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. 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J_ £ E c eU 1 Mr] 1 U__N_£ £ Mg oUmF ££ 7Tsi £ A £ ISIO Na! rMa £OE■ T I TJo K N I F £■ I IMNSMEDEN y|e|als|tßrla|g|sßr|a|nld 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 ■■tiiidteiiniUtei ■ - 30 ] M 1 3; 3? 34 35 3^Mp9 __ " 42 _ ■■44 46 “ ' ~54 55 56 57 ” f 158 59 60 61 62 63 _ '■■64 BBB7T 66 ' ~ " " " + "' .SHjp 6S jHp' ' 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.

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