The Salina Journal from Salina, Kansas on October 5, 1997 · Page 53
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The Salina Journal from Salina, Kansas · Page 53

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Sunday, October 5, 1997
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disciission are effective. '^f, cguld spend bn« 0f your tigh school years studying in , TolQio or Rome. > breath of fresh air when we studied the Roaring '20s. Each of us came up with an idea for a screenplay or a newspaper or a musical that captured not only the era, but our own way of expressing it. So we didn't just plod through the historical data — instead we bobbed our hair, played Duke Ellington records and danced the Charleston in the desk aisles. We imagined ourselves at the end of the dock with Gatsby, gazing at his "green light," his hope and promise of the future. Unfortunately, the green light soon dimmed when the one project billed as "creative" by our teacher ended. Why should creativity be isolated in that way? Can't all projects have an element of surprise and spark? Too much of what we did was a push to get ready for college. "It will be on the SATs" was the ominous reason to do everything, and as a result we were brain- numbed with unconnected facts. We're told if we endure years of standardized-test preps, we'll be ready for the freedom and seriousness of college work. I think kids are ready for this kind of work much sooner than high school allows. As it is, junior year is a tortuous time to be alive, and senior year is a downhill slide, a joke. A lot of kids I know leave high school without any idea of what they want to major in, or what they are good at. I know I was watching the clock for years. I wanted to learn and write and think, desperately — but I had to leave high school to do it. C3 Hinds, 17, attends Simon's Rock College of Bard, in Great Berrtngton, Mass., for high school students who are ready for a college curriculum and typically leave high school after their sophomore year. USA WEEKEND • Dot. 9-5.188? 19 STOP YOUR RUNNY NOSE WITM ATRQVENT® NASAL SPRAY (ipratropium bromide) Mrovent 8 For illitglc and nonillitglc perennial riilnltlt .— .jratropium bromide) Nasal Spray 0.03% Is Indicated lor the symptomatic relief of rhlnorrhea associated with allergic and noraJerglc perennial rhinitis In adults and children age 12years and older. ATROVENT Nasal Spray 0.03% does not relieve nasal congestion, sn» allergic or nonaUerglc perennial rhinitis. i) congestion, sneezing or postnasal drip associated with CONTRMNOIUTKUIS ATROVENT* (Ipratropium bromide) Nasal Spray 0.03% Is contralndlcated In patients with a history of hypersensltMty to at/opine or its derivatives, or to any ol the other ingredients. WARNINGS Immediate hypersensltlvlty reactions may occur alter administration ol Ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema. PRECAUTIONS General ATROVENT' (Ipratropium bromide) Nasal Spray 0.03% should be used with caution In patients with narrow-angle glaucoma, prostatte hypertrophy or bladder neck obstruction, particularly If they are receiving an anttchollnergic by another route. Cases ol precipitation or worsening of narrow-angle glaucoma and acute eye pain have been reported with direct eye contact ol ipratropium bromide administered by oral inhalation. Information for Patients Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if ATROVENT Nasal Spray 0.03% comes Into direct contact with the eyes. Patients should be instructed to avoid spraying ATROVENT Nasal Spray 0.03% In or around their eyes. Patients who experience eye pain, blurred vision, excessive nasal dryness or episodes of nasal bleeding should be Instructed to contact their doctor. Patients should be reminded to carefully read and follow the accompanying PATIENTS INSTRUCTIONS FOR USE. Dni| Interactions No controlled clinical trials were conducted to Investigate drug-drug Interactions. ATROVENT Nasal Spray 0.03% is minimally absorbed into the systemic circulation; nonetheless, there Is some potential for an additive Interaction with other concomltanlly administered antichollnerglc medications, Including ATROVENT for oral CirdnoMMsli, Mutageneils, Impairment ol Fertility Two-year oral cardnogenldty studies In rats and mice have revealedno carcinogenic activity at doses up to 6 mg/kg/day. This dose corresponds, in rats and mice respectively. Nasal Spray 0.03%. Results of various mutagenlcity studies (Ames test, mouse dominant lethal lest, mouse mlcronudeus test and chromosome aberration of bone marrow In Chinese hamsters) were negative. Fertility ol male or female rats at oral doses up to 50 mg/ks/day about 1 ,660 times the MRHD on a mg/m< basis) was unaffected by ipratropium bromide administration. At doses above 90 mg/kg/day (about 3,000 times the MRHO on a mo/rrV basis), a decreased conception rate was observed. Pregnancy TERATOGEMC EFFECTS Pregnancy dttgory B. Oral reproduction studies were performed at doses ol 1 0 mg/kg/day in mice, 1 00 mg/kg/day In rats and 1 25 rngTkg/day In rabbits. These doses correspond, in each species respectively, to about 160. 3,OMand 8,000 times the MRHD of ATROVENT Nasal Spray 0.03% In perennial rhinitis [252 meg/flay) on a mg/nr basis. Inhalation reproduction studies in rats and rabbits at doses of 1 .5 and 1 £ mg/kg/day (about 50 and 1 20 times the MRHD on a malm' basis for each species, respectively) have demonstrated no evidence olterato«nlc effects asaresult of Iprrtoplum bromide. At ^^ the MRHO on a rng/m 1 basis) embryotoxlcity was observed as Increased resorpBon. This effect Is not considered relevant to human use due to the large doses at which it was observed and the difference In route of administration. However, no adequate or well controlled studies have been conducted Inpregnant women. Because animal reproduction studies are not always predictive of human response, ATROVENT Nasal Spray 0,03% should be used during pregnancy only If dearly needed. Nursing Mothers It Is known that some Ipratropium bromide Is systemlcally absorbed following nasal administration; however the portion which may be excreted in human milk Is unknown. Although llpld-lnsoluble quaternary bases pus Into breast milk, the minimal systemic absorption makes it unlikely that Ipratropium bromide would reach the Intent In an amount sufficient to cause a clinical effect. However, because many drugs are excreted In human milk, caution should be exercised when ATROVENT Nasal Spray 0.03% Is administered to a nursing woman. Pedlalric Use Safely and effectiveness of ATROVENT Nasal Spray 0.03% in patients below the age of 1 2 years have not been established. ADVERSE REACTIONS Adverse reaction Information on ATROVENT* (Ipratropium bromide) Nasal Spray 0.03% in patients with perennial rhinitis was derived from lour mulllcenter, vehicle-controlled clinical trials involving 703 patents (356 patients on ATROVENT and 347 patients on vehicle), and a 1-year, open-label, follow-up trial. In three of the trials, patients received ATROVENT Nasal Spray 0.03% ihree times dally, for B weeks. In the other trial, ATROVENT Nasal Spray 0.03% was given to patients two times dally for 4 weeks. 01 the 265 patients who entered the open-label, follow-up trial, 232 were treated lor 3 months, 200 (or 6 months, and 159 up to 1 year. The majority (>86%) of patients treated lor 1 year were maintained on 42 meg per nostril, two or three times dally, of ATROVENT [ipratropium bromide) Nasal Spray 0.03%. The following table shows adverse events, and the frequency that these adverse events led to the discontinuation of treatment, reported for patients who received ATROVENT Nasal Spray 0.03% at the recommended dose of 42 meg per nostril, or vehicle two or three times dally for 4 or 8 weeks. Only adverse events reported with an incidence of at bast 2.0% In the ATROVENT group and higher In the ATROVENT group than In the vehicle group are shown. AtfOVBfrt 8 .. ... _ „.. For the common cold (ipritroplum bromide) Natal Spray 0.06% Brief Summary of Prescribing Information INDICATIONS AND USAGE ATROVENT* (Ipratropium bromide) Nasal Spray 0.06% is Indicated lor the symptomatic relief of rhinorrhea associated with the common cold for adults and children age 12 years and older. ATROVENT Nasal Spray 0.06% does not relieve nasal congestion or sneezing associated with the common cold. The safety and effectiveness of the use of ATROVENT Nasal Spray 0.06% beyond four days In patients with the common cold has not been established. CONTRAINDICATIONS ATROVENT* (Ipratropium bromide) Nasal Spray 0.06% Is contraindicaled In patients with t history ol hypersensllivlty to alroplne or its derivatives, or to any of the other ingredients. WARNINGS Immediate hypersensltivity reactions may occur after administration of Ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema. PRECAUTIONS General ATROVENT' (Ipratropium bromide) Nasal Spray 0.06% should be used with caution in patients with narrow-angle glaucoma, proslatlc hypertrophy or bladder neck obstruction, particularly If they are receiving an antichollnerglc by another route. Cases of precipitation or worsening of narrow-angle glaucoma and acute eye pain have been reported with direct eye contact of ipratropium bromide administered by oral inhalation. Information for Patients Patients should be advised that temporary blurring of vision, precipitation or worsening ol narrow-angle glaucoma or eye pain may result If ATROVENT Nasal Spray 0.06% comes into direct contact with the eyes. Patients should be Instructed to avoid spraying ATROVENT Nasal Spray 0.06% In or around the eyes. Patients who experience eye pain, blurred vision, excessive nasal dryness or episodes of nasal bleeding should be Instructed to contact their doctor. Patients should be reminded to carefully read and follow the accompanying PATIENTS INSTRUCTIONS FOR USE. Drug Interactions No controlled clinical trials were conducted to Investigate potential drug-drug Interactions. ATROVENT Nasal Spray 0.06% Is minimally absorbed Into the systemic circulation: nonetheless, there is some potential for an additive Interaction with other concomltanlly administered anticholinerglc medications, Including ATROVENT for oral Inhalation. CirclnogtMSls, MutagtMsls, Impairment of Fertility Two-year oral cardnogenldty studies In rats and mice have revealed no carcinogenic activity at doses up to 6 mg/kg/day. This dose corresponds, in rats and mice respectively, to about 70 and 40 times the maximum recommended human daily dose (MRHO) on a mg/m' basis of ATROVENT Nasal Spray 0.06%. Results of various mulagenlcity studies (Ames test, mouse dominant lethal test, mouse mlcronudeus test and chromosome aberration ol bone marrow In Chinese hamsters) were negative. Fertility of male or female rats at oral doses up to 60 mg/kg/day (about 600 times the MRHD on a mg/m' basis) was unaffected by Ipratropium bromide administration. At doses above 90 mg/kg/day (about 1.000 times the MRHO on a mg/m' basis) a decreased conception rate was observed. Pregnancy TtRATOGENIC EFFECTS Pregnancy Category B. Oral reproduction studies were performed at doses of 1 0 mg/kg/day In mice, 1 00 mg/kg/day in rats and 1 25 nvykg/day In rabbits. These doses correspond, In each species respectively, to about 60, 1 .200, and 3,000 times the MRHD of ATROVENT Nasal Spray 0.06% In the common cold . (about 20 and 40 limes the MRHO dose on a mg/m' basis for each species, respectively) have demonstrated no evidence of teratogenlc effects as a result of Ipratropium bromide. At oral doses above 90 mg/kg/day In rats (about 1,000 times the MRHD on a mg/m' basis) embryotoxlcity was observed as increased resorprton. This efled is not considered relevant to human use due to the large doses at which it was observed and the difference In route of administration. However, no adequate or well controlled studies have been conducted In pregnant women. Because animal reproduction studies are not always predictive ol human response, ATROVENT Nasal Spray 0.06% should be used during pregnancy only If clearly needed. Nunlug Mothin It it known that some ipratropium bromide Is syslemlcally absorbed Mowing nasal administration; however the portion which may be excreted in human milk Is unknown. Although llpld-lnsoluble quaternary bases pass Into breast milk, the minimal systemic absorption makes It unlikely that Ipratropium bromide would reach the infant In an amount sufficient to cause a clinical effect. However, because many drugs are excreted In human milk, caution should be exercised when ATROVENT Nasal Spray 0.06% Is administered to a nursing woman. Pedlalric Use Safety and effectiveness of ATROVENT Nasal Spray 0.06% In patients below the age of 12 years have not been established. ADVERSE REACTIONS Adverse reaction information on ATROVENT 1 (ipratropium bromide) Nasal Spray 0.06% in patients with the common cold was derived from two mutlicenter, vehicle-controlled clinical trials Involving 1276 patients (195 jatails on ATROVENT Nasal Spray 0.03%. 352 patients on ATROVENT Nasal Spray 0.06%, 189 patients on ATROVENT Nasal Spray 0.12%, 351 patients on vehicle and 189 patients receiving no treatment). The following table shows adverse events reported for patients who received ATROVENT Nasal Spray 0.06% at the recommended dose of 84 mcgper nostril, or vehicle, administered three or lour times dairy, where the Incidence is 1% or greater In the ATROVENT group and higher In the ATROVENT group than In the vehicle group. %»l Patients Reporting Events' ATROVENT Natal Spray 0.03% (n-356) Incidences Discontinued* Headache Upper respiratory tract Infection Nasal dryness Nasal Irritation' Other nasal symptoms' Pharyngitis Nausea 9.8 9.6 9.0 S.1 2.0 3.1 6.1 2.2 0.6 1.4 0.3 0 0 1.1 0.3 0.3 Vehicle Control (n«M7| Incidences Discontinued % 9.2 7.2 4.6 0.9 1.7 1.7 4.6 0.9 0 1.4 0.3 03 0.6 0.3 0 0 EptsUuds 1 Dry Mouth/Throat Nasal Congestion Nasal Dryness %«l Patents Reporting Events' ATROVENT Nasal Spray 0.06% Vehicle Control (n-352) (r*351| 8.2V 2.3% 1.4% 0.3% 1.1% 0.0% 4.8% 2.8% ' Eplstaxls reported by 7.0% of ATROVENT patients and 2.3% ol vehicle patients, blood-tinged mucus by 2.0% ol ATROVENT patients and 2.3% ol vehicle patients. ' Nasal Irritation Includes reports of nasal Itching, nasal burning, nasal Irritation and ulcerallve rhinitis. 1 Other nasal symptoms Include reports of rasa/congestion, Increased rhinorrhea, Increased rhinitis, p drip sneezing nasal polyps and nasal edema. ' This table Includes adverse events which occurred at an Inddence rate of at least 2.0% in the ATROVENT group and more frequently In the ATROVENT group than In the vehicle group. • All events are Bsted by their WHO term; rhinitis has been presented by descriptive terms lor clarification. ATROVENT Nasal Spray 0.03% was well tolerated by most patients. The most frequently reported nasal adverse events were transient episodes ol nasal dryness or eplsjaxls. these adverse events were mild or moderate In nature, none was considered serious, none resulted in hospttalization and most resolved spontaneously or following a dose reduction. Treatment for nasal dryness arid epistaxis was required Infrequently (2% or less) and consisted of local application of pressure or a moisturizing agent (e.g., petroleum jelly or saline nasal spray). Patient discontinuation lor epistaxis or nasal dryness was Infrequent In both the conlrolled (03% or toss) and 1-year, open-label (2% orlws) trials. There was no evidence ol nasal rebound (I.*., iidlnjcaJy slgrta Increase in (torheipostertor nasal drip, sneezing or nasal congestion severity compared to baseline) upon discontinuation ol double-blind therapy In these trials Adverse events reported by less than 2% of the patients receiving ATROVENT Nasal Spray 0.03% during the controlled clinical trials or during the open-label lollow-up trial, which are potentially related to the local or systemic antichollnerglc effects of AUovent Indude: dry mouth/throat, dizziness, ocular Irritation,blurred vision, conjunctivitis, hoarseness, cough and taste perversion. Additional anlichotarglc eflecli noted with ottw ATROVENT dosage formllATROVENT* Inhalation Solution, ATROVENT Inhalation Aer(isoUnd ATROVENT* Nasal Spray 0.06%) include: precipitation or worsening of narrow-angle glaucoma, urinary retention, proslatlc disorders, lachycaidia, constipation, and bowel obstruction. There were Infrequent reports ol skin rash in both the controlled and unconUoBed clinical stud W. Other allergic-type reactions such w angtoidema of the throat, tongue, UPS and lace, urticaria, laryngospasm and anaphytefic reactions tiave been rep^rW with otlwlprw opium Eromlde products. No controlled trial was conducted to address the relative Inddence of adverse events ol BID versus TID therapy. HO* 8UPPUED ATROVENT* (ipratropluni bromide) Nasal Spray 0.03% Is supplied as 30 ml oTsolutlon In i Ugh density polyethylene (HOPE) bottle luted with a melered nual spray pump, a safety, dip to prevent accidental duSroe ol the spray, and a dear plastic dull cap. The 30 ml bottle of ATROVENT Nasal Spray Is designed to deliver 345 sprays ol 0.07 ml wen (21 meg IpnUoplym bromide), or 28 days of therapy at the maximum IJiCOfflWl $5Sd fewS-F (l^iKdW'FTM'TAvoid freezing. Keep out ol reach ol children. Avoid AN.03-BS-10/95 'This table Includes adverse events lor which the inddence was 1% or greater In the ATROVENT group and higher In the ATROVENT group than In the vehicle group. * 'Epistaxis reported by 5.4% ol ATROVENT patents and 1.4% of vehicle patients, blood-tinged nasal mucus by 2.8% of ATROVENT patients and 0.9% ol vehicle patients. ATROVENT Nasal Spray 0.06% was well tolerated by most patients. The most frequently reported adverse events were transient episodes of nasal dryness or epistaxis. The majority of these adverse events (96%) were mild or moderate In nature, none was considered serious, and none resulted In hosptatatlon. No patient required treatment for nasal dryness, and only Ihree patients (<1%) required treatment for eplstaxls. whichconsisled of local appjication ol pressure or a moisturizing agent (e.g., petroleum jelly). No patient receiving ATROVENT Nasal Spray 006% was discontinued from the trial due to either nasal dryness or bleeding. Adverse events reported by less than 1% of the patients receiving ATROVENT Nasal Spray 0.06% during the controlled clinical trials which are potentially related to to Iccal or sysl«rr^antichollr«ralc effects olAUovenl Include: oosterior nasal b** 1 perve/slon,na^burrta),corijunctivibs.ci»ighing, dizziness, hoarseness, pal|iltaDW.ptmynoitb, tachycardia, i*» thirst, tinnitus and blurred vision. Additional anfUnerglc effects noted with other ATROVENT dosage forms , . (ATROVENT* Inhalation Solution, ATROVENT* Inhalation Aerosol and ATROVENT* Nasal Spray 0.03%) Include: precipitation or worsening of narrow-angle glaucoma, urinary retention, prostate disorders, constipation and bowel obstruction. There were no reports ol allergic-type reactions In the controlled clinical trials. Allergic-type reactions such as sUn rash, angioedema of the tongue, UPS and face, urticaria, laryngospasm and anaphyiacttc reactions have been reported with other Ipratropium bromide products. No controlled trial was conducted to address the relative Inddence of advene events for TID versus QlD therapy. HOW SUPPLIED ATROVENT* (Ipratropium bromide) Nasal Spray 0.06% Is supplied as 15 ml of solution In a high density polyethylene (HOPE) bottle fitted with a melertd nasal spray pump, a safety clip to prevent accidental discharge ol the spray, and a dear plastic dust cap. The 15 ml bottle ol ATROVENTIIasal Spray is designed to deliver 165 sprays of 0.07 ml each (42 meg Ipratropium bromide). Store tightly closed between 59'F (15'C) and 86'F (30'C). Avoid freezing. Keep out of reach of children. Avoid spraying In or around the eyes. Consult package Insert before prescribing. AN.06-BS-10/95 Boehringer Ingelheim Pharmaceuticals, Inc. RidgeHeld. CT 06877 01997. Boehringer Ingelheim Pharmaceuticals, inc. All rights reserved.

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