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NASONEX' PRODUCT INFORMATION (mometasone furoate monohydrate) Nasal Spray, 50 meg* FOR INTRANASAL USE ONLY ’calculated on the anhydrous basis BRIEF SUMMARY (For lull Prescribing Information, see package insert) INDICATIONS AND USAGE NASONEX Masai Spray 5G meg s mdcatec tor the treatment of the nasal symptoms ot seasonal allergic and perennial aileron: minu te m adults anc pediatnt patiems 2 vea-s ot age and outer NASONtX Nasal Soray. 50 meg b Seated tor the propnvtaxis of the nasai symptoms of season al allergic rhtnms m adult and adolescent patients 12 -/ears anc Okie- ir patterns wth a known season* allergen that preapiates nasai symptoms o' seasonal allergic rhinitis, initiation of prophylaxis with NASONEX Nasal Spray. 50 meg is -ecommenoec 2 to 4 weeks prior to the anticipated start of the poller season. Safety arc effectiveness ot NASONEX Nasal Spray 50 megm pediatnc patients less than 2 yea" of age nave net ceen established NASONEX Nasal Spray. 50 meg. i$ ndeded for the treatment of nasai potvps m patients *8 years cf age and oide- Safety anc effectiveness of NASONEX Nasal Spray 50 meg tor me treatment ot rasa! polyps m pediatnc patients less than *8 years o* age nave not teen estaWisnec CONTRAINDICATIONS Hypersensitivity to any of the ingredients of ths prepara tion contraindicates its use WARNINGS The replacement ot a systemic corticosteroid with a topical con - costeroic can be accompanied by signs ot adrena* insufficiency and. m addi tion some patients may- experience symptoms of withdrawal ie joint and or muscutar pain lassitude anc depression Careful attention must be given when patients previously treated for prolonged periods with systemic cortico steroids are transferred to topical corticosteroids .vitn careful monitoring for acute acrenai insufficiency m response to stress "his is particularly important in those patients who have associated asthma or other clinical conditions where too rapid a decrease m systemic corticosteroid desmg may cause a severe exacerbation of ther symptoms ft recommendec doses of intranasal corticosteroids are exceeded or if mdMduais are partcuiartv sensitive or predisposed by virtue of recent system: stereo thera py symptoms of hypercortcsm may occur. mcJudmg very rare cases of menstrual regularities acreftorr- lesions and cushmgc-d features’ K such changes occur teptea corticosteroids should oe ascontmuec sioMy. consistent with acceptec pro cedures tor fliscohbnur; oral stemid therapy Persons who are on drugs when suppress the immune system am more sus ceptoie to infections than neafthy mawifluals. Chickenpox arc measles tor exam ine an have a more senous or even fata: course m rorammune children or adults on cortcoflßtefls Ir such children or adults who have not had these diseases particular cate should be taken to avoid exposure How the dose route, ana dura tor. of corticosteroid admmstra&on affects the risk of developing a disseminated infection is net known Tne contribution of the undertymg disease and/or prior corticosteroid treatment to the risk is also not known it exposed tc chickenpox. prophylaxis with vanceaa zoster >nmune gioom (VZIG) may be inflated. i f ecosec to measles, prophylaxis with pooled intramuscular immunqgloDJHn riG i may be inflated .See the respective package inserts for complete VZiG and iG prescribing information i if cruckenpox develops treatment with antiviral agents may be cons,aered PRECAUTIONS General Irtranasai corticosteroids may cause a reduction m growth velocity when admimsterec tc pediatric patients isee PRECAUTIONS Pediatnc Use sectioni in omcai studies with NASONEX Nasal Spray. 50 meg. the development ot localized infections of the nose arc pnarynx with CanMaatocans has occurred only rarefy When such ar infection develops, use of NASONEX Nasai Sp-ay 50 meg snoiXd be discontinued and appropriate loc* or systemic therapy msKutec if needed Nasa : corticosteracs should be used with caution if at all m patents with active or qwescen' tjtertukxis infection of the respiratory tract, or n jntreatec fungai. Bacterial. svsteow vial infections or ocular herpes simplex Rarely immediate hypersensitivity reactions may occur atter me mtranasai administration of mometasone furoate monohydrate Extremely rare instances of wheezing nave been reported 3 are instances cf nasai septum oertoration anc increased intraocular pressure nave aisc been reported fotowng me ntranasai aopi-catior of aemsoiized cortico sfera-cs As win any long-ferm topeai treatment ot the nasal cavitv patents using NASO»€X Nas* Spray 50 meg ove' several months or longer snouto be examinee IMhodcaly to- oossce Ganges n the nasai muccsa Because of me rhCitc'y effect of corticosteroids or wound heakng patients who have experienced recent nasa ; sepr.'um, mcere nasai surgery or nasa- 'rauma should net use a nasal ccrtcoste r oid until heating "as occurred Glaucoma anc cataract formation was evaluated « one controlled study ot 12 weeks' duration and one uncontrolled study of 12 months duration in patients treated with NASONEX Nasai Spray 50 meg at 200 mcgttiy using intraocular pressure measurements and slit lamp examination No significant change from baseline was noted m the mean intraocular pressure measure ments tor the f4i NASONEX-treated patients m the 12-week study as com pared with 141 piaceoc-treated patients No individual NASONEX-treated patient was noted to have developed a significant eievation in intraocular pres sure O' cataracts in this 12-week study Likewise no significant change from baseline was noted m the mean intraocular pressure measurements tor me 139 NASONEX-treated patients m the 12-month study and again no cataracts were detected in these patients Nonetheless nasal and mhaied corticosteroids have been associated with the deveiopnent of glaucoma and/or cataracts Therefore close follow-up s warranted m patients with a change m vision and with a history cf giaucoma tnd'or cataracts When nasal corticosteroids are used at excessive doses systemic cort*- coste'CHd effects such as hvpercorticisn and adrena' suopressior mav appear If such changes occur NASONEX Nasal Spray 50 meg should be dis continued stovry consistent with accepted procedures for discontinuing oral steroid therapy Information tor Patients Pawns De«g treated w*h NASONEX Nas» Spray 50 meg shouc be given the tokowng mtonratwr and instructions Tas information s rtendedteaem the safe and effective use of toemedation ttsrw a disclosure of a -mended or posstte adverse effects s aoents show: use NASONEX Nasai Spray. 50 meg at regular mfertiats isee DOSAGE AND ADMMISTRATION s rr x its effectiveness depends or regular use improvement r nasal symptoms of anergic mms has been snowr tc occur with* 11 hours after the first dose based or one smgtetoose paratei-gmup study of patients man outdoor part setting iparvstextv* anc one environmental exposure umt (EEU) studv anc witen 2 days after the first dose m twe randomized dcudfe-oknc pfacebc-cortrofled parafcj-grouc seasonal allergic mirets studies Maximum benefe-s usualv achieved'.-rthin Ito 2 weeks after initiator of aosmg Patients should take me medcabor as tweeted anc should not increase toe prescribed dosage«an attempt to increase its effectiveness Patents should contact their physician if symptoms dc not improve, or if the condition wors ens. To assure proper use of this nasai spray anc to attain maxanum benefit, patients should read and Mow the accompanying Patents instructions to- Use carefully Administration to young chidren should Oe wed bv an adult Patients should be cautiorec not to spray NASONEX Nasai Spray 50 meg into the eyes or directly onto tne rasai septum Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and patients should also be advised that if they are exposed, medical advice should be sought without delay Carcinogenesis Mutagenesis Impairment ot Fertility In a 2-year carcino genicity study ip Sprague Dawiev rats mometasone ‘uroate demonstrated no statistically significant increase m the incidence of tumors at inhalation doses up to 6" meg. kg (approximately 1 and 2 times the maximum recommended daily mtranasai dose iMBDiD] in adults ;400 meg.' and children (i 00 meg; respec twefy on a meg'n basis) in a 19-montn carcinogenicity study m Swtss CD-1 mice mometasone furoate demonstrated no statistically significant increase m the incidence of tumors at inhalation ooses up tc ’6O meg kg (approximately 2 times the MRDC'-r. adults arc cni c-e- respectively onamCQMl basil Mometasone furoate increased chromosomal aoerrations in an ■ . •- • Chinese hamster cvary-ceii assay but did not increase chrcmoscma: aberrations m an - . Chinese ramste- lung ceil assay Mometasone furoate was not mutagenic n the Ames test or mouse-lvmphoma assay anc was not ciasfogenic .n ar ... mouse mcronucieus assay anc a rat bone marrow chromosomal abemation assay or a mouse male germ-ceil chromosomal abe"atioc assay Mometasone furcate also did not mcuce unscheduled DNA synthesis ' ■ w m rat heoatocvtes Ir, reproductive studies n rats, impairment of fertility was not produced by subcutaneous doses up to : 5 meg'kg ness than the MRDID m adults on a meg/m basis) [NASONExj (mometasone furoate monohydrate) Nasal Spray,somcg* Pregnancy Teratogenic Effects Pregnancy Category C When admtnstefed to pregnant mice rats and rabbits mometasone furcate increased fetal malforma tions The doses that produced malformations aisc dec'eased fetal growth, as measured by lower feta neghts anc ex deayec cssrticancr Mometasone furcate also caused dystocia anc rested implications v/nen administered tc rats during the er: of pregnane. ir mice mometasone furoate caused cief? paiate a: subcutaneous acses of 60 mcgkg and above (less than the MRDID m adults on a megm basis,- fetal sur vival was mcucec at 180 mcgAg (approximately 2 times the MRDID n adults on a meg'm basis) No texoty was observed at 2d mcgkg (less than the MRDID n adults or amegrm bass- In rats mometasone furoate produced umbilical nern.a at topical dermal doses o* 600 meg/kg and above 'approximately 10 times the MROIO in acufts on a meg/m basis i A dose of 300 meg/kg iapproximately 6 times the MROIO m adults on a meg’m oasis' produced delays in ossification, but no malformations in rabbits, mometasone furoate caused multiple malformations eg flexed ‘-ont paws gallbladder agenesis umbilical hernia hvdrocepnatv- at topical oemiai doses of 150 mcgkg and above (approximately 5 times the MRDID in adults or a mcg/m- basis) in an oral study mometasone ‘uroate increased reso'ptions anc caused cleft paiate anchor head malformations i hydrocephaly or domed head) at TOO meg/kg (approximately 30 times .he MPD’iD in adults on a meg.m basisi At 2800 mcg'kg (approximately i l O times the MRDID in adults on a meg m basis) most litters were aborted or 'esorbec No toxicity was observed at 140 mcg'kg i approximately 6 times the MRDID in adults on a meg m basiSi When rats rece-vec subcutaneous coses ol mometasone furoate throughout pregnancy or during the ater stages of pregnane. l 15 mcg'kg -'less than me MRDID m acufts or a meg'm- oasis i caused prolonged anc difficult labor and reduced me number of live births, birth weight anc earn pup survival Similar effects were not observed a 7 5 mcgixg (less than the MRDID in adults on a megm- oasis i There a*e no adequate and wrt-controled studies m pregrant v/omen. NASONEX Nasal Spray 53 meg. -like other corticosteroids, should be used dur ing pregnancy omy it the potential benefits justify the potential risk tc the fetus Experience with oral corticostertucs since meir introduction -r pnamacciogic as opposec to physiwogic doses suggests mat rodents are more prone to teratogenic ertects iron comcostemics man humans In addition because there s a natural 'ncrease in corticosteroid production curing oregnanev most women will require a tower exogenous corticcste'oid dose and many will not need corticosteroid treatment curing pregnane.. Nonteratogemc Effects: Hypcad'enaasm may occur m infants bom to v/omen receiving corticosteroids during pregnancy Such infants shotHC be carefully monitored Nursing Mothers ft is net known if mometasone ‘uroate is exemtec in human milk Because other corticoste'cics are excreted m human milk, caution snouic be usee when NASONEX Nasal Spray 50 meg is admimsterec tc nursing women Pediatric Use: Controlled clmical studies have shown mtranasai cortico steroids may cause a reduction m growth velocity m pediatric patients This effect has been observed m the absence of laboratory evidence of hvcothaiamic-piiu nary-adrenal (HPA) axis suppression suggesting that growth velocity -s a more sensitive indicator of systemic corticosteroid exposure m pediatric patients tnar some commonly used tests of HPA axis function ’he tong-tem effects ot this reduction in growth velocity associated with mtranasai corticasteroids including the impact on fin* aduf? height, are unknown ’he potential 'or catch up growth toftowmg discontinuation of treatment with intranasal corticoste r o«Js has not been aoequatetv studied ’ne growth of pediatnc patients receiving mtranasai . corticosteroids mdudmg NASDNtx Nasai Spray 5C meg should be monitorec routtnety (eg. via stadtometry) The potential grov/to effects ot prolonged treat mem shouic be weighed against cfcncal benefits obtained and the avaiiaoikty of sate and effective noncorticcsteroid treatment alternatives Tc minimize the sys temic effects of -ntranasai cortostero;os including NASONEX Nasai Spray 50 meg each patient should be titrated to hivher wrest effective dose Seven hunpred and twenty (720) patients 3 to 11 years ot age with alfergic rhinitis were heated with mometasone furoate nasal spray 50 meg ’OO meg fotai daily dose- m controlled cimcai trials see CLINICAL PHARMACOLOGY Clinical Studies section) Twenty-eight .28- salients 2 to 5 years of age with anergic rhinitis were treated with mometasone furoate nasai spray 50 meg HOG meg total daily dose) m a controlled trial tc evaluate safer -see CLINICAL PHARMACOLOGY. Pharmacokinetics section- Safety and effect'veness m chil dren less than 2 years of age with allergic rhinitis and in children less than ’8 years o? age with nasai polyps nave not been established A clinical study has been conducted tor f year m pediatnc patients with allergic rhinitis i ages 3 to 9 years i tc assess the effect of NASONEX Nasal Sprav. 5G meg -t 00 meg total daily dose) on growth velocity No statistical significant effect on growth vetoaty was observed tor NASONEX Nasai Spray. 50 meg comparec to piacehc No e*vicence or clinically relevant HPA axis suppression was observed following a 30-minute cosyntropm intuswn ’he potential of NASONtX Nasai Spray 50 meg to cause growth suppression in susceptible patients or when given at ingner dcses cannot oe luiec out Geriatric Use A total of 28C patients above 64 years ot age with allergic -hmitis or nasai ootyps -age range 64 tc 86 years: nave been treated with NASONEX *iasai Spray 50 meg for up to 3or 4 months, respectively r he adverse reactions report ed m this population were similar m type and incidence to those reported by younger patients ADVERSE REACTIONS Allergic Rhinitis. Ir. controlled US and international clin ical studies a rot* ot 321 C adurt and adolescent patients ages 12 years and oider with aHercic rtuntis received treatment '.-nth NASONEX Nasal Sprav. 50 meg at doses ot 5C ic 80G meg-day ’he maionty of patients r = 21C3'- were treated with 200 meg-day in controlled US and international studies a total of 990 pediatnc patients iaaes 3 to 11 years) with afergic rhinitis received treatment with NASONEX Nasai Spray. 50 meg. at doses at 25 to 200 meg/oay ’he majority of pediatnc patients (720) were treated with fOO meg/da. A total ot 513 aoult. ano •escent and pediatric patients nave peer treated lor ‘ rear cr longer 'he overa'i incidence of adverse events 'cr patients treated with NASONEX Nasai Spray 50 meg was comparable to patients treated with the vehicle placebo Also adverse events cid not differ significantly based or age sex or race Three pecen: cr less of patients in ciimcai trials discontinued treatment because o' adverse everts this mte was similar for the 'vehicle and active comparator. All adverse events regardless of relationship to treatment -eoGrted by or more tr adult and adolescent patients ages 12 ./ears anc cider '/ho received NASONEX Nasai Spray. 5G meg. 200 meg/day ana by pediatnc patients ages 3 to 11 years who received NASGNEx Nasal Spray. 50 meg ’OO meyday n clinical tnais vs piaceDG and that were more common, with NASCNEx Nasai Spray 50 meg than placebo, are displayed ;n the able below ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL ALLERGIC AND PERENNIAL ALLERGIC RHINITIS (PERCENT OF PATIENTS REPORTING) Adult and Aflciescem Patterns Pediatnc Patients Ages 12 years anc ower 3 tc n years NASCNEX VEHICLE NASCNEX VEHICLE 200 meg PLACEBO ‘OO meg PLACEBO in = 21031 (ns 1671) n = 374) ,n.- 376) Heaflache 26 22 i_7 18 rai infection 14 n 8 9 Pharyngitis ]2 10 10 iQ Epistaxis Bfooc- Tinqed Mucus 11 6 3 9 Coughing 7 6 13 Upper Respiratory Tract Infection 6 2 5 4 Dysmenorrhea 5 3 1 G Musculoskeletal Pam 5 3 1 ’ Sinusitis 5 3 4 4 )mitmg 1 1 5 4 Qthe r adverse events wh“Ch occureo r ess than s°« but greater than or eaua tc 2 : » of rremetasone tumate adult and adolescent patients -ages 12 years anc omen treated win 200-ncg acses recarciess of relationship to treatment) and more treouendy than ir the placet)-: group included arthralgia asthma bronchitis chest par conjunctivitis danhea. dyspepsia, earacne flu-iike symptoms, mvaigia nausea anc rhinitis Other adverse events which occurred in less than 5% but greate- than oi eauai to 2% of mometasone furoate pediatnc patients ages 3to f 1 years treated with 100-mcg coses vs piacehc - regardless of relationship to treatment) and more fre quently than m the piaceDo group included, darmea. nasai irritation otitis media and wheezing. The adverse event regardless of relationship to treatment) reported by s“e of pediatnc patients ages 2 tc 5 vears who received NASCNEX Nasal Spray 50 meg. *OO mcg'dai m a clinical trial vs piaceoc including 56 subjects (28 each NASONEX Nasal Spit/ 50 meg and piacetoi arc mat was more common with NASONEX Nasai Sprav SO meg than placebo induced upper respirator tract -ntection (7% vs 0V respectively) T ie other adverse even: which occurred ir less than 5% but greater than or equal to 2S of mometasone furoate pediatnc patients ages 2 tc 5 years treatec with tOC-mcg doses vs piacehc - regardless of relationship to treatment and more frequently tnar ,n the piacebc group included skin trauma tosa/ Polyps n controtlec cmical studies the types ot adverse events observed in patients with nasai polyps were simitar to those observed 'cr patients win allergic rhinras A tot* ot 594 adult patients rages '5 tc 36 .ea r s received NASONEX Nasai Soray 5G meg at coses of 2QG meg once or twice daily for up tc 4 months lor treatment or rasa poiyps The overall mcioence of acveree events tor patients treated with NASONEX Nasai Sprav 50 meg was comparable tc patients treated with the piacebc except 'or epistaxis .when was 9% for 200 meg once cany 13S tor 200 meg twice oariy ana s°« for placebo Rare cases cf nasal ulcers ano nasal and ora; candicias;s were also reported m patients treatec with NASONEX Nasai Spr3y 50 meg. onmarily m patients heated tor longer than 4 -reeks in postmarketing surveillance o' this product cases of nasal burning anc citation, anaphylaxis and angioeoema aid rare cases of nasal septa; per foration nave been reported Disturbances of taste and snier have been reported very rareiy OVERDOSAGE ’here are no data available on the effects of acute or chronic over oosage witn NASONEX Nasai Spray 50 meg Because ot ow systemic bicavailaoi:- 1y and ar absence of acute drug-reiatec s-zstemic findings m cknical studies over dose s unimety to require any therapy other than observation .ntranasai adminis tration of f6OO mm (4 times the recorrnenoed oose of NASONEX Nasal Spray -50 mcg.i daiiv for 29 cays fc healthy human volunteers, was :ie ß toratea with nc increased incidence of adverse events S ngie ntranasai doses up to 49X meg ha-re Deer studies m human volunteers with no adverse elects reported Single orai ooses up to BCOC meg have been studied m human vo-unteers with nc adverse effects reported Chronic twraosage with anv comcoste'c.d mav result in signs or symptoms of hypercortiasm :see PRECAUTIONS -cute overcosage f this dosage tom $ unlikely since one bottie of NASGNEX Nasai Sprav 50 meg mn tarns approximately 3500 meg of mometasone 'uroate CL \‘/u?tSsy Scnenng Corporation Kenilworth NJ 07033 USA Copyright © 1997.2003.2005. Scnenng Corporation All rights reserved Rev 9/05 26405289TJ8S Home J Creating Gift Wrap You've bought or made the perfect gift, but that's only the first step. Wrap ping your present in a creative and unexpected way makes a gift even more personal, can be fun to do and, in todays "disposable" world, is kinder to the environment when you use materi als that otherwise would be tossed in die trash. "Think seasonally," suggests Karen Keenan, owner of Pamela Loring Gifts in Lee, Mass. (pop. 5,985). “Top your package with an old holiday ornament, spray of fall leaves, holly, or flow ers—real or artificial." If giving homemade breads, casseroles or other goodies, buy inexpensive plates, dishes and baskets at yard sales and flea markets for food containers. Top jars ot your special preserves with material from your scrap box or by cutting pieces from a child's outgrown garment. Tag sales can yield other wrapping materials such as iinens, fabric scraps, doilies and napkins. "Get creative with paper," says Keenan, whose shop wraps dozens of presents daily. "Blueprints, maps, wallpaper, brown butcher' paper, sheet music, brown paper bags, alumi num foil and plastic wrap all work well." Reuse newspapers, matching the sec tion to the recipient's interest. Consider the sports pages for a sport fan, cartoons for a child, stock listings for a business diehard, and the food section for someone who loves to cook. Wrap a graduates gift in the clas sified job ads, and use the real estate section to package a housewarming present. To top it all off, recycle old ribbons in new ways. Cut them into “confetti" and put them inside clear plastic wrapping or glue them to the outside of your package. You can even wash out empty potato chip bags and cut them into strips, using the shiny side as a ribbon. Double your gift by wrapping it in a related gift item. Tie a baby shower present in a cotton receiving blanket. Give a book in a reusable canvas bag; gardening tools in an apron; seed packets taped to a pitted plant; or a kitchen gadget wrapped in a new dishcowel. While gift bags are quick and easy, a present wrapped with personal flair is likely to be remembered long after the occasion, as is the giver. 3^ Man S. Cold is a fretlasia: u riter m Sl-u York. Page 10 • www.americanprofile.com bv MARI S. GOLD