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8 WEDNESDAY, NOVEMBER 10, 2004 Enterprising students keep eyes on the prize Teams gear up for Carolina Challenge BY MARY GRACE MILLER STAFF WRITER Senior Adam Braxton’s plan to prove that men actually like to shop is cloaked in secrecy. But revealing it might win him more than $27,000. Braxton, a classical archaeology major, is joining up with two other UNC students to compete in the Carolina Challenge, an entrepre neurial competition for teams of students to create a business plan ihj i \ experiences km fjP§P\\clorvb belong on i/JB m\l y Qurnesum# Book \ 1 Qncun mewico $609 \lt 5 nighcs ac Che Acqasol Hocel trip | I Hq/ZQU, Bahama/ $559 now! I"\ J 5 nighcs ac Che Sun Fun Resort I Subject to chMige r S3S negrll, Jamaica $939 othor taM are not. ’ roundtiip airfsra from * 5 nighcs qc Che Villa la Cage Raltoigtv Pricas ara baaad on quad occupancy. , EMtravell (919)926.6644 1 www.statravel.com STUDENT TRAVEL & BEYOND I ORTHO EVRAf® (NORELGEST ROMIN / ETHINYL ESTRADIOL TRANSDERMAL SYSTEM) alhoraalaS l * lM Be only ORTHO EVRA® is a corntination transdemral contraceptive pater with a contact surface area of 20 cm 2 .l contains 6.00 mg norefgestromb and 0.75 mg ethinyl estradiol (S). and releases 150 mioograms of norelgestromln and 20 micropams of EE to (he bloodstream per 24 hours MPORTANT NOTE-TNs Intonation Is a BRIEF SUMMARY of IhtcompMa prasaMng Information provided with tha product and tharsfore should not be uaad as lie basis for prsscriblngfhs product. Ttite summary ams prepared by dsMng tram the complstepre scrtMnglnfcnnaßaii certain tsuttabtse and references. Thephyskrlan should bethomughty tandtar with the oonpiele gnsaMig Worrmtkm baton prescribing the product MOKAnCNS MB USAGE: ORTHO BWP toMcated tor the prawnbonot pregnancy. Ike oral contracepßses, ORTHO BSA® le dteeftre I used as recommended In this hbel CONTIUUNDICAJKINS ORTHO EVRA* should not be used h women who cunentV have the tolowhg conditions: 1. Thrombophlebtis, thromboembolic disorders Z Apast history ot deep veil thrombophlebitis or thromboembolic disorders 3. Cerebrovascular or coronary artery disease (current or past hestory) 4. Valvular heart disease wlh complications 5. Severe hyper tension 6. Diabetes with vascular irvolve merit 7. Headaches with focal neurological symptoms 8. Major surganr wlh prolonged im mobilization 9. Knowt or suspected cardnoma of the breast or personal hfctery of breast cancer 10. Carcinoma of the endometrium or other known or suvecledeetogendependentneoplasiall.UnApioeedsbicrmal genital bteedbvgl2. Cholestatic jaundee ot pepnney or pundice with prior hormonal contraceptive use f 1 Acute or chronic hepatocellular disease with abnormal liver Auction 14. Hepatic adenomas or carcswmas 15. Known or suspected pregnancy 16 Hypeisensllvly to arty component of tiis product WARWNQS g) tUi tthfil from hormonal conbacaptlve use. This iHktncraasesviHh ape and with heavy amokiog (15 or mora ctparattas par day) and la yalta nrarkad In woman ovsf 96 yttre of ip, Wtninn who übo honnoral MflfrMwtvw, IndHdkio OfTTHO EVRA*, ahordd be tborttpy adWead not So smoke. ORTHO EVRA* and other contraceptives that contain both an estrogen and a progestin are called combriation hormonal contraceptives. There is no epidemiologic data available to determ he whether safety and efficacy wth the transdermal route ot admhistratjai would be different than the oral route. Practitioners presenting ORTHO EVRA® should be familiar wlh the foUowng information relating to risks. The use ol combimtion hormonal contraceptives is associated with increased risks and several serious conditions including myocardial Infarction, thromboembolism, stroke, hepatic neoplasia, and galbtadder disease although the rlak ot serious moitiidity or mortally is very small n healthy women without underlying nek factors. The risk of moibidly and mortality increases agntticanty It the presence of other underiyhg risk factors such as hypertension, hypertpidemias, obesity and dsbetes. The information contahed in the package nsert is princpally based on studies carried out in women who used combination oral contraceptives wlh hkpier formulaJions ot estrogens and progestris than those in common use today. The effect ol long-term use ot comtohatton hormonal contraceptives with lower Ooee6 0t both eetrogen and progestradmPetered by my route remans to be determned. ThraHfnut this tabelrig, epidemiological studies reported are of two types: retrospective or case omtrol studies and prospectwe or cohort studies. Case control studies provide a meas ise ot the relative risk of a disease, namely, a ratio ot the Incidence of a dieease among oral contraceptive users to that among nonusers. The relative risk does not provide hlormation on the actual cknlcal occurrence ot a disease. Cohort studies provide a measure of attributa ble risk, which Is the rttterence h the heidenoe ot di6eaee between humoral contraceptive users and nonusers. The attributable rick does provide information about tie actual ocor rence ol a disease to the population (adapted trom rets. 2 and 3 with the author's permission). For hither Information, the reader is referred to a text on epidemiological msffiots. 1. Tfiremb*en*o*c Disorders And Otar Vascular Problems: a. Thromboembolism: An ncreased risk of thromboemboic and thrombotic disease associated with the use ot hormonal contraceptives Is well established. Cs6e control studies have found the relative risk ot users compered to nonuears to be 3 lor the first episode of superficial venous thrombosis. 4 to 11 for deep veh thrombosis or pulmonary emboism, and 1.5 to 6 for women with predisposhg conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to be somewhat lower, about 3 tor new cases and about 45 tor new cases requmg hosptaliza tion. The risk ot thromboembolic disease associated wlh hormonal contraceptives Is not rented to length ct use and disappears alter hcrmonal contraceptive use le stopped. A two- to four-fold Increase n relative risk of poet-operative thromboembolic complications has been reported with the use of hormonal contraceptives The restive risk ot venous thrombosis n women who have predisposing card Hons Is twice that ol women wilhout such medical con ditions. If feastke. hormonal contraceptives should be discontinued at bast four weeks prior to and for two weeks after elective surgery of a type assoebted wti an net ease n risk of thromboembolism and dwirg and following prolonged immobilzation. Slice the immediate postpartum period b also assoebted wth an increased risk of thromboembolism, honmral contraceptives should be started no earlier than tour weeks after deliveiy h women vbw elect not to breast-feed, kt the Urge cinical trials (N= 3,330 with 1,704 woman-years ot ebnsure), one case ol non-fata! pulmonary embolbm occurred during ORTHO EVRA* use, and one case ot poet-operative non-fatal pulmonary embolbm was reported following ORTHO EVRA* use. t b unknowi It the rbk of venous thromboembolbm w#i ORTHO EVRA* use b dtferent than wth use ot combriation oral contraceptives As with any combination Ixrmonal contracep tives, tie cinicbn should be alert to tie eeriest manifestations ol thrombotic disorders (throm bophlebitis, pulmonary embolbm, cerebrovascular disorders, and retrial thrombosis). Should any ot these occur or be suspected, ORTHO EVRA* should be discontinued immedbtely. b. MyocerdM MarcHoit An ricreesed rbk of myocardial infarction has been attributed to hormonal contraceptive use. Thb rbk b primarily ri emokere or women wth other underiyhg rbk factors for coronary artery disease such as hypertension, hyperchobsterobmb. morbid obesity, and dbbetee. The rebtlve rbk ol heart attack for curent hormonal contraceptive usera has been estimated to be two to sx compared to non- userc. The ri* b very low inter the age of 30. Smoking ri combrtation with oral contraceptive use has been shown to contrtute sub stantblly to the incidence of myocardial rifarctbns ri women ri the! mid-thirties or older wlh smokrig accounting for the majority ot excess cases. Mortality rates assoebted with circula tory disease have been shewn to ricrease subetantbly ri smokers, eepeeb ly ri those 35 years ot age and older among women who use oral contraceptives. Hormonal contraceptives may compound the effects of well-known rbk factors, such as hypertension, dbbetes, hypertbi dembs, age and obesly. ri particular, some progestris are known to decrease HDL choles terol and cause glucose intolerance, while estrogens may create a state ot hyperinsulinbm. Hormonal contraceptives have been shown to ricrease blood preeeure among some users (see Section 9 in WARNINGS) . Sim iar effects on rtok (adore have been assoebted with an increased rbk of heart disease. Hormonal contraceptives, ridudrig ORTHO EVRA*, must be used wlh caution In women with cardiovascular disease rbk factors. Norgestimate and norelgeslromri havemriimalandrogenbartivity (see CLN CAL PHARMACOLOGY in tul Prescribrigrilormation). There b some evidence that the risk ot myocardbl infarction assoebted with hormonal contraceptives b lower when the progestin has minimal androgenic adivly than when the activity b greater, c. Cerebrovascular Omm Hormonal contraceptives have been blown to ricrease both the relative and attrtutable risks ot cerebrovascubr events (thrombotic end hemorrhagic strokes), although. In general, the rbk b greatest ameng older (>35 years), hypertensive women who also smoke. Hypertension was found to be a rbk fader lor both users and nonusere, for both types ot strokes, and smoking interaded to increase Ihe rbk ol stroke, h a large study, the relative rbk of thrombotic strokes has been shown to range from 3 lor normotensive users to 14 tor users with severe hypertension. The retatbe risk ol hemorrhagic stroke b reported to be 1 2 tor non-smokere who used hormonal contraceptives, 2.6 for smok ers who did not use hormonal contraceptives, 7.6 lor smokers who used hormonal contra ceptives, 1.8 tor normotensive users and 25.7 tor users with severe hypertension. The attributabte rbk b also greeter ri older women, and. Cow-related risk of wecular disease trom hormonal contraceptives: A positive association has been observed between the amount ot eslrogen and progestin ri hormonal contraceptives and the risk ot vascular disease. A decline ri 6enim high-density Upoprdeins (HDL) has been reported with many progestational agents. A decline risemm high-density Ipoprotems has been aesocated with an ncreased incidence of ischemic heart disease. Because estrogens ricrease HDL cholesterol, the net efled ot a hormonal con traceptive depends on a balance achbved between doses ot estrogen and progertri and the adivfty of the progestri used ri the contraceptives The adivly and amount ot both hormones should be considered In the choice of a hormonal contraceptive, * Perbetence ol rtek ot ma cular disease There are two studies that have shown persistence ot rbk of vascular disease for eva-users ol combination boimonal contraceptives, m a study In the Uhted States, the rbk ol developing myocardbl ritadion alia dbcontriung combination hormonal contraceptives persists tor at bast 9 years tor women 40-49 years who had used comb nation hormonal con traceptives fa live a more years, but thb no eased rbk was not demonstrated ri other age groups. In another study in Great Britain, he rbk ol developing caebrovascubr disease persisted la at bast 6 years atta dbcontriuation ot combination hcrmonal contraceptives, alhough excess rbk was very smal. Howeva, boh stud bs were performed wlh combhation hormonal contraceptive formulations contaririg 50 mkrograms a hlgha of estrogens. It b unknown whetha ORTHO EVRA® b dbtind trom otha combination hormonal contraceptives wlh regard to the occurrence ot venous and arteral thrombosis. Z Estimator! ot Mortality From Combination Hormonal Conlncaptlvo Us* One study gathered data trom a variety of sources that have estimated the mortality rate assoebted wlh diffaent methods ol for a product or a company. The winners, who will receive a prize of more than $27,000, will be announced April 16 during the annual Carolina Entrepreneurship celebration. Braxton aims to win by demon strating that companies can suc cessfully market their products to men. “There are several profiles that men fall into, and one is that men don’t like to shop,” he said. “There’s contraception at dlferent ages. These estimates indude he combried rbk of deah associ ated wlh oontraoeptlve mehods plus he risk atfrlbutebte to pregnatxy ri he evert of method fable. Bedi method of centraception has its specific benefits and risks. The stidy concluded hot wih the exception ot combination oral contraceptive usere 35 and older who smoke, and 40 and older rio do not smoke, mortality associated wlh all methods ol birth control b low and below that assoebted wih chUbirth. The obeenntion of a possible ricrease h rbk of mortally wth age for combriatkxi oral con traceptive ueera S based on data gathered h the 1970's but not reported until 1983. Cunert cMcal recommendation involves he use rt lower estrogen dose tormubtions and a careful consideration at rbk factors, ri 1989, the Fertilffy and Maternal Heath Drugs Advisory Commltee was asked to review he use of combination hormcnal contraceptives ri women 40 years ol age and over. The Commltee concluded hat alhough cardiovascubr disease risks may be Increased wlh combination hormonal contraceptive use after age 40 h healthy non-smokrig women (even wlh he newer low-dose formulations), there are also greeter potertbl health risks assoebted wth pregnancy In older women and wlh he alternative surgical and medical procedures hat may be neceasary it such women do not have access to effective and acceptable means ol conkaception. The Committee recommended that he benefits ot low-dose combi nation hormonal conbeceptbe use by heamy non-smokrig women over 40 may outweigh he poestte rbka. Alhough he data are mainly otlahed vrlh oral contraceptives, thb b Ikely to apply to ORTHO EVRA® as wel. Women ot all ages who use combination hormonal cortra cepHvas, should use he lowest possMe dose lormubtlon that b effective and meets he ridi vidual patient needs. 5 Cardnoma Ot The Reproductive Organs And Bresits: Numerous epidemiologfal studies give conflicting reports on he rebtionship between breast cancer and COC use. The risk of havrig breast cancer dbgnosed may be slightly ncreased among current and recent users ot combination oral contraceptives. However, this excess rbk appears to decrease over time after COC discontinuation and by 10 years after cessation he increased rbk disappears. Some studies report an ncreased rbk wlh duration ol use while other stud lee do not and no consistent rebtionshps have been found wih dose cr type ot steroid. Some studies have found a small Increase ri rbk lor women who fist use COCs before age 20. Most studies show a similar pattern and rbk wlh COC use regardless ot a womans reproductive history or her tamiy breast cancer history. In addition, breast cancers dbgnosed in ament cr ever oral contraceptive users may be less cWcaly advanced than ri never-users. Women who currently have or have had breast cancer mould not use hormonal contraceptives because breast cancer b usualy a hormonally sensitive tumor. Some etudes suggest hat combhation oral contraceptive use has been assoebted wih an increase h the rbk of cervical htraep- ItheSal neopbsb in some populations and women. However, here continues to be controversy about he extent to which such thdhgs may be due to dllerences ri sexual behavkr and other (actors. In epte ot many studies ot he rebflonshpi between oral contraceptive use and breast and cervical cancels, a cause-and-eflect rebtionshp has nd been established. It b not known whether ORTHO EVRA® b district from oral contraceptives with regard to he above state ments. 4. Hepatic Neoplaala: Benign hepatic adenomas are assoebted wih hormonal con traceptive use, alhough he incidence of benii tumws b rare ri he Unled States. Indirect calculations have estimated he attrtutable risk to be in he range of 3.3 cases/100,000 for users, a rbk hat noeases alter tour or more years and use, especially wih hormonal contra ceptves contarihg 60 mkrograms or more and estrogen. Rupture ot benign, hepatic adenomas may cause deah through ntra-abdomhal hemorrhage. Studies trom Britan and he US have shout an ricreased rbk and developing hepetocelkibr cardnoma ri long term (a 8 years) oral contraceptive users. However, these cancers are extremely rare ri he U.S. and he attrtute bleriek (he excess incidence) driver cancers in oral contraceptive users approaches less than one per mllion users. I b unknown whether ORTHO EVRA® b district from oral contraceptives in hb regard. 5 Ocular Lmlon* There have been clinical case reports and retrial hrontesb assoebted wlh he use ot hormonal contraceptives. ORTHO EVRA® should be dbcontriued I there b unexplained paitbl or complete loss of vision: onset ol proptosb or diplopta; papilledema: or retinal vascular lesions. Appropriate dagnostic and therapeutic measures should be undertaken immedbtely 8 Hwmond Contraceptive Uw Before Or During Earty Pregnancy: Extensive epidemiological studies have revealed no Increased rbk ol birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not indicate a teratogenic eftecL particularly h so tar as cardiac anomalies and Imb reduction detects are concerned, when oral contraceptives are taken riadvetterffy during early pregnancy. Combination hormonal contracefHves such as ORTHO EVRA® should not be used to induce wiihrtawel bleed ing as a test for pregnancy. ORTHO EVRA® should not be used dumg pregnaicy to treat threat ened orhabitual abortion. Itbrecommendedthatloranypatient who has mbsed two consecutive periods, pregnancy mould be mled out It he patient has not adhered to the presetted sched ule for he use ol ORTHO WRA® he posstxlly ol pregnancy should be considered at he flme ot the fret mbsed period. Hormonal contraceptive use should be dbcontriued I pregnaicy b confirmed. 7. Gallbladder Dtaaaa* Earlier etudes have reported an ricreased lifetime reta tive rbk ol gaflbbdder siigery ri users of hormonal contraceptives and estrogens. More re cent etudes,however,have shown hat he rebtlve rbk ol developing gafcbdder disease among hormonal contraceptave users may be minimal. The recent findings ol mhhial rbk may be re lated to he use o! hormonal contraceptive lormubtkms contahing tower hormonal doees ol estrogens and progestris. Combination hormonal contraceptives such as ORTHO EVRA® may worsen exbtrig galbbdder disease and may accelerate the development of hb disease h previously asymptomatic women. Women wlh a history ol combination hormonal contraceptare-rebted cholestasb are more Ikely to have he condition recur wlh subsequent combination hormcnal contraceptive use. 8 Carbohydrate And Upld Metabolic Effect* Hormonal contraceptives have been shown to cause a decrease h glucose tolerance n some usere. However, in he non-dbbetic woman, combination hormonal contraceptives xjoear to have no effect on fasting blood glucose. Predbbetic and diabetic women in particutoshould be caretuty monitored whibtakrig combhation hormonal contacepdves suchasOßTHO EVRA® ri cinical trbto wth oral contraceptives containing ethinyl estradiol and norgestimate here were no dricatiy son heart changes in tasting blood glucose leveb. There were no ethically significant changes ri glucose bveb over 24 cycles ot use. Moreover, glucose tolerance tests showed no clinically significant changes trom baseline to cycles 3.12 aid 24 ha6-cyde cinical trial wlh ORTHO EVRA® here were no ethically significant changes in tasthg blood glucose from baselrie to end ol treatment. A smal proportion ot women will have persistent hypertriglyceridemb while taking hormonal contraceptives. As discussed eerier (see WARN INGS 1a and 1d), changes ri serum triglycerides and lipoprotein bveb have been reported ri hormcnal ccntracepdve usere. 8 Berated Blood Pretsur* Women wlh sigrittoart hyper tension should not be started on hormonal contraception. Women wih a history of hyperten sion or hypertension-related diseases, or renal disease should be encouraged to use mother method ot contraception. I women ebet to use ORTHO EVRA®, hey should be monitored closely and if a ctiically significant elevation of blood pressure occurs, ORTHO EVRA® should be dbcontriued. For most women, elevated blood pressne wil return to normal after stopprig hormonal corlraceptives, and there b no difference ri he occurrence of hypertension between former and never usere. An increase h blood pressure has been repotted h women taping hormonal contraceptives and hb ricrease b more Ikely ri older hormcnal contraceptive users and wih extended dilation o use. Data from he Royal College ol General Practitioners and subsequent randomized trials have show! hat he Incidence of hypertension ncreases wih Increasing progestational activity. 10. Headache The onset or exaceibatlon ol migraine headache or the development (4 headache wlh anew pattern hat b recurrent persistent or severe requres dbcontriuation ot ORTHO EVRA® and evaluation of the cause. 11. Bleeding kragutartttac Breakthrough bleeding and spottrig are sometimes encountered in women using ORTHO EVRA®. Nan-hoimonal causes should be considered and adequate diagnostic meas ures taken to rule out malignancy, other pathology, or pregnancy in he evert rf breakthrough bleeding, as ri he case of any abnormal vaghal bleed rig. It pathology has been excluded, time or a change to another contraceptbe product may resolve the bleeding, ri he evert ot amen orrhea, pregnancy should be ruled out before initiating use ot ORTHO EVRA®. Some women may encounter amenorrhea or oligoinenonhea after discontinuation ot hormonal contracep tive use, espectaly vhen such a condition was pre-exbtent. Bleeding Patterns: ri he clinical triab most women started her withdrawal bleeding on he fourth day of the drug-free interval, and he median duration of withdrawal bleeding was 6 to 6 days. On average 26% of women per cycle had 7 or more total days of bleeding and/or spotting (his includes boh with drawal flow and breakthrough bleeding and/or spottrig). 18 Ectopic Pregnancy: Ectopic as well as Intrauterine pregnancy may occur in contraceptNe failures. PRECAUTIONS: Woman should be counseled hat ORTHO EVRA® dote not protect against HIV Infection (AIDS) and other sexually transmitted Infection* 1. Body Weight *196 ha. (SO kg): Reeuts ot clinical trbto suggest that ORTHO EVRA* may be less effective in women wlh body weigrit >l9B lb. (90 kg) than in women wih lower body weights. 2. Physical Examination And Follow-Up: I b good medical practice lor women usrig ORTHO EVRA®, as for all women, to have annual medical evaluation and physical damnations. The physical examination, however, may be deferred until after initiation of hormonal contraceptives if requested by he woman and judged appropriate by he cinicbn. The physical examriation should hdude special reference to blood pressure, breests, abdomen and pelvic organs, mduding cervical cytology, and relevant bboratoiy tests, in case ot undbgnosed, persistent or recurrent abnormal vagrial bleedng. approprbte measures should be conducted to rub out malignancy or other pathology. Women wlh a strong family hbtory ol breast cancer or who have breast nodules should be monlored wih particular care. 3. Upld Disorder* Women who are being treated tor hyperlipidembs should be Mowed closely it hey elect to use ORTHO EVRA*. Some progestins may elevate LDL teveto and may tender he control of hyper lipidembs more difficult. 4. Uver Function: It jaundice develops in any woman using ORTHO EVRA®, he medication should be dbcontriued. The hormones In ORTHO EVRA® may be poorly metabolized ri patients wih impaired liver function. 5. Fluid Retention: Steroid hor mones like tho6e ri ORTHO EVRA® may cause some degree ol ttokt retention. ORTHO EVRA® should be prescribed wih caution, and only wlh careful monitoring, in patients wih conditions which mkht be aggravated by fluid retention. 8 Emotional Meonterc Women vho become significantly depressed while using combination hormonal contraceptives such as ORTHO EVRA® should slop the medication and use another method of contraception ri an at tempt to determine whether the symptom b bug rebted. Women wlh a hßtoiy m depression should be carefully observed and ORTHO EVRA® dbcontriued I significant depression occurs. 7. Contact Larne* Contact bne wearers mho develop visual changes or changes ri tens toE erance should be assessed bv an ochthalmoioaßt 8. Drug Intaracßona: Chances inrxininicßrtivrr Etlectaranesa Associated with Co-Admribtration ol Other Druas: Contraceptive effectiveness may be reduced when hormonal contraceptares are co-adminbtered wih some antibiotks, a crisis in the way men are per ceived.” For Braxton, the challenge will be a learning experience and an addition to the portfolio he will need when applying to graduate school at N.C. State University. “My project has taken off well,” Braxton said. “It shows that I have a business and managerial sense as well as design and aesthetic skills. I can prove that I can access what the public needs and wants.” Jeff Reid, executive director of UNC’s Center for Entrepreneurial Studies, said he is enthusiastic about the start of the program. “The student interest has been phenomenal,” he said. “We’ve put together a great marketing blitz.” Junior business major Bart Welch, student chairperson of the Carolina Challenge, said student fc ATTENTION | *1; tj Da you have —Wnrane Heafadas? North Carolina Clinical Research is seeking participants for a migraine research study who meet these qualifications: ’ Suffer with migraines at least 2 times MMMmHMRH a month Eligible participants will receive at no cost; • Office Visits ' • Research Medication • Study-Related Physical Examination • Compensation up to $150.00 NC Clinical Research - Dr. Craig LaForce and Dr. Karen Dunn, Board Certified in Allergy and Immunology NORTH CAROLINA “Where patient care and the future of ■■■ medicine come together." g News participation has been more than he expected. “We have about 400 people on our online listserv, which was sur prising because we expected it to be a hard push,” Welch said. Since September, neurobiology graduate student Lauren Anderson has been working with administra tors at UNC and Johns Hopkins University on a housing develop ment and community program as her business project for the chal lenge. Because she is in competition, she can’t reveal much, but her proj ect involves community organiza tions like the Boys and Girls Clubs and looks at urban renewal. “I’m not working closely with one particular company because I’m trying to keep the idea open,” she said. “I don’t want it to be spe anflftrigate,artteonvutsants, and other dugs that ricrease metabolism of oontaceptke steroids. Tbb could resut in unintended pregrancy a breaktbrougft bteedrig. Examples include barbi turates, griseofuMn, rifampin, phenytxitazone, phenytoin, carbemazephe, febamate, oxcar bezeprie, topirvmate and possibly wilh ampicilin. The propoeed mechanism ot hteraction ot artbtotics to different from that ot Hirer enzyme-inducing dugs. Lterature suggests posable interactions with the concomitant use ot hamonal cartracepftyes and ampicilin or telracy drie. b a pharmacokinetic drug interaction study, oral admrihtratton of tetracydrie HCI, 500 mg q.i.d. for 3 days prior to and 7 days duringwear of ORTHO EVRA® did not significantly affect the pharmacokhetics ot norelgestromh or EE. Several ot the anti-HIV protease hhbitors have been studied with co-admhistration ot oral combination hormonal contraceptives; significant changes (increase and decrease) ri the mean AUC of the estrogen and progesth have beer noted ri some cases. The efficacy and safety of oral contraceptive products may be affected: it is unknown whether this applies to ORTHO EVRA®. Healhcare professionals should refer to the label of the individual anti-HIV protease inhibitors for further drug-dug hteraction informatkn. Heibal products contaririg SL John's Wort (hypericum perlcratum) may riduce hepatic enzymes (cytochrome P 450) end p-glycoprotein transporter and may reduce the for ethinyl eelradtol by aroximatety2o%. Ascorbic add and acetaminophen may Increase plasma ethinyl estradiol levels, possbly by hhWbon of conlugstlon. CYP 3A4 hhbitors such as Iraccnazote or ketoconazote may ricrease plasma honnene levels, damp* in wanna imuc ol Co-Administered Drugs: Combhation hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may hhbit the metabolism ol other oompounds. hcreased plasma concentrations ot cydosporrie, prednisolone, and thexphyllrie have been repaled wih concomitant administration of oral contraceptives, h addition, oral cortracopbves may riduce the conjugation ol rther compands. Decreased plasma concentrations ot acetaminophen and ricreased clearance of temazepam, salicylic add, motphiie and ctoflbricadd have been noted when these dugs were admriistered wlh oral cartraceptlves. Although norelgestromh and its metabolites hhbit a variety of P 450 enzymo6 h human Iver mlcro6omes, the cinical consequence ot such an interaction on the teveto ot olher concomitant medications Is Neely to be hsignificanUJhder the recommended dosing regimen, the ri vivo concentrat tons of norelge stromh and Is metabolites, even at the peak serum levels, are relatively low compered to the rihblory constant (Kl) (based on resuts ol in vitro studies). Health care professionals are advised to also refer to prescribing Information ol co-admiitotared drugs for recommendations regardhg management ot ccncomlart therapy. Glntaractlons With Laboratory Tost* Certari endocrine and liver function tests and blood components may be affected by hormonal contraceptivee: a. ricreased prothrombin and factors VII. VII, K, and X; decreased antltftrom bri 3; increased norephephrhe-hduced platelet aggregabilly. b. Increased thyroid bridrig gtobuki (TBG) leading to increased chcutotrig total thyroid hormone, as measured by protein bound iodrie (PB|, T 4 by cobmn or by radioimmunoassay. Free 13 resin uptake to decreased, reflecting the elevated TBG, tree T 4 concentration Is unaltered, c. Other binding proteins may be elevated ri serum, and. Sex hormone binding globulhs are ricreased and result ri elevated teveto ol total drculating endogenous set steroids and corticoids; however, tree or biologically aettee teveto either decrease a remain unchanged, e. Triglycerides may be ricreased and teveto of various other iprds and llpcproteris may be affected, t. Glucose tolerance may be decreased, g. Seram folate levels may be depressed by hormaral contraceptive therapy. This may be of ctibal significance it a woman becomes pregnant shortly alter disoorttnuhg ORTHO EVRA®. 16 Cardnoganaata: No carcinogen blty studies were conducted wlh norelge stromh. Howeva, bridghg PK studies were conducted usrig doses and NGM/EE which were used previously ri the 2-year rat carcinogenicity study snd 10-yeer monkey tadcity study to support the approval of ORTHO-CYCLEN and ORTHO TRI-CYCLEN under NDAs 19653 and 19697, respectively, the PK studies demonstrated that rats snd monkeys were eiposed to 16 and 8 times Die human exposure, respectively, wlh the proposed ORTHO EVRA® transdermal contraceptive system. Norelgeslromri was tested rih-vftromutagentoly assays sactertal plate incorporation mutation assay, CHO/HGPRT mutation assay, chromosomal aberration assay usrig culured human peripheral lymphocytes) and In one in-wtvo ted gat mkronucteus assay) and found to have no genotexicpotortlaL See WARNINGS Section. 11. Pregnancy: Pregnancy Category X See CONTRAKOICATIONS and WARNNGS Sections. Norelgestromin was tested lor its reproductive toxicty ri a rabbit developmental toxicity study by the SC route ol administra tion, Doses of 0,1,2,4 and 6 mg/kg body weight which gave systemic exposure ot approxi mately 25 to 125 times the human exposure wlh ORTHO EVRA®, were administered dally on gestation days 7-19. Malformations reported were paw hyperttexion at 4 and 6 mg/Vg and paw hyperextension and deft palate at 6 mg/kg. 18 Nuralng Mother* The effects ol ORTHO EVRA® In nursing mothers have not been evaluated and are unknown. Small amounts of combhation hormonal contraceptive steroids have been Identified ri the mik of nurerig mothers and a tew adverse effects cn the chid have been reported, ridudhg jaundice and breast enlargement. In addition, combination hormonal contraceptives given ri tie postpartum period may interfere with lactatkh by decreashg the quantity andqualKyof breast milk, long term followup ot infants whose mothers used combhation hamonalcortraceplives while breast feeding has shown no deleterious effects. However, the nursing mother should be advised not to use ORTHO EVRA® but to use other forms cf certraceptkn until she has com pletely weaned her chid. 13. Pad able Us* Safety and efficacy of ORTHO EVRA® have been established ri women of reproductive age. Safety and efficacy are ejected to be the same tor post-pubertal adolescents under the age of 16 and for users 16 years and older. Use ot this product brtore menardre Is not indicated. 14. Geriatric Us* This product has nrt been stud ied In women over 65 years ol age and is not ridicated ri this population. 15 Sexually Transmuted Disease* Patients should be counseled that this product does not protect against HIV ritectlon (ACS) and other sexuata transmitted diseases. 18 Patch Adhesion: Eipertance wfhmae than 70,000 ORTHO EVRA® patches worn for contraception for 6-13 cycles showed that 4.7% of patches were replaced because they either tel off (1.8%) a were patty detached (89%). Similarly. In a smal study of patch wear under conditions ol physical exertion and vari able temperature and humidity, less than 2% ol patches were replaced la complete or partial detachment. If the ORTHO EVRA® patch becomes partially or completely detached and remans detached, hsufficiert drag delivery occurs. A patch should not be re-applied it Kis no longer sticky, I it has beoome stuck to itsel or another surface, it It has other material stuck to I, or It It has become loose or fallen off before. Ia patch cannot be re-applied, anew patch should be applied immediately. Supplemental adhesives or waps should not be used to hold the ORTHO EVRA* patch in price. If a patch is partially or completely detached tor mao than one day (24 hours or more)Oß i the woman Is not sure how long the patch has been detached, she may not be protected from pregnancy. She should stop the current contraceptive cycle and start anew cycle immediatey by applying anew patch. Back-up contraception, such as con doms, spermicide, a diaphragm, must te used lor the first week ot the new cycle. INFORMATION FOR THE PATIENT: See Patient Package Insert. ADVERSE REACTIONS: The most common adverse everts reported by 9 to 22% ot women usrig ORTHO EVRA® in clinical trials (N= 3,330) were the folowhg, ri order of decreasrig incidence breast symptoms, headache, application site reaction, nausea, upper respiatory infection, menstnial cramps, and abdominal pain. The most Ireojent adverse everts leadrig to discontinuation ri 1 to 2.4% ol women usrig ORTHO EVRA® ri the trials Included (he tdlowrig: nausea and/a vomiing, application site reaction, breast symptoms, headache, and emotional labifty. Listed below are adverse events that have been associated with the use of combination hormonal caitracoptlves. These are also likely to apply to combination tranadermal hormonal contraceptives such as ORTHO EVRA®. An haeased risk of the folowrig serious adverse reactions has been associated with the use ol combriation hormonal contraceptives (see WARNINGS Section): 1. ThrombophteMto and venous thrombosis with or without emboltom 2. Arterial thromboembolism 3. Pulmonary embolism 4. Myocardial Warden 5. Cerebral hemorrhage 6 Cerebrallflrombo6to 7. Hyperteneion 8. Galbiadder disease 9. Hepatic adenomas or benign liver tumors There is evidence ol an association between the toltowrig conditions snd the use ot oombria tion hormonal contraceptives: 1. Mesenteric thrombosto 2. Retrial thrombosis The folkwrig adverse reactions have been reported ri users ol combriation hormonal con traceptives and are beteved to be drug-related: I.Nausea2.Vomiting3. Gastrointestinal symp toms (such as abdominal cramps and bloatrig) 4. Breakthrough bleeding 5. Spottlng6. Change ri menstnial flow lAmenartieaßTemporary Werti*y after dtoconlriuattonol treatment 9. Edema 10. Melasma which may persist 11. Breast Oranges: tenderness, enlargement, secretion 12. Change in weight (increase or decrease) 13. Change in cervical erosion and secretion 14. Diminution in lactation when given immediately postpartum 15. Cholestatic jaundice 16 Migraine 17. Rash (allergic) 18. Mental depression 19. Reduced tolerance to carbohydrates 20. Vaginal candidiasis 21. Change in comeal curvature (steepening) 22. Intolerance to contact tenses The following adverse reactions have been reported ri usere ol combination hormonal contraceptives and a cause and effect association has been neither confirmed nor reluted: 1. Pre-menstnral syndrome 2. Cataracts 3. Changes in appetite 4. Cystitis-like syndrome 5. Headache 6. Nervousness 7. Dizziness 6 Hirsutism 9. Loss ol scalp hair 10. Eiythema multilorme 11. Erythema nodosum 12. Hemorrhagic etuption 13. Vaginitis 14. Porphyria 15. Impaired renal function 16 Hemolytic uremic syndrome 17. tale 18 Changes ri libido 19. Colitis 20. Budd-Chlan Syndrome OVERDOSAGE: Serious ill effects have not been reported loßowing accidental rigestton ol Iwge doses tfhamaral contraceptives. Overdosage may cause nausea and vomiting, andwthdrawal bteedrig may occur in females. Ghren the nature and design ol the ORTHO EVRA® patch, It Is unlikely that cverdosage will occur. Serious 111 effects have net been repoted folowlng acute rigestton ot large doses of aal contraceptives by young children, ri esse of suspected overdose, all ORTHO EVRA® patches should be removed and symptomatic treatment given. ORTHg^?cNEIL ORTHO-McNEII PHARMACEUTICAL, INC. Raritai, New Jersey 08869 ©OMP2OCI Revised: May 2003 631-10660-2 B cific to Chapel Hill” Junior business major Justin Wade also is vying for the prize, using his experience in the com puter services industry to back his team’s efforts. “The Carolina Challenge is a great opportunity to learn some things we wouldn’t catch on our own,” he said. Along with three other students, Wade is working on a computer soft ware and diagnostics repair compa ny he started a few years ago. The group plans to launch the company sometime during the school year and to continue working on it during the summer, regardless of the competition’s outcome, Wade said. The possibility of winning more than $27,000 does act as an incen tive for the group Wade said it would be a tremendous help in launching the company. Student participants in the Carolina Challenge are not only required to write their plan but also must interact with their target Students hover above standards Class stresses hands-on math } science BY TANNER SLAYDEN STAFF WRITER A group of eighth-graders rode hovercrafts around the hallways of McDougle Middle School on Tuesday morning, yelling and cheering on their friends —and their teachers didn’t stop them. ©p Sailg ®ar liM market an experience meant to provide valuable skills for prospec tive business majors. But Welch stressed that the Challenge is not only for business majors. “The Carolina Challenge is important for all students,” he said. “Entrepreneurship makes the world go ‘round.” Braxton agreed that the Carolina Challenge is not only a beneficial experience for business majors. “There’s no reason not to do the Carolina Challenge,” he said. “There’s so much growth potential for everyone.” Students’ enthusiasm for the project has survived the begin ning weeks and as their projects take off, their determination is increasing. Anderson plans to complete her project in spite of any obstacles, she said. “Whether I win or whether I get the money, I will do this.” Contact the Features Editor atfeatures@unc.edu. “I only ask the students to be quiet for the first three minutes and the last three minutes,” said Peggy Dreher, the teacher of the Activities in Math and Science class. “This class breaks all the rules.” AIMS is an applied elective that encompasses math, science and a Me bit of everything else, she said. The program, found in almost 40,000 schools nationwide, was developed by the AIMS Education Foundation, a nonprofit organiza tion. Its activities are aligned with key math and science standards, including many state standards. “I have never been in a class where we get to ride on hovercrafts,” said eighth-grader Austin Crook. The students not only get to ride on hovercrafts they also get to make them. Each contraption was built out of plywood, a shower curtain, duct tape and engines that came from vacuum cleaners and leaf blowers. “I liked building the hover craft more than riding on it,” said eighth-grader Jessica Todloski. “It is fun to build and be creative, and I could do it again. The materials are basic enough.” Since the seventh-grade writing test and a special African drum per formance for sixth-graders were tak ing place Tuesday during the second period AIMS class, the students had the hallway to themselves. They raced and bumped into one another, and one group’s Barracuda blower engine was so strong it bent the plywood. “You have to strategically cut the holes so enough air gets out and doesn’t rip the plastic,” explained eighth-grader Brian Miller. “At first I didn’t think we could do it, then I was surprised that it worked.” The class has received a good amount of attention for its endeav or. School officials, students and newspapers have come to watch their inventions at work. “Everyone wishes they were in this class,” said eighth-grader Mariana Hernandez. “And we don’t get in trouble when the principal walks by.” The class also had a “Hovercraft Assessment” test that incorporated creative writing into the classroom. The students had to come up with a word or phrase for each letter of the alphabet that related to what they learned during the exercise. “The test wasn’t too hard,” Crook said. “The hardest part (of the class) is choosing people you work well with. It helps prevent fights.” The sixth period class was split into one girl group and two boy groups, and each group experi mented with using gas and elec tric engines for the hovercraft, Hernandez said. The groups competed by taking their “giant air hockey pucks” on a obstacle course, Hernandez said. “The girls won, and we sort of rubbed it in (the boys’) faces after ward,” she said. Dreher said that their hover crafts are “works of art,” but that the class is more than just hover craft building. She said the class has made eggs bounce, prepared candy, operated a business and put together a maze out of junk. It is also getting ready to build a roller coaster. This class is hands-on,” said eighth-grader Gabe Gran. “She isn’t showing us what to learn we are experiencing it ourselves.’? Contact the City Editor at citydesk@unc.edu.
Daily Tar Heel (Chapel Hill, N.C.)
Standardized title groups preceding, succeeding, and alternate titles together.
Nov. 10, 2004, edition 1
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