Eetiiizine HCI For Seasonal and Year-round Allergies and Chronic Idiopalhic Urticaria. Due caution should be exercised when driving a car or operating potentially dangerous machinery. BRIEF SUMMARY mm? (CEraraw HYDHOCHUWBE) TMUTS AND SYBUP FOR ORAL USE (FOR FUU PRESCRIBING INFORMATION, CONSULT PACKAGE INSERT) CONTRAINDICATIONS ZYRTEC is contraindicated in those patients with a known tmersensitivity to it or any of its ingredients or rryrjroxyzine. PRECAUTIONS Activities Requiring Mental Alertness: In clinical trials, the occurrence of somnolence has been reported in some patients taking ZYRIEC: due caution should therefore be exercised when driving a car or operating potentially dangerous machinery. Concurrent use ol ZYRIEC with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment ol CNS performance may occur Drag-tog IriinctiMr No clinically significant drug interactions have been lound with theophylline at a low dose, azithromycin, pseudoephedrine, keteonazole, or erytnromycin. There was a small decrease in the clearance ol cetirizine caused by a 400 mg dose ol Iheophylline; it is oossirjle that larger theo phylline doses could have a greater effect Canlnogmtdi, Mmnimill ind ImpilmMiH at F«rtHHy: No evidence ol car- cinogenicity was observed in a 2-year carcinogenicity study in rats at dietary doses up to 20 mg/Vg/day (approximately 10 times the maximum recommended human daily oral dose on a moAn 2 basis). An increased incidence ol benign liver tumors was tound in a 2-year catcinogenicity study in male mice ata dietary dose o( 16 mg/kg/day(approximalely 4 limes tfiemaximum recommended human daily oral dose on a mg/mz basis). The clinical significance of these findings during long-term use ol ZYRTEC is not known. Cetirizine was not mutagenic in the Ames test, and not clastogenic in Die human lymphocyte assay, the mouse lymphoma assay, and m vivo micronucteus lest in rals. No impairment ol fertility was found in a fertility and general reproductive performance study in mice at an oral dose ol 64 mgAg/day (approximately 26 times the maximum recommended adull human daily oral dose on a mg/m 2 basis). Pngnwicy Category B: Cetirizine was not teratogenic in mice, rats and rabbits at oral doses up to 96,225. and 135 msAg/day (or approximately 40,160, and 215 limes Ine maximum recommended adult human daily oral dose on a rnjtn 2 basis), respectively. There are no adeouale and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, ZYRTEC should be used in pregnancy only II clearly needed. Nunlig MoMm: Retarded pup wo.nl gain was lound in mice during lactation when dams were given Wirizine at 96 mgAg/day (approximately 40 times the maximum recommended adull human daily oral dose on a mg/tn' basis). Studies in beagle dogs Indicate that approximately 3% ol the dose is excreted in milk. Cetirizine has been reported to be excreted in human breast milk. Because many drugs are excreted in human milk, use ol ZYRTEC in nursing mothers is not recommended. Gvtltrk Un: In placebo-controlled Irals, 186 patients aged 65 to 94 years received doses ol 5 to 20 mg ol ZYRTEC per day. Adverse events were similar in this group to patients under age 65. Subset analysis ol efficacy in this group was not done. PMMric Un: The safety ol ZYRTEC, at daily doses ol 5 or 10 mg, has Deen demonstrated in 376 pediatric patients 6-11 years ot age in placebo-controlled trials lasting up to lour weeks and in 254 patients in a non-placebo-controlled 12 week trial. The effectiveness ol ZYRTEC lor me treatment of seasonal and perennial allergic rhinitis and chronic imopathic urticaria in this pediatric age group is oased on an extrapolation ol the demonstrated efficacy ol ZYRTEC in adults in these conditions and the likelihood that Die disease course, paltiopliysiology and the diug's eflect are substantially similar between these two populations. The recommended doses lor the pediatric population are based on a cross-study comparison ol the pnarmacokinelics and pharmacodynamics ol cetirizine in adults and pediatric subjects and on the safely profile ol cetirizine in Dolh adults and pedialric patients at doses eoual to or higner than the recommended doses. The cetirizine AUC and Cmax m peaiatric subjects 6-11 years ol age who received a single dose of 10 mg of cetirizine syrup was eslimaied lo be intermediate between that observed in adults who received a single dose ol 10 mg ol celirizine tablets and those who received a single dose of 20 mg ol cdirizine tablets. ADVERSE REACTIONS Controlled and uncontrolled clinical trials conducted in the United States and Canada included more than 6000 patients aged 12 years and older, with more than 3900 receiving ZYRTEC at doses ol 5 lo 20 mg per day. The duration ol treatment ranged from 1 week to 6 monlhs with a mean exposure of 30 days. Most adverse reactions reported during therapy with ZYRTEC were mild or moderate. In placebo-controlled trials, the incidence ol discontinuations due lo adverse reactions in patients receiving ZYRTEC 5 mg or 10 mg was not significantly different from placebo (2.9% vs. 2.4%. respectively). The most common adverse reaction in patients aged 12 years and older that occurred more Irequently on ZYRTEC than placebo was somnolence. The incidence ol somnolence associated with ZYRTEC was dose related. 6% in placebo, 11% at 5 mg and 14% at tOmg Discontinuations due to somnolence lor ZYRTEC were uncommon (1.0% on ZYRTEC vs. 0.6% on placebo). Fatigue and dry mouth also appeared lo be treatment-related adverse reactions. There were no differences by age, race gender or by body weight witn regard to the incidence ol adverse reactions. Table 1 lists adverse experiences in patients aged 12 years and older which were reported lor ZYRTEC 5 and 10 mg in controlled clinical trials in the United Stales and that were more common with ZYRTEC than placebo Tito 1. A*Mn» EipttlMCM taunted \» P»U«m n* 12 »nn M* <Mn to PUMte-CMHIW MM SttM ZYRTEC Tnih (Mubnuffl DOM ot 10 rog) •( RUM ot 2% a GnrtM (Pwort tacUM), ZYRTEC (IUOM)» PHerto (ft.1612) rMMdivtly: Somnolence (137% vs 6.3%). Fatigue (5.9% vs 2.6%); Dry Moutn (5.0% vs 2.3%): Pharyngitis (2.0% vs 19%), Dizziness (2.0% vs 1.2%). In addition, headache and nausea occurred in more than 2% of the paients but were more common in placebo patients Pedialric studies were also conducted with ZYRTEC. More than 1300 pedi- alric patients (6 to 11 years) with more than 900 treated wild ZYRTEC al doses 0(1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in tne United Stales. The duration ol treatment ranged from 2 to 12 weeks. The majority ot reported adverse reactions reported in pediatric patients (6 lo 11 years) wilh ZYRTEC were mild or moderate. In placepc-con- Irolled trials. Ihe incidence ol discontinuations due lo adverse reactions in pediatric patients receiving up to ZYRTEC 10 mg was uncommon (04% on ZYRTEC vs 1.0% on ptobo) Table 2 lists adverse experiences which were reported for ZYRTEC 5 and 10 nig in pedialric patients (6 to 11 years) in placebo-conlrolied clinical Irials in the United States and were more common with ZYRIEC than placebo. Ot these abdominal pain was considered treatment-related and somnolence appeared lo be dose related. 1.3% in placebo 19% at 5 mg and 4 2% at 10 mg. Tikll 2. Mmn* fifUluut HwinW In PtttMc PlilM* (f lo It pin) In Plaato-CoabolM UuM SUM ZYHTEC Triita (5 M 10 ngtoM) Wkkk Occumd M i Frn»Mey m a m, I* EWMt ttw S mg or UM 10 m( ZYRTEC Srom. Md Man FntuMtty Tton in U» Ptaako Group. ZYRTEC 5 mg (N.161), 10 mg (N-215) w Pfutto (M-3M): Heaaache (11.0%, 5 mg, 14.0%. 10 mg: 12.3%. pteM); Ptavngilis(6.2%, 5 mg: 28%. 10 mg, 2.9%. placebo); Abdominal pain (4.4%,5 mg: 5.6%, 10 mg; 1.9%. placebo); Coughing (4.4%, 5 mg; 2.8%, 10 mg, 3.9%. placebo), Somnolence (1.9%, 5 mg; 42%. 10 mg; 13%. placebo); Diarrnea (3.1%, 5 mg; 1.9%, 10 mg, 13%. placebo), Episaxis(37%,5mg, 1.9%, 10 mg; 2.9%, piaceoo); Branctapasm (3.1%, 5 mg.1,9%. 10mg; 1.9%, placebo); Nausea (19%, 5 mg; 2.8%, 10 mg: 1.9%. placebo); Vomitjng (25%. 5 mg; 2 3%, 10 mg: 1,0%, placebo). The Mowing events were observed infrequently (less than 2%), in eilner 3982 adults and children 12 years and older or in 659 pediatric (6 to 11 years) patients who received ZYRTEC in US Irials inducing an open adull study ol si* months duration; a causal relationship with ZYRTEC administration has not been established. AMmmk Ntnmn Syttun: anoiexia, urinary retention, flushing, increased salivation ory mouth CwdkNiicular. palpitation, tachycardia, hypertension, cardiac lailure. Cwlral Md Ptriiktnl Ntnout Syttina: pareslhesia. coniusion. hvperkinesia. hypenonia migraine, tremor, vertigo, leg cramps, ataxa dysphonii abnormal coordination, hyperesthesia, nypoeslhesia myelitis, paralysis, ptosls. (witching, visual Held detect, syncope, dizziness. GutroMttUul: increased appetite, dyspepsia, abdominal pain, dianhea. llatuance. constipation, vomiting, iterative stomati- tis, aggravated tooth caries, slomalilis. tongue discoloration, tongue edema, gastritis, rectal hemorrhage, hemorrhoids, melena, abnormal hepatic function, eructation GMUtourinaiy: polyuria. urinary tract infection, cystitis, dysuria. hemaluria. micturition Ire- quency, urinary incontinence. Huiteg Mil VMtikular. earache, tinnitus, deafness, ototoxicity. Mct»MUc/NukW«m: thirst. dehydration, diabetes mellitus MmnilMtllttil: myalgia, artnralgia, arlhiosis, arthritis, muscle weakness. PmkWric: insomnia, sleep disorder, nervousness, depression, emotional lability, impaired concentration, aruiely. depersonaiizaiion, paroniria abnoimal thinking ag'lation. amnesia, decreased libido, euphoria Rwyktloiy Spfcn: epistaxis, rhinitis, coughing, txon- cnospasm. dyspnea, upper respiratory tract infection, hypervsililalion. sinusitis, increased sputum, bronchitis, pneumonia respiratory oisoioet HuroducUM: dysrnencnnea, female breast pain, intermenstrual bleeding, leukorinei menonnagia. vaginilis. RfttcukxndolMUil: lymphadenopalny 8kki: pruritus, rash, dry sxin, urticaria acne, dermatitis, aythemalous rash, increased sweating, alopecia. ang,oedema, lurunculosis. oullous eruption, eczema hyperkeralosis, hypertrichosis. pholosensitivity reaction, Photosensitivity toxic reaction, macuiopapular rash, seborrhea. purpura skin disorder, skin nodule. Sydctel Tmtr taste perversion aste loss parosmia. VWw: blindress. loss ol accommodation, eye pain conjunctivitis, xerophlhalmia. glaucoma ocu- 'ar riernoirriage Body u i (Molt: Increased weight, back pain, malaise, lever, asthenia, generalized edema, periorbtol edema. Kripneral edema, rigors leg edema, (ace edema, hct (lashes, enlarged abdorren nasal polyp, pain, pallet chest pain, aarderilal 'ijury. Occasional instances ol transient, reversible hepatic iransaminase elevations have occurred ouririg cetirtiine therapy A single case ot possible drug-induced hepatitis with significant transaminase elevation (500 lo 1000IU/L) and elevated bilirubin has teen reported In foreign markang experience tne foHowina. additional rare, out potential severe adverss events lave been reported: nemoiytic anemia thiombocytcpema. orolacial dyskinesa. seven: liypolension anaphyiaxis. tspatilis. glomerulonephntis, still- Dirtn. and chclestasis. DRUG ABUSE AND DEPENDENCE There is no inlormxion to indicate that abuse or dependency occurs MnZYKTEC OVEHOOSAGE Overdosage has been reported with ZYRTEC In one adull palienl*ho look 150 rog ol ZYRTEC, Ine Calient was somnolent but did not display 1 any olr« clinical signs or abnormal blood chemistry or hemalology results. In an 18- momh-cld pedal'ic pal enl wfio look an overdose ol ZYRTEC (approximaely 180 mg), restlessness and irritability were observed 'miraiy f's *as lolloped by drowsiness. Should overdose occur treatment should be symptomatic ot supportive, taking into account any coreomitaritly ingested medications (here is no known specific anlidole» ZYRTEC. ZYRTEC is not effectively removed oy dialysis and dialysis will be inetfcdive unless a daiyzable agent has been concomilantly ingested. The acute minimal lethal oral doses in nice and rais were 23? arid 562 rnfl/luj. respectively (approximately 55 and 265 limes tne maximum recommended human daily oral dose on a mtj/'m- basis) In rodents. Ihe target ol acute loxioty was ine central nervous system, and the target ol rnultipte- dose loxioly was trie Inw. DOSAGE AND AOMiUtTHATION AMU wd ChUdrM 12 y«4n ud oMir The recommended initial dose ol ZYRTEC is 5 or 10 rng per day in adults and children 12 yeas and older, depending on symptom severity Most pawns m clinical Ms staled it 10 n'o ZYRTEC is given as a single daily dose with or wirjtout food. Tie time of administration nay be var- itd to suit individual patent needs In patienis wilh rjecreased lenal (unction (crealimre clearance 11-31 ml/min). paierfc on liernodal- ysis (creatinine clearance less than / ml/min), and m hepafcally impaired patients, a dose cd 5 mg once daily is lecommended. Children 6 lo 11 yon: lit lecorrtiuxJed init^l dose of ZYRTEC in children aged 6 to 11 years is 5 or 10 mg (1 or 2 teaspoons) once daily depending on syrnplorn severity T!« time ol administration may be varied lo suit individual paient needs. Cetirizine is liaised Iran UCB Pharma Inc. Printed in U S A. 70-4573-00-1 Revised September 1996 CL069A97M-1D © 1997, Plizer Ine SOCIETY What your birth order says about you Most baby boomers are rebellious "laterborns, bent On SOCial Change. BY CHERYL RUSSELL I'.Si. Pbu-uuc«uilc*l» Cruuti F OLLOWING ON THE heels of the so- called Silent Generation, why are baby boomers so noisy? Maybe because so many are younger brothers and sisters. Through an exhaustive scientific investigation, Massachusetts Institute of Technology scientist Frank J. Sulloway concludes that a person's perch on the family tree — firstborn vs. "laterborn" — has a lifelong impact on personality. "The effects of birth order transcend gender, social class, race [and] nationality," Sulloway writes in his 1996 book Bom to Rebel: Birth Order, Family Dynamics and Creative Lives. And one aspect of personality that birth order influences profoundly, he says, is what he calls "revolutionary allegiances." "Because they identify with parents and authority, firstborns are more likely to defend the status quo," Sulloway says. In contrast, "laterborns are more likely to identify with the underdog and challenge the established order." What sends laterborns down this rebellious path? Natural selection, Sulloway says. In the sibling competition for attention and affection, firstborns already fill the role of parents' close allies. Laterborns must search for unoccupied niches in the family. This makes them open to new ideas and more accepting of change. For most of the 20th century, baby booms and busts have succeeded one another like the hills of a roller coaster. Seen in light of Sulloway's conclusions, the lurching social and political change of the past four decades might be due in part to the varying proportions of firstborns in different eras. For example: During the Depression of the 1930s, families averaged 2.5 children. Eldest children were 41 percent of those born — a larger firstborn share than ever before. It's not terribly surprising that this group became the Silent Generation, defending the status quo. Then came the postwar baby boom. Firstborns' dominance retreated as boomers multiplied. Because the parents of baby boomers averaged three and four children, only 32 per- 16 USA WEEKEND • May 9-11,1897 The older, 50-ish boomers now taking the reins of power tend to uphold the status quo. But their youngfir siblings are poised to challenge them. cent of those born in the 1950s are firstborns. Many of the oldest boomers, now entering their 50s, are firstborns. They are "the most tough-minded individuals," Sulloway says, and so may be firm taskmasters as they take over the reins of power in business, political and social arenas. If Sulloway is right, this may help to explain welfare reform, the Contract With America, the rise of the religious right and the crackdown on drugs and smoking. About 10 years down the road, boomers born in the late '50s and early '60s will move into positions of greater power. Many are younger siblings; their openness to change and acceptance of new ideas could provide the impetus to reinvent Social Security, health care and other social systems. Sulloway says lastborns in particular are militant, but not in the same way firstborns are: "Their militancy arises because they are daring, zealous and liberal, not because they are particularly dominant or punitive" like their firstborn siblings. The children of boomers will display an interesting mix of birth-order traits as they grow into adulthood. Because today's families average less than two kids, the proportion of firstborns was 43 percent in 1994, a record level. These children ought to conform to their parents' values, according to Sulloway's research — but those values will depend on which boomers are their parents. The firstborns of firstborn boomers may try to counteract some of the changes instituted by laterborn boomers. But their younger siblings, along with the firstborns of laterborn boomers, soon will come along to stir things up. One factor that could complicate the transition: Today's comparative lack of middleborns, who play the role of mediator and ease the passage from one era to the next. In a world of two- child families, the contrast between firstborns and lastborns could become stark indeed, ca Cheryl Russell is author of How We Live: The Mid-Youth Market (NEW StRAiEcist PUBLICATIONS) and editor of The Boomer Report (Aox WAVE COMMUNICAIIONS COUP). Reprinted with permission: Copyright © 1997, American Demographics.
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