The Salina Journal from Salina, Kansas on May 18, 1997 · Page 52
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The Salina Journal from Salina, Kansas · Page 52

Salina, Kansas
Issue Date:
Sunday, May 18, 1997
Page 52
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BRIEF SUMMARY SHAKE GENTLY BEFORE USE. FLONASE* (flutlcaione prop Haul Spray, 0.05% w/w For Intrenittl Ute Only. The following Is a brief summary only; see full prescribing Information tor complete product Information. CONTRAINDICATIONS: FLONASE Nasal Spray is contralndl- cated In patients with a hypersensltlvlty to any of Its Ingredients. WARNIN8S: The replacement of a systemic glucocortlcold with a topical glucocortlcold can be accompanied by signs ol adrenal Insufficiency, and In addition some patients may experience symptoms ot withdrawal, e.g.. joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic glucocorticoids and transferred to topical glucocortlcolds should be carefully monitored for acute adrenal Insufficiency In response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic glucocortlcold treatment, too rapid a decrease In systemic glucocortlcolds may cause a severe exacerbation ol their symptoms. The use ol FLONASE Nasal Spray with alternate-day systemic prednlsone could Increase the likelihood ol hypothala- mlc-pltultary-adrenal (NPA) suppression compared with a therapeutic dose of either one alone. Therefore, FLONASE Nasal Spray should be used with caution In patients already receiving alternate-day prednlsone treatment for any disease. In addition, the concomitant use of FLONASE Nasal Spray with other Inhaled glucocortlcolds could Increase the risk ot algna or symptoms ot hypercortlclsm and/or suppression of the HPA axis. Patients who are on Immunosuppressant drugs are more susceptible to Infections than healthy Individuals. Chickenpox and measles, lor example, can have a more serious or even latal course In patients on Immunosuppressant doses of cortlcosterolde. In tuch patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route, and duration ol cortlcosterold administration affects the risk ol developing a disseminated Infection It not known. The contribution of the underlying disease and/or prior cortlcosterold treatment to the risk Is also not known. It exposed to chlckenpox, prophylaxis with varicella zoster Immune globulin (VZIG) may be Indicated. It exposed to measles, prophylaxis with pooled Intramuscular Immunoglobulln (16) may be Indicated. (See the respective package Inserts lor complete VZIG and lG prescribing Information.) If chlckenpox develops, treatment with antiviral agents may be considered. PRECAUTIONS: QeMial: Rarely. Immediate hypersensltlvlty reactions or contact dermatitis may occur after the Intranasal administration of flutlcasone proplonate. Rare Inatancet ol wheeling, natal septum perforation, cataracts, glaucoma, and Increased Intraocular pressure have been reported following the Intranasal application ol glucocortlcolds. Use of excessive doses ol glucocortlcoldt may lead to signs or symptoms of hypercortlcltm, suppression ot HPA function, and/or suppression of growth In children or teenagers. Knemometry studies In asthmatic children on orally Inhaled glucocortlcoldt showed inhibitory effects on short-term growth rate. The relationship between short-term changes In lower leg growth and long-term effects on growth Is unclear at tnis time. Physicians should closely follow the growth of adolescents taking glucocortlcolds, by any route, and weigh the beneflti ol glucocorticoid therapy against the possibility of growth suppression II an adolescent's growth appeara slowed. Although systemic effects have been minimal with recommended dotes of FLONASE Natal Spray, potential rltk increases with larger doses. Therefore, larger than recommended dotes of FLONASE Nasal Spray should be avoided. When used at larger doses, systemic glucocortlcold effects such as hypercortlclsm and adrenal suppression may appear. It such changes occur, the dotage of FLONASE Natal Spray should be discontinued slowly consistent with accepted procedures for discontinuing oral glucocortlcold therapy. In clinical studies with flutlcaaone proplonate administered Intranasally, the development of localized Infections of the nose and pharynx with Candida tlblcins has occurred only rarely. When tuch an Infection develops, It may require treatment with appropriate local therapy and discontinuation of treatment with FLONASE Nasal Spray. Patients using FLONASE Nasal Spray over several months or longer should be examined periodically for evidence ot Cindid» Infection or other tlgnt of adverse effects on the nasal mucoaa. FLONASl Natal Spray should be uttd with caution, If at all, In patlentt with active or quiescent tuberculout Inlec- tlont; untreated lungal, bacterial, or systemic viral Infections; or ocular herpet simple*. Becaute ol the Inhibitory effect of glucocortlcoldt on wound healing, patients who have experienced recent nasal septal ulcers, natal surgery, or natal trauma should not use a natal glucocortlcold until healing hat occurred. Inltfauliai for tiUMtt: Patlenta being treated with FLONASE Naeal Spray should receive the following Information and Instructions. This Information Is Intended to aid them In the safe and effective use ol this medication. It It not a disclosure of all possible advene or Intended effects. Patlentt should be warned to avoid exposure to chickenpox or meatles and, If expoted, to consult their physician without delay. Patlentt should use FLONASE Nasal Spray at regular Intervals as directed since Id effectiveness depends on lit regular ute. A decrease In natal symptoms may occur at toon as 12 hours altar starting therapy with FLONASE Natal Spray. Results In several clinical trials Indicate statistically significant Improvement within the first day or two ol treatment; however, the full benefit of FLONASE Natal Spray may not be achieved until treatment hat bean administered lor ttvtral days. The patient should not Increatt the prescribed dotage but should contact the physician If symptoms do not Improve or If the condition worsens. For the proper use ol the natal spray and to attain maximum Improvement, the patient Should read ind lollow carefully the patlent't Instructions E mpanylng the product. MHtnetlt, MuUgenetlt, Impairment el Fertility: ;atone proplonate demonstrated no tumorlgenlc potential In studies ol oral doses up to 1.0 mg/kg (3 mg/m'as calculated on a surface area basis) lor 78 woekt In (he mouse or Inhalation ol up to 57 meg/kg (336 mcg/m') for 104 weeks In the rat. Flutlcatone proplonate did not Induce gene mutation In prokaryotlc or eukaryotlc cells In vitro. No significant clatto- genlc effect was seen In cultured human peripheral lympho • cytts In vitro or In the mouse mlcronucleus tett when administered at high dotes by the oral or subcutaneous routet. Furthermore, the compound did not delay erythro- blaat division In bone marrow. aOMK* (IMeifa»prcv*MM)NlMlStnKlUIGK No evidence ol Impairment of fertility was observed In reproductive studies conducted In rats dosed subcutaneously with doses up to SO meg/kg (295 mcg/m') In males and lemales. However, prostate weight was significantly reduced In rats. meg/kg, respectively (135 and 590 mcg/m', respectively, as calculated on a surface area basis), revealed letal toxlcliy characteristic ol potent glucocortlcold compounds, Including embryonic growth retardation, o " J retarded cranial ossification. , , omphalocele, cleft palate, and . In the rabbit, fetal weight reduction and cleft palate were observed following subcutaneous doses of 4 meg/kg (48 mcg/m'). However, following oral administration of up to 300 meg/kg (3.6 mg/m') of flutlcasone proplonate to the rabbit, there were no maternal effects nor Increased Incidence of external, visceral, or skeletal fetal defects. No tlutlcasone proplonate was detected In the plasma In this study, consistent with the established low bloavallablllty following oral administration (see CLINICAL PHARMACOLOGY section of full prescribing Information). Less than 0.009% of the dose crosses the placenta following oral administration to rats (100 meg/kg, 590 mcg/m') or rabbits (300 meg/kg. 3.6 mg/m'). There are no adequate and well-controlled studies In pregnant women. Flutlcasone proplonate should be used during pregnancy only It the potential benefit justifies the potential risk to the fetus. Experience with oral glucocortl- colde since their Introduction In pharmacologlc, as opposed to physiologic, doses suggests that rodents era more prone to teratogenlc effects from glucocorticoids than humans. In addition, because there Is a natural Increase In glucocortl- cold production during pregnancy, molt women will require a lower exogenous glucocortlcold dote and many will not need glucocortlcold treatment during pregnancy. Nursing Hotttera: It Is not known wnether flutlcasone propl- onate Is excreted In human breast milk. Subcutaneous admlnlatratlon of trltlated drug to lactitlng rats (10 meg/kg, 59 mcg/m 1 ) resulted In measurable radioactivity In both plasma ami milk. Because other glucocorticoids are excreted In human milk, caution should be exercised when FLONASE Nasal Spray It administered to a nursing woman. Prilitrtc Use: The safety and effectiveness of FLONASE Naaal Spray In children below 12 years of age have not been established. Oral glucocorticoids have been shown to cause growth suppression In children and teenagers with extended use. If a child or teenager on any glucocortlcold appears to have growth suppression, the possibility that they are particularly sensitive to this effect of glucocorticoids should be considered (eee PRECAUTIONS). Berlatrlc DM: A limited number of patients above 60 years ol age (n-132) have been treated with FLONASE Nasal Spray In US and non-US clinical trials. While the number of patients Is too small to permit separate analysis of efficacy and safety, the adverse reactions reported In this population were similar to those reported by younger patients. ADVERSE REACTIONS: In controlled US studies. 2,427 patients received treatment with Intrants*! flutlcaaone pro- plonate. In general, advene reactlona In clinical studies have been primarily associated with Irritation of the nasal mucous membranes, and the adverae reactloni were reported with approximately the tame frequency by patlenta treated with the vehicle Ittelf. The complaints did not usually Interfere with treatment. Less than 2% of patlentt In clinical trials discontinued because of advene eventt; thlt rate was similar for vehicle and active companion. Systemic glucocortlcold eld* enacts were not reported during controlled clinical studies up to 6 months' duration with FLONASE Nasal Spray. II recommended dosee are exceeded, however, or If Individual! ire particularly ttnsltlve or If In conjunction with tystemlcally administered glucocor- ticoids, symptoms ot hypercortlclsm, e.g., Cuihlng't syndrome, could occur. The following Incidence ot common advene reactions Is baaed upon seven controlled clinical trials In which 536 patlenta (57 girl! and 108 boys aged 4 to 11 years, 137 female and 234 male adolescents and adults) were treated with FLONASE Natal Spray 200 meg, once dally over 2 to 4 weeka and two controlled clinical trials In which 246 patients (119 female and 127 male adoleacentt and adults) were treated with FLONASE Nasal Spray 200 meg once dally over 6 months. Incidence better than IK (Ciuttl Relationship PMtlMei): tuflrtlHi: Eplttaxls, nasal burning (Incidence 3% to 6%); blood In naeal mucus, pharyngitis, nasal Irritation (Incidence 1% to 3%). murtltfletl: Headache (Incidence 1% to 3%). Incline* leu UMR 1* (Cental Rtlatlonaklp Pgttlile): Huflnlfff: Sneezing, runny note, natal drynett , sinusitis, nasal congestion, bronchitis, natal ulcer, natal septum excoriation. MewcJMte*/: Dizziness. |MC/</ MMM; Eyt disorder, unpleasant taste. tljHiUn: Nausea and vomiting, xerostomia. MM utf JwewttfM: Urticaria. PMtMikitlM ExawlMce: In addition to the eventt Irom clinical trials, the following have been reported during pott- marketing experience. Hypersentftlvlty reactions, Including tngloedema, tkln rath, edema ol the lace and tongue, pruritus, urticaria, bron- chospatrn, wheezing, dyspnea, and anaphylaxlt/anaphylac- told reactions, which In rare Instances were aevere. Alteration or Ion of tentt of title and/or tm«ll and, rarely, nasal septal perforation. OVUDOUM: There are no data available on the etlictt ol acute or chronic overdotage with FLONASE Natal Spray. Intranasal administration ol 2 mg (10 times the recommend id dote) of flutlcaione proplonate twice dally lor 7 days to healthy human volunteers wet well tolerate* Single oral dot*! up to 18 mg havt botn studied In human voluntiart with no acute toxic 80 mg dally lor 10 daye In volunteers and repeat oral doses up to 10 mg dally lor 14 days In patients were well tolerat- td. Adverse reactloni were of mild or moderate severity, am Ingle oral . volunttert Ic etlectt reported. Repeat oral doset up to GlaxoWellcome Gluo Welcome Inc. October 1996 Heeevch Triangle Park, NC 2/709 RL-367 Made In England GIA-01439SS SAFETY Silent cause of traffic deaths: falling asleep Drivers who doze at the wheel cause 100,000 crashes each year. Here's how to stay alert on your summer drives. BYTHAUAZEMTOS W HEN MICHAELDoucette, 17, won the National Driver's Excellence Contest, his prize was a new car and the title "America's Safest Teen Driver." But a few months later, at 5 p.m. on a day in February 1990, Doucette fell asleep at the wheel while driving on a highway near his home in Concord, N.H. The resulting crash killed him and Sharon Ann Link, 19, the driver of another car. 31 percent of drivers have, at some time, dozed off. Safety Administration reports thai 100,000 motor vehicle crashes each year are caused by drivers who fall asleep at the wheel, killing 1,500 people and injuring 71,000 more. Because reporting is inconsistent and little physical evidence remains to prove crash causes, experts agree these numbers are understated. A 1995 Gallup Poll found that 52 percent of Americans had driven while drowsy and that —- - • — - •••— M«*U-»**W* VUA t WllUC UUJWDV ill*** *•*!*• Drowsy driving is America's silent 31 percent had, at some time, dozed killer. And while public education off at the wheel, campaigns have raised awareness of the dangers of driving drunk, few WHEN AND WHY IT HAPPENS realize that driving drowsy can be "America is sleep-deprived," says just as fatal. Sleepiness slows a driv- Joan Goldberg, of the National er's reaction time, decreases aware- Sleep Foundation. "We cram more activities into each day, cheating ourselves of precious sleep time." ness and impairs judgment, just as drugs and alcohol do. The National Highway Traffic Busy people may be playing beat 01 997 Claxo Wellcome Inc. All righti reserved. Printed in USA FLN511RO July 1987 12 USA WEEKEND > May 16-18,1887

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