 30. Smoking in combhatlon with oral contraceptive use has been shown to contribute sub
stantially to the stddence of myocardial infarctions at women at their mid-thirties u older wlh
smokng accounting for the majulty ot excess cases. Mortality rates associated with circula
tory disease have been shown to mease subetantialy in smokers, especialy it those 35 years
of age and older among women who use oral oontraceptkres. Humoral contraceptkies may
compotixt (he effects ot well-known risk factors, such as hypertension, diabetes, hyperß)l
-demias, age and obesly. it particular, some progestiis are known to decease HDL choles
terol and cause glucose ntoierance, while estrogens may uaate a state of hyperinsulnism.
Hormonal contraceptives have been shown to hcreese blood pressure among some users (see
Section 9 In WARNINGS). Sim lar effects on risk factors have been associated with an increased
rMs of heart disease. Hormonal contraceptives, nctudng ORTHO EVRA®, must be used wtti
caution In women with cardiovascular disease rkk factors. Norgestimate and noratoestromn
have mhimal androgenic activity (see CUNCAL PHARMACOLOGY in ful Presaibrtg rttormabon)
There Is some evidence that the risk of myocardial inlirction associated with hormonal
contraceptives is lower when the progestin has minimal androgenic activly than when the
activity Is greater, e. Cerebrovascular diseases: Hormonal contraceptives have been shown
to increese both the relative and attrtutable risks of cerebrovascular events (thrombotic and
hemonhsgic strokes), although, In general, the risk is greatest amatg older(>3syesra),
hypertensive women who also smoke. Hypotension was fouid to be a risk factor for both users
and nonusere, tor both types of strokes, and smoking Interacted to increase the risk ot stake.
In a large study, the relative risk ot thrombotic strokes has been shown to range from 3 for
normotenstve users to 14 for users with severe hypertension. The relative risk of hemonhagic
stroke Is reported to be 1 2 tot non-smokers who used hormonal contraceptives, 38 tu smok
ers who did not use hormonal contraceptives 7.6 tu smokers who used hormonal contra
cepbves, 18 for nor motensive users and 25.7 tu users with severe hypertension. The attributable
risk is ako greater In older women, and. Dote-raHted risk ot macular cheese tram hormonal
contraceptive* A positive association has been observed between the emourt ot eetrogen
and progestin h hormonal contraceptives and the risk of vascular disease. A decline rt serum
hidi-denelty Ipoprotelns (HDL) has been reported with many progestational agents. A decline
>i semm htfv density Ipoprotelns has been associated wHh an increased incidence of scheme
heal disease Because estrogens increase HDL cholesterol, the net effect of a hormonal con
tracepUve depends on a balance achieved between doses of estrogen and progestin and the
activity ot the progestin used rt the contraceptives. The activity and amount of both hormones
should be considered n the choice of a hormonal contraceptive. * Perk stance of rM of vas
cular disease: There we two studies that have shown persistence of rkk of vascular disease
tor evw-usere ot combnation hotmoral contraceptives. In a study in the Ihfed States, the risk
of developing myocardial intwetion aflw dkcontrturtg combination hormonal contraceptives
persists tor at least 9 years for women 40-49 years who had used combhatkm hormonal con
traceptives tu five or more years, but this increased risk was not demonstrated rt other age
rroupe. In another study n Great Britain, the risk of developrtg cerebrovascular disease
persisted tu at least 6 years after disconthuatlon of combination hormcra! contraceptives,
a though excess risk was very small. However, both studies were performed with combhatlon
hormonal contraceptive formulations contahhg 50 micrograms u higher ot eetrogera. It Is
unknown whether ORTHO EVRA* k district from other combnation hormonal contrace(tives
wlh regard to the occuirance of vanous and arterial thrombosis. 1 Estimates 01 Mortaity
from Combination Hormonal Contraceptive Uo One study gathered data from a variety
ot sources that have estimated the mortality rate associated with different methods of
three games.
The quarterfinal and semifi
nal matches showed the potential
UNC possessed all season. The
final match represented how they
played for most of the season.
“We always talked about play
ing hard, playing smart, playing
together,” said sophomore middle
hitter Amy Beaver. “Once we played
together, it went really smoothly,
and we started to dominate.”
The Tar Heels dominated the
Seminoles throughout After getting
swept during the regular season,
North Carolina beat fourth-seeded
Florida State 30-17,33-31,30-24.
Beaver set the tone early.
21 Homesteader
22 Greek letters
25 Intense hatred
26 Inclined to flow
27 Player
29 Actor Lew
30 Ms. Caldwell
32 One Jackson
33 Soap plant
34 Not as refined
36 Actor Omar
38 Air shaft
41 "Evil Woman" grp.
42 Postponed
1 TANARUS““ 6 7 io |n 12 13
20 1 ' 21 122
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contraception at diluent ages. These estimates Indude the oombried risk ot death associ
ated with contraceptive methods plus the nek attrtutoble to pregnancy rt the event ot methoo
talure. Each method of contraception has Its spectic benefits and risks The study conducted
that with the exception ot combnation oral contraceptive users 35 and otter who smoke, and
40 and older who do not smoke, mortality associated wlh all methods ot birth control is low
and below that associated with chldbirih.
The observation of a possHe increese it risk of mutaliy wlh age tu combination oral con
traceptwe users k based on data gathued In the 1970* but not reported until 1983. Current
dnical recommendation Involves the use of lower estrogen dose fumulations and a cueful
consideration ot rkk factor*, hi 989, the Ferdltiy and Maternal Health Drugs Advisory Commltee
was asked to review the use ot combiratiai humonai contraceptkies in women 40 years of
age and over. The Committee concluded that although cardkwascular disease risks may be
increased wlh combination humoral contraceptive use alter age 40 h heallhy non-smokng
women (even with the newer low-dose formulations), there are also greater potential healh
risks assockted wlh prepmney In older women and with the alternative surgical and medical
procedures flat may be necessary If such women do not have access to effective and acceptable
means of contraception. The Committee recommended thatthe benefits ot low-dose combi
nation humoral contraceptive use ty heathy non-smoking women over 40 may outweigh the
possible rikrs. Allhough the data are mainly obtaried wlh oral contraceptives, this is Ikety to
apply to ORTHO EVRA® as wel. Women of all ages who uee combination hormonal contra
ceftives, should use the lowest possible dose formutetion that Is effective and meets (he irtdi
vrtual patent needs. 8 Carcinoma Of The Reproductive Organs And Brents: Numerous
epidemiological studies give conflicting reports on the relationship between breast cancer and
COC use. me tkk ot havrtg breast cancer dkgnosed may be slightly released among current
and recent usere ot combination oral contracepti/es. However, this excess rkk appears to
decrease over tine after COC dkourtlnuatkin and by 10 years alter cessation the increased
risk disappears. Some studies report an increased risk wth duration ot use while other stud
ies do not and no consistent relationships have been found with doseu typed steroid. Some
studies have (and a small increase it risk tu women who fist use COCs before age 20. Most
studies show a similar pattern ot risk wlh COC use regardless ot a woman* reproductive
history or her family breast cancer histuy In addition, breast cancers dkgnosed In current u
ever oral contraceptive usere may be less dnicaly advanced than In never-usere. Women who
curendy have u have had breast cancer should not use humonai cuitraceptlves because
breast cancer k usually a humorally sensitive tumu. Some studies suggest that combnation
oral contraceptive use has been assocnted with an increase rt the risk of cervical Nraep-
Ithetal neopksk n some populations ot women. However, there continues to be controversy
about the extent to iMdch such fhdhgs may be due to dlferances h sexual behavior and other
factors. In spte of many studies of the rektkmshp between oral contraceptive use and breast
and cervical cancers, a cause-and-eflect rektkmshp has not been established. It Is not known
whether ORTHO EVRA® is distiid from oral contracepXkes with regard to the above state
ments. 4 Hepatic Neoplasia: Benign hepatic adenomas are assockted with hormonal con
traceptt/e use, the incidence ot benign tumor* Is rare it the united States. Indirect
calculations have estimated the attributable rkk to be In die range of 33 cases/100,000 tu
users, a rkk that rtcreases after tax u more years of use, especially with hormonal contra
ceptives contalnrig 50 mkxotrams u mue ot estrogen. Rupture of benign, hepatic adenomas
may causa death through iitra-abdomrial hemorrhage. Studies from Britain and the US have
shown an hcreased ridr cl developing hepatocellular cucinoma n long term (* 8 yearn) oral
contraceptive users. However, these cencere are extremely rare P the U.S. and the attrbuta
ble rkk (ft* excess incidence) ot iru cancers P oral contraceptive usere approaches less than
ohe per mllbn usere. I k unknown wheffier ORTHO EVRA® Is distiid from oral contraceptives
P this regard. 5 Ocular Led on* There have been dppal case reports of retinal thrombosis
associated with the use ot humoral contraceptees ORTHO B/RA® should be discontinued I
there is unexplained partial u complete loss of vision: onset of proptosis u diplopia;
papilledema; u retinal vascular lesions. Appropriate diagnostic snd therapeutic measures
should be tndertaken Immediately, a Hormonal Contraceptive Use Before Or During Early
Pregnancy: Extensive epidemiological studies hsve revealed no increased risk of birth defects
P vmen who have used oral contraceptives pnu to pregnarxy. Studies ako do not indicate
a teratogenic efted, parttcularty p so far as cardiac anomalies and imb reduction defects are
concerned, when oral contraceptives retaken inadvertently during early pregnancy. Combination
hormonal conlraceptiveseuchasOßTHOßlßA® should not be used to nducewithdrawalbleed
mg as a test tu pregnancy. ORTHO EVRA* should nd be used durpg pregnancy to treat threat
eraduhabltiialabortPnltisrecommendedthatfuanypatientwhohasmissedtwoconsecutive
periods, program* thould be ruled out It the patient has not adhered to the presetted sched
ule fu the use oIORTHO B/RA® the posstiillyotpreflranqf should be corektered at the time
ot the tret missed period. Hormonal contraceptire use should be discontinued it pregnancy k
confirmed. 7. EMbtaddar Meats* Earlier studies have repotted an Pcreased lifetime rela
tive risk of galbtaddw surgery p users and hormonal contraceptives and estrogens. Mue re
oent studies, however, have shownthat the rektive risk of developing gaiiladder disease among
hormonal contraceptire users may be mPPtal. The recent findings and mnima! rkk may be re
lated to tie use ot hormonal contraceptive fumulations contanlng tower hormonal doses ot
estrogens and pnogestPs. CombPation hormuial contraceptives such as ORTHO EVRA* may
worsen existing gallbladder disease and may accelerate the development of this disease P
previously asymptomatic women. Women with a history ot combination humonai
contraceptive-related choleelask are mue Ikely to have the and toon recur with sutKequart
combnation humeral contraceptive use. 8 Carbohydrate And Upid Metabolic Enact*
Humoral caitraceptives have been shown to cause a decreese P glucose tolerance P some
user*. However, P the non-dkbetic woman, combnation humonai contraceptives appear to
have no efted on tasting blood glucose. Predkbetic and diabetic women Pparticuiar should
be carefully monitored while takng combnation humoral conkareptives sudi as ORTHO E\4tA®.
P dnical triak wlh oral contraceptives contanlng ethnyl estradiol and nugestimate there
were no dnicafy significant changes P tasting blood glucose levels. There were no dPically
significant changes P glucose levels over 24 cycles of use. Mueover, glucose tolerance tests
showed no dPically significant changes from baseine to cydes 3,12 and 24. P a 6-cycle
dnical trial wth ORTHO BIRA® thus were no dPically significant changes P fasting blood
glucose from baseine to end ot treatment A small proportion of women will have persistent
hypertriglyceridemia whle taking humonai contraceptires. As discussed earlier (see WARN
INGS 1a and 1d), changes p serum triglycerides and tpoprdeP levels have been reported P
hormonal contraceptive users. 8 Bwated Blood Prernr* Women wth skplfcant hyper
tension should not be started on hormonal contraception. Women with a history of hyperten
sion u hypertension-related diseases, u renal disease should be encouraged to use another
method of contraception. I women elect to use ORTHO EVRA®,they should be monitored closely
and It a ckiically signKcant elevation ot blood pressure occurs, ORTHO EVRA® should be
discontinued. Fu most women, elevated blood pressure wtl return to numal alter stopppg
hormonalcontracettlves, and there Is no difference P the occurrence of hypertension between
turner and never users. An Pcreese P blood pressure has been repotted P women taking
hormonal contraceptives and this Increase k mue likely P older humoral contraceptive users
and with extended duration of use. Data from the Royal College ot General Practitioners and
subsequent randomized triak have shown that the incidence ot hypertension Pcreases wlh
increasing progestational activity, to. Headache: The onset u exacerbation of migraine
headache u the development ot headache with a raw pattern that is recurent, persistent u
severe requtes dscontruation ot ORTHO EVRA* and evaluation ot the cause 11. Bleeding
kregutarities: Breekthroutfi bleeding and spottpg are sometimes encountered P women using
ORTHO BIRA®. Ntp-hormonal causes should be considered and adequate diagnostic meas
ures taken to rale out maigrancy, other petbotogy, u pregnancy P the event ot breakthrough
bleeding, as P the case of any abnormal vaginal blesdng. It pathology has been excluded, tPie
or a change to another contraceptwe product may resolve the bleeding. P the event of amen
otrhea, pregnancy should be ruled out betore Plating use ot ORTHO EVRA®. Some women
may encounter amenorrhea u oHgomsnonhea alter discontinuation ot humoral contracep
tive use, espedaly when such a condition was pre-existent. BtoedPa Patterns: p the dnical
triak most women started their withdrawal bleeding on the fourth day ot the drug-tree
Interval, and Ihe median duratiut ot withdrawal bleeding was 5 to 6 days. On average 26% of
women per cycle had 7 u mue total days of bleeding and lor spotting (jhk Pcludes both with
drawal flow and brsakthraigh bteadpg and/u spottpg). 12. Ectopic Pregnancy: Ectopic as
well as PtrauterPe pregnancy may occur P contraceptire failures.
PRECAUTIONS: Woman shoikdbecouneeted that ORTHO EVRA* does not protert again*
HIV Infection (AIDS) and other sexually transmitted Infection*. 1. Body Weight *l9B be.
(90 kg): Rasuls ot dnical triak suggest that ORTHO EVRA® may be toss effective P women
wlh body wetfit <l9B bs (90 kg) titan P women wlh towu body weights. 2. Physical
Examination And Follow-Up: I k good medical practice tu women uspg ORTHO EVRA®, as
tu all women, to have annual medical evaluation and physical examhations. The physical
examination, howewr, may be detetred until after Pltiatlon ot hormonal contraceptives It
requested by the woman and judged appropriate by the dnickn. The physical exam nation
thould Pdude special reference to blood preesure, breasts, abdomen and pelvic ugans,
Including cervical cytology, and relevant laboratory tests. P case ot undhgnosed, persistent u
recurrent abnumal vagpal bleedpg, appropriate measures should be conducted to rule out
malignancy u other pathology. Women with a strong family history ot breast esneu u who
have breast nodulse should be monlued with particular care. 3. Upld Disorders: Women
who are being treated tor hyperlipidemias should be followed ctoeely It they elect to use
ORTHO EVRA*. Some progestine may elevate LDL levek and may rendu the control of hypu-
Upktemlas mue difficult 4. Llvar Function: II jaundice develops P any woman uspg
ORTHO BIRA®, Ihe medication should be dkouitPued. The humones P ORTHO EVRA® may
be pouly metabolized p patients with impaired liver function. 5 Huld Retention: Steroid hu
mones Ike these P ORTHO EVRA® may cause some degree of fluid retention. ORTHO EVRA®
should be preserbed with caution, and only with careful monitoring, P patients with conditions
which might be aggravated by flub retention. 8 Emotional Meorderc Women vtito become
significantly depressed while using combPatlon humoral contraceptives such as
ORTHO BRA® should Pop the medication and use anotiw method of contraception P an at
tempt to determine whether the symptom k drug related. Women with a history U depression
should be carefully observed and ORTHO EVRA® discuitPued It spnf leant depression occurs.
7. Contact Lame* Contact lens wearers Po develop visual changes or changes P lens tol
erance should be assessed by an optdhalmotogst 8 Drug Interaction*: amgsJttSSOlHaStStfS
Effectiveness Associated with Co-Admnistration ol Other Drags: Contraceptive effectiveness
may be reduced when humonai contraceptNes ere co-admPistued with some antibatiics,
Sports
“The first few points, it was the
Amy Beaver Show,” said co-captain
Molly Pyles. “She really set the tone
in game one.”
Both players received an all
tournament team selection.
“I always get angry when I play
against (FSU),” Beaver said. “The
way that they play inspires me to
want to beat them.”
Against Florida State, Beaver hit
at a rate of almost 43 percent and
recorded an impressive nine blocks.
“She had a burning desire to
shut them down,” Pyles said.
Beaver said Florida State brought
out an intense passion the team often
lacked during the season. UNC fed
(C)2004 Tribune Media Services, Inc.
All rights reserved.
47 Performer
49 Indefinite time periods
52 First name in cosmet
ics
54 Climbing plants
55 Present packaging
56 Wife of Zeus
57 Writer Kingsley
58 Sign of things to come
59 Seldom seen
60 Come to grips with
61 Sioux tribe
62 Rip apart
off that energy early and often.
“We felt like we had nothing to
lose, we came out so hard and beat
them so bad,” Beaver said. “We’re
not very fond of them. We pounded
them from the get-go.”
The Tar Heels carried that
momentum into Saturday’s semi
final against Clemson, beating the
Tigers 30-19, 31-29, 30-23.
Beaver starred again, recording
10 kills and hitting a whopping 60
percent. With the eight blocks she
added, Beaver’s play was UNC’s
best of the tournament.
“We passed well, and we were
able to set her a lot, more than we
have been,” said Coach Joe Sagula.
The team focused on passing to
the middle hitters because it knew
opponents would key on Pyles
and fellow outside hitter Dani
Nyenhuis.
But UNC faltered in Sunday’s
ACC final.
“We didn’t pass well, we didn’t
dig well, we didn’t block well,”
Sagula said. “All facets of the game
were at a much lower level."
Perhaps the Terrapins caught
the Thr Heels off guard.
“Maryland played three straight
matches already,” Pyles said. “We
thought they may be tired. Hats
off to them.”
Despite the setback, UNC felt it
met its expectations.
“Our goal was to make a run and
play really well,” Sagula said. “So I
think we exceeded that.”
Sagula added that he thought
the Tar Heels would have reached
the finals if they knocked off the
Seminoles.
But as for a bid to the NCAA
Tournament, Sagula was skeptical.
“My gut says no,” he said.
“Stranger things have happened, I’d
be more surprised than expect it.”
Contact the Sports Editor
at sports@unc.edu.
artltungak,anticonvulsants, and other dregs that hcreasemetaboltem ot amtsceptlve steroids.
Ttik could resul In unintended pregnancy or breakthrough bleedhg. Examples titdude barbi
turates, griseofutvin, rifampin, phenybutazone, phenytoin, carbamazeptie, fetamate, oxcar
bazepne, topaamate and possibly with ampicilin. The proposed mechanism of Interaction ot
antblotics k different from that of liter enzyme-inducing drug* Uterature suggests possitie
Interactions with the concomitant use ot hotmoral caitraceptives and ampidHin u tetracy
diie. In a pharmacokinetic dug interaction study, oral admtoktration of tetracydrie HCL
500 mg q.t.d. tor 3 days prior to and 7 days duringwear ol ORTHO BIRA® did not significantly
affect the pharmacoKretics of norelgestromn or EE Several of the anti-HlVprotease hhtoitore
have been studied with co-admnktratlon of oral combination hormonal contraceptives:
s (7l (leant changes Increase and decrease) n the mean AUC of the estrogen and progestin
have been noted n some cases. The efficacy and safety of oral contraceptire products msy be
affected; It k unknown whether this applies to ORTHO EVRA®. Healhcare professionals should
refer to the label ot the Individual anti-HIV protease nhtxtore lor further drag-drug nteraction
information. Hemal products contahhg SI John* Wort (hypericum perforatum) may hduce
hepatic enzymes (cytochrome P 450) and p-glycoproteh transporter and may reduce the
effectiveness ot cmtraceptive steroids Thk may ako result h breakthrough bleeding. Increase
m Plasma Hgtmone.Uwly teyocnM wfth Ptw; Co-admhktratlon and
atorvastath and certah ual contraceptives contalnhg ethinyl estradiol Increase AUC values
tor ethinyl estradiol by approximately 20%. Ascutxc acid and acetaminophen may haease
plasma etiihyl estradiol levels, ptksbly by hhUtlon of conjugation. CYP 3A4 hhbltore such
as tracorazole u ketoconazole may haease plasma hotmone levek. Changes h Plasma Levels
ot Co-Administered Drags: Combhatkm hormonal contraceptives contahhg some synthetic
estrogens (e g., ethinyl estradiol) may hhbit the metabolsm ot other compounds, hcreased
plasma concentrations of cyclosporine, prednisolone, and theophyllhe have been reported wlh
concomitant administration of oral contraceptives, h addition, oral contraceptives may hduce
the conjugation ol other compounds. 0 ecreased plasma concentrations ot acetam hophen and
Increased clearance ot temazepam, salicylic add. motphhe and dotibric add have been noted
when these drags were admhktered wlh oral contraceptives. Although norelgestromh snd
its mdabolites inhibit a variety of P 450 enzymes h human iver mtoroGomes, the dnical
consequence of such an Interaction on the levek ol other concomitant medications k likely to
be Insignificant. Under therecommended dosing regimen, the h vivo concentrations of norelge
stromh and Is metaboltes. even at the peak serum levek, are relatively low compared to the
hhMoty constant (KO (based on results ot in vitro studies). Health care prote6slonak arc
advised to also refer to prescribing htormatlon of co-admhktered drags for recommendations
regardhg management and concordant therapy. 8 Interactions With LaboratoryTect* Certain
endocrine and liver function tests and blood components may be affected by hormonal
contraceptives: a. Increased prothrombin and factors VII, VII, IX, and X; decreased anttihron
bh 3: increased norephephrhe-hduced platelet aggregabllty. b. Increased thyroid bhdftg
globulin (TOG) leading to increased circulating total thyroid hormone, as measured by praten
bound iodhe (PBD, T 4 by cobmn a by radioimmunoassay. Free T3 resin uptake k decreased,
reflecting the elevated TBG, free T 4 concentration Is unaltered, c. Other binding proteins may
be elevated h serum, and. Sex hormone bhdhg globulins are hcreased and result h elevated
levek of total drculathg endogenous sex steroids and cortlcolds; however, free ot biologically
aettre levek either decrease or remah unchanged, e. Triglycerides may be increased and
levek ot various other Ipids and lipoproteins may be affected, f. Glucose tolerance may be
decreased, g. Seram folate levels may be depressed ty hormonal contraceptive therapy. Thk
may be of dnical significance If a woman becomes pregnant shortly after discontinuing
ORTHO EVRA®. 10. Carctnogeneela: No carcinogenicity studies were conducted wlh nuelge
stromh. However, brldghg PK studies were conducted ushg doses ot NGM/EE which were
used previously h the 2-yearrat carcinogenicity study and 10-yaar monkey toxicity study to
support the approval ot ORTHO-CYCLEN and ORTHO TRI-CYCLEN under NDAs 19-653 and
19-697, respectively. The PK studies demonstrated that rats and monkeys were eiposed to f 6
and 8 times Die human exposure, respectively, win Ihe proposed ORTHO B/RA® transdermel
contraceptive system. Norelgestromn was tested h n-vitro mutagenicity essays bacterial plate
incorporation mutation assay, CHO/HGPRT mutation assay, chromosomal aberration assay
ushg cultured human peripheral lymphocytes) and h one h-vlvo test (rat mkxonudeus assay)
and found to have no genotoxic potential. See WARNNGS Section. 11. Pregnancy: Pregnancy
Category X See CONTRANDICATIONS and WARNNGS Sections. Noretgestromh was tested fu
Its reproductive toxicly h a rabbit developmental toxicity study by the SC route ol admhklra
tion. Doses ot 0,1,2,4 and 6 mg/kg body weight which gave systemic exposure ol approxi
mately 25 to 125 times the human exposure with ORTHO B/RA®, ware admhktered daly on
gestation days 7-19. Malfumations reported were paw hyperflexlon at 4 and 6 mg/kg and
pew hyperextension and dett palate at 6 mg/kg. 12. Ntrilng Mother* The effects of
ORTHO B/RA® h nursing mothers have not been evaluated and are unknown. Small amounts
of combhatlon hormonal contraceptive steroids have been identified h the mik ot nurshg
mothers and a few adverse effects on the chid have been reported, hdudhg jaundice and
breast enlargement, h addition, combnation hormcral contraceptires given In the postpartum
period may interfere with lactation by decreashg Ihe quantity and quality of breast mik. Long
term foUovHp ot Wants whose mothers used combhatkn hormonal caitraceptives white breast
feedhg has shown no deleterious effects. However, the reusing mother should be
advised not to use ORTHO EVRA® but to use other forms ol contraception until she has com
pldely weaned her diM. 13. Pediatric Ut* Safety and efficacy ot ORTHO B/RA® have been
established h women of reproductive age. Safety and efficacy are ejected to be the same tu
post-pubertal adolescents under the age ot 16 and for users 16 years and older. Use oflhte
product before menarche k not Indicated. 14 Geriatric U Thk product has not been stud
ied h women over 65 years of age and k not hdicated h thk population. 18 Sexually
Transmitted Disease* Patientsshould be counseled that Ihk product does not protectagahst
HIV htection (AIDS) and other sexualy transmitted diseases. 18 Patch Adhesion: Experience
wlh mue than 70,000 ORTHO EVRA® patches wan tor ccntraceptkn for 6-13 cycles showed
that 4.7% ot patches were replaced because titey either tel off (1.8%) u were pally detached
(2.9%). Simiariy, in a small study ot patch wear ureter conditions of physical exertion and vari
able temperature and humidity, less than 2% ol patches were repfaced tu complete u partial
detachment. If the ORTHO EVRA® patch becomes partially or completely detached and
remans detached, Insufficient drug delivery occurs. A patch should not be re-applied It t k no
longer sticky, llt has become stuck to Itsel another surface, If It has other material stuck
to ft, or if It has become tocse or fallen off before. Ia patch cannot be re-applied, anew patch
should be applied Immediately. Supplemental adhesives or wapa should not be used to hold
the ORTHO B/RA® patch h place. It a patch k partially u completey detached fu mue than
one day (24 hours u mue) ORI the woman k not sure how tong the patch has been detached,
she may not be protected from pregnancy. She should stop the current contraceptive cycle and
start anew cycle immediately by applying anew patch, eack-cp contraception, such as con
doms, spennlcide, or diaphragm, must be used fu the list week ol the new cycle.
INFORMATION FOR THE MTIENT: See Patient Package Insert.
ADVERSE REACTIONS: Die most common advuse events reported by 9 to 22% ol women
ushg ORTHO EVRA® h clinical triak (N= 3,330) were the folowhg, h onter ot deueashg
Incidence: breast symptoms, headache, application site reaction, nausea, upper respiratory
htection, menstrual cramps, and abdominal pah.
The moat frequent adverse events leading to discontinuation h 1 to 2.4% of women ushg
ORTHO B/RA® h the triak included the following: nausea and/u vomthg, application site
reaction, breast symptoms, headache, and emotional labiity.
Listed below are adverse events that have been associated with the use ol combination
humoral contraceptives. These ue also likely to apply to combination transdermal humcnal
contraceptives such as ORTHO B/RA®.
An increased rkk of the lolowhg serious adverse reactions has been associated with the use
of combhatlon hormonal contrixptlves (see WARNINGS Section): 1. ThrombophletJle and
venous thrombosis with or without embolkm 2. Arterial thromboembolism 3. Pulmonary
embolkm 4 Myocardhl hfarctlon 5. Cuebralhemonhage 6. Cerebralthrombosk 7. Hypertension
8. Gallbladder disease 9. Hepatic adenomas u benign Kvu tumors
There k evidence of an association between the folowhg conditions and the use of combha
bon humoral contraceptives: 1. Mesenteric thrombosk 2. Rethal thrombosis
rite following adverse reactions have been reputed h user* of combhatkn humoral con
traceptives and ve believed to be drug-related: 1. Nausea 2. Vomiting 3. Gastrointestinal symp
toms (such as abdomhal cramps and bloathg) 4. Breakthrough bleeding 5. Spotting 6. Orange
h mertstiualftow 7. Amenonhee B.Tempu*ra htertllly alter dteoorthuatton Utreatmert 9. Edema
10. Melasma which may persist 11. Breast changes: tenderness, enlargement, secretion
12. Change h weight (increase or decreeee) 13, Change h cervical erosion and seuetkn
14. Diminution h lactation when given immediately postpartum 15. Cholestatic jaundice
16. Migraine 17. Rash (allergic) 18. Mental depression 19. Reduced tolerance to cartMhydrates
20. Vagina! candidlask 21. Change h comeal curvature (steepening) 22. Intolerance to
contact lenses
The following adverse reactions have been reputed h users of combination humonai
contraceptives aid a cause and effect association has been neither confirmed nu refuted:
1. Pre-menstrual syndrome 2. Cataracts 3. Changes h appetite 4. Cystitis-like syndrome
5. Headache 6. Nervousness 7. Dizziness 8. Hirsutism 9. Loss ot scalp hair 10. Erythema
multitume 11 Erythema nodosum 12. Hemonhagic eruption 13. Vaginitis 14. Puphyrk
15. Impaled renal function 16. Hemolytic uremic syndrome 17. Acne 18. Changes tit libido
19. Colitis 20. Budd-Chiari Syndrome
OVER DOSAGE Serious ill effects have not been reputed folowlng accidental hgestion ot luge
doses ol humonai contraceptives. Ovudosage may cause nausea and vomiting, and withdrawal
bleedhg may occur h females. Given the nature and design ot the ORTHO B/RA* patch, It k
unlikely that ovudosage will occu. Sukxis ill effects have not been reputed folowlng acute
hgestion ot luge doses of ual contraceptives by young children, h case ot suspected overdose,
all ORTHO EVRA® patches should be removed and symptomatic treatment given.
ORTHg^cNEIL
ORTHO-McNEIL PHARMACEUTICAL, INC.
Raritan, New Jersey 08869
O OMP 2001 Revised: May 2003 631-10-660-2 B
UNC bounces back
to defeat Cougars
THE ASSOCIATED PRESS
LAHAINA, Hawaii Raymond
Felton made quite a difference for
North Carolina.
The junior guard missed the Tar
Heels’ season-opening loss to Santa
Clara, but he was back and so was
No. ll North Carolina’s defense in
an 86-50 victory against Brigham
Young on Monday night in the open
ing round of the Maui Invitational
The Tkr Heels, who were No. 4
in the poll before the loss, will play
either Stanford or Tennessee in
Tuesday's semi
final at 9:30
p.m. EST.
Felton, who
started all 65
games in his
MEN'S
BASKETBALL
BYU 50
UNC 86
first two seasons at North Carolina,
missed the opener as he served a
one-game NCAA suspension for
playing in an unsanctioned sum
mer league.
The Tar Heels lost 77-66 to
Santa Clara in Oakland, Calif.,
only the fifth time in 70 years
North Carolina dropped its season
opener.
With Felton back at the point,
the Tar Heels (1-1) made sure there
was no losing streak, opening the
game against BYU (0-1) with a 25-
3 run. The Cougars missed nine of
their first 10 shots from the field
and hit just 18.5 percent (5-for-27)
in the first half as the Tar Heels
took a 48-18 lead.
With Felton pressuring the ball
and Sean May establishing a pres
ence inside, North Carolina just
wouldn’t let the Cougars get a good
look at the basket
Felton missed all six of his shots
from the floor in the first half, but
he had seven assists and two steals
in reassuming his spot in the line
up. He finished with six points and
attp Satlg ®ar Bffl
UNC 86, Brigham Young 50
Briohxwt Younn 18 32 50
North Carolina 48 38 86
Brigham Young (SOI
fg ft fix
irin m im at ■ gf tp
Meads 22 1-6 00 3-9 1 3 2
Jensen 26 M 2-3 0-3 1 4 8
Hal 25 4-15 02 14 0 4 10
Rosa 15 2-7 00 0-1 0 0 5
Naahif 23 1-3 OO 01 4 1 3
toung 23 3-8 W 6-10 0 1 9
Nng* 18 2-3 00 01 1 1 6
SBurgamlß 2-7 00 01 0 4 4
DRurgessß 01 00 00 0 2 0
Dnmt 3 00 1-2 00 0 0 1
Rusted 18 02 2-2 1-3 1 0 2
lie ) 01 00 3-5 0 1 0
fetal ZOO 1667 414 13-38 I 21 SO
Percentage! - FG 3. FT .671 Opoim gdal* - 6-23
261 (Hal 2-8. Ainge 2-3. flora 1-5. Nastlf 1-3. You* 0-2.
S Burgess 02). feint rebound* - 6 Bockad etrata
- 4 (Meads. Ha#. Ybung. Mies). Turnover* - 27 (Narilit
8 Ange 4. Meads 4. Hall 4. S.Burgess 2. Jansen flora.
Dawes. Ptarsted. Mites). Bteal* - 7 (Meads 2. Jem.
Hal. NasM. Angle. 0 Birgess).
North Carolina (66)
fg ft re
min naa m-a ®-t a pf
JVWran*23 49 3-6 1-6 0 1 11
May 23 7-11 46 38 0 2 18
Ftfton 26 2-10 00 02 7 3 6
Manuel 24 2-6 2-3 1-2 2 0 8
McCants 22 6-9 OO 06 33 13
Scott 13 3-6 22 00 0 0 10
ferry 6 24 00 1-1 0 1 5
Thomas 8 01 OO 00 2 0 0
Everett 2 00 00 00 0 0 0
MOfet 6 0-2 00 00 1 0 0
MVMxnrSO 14 66 30 1 3 8
dart 4 04 00 22 0 0 0
titod 17 34 1-1 2-7 3 4 7
Hooker 2 00 00 00 0 0 0
Sanders 4 1-1 00 41 0 0 2
fetal 200 3049 18-23 1440 19 T 7 86
Percentages - FG .435. FT .783. 3pcim goals - 8-
26.308 (McCants 30. Felton 2-7. Scott 2-5. fetry 12.
J.VMSams 02. Manuel 0-2, MU* 02). Team rebounds
—2. Blocked shots -> 1 (J.tftiHams). Turnover*
-12 (Mav 3. feny 3. M.VWlams 2, Fettixn 2. McCants.
Thomas). Steals -15 (May 3. Manual 3, M.VWHarm 3.
Felton 2. Noel 2. McCants. Scott).
technical fouls None Attendance 2.600
seven assists in 26 minutes.
Felton said it was the first time he
ever missed a game for any reason,
even injury, since he started play
ing organized basketball in grade
school.
May had 18 points and eight
rebounds for the Tar Heels, while
Rashad McCants had 13 points.
Mike Hall had 10 points for
BYU, which finished 13-for-30
from the field (31.6 percent) and
had 27 turnovers.
North Carolina’s biggest lead
was 39 points, which it reached
three times, the last at 83-44.
The biggest margin of victory in
the 21 years of the tournament was
Boston College’s 108-61 win over
Chaminade in the opening round
in 1993. ccvrrrr. err,
Tar Heels
finish 10th
atNCAAs
FROM WIRE REPORTS
The No. 10 North Carolina wom
en’s cross country team finished
10th at the NCAA Championships
Monday morning at Indiana State
University in Terre Haute, Ind.
The Tar Heels finished the race
with 336 points, edging Missouri
to finish in the top 10.
Colorado won convincingly, tal
lying 63 points to take the crown.
Duke was the top ACC finisher, plac
ing second overall with 144 points.
North Carolina junior Carol
Henry was the only harrier from
an ACC school to crack the top 10,
as her 6K time of 20 minutes, 42
seconds was good for seventh.
Senior Erin Donohue was next
to cross the line for UNC, finishing
44 th in 21:17. Alice Schmidt, Jessica
Perry and Meghan Owen rounded
out the scoring for the Tar Heels.
Nicole Boykin and Jennie Sucher
also competed for North Carolina,
but did not score.
“We are very happy with a top
-10 finish,” said Coach Michael
Whittlesey. “Anytime you can fin
ish in the top 10 in the country,
it’s been a great year. I thought we
had a solid race and we were tough
competitors on a muddy course.”
Henry received All-America
honors for her performance. After
finishing eighth overall in 2003,
UNC has now finished in the top
10 at the NCAA Championships
in back-to-back years for the first
time in school history.
Colorado AD steps down
BOULDER, Colo. Colorado
athletic director Dick Tharp
resigned Monday, ending a nine
year tenure sullied by accusations
of recruiting violations and fiscal
mismanagement.
The resignation came just months
after the school’s football program
was rocked by allegations that sex
and alcohol were used to entice
recruits, and lawsuits accused play
ers or recruits of sexual assault.
New allegations about fund
raising problems surfaced this
month. The school told the NCAA
last week that a small booster club
that had not been audited under
university auspices bought equip
ment for the athletic department,
an NCAA violation.