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NASONEX® PROOUCT INFORMATION (mometasone furoate monohydrate) Nasal Spray, 50 meg* FOR INTRANASAL USE ONLY * calculated on the anhydrous basis BRIEF SUMMARY (For hill Prescribing Information, see package insert.) INDICATIONS AND USAGE NASONEX Nasal Spray. 50 meg is indicated for the treatment ot the nasal symptoms of seasonal allergic and perennial allergic rhini tis. m adults and pediatric patients 2 years of age ana older. NASONtX Nasal Spray. 50 meg is indicated for the prophylaxis of the nasal symptoms of season al allergic rhinitis in adult and adolescent patients 12 years and older. In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, initiation ot prophylaxis with NASONEX Nasal Spray. 50 meg is recommended 2 to 4 weeks prior to the anticipated start ot the poller season Safety and effectiveness of NASONEX Nasal Soray. 50 meg m pediatric patients less than 2 years of age have not been established NASONEX Nasal Spray. 50 meg is indicated for the treatment of nasal polyps m patients 18 years of age and older Satetv and effectiveness of NASONEX Nasal Spray. 50 meg. for the treatment of nasal polyps m pediatric patients less than 18 years of age have not been established CONTRAINDICATIONS Hypersensitivity to any of the ingredients of this prepara tion contraindicates its use. WARNINGS Tne replacement of a systemic corticosteroid with a topical corti costeroid can be accompanied by signs of adrenal insufficiency and. in addi tion some patients may experience symptoms o' withdrawal: ie. joint ano or muscular pam lassitude and depression Carefui attention must be giver when patients previously treated for prolonged periods with systemic cortico steroids are transferred to topical corticosteroids, with careful monitoring for acute adrenal insufficiency in response to stress This is oarticulariy important in those patients who nave associated asthma or other clinical conditions where too rapid a decrease in systemic corticosteroid dosing mav cause a seveie exacerbation of their symptoms If recommended ooses of intranasal corticosteroids are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent systemic steroid thera py. symptoms of hypercolicism may occur, including very rare cases of menstrual irregularities acneilorm lesions and cushtngod features' if suen changes occur topical corticosteroids should be discontinued slowly consistent with accepted pro cedures tor discontinuing oral steroid therapy Persons who are on drugs which suppress the immune system are more sus ceptible to infections than healthy individuals Chickenpox anc measles for exam ple. can have a more serious or even lata! course m nommmune children or adults on corticosteroids in such children or adults who nave not hac these diseases particular care should be taxen to avoid exposure How tne dose route, and dura tion ot corticosteroid administration affects the nsk of developing a disseminated infection t$ not known The contribution of the underlying disease andror prior corticosteroid treatment to the risk is also not known it exposed to chickenpox prophylaxis with varicella zoster immune globin (VZIGi mav be indicated if exposed to measies, prophylaxis with pooled intramuscular immunoglobulin ;iG) may be indicated (See the respective package inserts fo r complete VZIG and lG prescribing information.) h chickenpox develops, treatment with antiviral agents may be considered PRECAUTIONS General: intranasal corticosteroids may cause a reduction m Sowth velocity- when administered to pediatrc patients isee PRECAUTIONS. idiatric Use section). In dmo studies with NASONEX Nasal Spray. 50 meg. the development of localized infections of the nose and pharynx with CaW a&can has occurred only rarely When such an infection develops, use of NASONEX Nasal Spray 50 meg should be discontinued and appropriate local or systemic tnerapy instituted, if needed Nasal corticosteroids snouid be used with caution if at all in patients with acbve or quiescent tuberculous infection of the respiratory tract or in untreated fungal oactenai systemic viral infections or ocular herpes simplex Rarefy immediate hypersensitivity reactions may occur after tne intranasal administration of mometasone furoate monchydrate Extremes ra r e instances of wheezing have been reported Rare instances of nasal septum perforation and increased intraocular pressure have also Deer reported following the intranasal application ot aerosofzed cortico steroids As witn any iong-term topical treatment of the nasa: cavity, patients using NASONEX Nasal Spray 5C meg over several months or longer should be examined periodically for possible changes in the nasal mucosa Because of the inhibitory effect of corticosteroids on wound healing patients who have experienced recent nasal septum ulcers nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred Glaucoma and cataract formation was evaluated in one controlled study of 12 weeks' duration and one uncontrolled study of 12 months duration in patients treated witn NASONEX Nasal Spray 50 meg at 200 meg/day using intraocular pressure measurements ana slit lamp examination No significant change from baseline was noted in the mean intraocular pressure measure ments for the 141 NASONEX-treated patients in the 12-week study as com pared with 141 placebo-treated patients No individual NASONEX-treated patient was noted tc have developed a significant elevation in intraocular pres sure oi cataracts m this 12-week study Likewise no significant change from baseline was noted in the mean intraocular pressure measurements tor the 139 NASONEX-treated patients m the 12-month study anc again, no cataracts were detected in these patients Nonetheless nasal and inhaled corticosteroids have been associated with the development of glaucoma ana/or cataracts Therefore close follow-up is warranted m patients with a change in vision and with a history of glaucoma and/or cataracts When nasal corticosteroids are used at excessive doses, systemic corti costeroid effects such as hypercortiosm and adrenal supp-ession mav appear If such changes occur. NASONEX Nasai Spray 50 meg should be dis continued slowly, consistent with accepted procedures for discontinuing oral steroid therapy Information for Patients: Patients being treated with NASONEX Nasa' Spray 50 meg should be given the following information and instructions T his information is intended to aid in the safe and effective use of this medcat on It is not a disclosure of ail intended or possible adverse effects Patients should use NASONEX Nasai Spray. 50 meg at regular intervals (see DOSAGE AND ADMINISTRATION since its effectiveness depends on regular use Improvement m nasal symptoms of allergc rhinitis has been shown to occur within 11 hours after the first dose based on one sinole-dose. parallel-group study of patients in an outdoor park' setting (park study) and one environmental exposure unit (EEU) study and within 2 days after tne first dose in two randomized double-blind piacebo-controiied. paraiie l -group seascnai allergic rhinitis studies. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing. Patients should take the medication as directed and should not increase the prescribed dosage n an attempt to increase its effectiveness Patients should contact their physician if symptoms do not improve, or if the condition 'wors ens Tc assure proper use of this nasai spray ana to attain maximum benefit, patients should read and follow the accompanying Patients instructions fo r Use carefully Administration to young children should be aided by an adult Patients should be cautioned not to spray NASONEX Nasal Spray. 50 meg into the eyes or directly onto the nasal 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 it they are exposed medical advice should be sought without delay Carcinogenesis. Mutagenesis. Impairment of Fertility: In a 2-year carcino genicity study in Sprague Dawfey rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 67 mcglrg (approximately 1 and 2 bmes the maximum recommended daily intranasal dose [MRDfD] in adults (400 mcgl and children (100 meg) respec tively on a meg/m' basis) In a 19-month carcinogenicity study m Swiss CD-1 mice mometasone furoate demonstrated no statistically significant increase m the incidence of tumors at inhalation ooses up to 160 meg/kg (approximately 2 bmes the MRDID in adults and children respectively on a meg/m' basis) Mometasone furoate increased chromosomal aberrations m an m vitro Chinese hamster ovary-cell assay, but did not increase chromosomal aberrations in an •n v!rc Chinese hamster lung ceil assay Mometasone furoate was not mutagenic m the Ames test or mouse-lymphoma assay, and was not clastogemc in an in mo mouse micronucieus assay and a rat bone marrow chromosomal aberration assay or a mouse male germ-cell chromosomal aberration assav Mometasone furoate also did not induce unscheduled DNA synthesis m me in rat hepatocytes In reproductive studies m rats impairment of fertility was not produced by subcutaneous doses up to 15 meg/kg (less than the MRDID in adults on a meg/m basis) [nasqnexj (mometasone furoate monohydrate) Nasal Spray, 50mcg* ' r.i : os s Pregnancy Teratogenic Effects: Pregnancy Category C: When administered to pregnant mice rats and rabbits mometasone furoate increased fetal malforma tions. lie ooses that produced malformations also decreased fetal gw/th. as measured by lower fetal weights and/or delayed ossification Mometasone furoate also caused dystocia and related complications when administered to rats dunng the end of pregnancy in mice momerasone furoate caused deft palate at subcutaneous doses of 60 meg/kg and above (less than the MRDID in adults on a meg/m basis) Fetal sur vival was reduced at 180 meg/kg (approximately 2 times the MRDID in adults on a meg'm bas*s). No toxicity was observed at 20 meg/kg dess than the MRDID in adults on a megm basis) In rats mometasone furoate produced umbilical hernia at topical dermal doses of 600 mcg'kg ana above (approximately 10 times the MRDID in adults on a meg/m basis) A oose of 3CO meg/kg (approximately 6 times the MRDID in adults on a meg/nr basis) produced delays in ossification but no malformations In rabbits mometasone furoate caused multiple malformations (eg. flexed front paws gallbladder agenesis, umbilical hernia, hydrocephaly) at topical derma: doses of 150 mcg'kg and above (approximately 6 times the MRDID m adults on a megm- basis), in an oral study mometasone furoate increased resorptions and caused cleft paiate and/or head malformations (hydrocephaly or domed head! at 700 meg/kg (approximately 30 times the MRDID m adults on a megm oasis) At 28M mcg y kg iapproximately 110 times the MRDID in adults on a meg m basis) most liners were aborted or resorbed No toxicity was observed at 140 mcg.'kg (approximately 6 times the MRDID in adults on a megm' basis) When rats 'ecetved subcutaneous doses of mometasone furoate throughout pregnancy or durng the later stages of pregnancy. 15 mcg'kg (less tnan the MRD'D m adults on a meg'm basis) caused prolonged and difficult labor and reduced the number of live births, birth weight and early pup survival Similar effects were not observed at 7 5 meg/kg dess than tne MRDID m adults or a megm basis) There are no adequate and well-controlled studies m pregnant women NASONEX Nasal Soray 50 meg. like other corticosteroids should be used dur ing pregnancy only if the potential benefits justify the potential usk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are mere prone to teratogen c effects from corticosteroids than humans in addition because there is a natural increase in corticosteroid production during pregnancy most women will require a lower exogenous corticosteroid dose anc many will not need corticosteroid traatment during pregnancy Nonteratogemc Effects. Hypoadrenaksm may occur in infants born to women receiving corticosteroids dunng pregnancy Such infants should be carefully monitored Nursing Mothers. It is not known if mometasone furoate is excreted in human muk Because other corticosteroids are excreted in human milk caution should be used when NASONEX Nasal Spray 50 meg is administered tc nursing women Pediatric Use: Controlled clinical studies have shown intranasal cortico steroids may cause a reduction m growth velocity m pediatric patients This effect has been observed .n the absence ot laboratory evidence of hypothalamic-pitu itary-adrena. (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric, patients than some commonly used tests of HPA axis function. The long-term effects of this reduction m growth velocity associated with intranasal colcosteroids including the impact on final adult neignt are unknown. The potential for "catch up' growth following discontinuation of treatment with intranasal corticosteroids has not been adequate')- studied T he growth of pediatric patients receiving intranasal corticosteroids including NASONEX Nasai Spray 50 meg should be monitored routinely (eg. via stadiometry) The potential growth effects of prolonged treat ment snouid oe weighed agamst clinical benefits obtained and the availability of safe and effective noncorocosteroid treatment alternatives To minimize the sys temic effects of intranasal corticosteroids including NASONEX Nasal Sprav 50 meg each patient should be titrated to htstter owest effective dose Seven hundred and twenty (720) patients 3 to 11 years of age with allergic rhinitis were treated with mometasone furoate nasai spray 50 meg (100 meg total dauy cosei m controlled climca: trials <see CLINICAL PHARMACOLOGY. Clinical Studies section) Twenty-eight (28) patients 2 to 5 years of age with allergic rhinitis were treated with mometasone furoate nasal spray. 50 meg (100 meg total daily dose) in a controlled trial to evaluate safety isee CLINICAL PHARMACOLOGY, Pharmacokinetics section) Safety and effectiveness in chil dren less than 2 years o' age with allergic rhinitis ano in children less than ‘8 years of age with nasal polyps have not been established A clinical study has been conducted for 1 year in pediatric patients with allergic rhinitis (ages 3 to 9 years) to assess the effect of NASONEX Nasal Spray 50 meg (100 meg feta daily dose) on growth velocity No statistically significant effect on growth velocity was observed for NASONEX Nasal Spray. 50 meg compared tc placebo No evidence o! clinically relevant HPA axis suppression was observed following a 30-minute cosyntropin infusion The potential of NASONEX Nasal Spray. 50 meg to cause growth suppression in susceptible patients or when given at higher Ooses cannot be ruled out Geriatric Use: A total of 280 patients above 64 years of age with allergic rhinitis or nasal po<yps (age ranoe 64 to 86 years) have been treated with NASONEX Nasal Spray. 50 meg for up to a or 4 months respectively The adverse reactions report ed in this population were similar in type and incidence to those reported by younger patients. ADVERSE REACTIONS Allergic Rhinitis. In controlled US and international clin ical studies a total of 3210 adult and adolescent patients ages 12 years and older with allergic rhinitis received treatment with NASONEX Nasal Sprav. 50 meg at doses of 50 to 800 meg/day. The majority of patients (n = 2103) were treated with 200 meg/day. In controlled US and international studies, a total of 990 pediatric patients (ages 3 to 11 vears) with allergic rhinitis received treatment with NASONEX Nasal Spray 50 meg at doses of 25 to 200 meg/day. The majority of pediatric patients (720) were treated with 100 meg/day A total of 513 adult ado lescent, and pediatric patients have been treated for 1 year or longer The overall incidence of adverse events foi patients treated with NASONEX Nasal Spray. 50 meg was comparable to patients treated with the vehicle placebo Also adverse events did not differ significantly based on age. sex. or race. Three pecent or less of patients in clinical trials discontinued treatment because of adverse events this rate was similar for the vehicle ano active comparators All adverse events (regardless of relationship tc treatment) reported by 5% or more of aduit and adolescent patients ages 12 years and older who received NASONEX Nasal Spray 50 meg. 200 meg/day and by pediatric patients ages 3 to 11 years who received NASONEX Nasal Spray 50 meg. 100 meg/flay in clinical trials vs placebo and that were more common with NASONEX Nasal Spray'. 50 meg than piacebc. are displayed in the table Wow ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL ALLERGIC AND PERENNIAL ALLERGIC RHINITIS (PERCENT OF PATIENTS REPORTING) Acuit and Adolescent Patients Pediatnc Patients Ages 12 years and older 3 to 11 years NASONEX VEHICLE NASONEX VEHICLE 200 meg PLACEBO 100 meg PLACEBO (n = 2103) (n a 1671) (ns 374) (n = 376) Headache 26 22 17 18 Viral infection 14 11 8 9 Pharyngitis 12 10 10 10 Epistaxis/Biood- Tmged Mucus I_l 6 8 9 Coughing 7 6 13 15 Upper Respiratory Tract Infection 6 2 5 4 Dysmenorrhea 5 3 1 p Musculoskeletal Pam 5 3 1 1 Sinusitis 5 3 4 4 Vomitmo 1 1 5 4 Other adverse events which occurred in less than 5% but greater than or equai to 2% of mometasone furoate adult and adolescent patients (aoes 12 years and older) treated with 200-mcg doses (regard'ess of relationship to treatment), and more frequently than m the placebo group included arthralgia, asthma, bronchitis chest pam. conjunctivitis, diarrhea dyspepsia earache flu-iike symptoms, myalgia nausea and rhinitis 'Other adverse events which occurred in less than 5% but greater than or equal to 2% of mometasone furoate pediatnc patients ages 3 to 11 years treated with 100-mcg doses vs placebo (regardless of relationship to treatment) and more fre quently than in the placebo group included' diarrhea, nasal irritation, otitis media, and wheezing The adverse event (regardless of relationship to treatment) reported by 5% of pediatnc patients ages 2 tc 5 years who received NASONEX Nasai Spray. 50 meg. TOO meg/day in a clinical triai vs placebo including 56 subjects (28 each NASONEX Nasal Spray, 50 meg and placebo) and that was more common with NASONEX Nasal Spray. 59 meg than placebo included upper respiratory tract infection (7% vs 0% respectively). The other adverse event which occurred in less than 5% but greater than or equal to 2% of mometasone furoate pediatric patients ages 2 to 5 years treated with 100-mcg doses vs placebo (regardless of relationship to treatment) and more frequently than in the piacebo group included skin trauma Nasal Polyps in controlled clinical studies, the types oi adverse events observed in patients with nasai polyps were similar to those observed for patients with allergic rhinitis. A total ot 594 adult patients (ages 18 to 86 years) received NASONEX Nasal Spray 50 meg at doses of 200 meg once or twice daily for up to 4 months for treatment of nasal polyps The overall incidence of adverse events for patients treated with NASONEX Nasal Spray. 50 meg was comparable to patients treated with the placebo except for epistaxis which was 9% for 200 meg once daily 13% for 200 meg twice daily and 5% tor placebo Rare cases of nasal ulcers and nasal anc oral candidiasis were aiso reported in patients treated with NASONEX Nasal Spray. 50 meg. primarily in patients treated for longer than 4 weeks. In postmarketing surveillance of this product cases of nasal burning and irritation, anaphylaxis and angioedema and rare cases of nasal septai per foration have been reported Disturbances of taste and smell have been reported very rarely OVEROOSAGE There are no data available on the effects of acute or chronic over dosage with NASONEX Nasal Spray 50 meg Because of low systemic bioavailabil ity and an absence of acute drug-related systemic findings in clinical studies over dose is unlikeiy to require any therapy other than observation Intranasal adminis tration of 1600 mco |4 times the recommended dose of NASONEX Nasal Spray. 50 meg) daily for 29 days to hea'thy human volunteers was well tolerated with no increased incidence of adverse events Single intranasal doses up to 4000 meg have been studied in human volunteers with no adverse effects reported. Single oral ooses up to 8000 meg have been studied m human volunteers with no adverse effects repoled Chronic overdosage with any corticosteroid may result in signs or symptoms ot hypercolicism (see PRECAUTIONS. Acute overdosage with this dosage form is unlikely since one bottle oi NASONEX Nasal Spray 50 meg con tains approximately 8500 meg of mometasore furoate Cl Schenng Corporation Kenilworth. NJ 07033 USA Copyright © 1997 2003.2005. Schermg Corporation All rights reserved. Rev. 9/05 26405289T-JBS fm iftr yrfw* n * 1 o?.' / Photo: AldrV'Sd-’v r - Paul Revere fan Retta Zumwalt of Bentonville, Ark. (Continued from page 7) to their roots. Many live close to where they grew up, and return there on breaks between shows—Fabian to Connersville, Pa., Medley to California (he has homes in Newport Beach and Palm Springs) and Vee to St. Joseph, Minn. Several members of The Comets have bought homes in Branson, so certain that the crowds will keep coming. ‘‘Our music is good, clean American music,” says Comets sax player Joe DAmbrosio, 72. "And that’s what were about.” Zfr A/anna Nash is a frequent contributor to American Profile. Call (877) 588-1957 for more information. Rate This Story How did you like this story? Log on to www.americanprofile.com/rate. SPECIAL CD OFFER Do You 7, Love the FIFTIES Music of The Fabulous from Tim- et Life with 50 terrific hits from the original artists. Enjoy the music of Elvis, The Platters, Pat Boone, The McGuire Sisters and Bobby Darin, and hits like Que Sera, Sera, Chances Are, Mr. Sandman, Goodnight Irene, Sixteen Tons and -45 more Golden Memories. To receive 3 CDs for $29.99, visit www.americanprofile.eom/store or please have your credit card ready and call (800) 715-6248 or send check for $34.95 to ’sos Music - Dept. AP, P.O. Box 340, Harrison, AR 72602. CA. TN. IL, AR. NY residents add state sales tax. NSF checks automatically debited for amount of check plus applicable fees. Expires 11/3/06. Please allow 2-1 weeks for delivery. Offer good while supplies last! American Profile • Page 8