SEASONAL ALLERGY UPDATE Brfel Summary ol Prescribing Information a* of July 1996 ALLEGRA™ (fexofenadine hydrochloride) Capsules 60 mg INDICATIONS AND USAGE ALLEGRA™ Is indicated lor the relief ol symptoms associated with seasonal allergic rhinitis in adults and children 12 yean ot age and older. Symptoms treated effectively Include sneezing, rhlnorrhea, itchy nose/palate/throat, itchy/watery/red eyes. CONTRAINDICATIONS ALLEGRA™ Is conlralndicated In patients with known hvpersensitrvity to any ot Its ingredients. PRECAUTIONS Dniff tntatartlona In two separate studies, fexofenadine hydrochloride 120 mg twice dally (twice the recommended dose) was co-administered with erythromycin 500 mg every 8 houn or keloconuok) 400 mg once daily under snady- stata conditions to normal, healthy volunteen (n*24, each study). No differences In adverse events or OTc interval were observed when subjects ware administered lexofenadine hydrochloride alone or In combination with erythromycin or ketoconazole. The findings of these studies are summarized In the following table: Effects on staady-suu Fexotenadlne PharmacoWnetlca Alter 7 Days ol Co-AdmlrUstrallon with Fenolenadlne Hydrochlortde 120 mg Every 1Z Houn (twice recommended doae) In Normal volunteers (n>24) Concomitant Dnjg , , concefOntton) systemic exposure) Erythromycin +62% *109% (600 mg every 6 hn) Koloconazole +135% -f164% (400 mg ones daily) The mechanisms of these interactions are unknown, and the potential for Interaction with other azole anlJIungal or macroUde agents has not been studied. These changes in plasma levels were within the range of plasma levels achieved in adequate and wet-controlled clinical trials. Fexofenadine had no effect on the pharmacokinetics of erythromycin or katoconazole. Carctnooanaala. Mutanenfaia. Impairment ol Fertility mecarcinogenic potentlaT andI reproductive toxicity of fexofenadine hydrochlonde were assessed using terlenadlne studies with adequate lexofenadine exposure (based on plasma aroa-under-the-curve [AUC] values). No evidence of carcinogenicity was observed when mice and rats were given daily oral doses of 50 and 150 mg/kg of tailenadlne tor 18 and 24 months, respectively: these doses resulted in plasma AUC valuea of lexofenadine that were up to tour times the human therapeutic value (based on a 60-mg twice-daily fexofenadino hydrochloride dose). In in-vUro (Bacterial Reverse Mutation, CHO/HGPRT Forward Mutation, and Rat Lymphocyte Chromosomal Aberration assays) and in-vivo (Mouse Bone Marrow Micronudeua assay) testa, fexofenadine hydrochloride revealed no evidence of mutagenidty. In rat lenity studies, dose-relaled reductions In Implants and increases In postlmplanlatlon losses were observed at oral doses equal to or greater than 150 mg/kg ol terfenadine; these doses produced plasma AUC values ol fexofenadina that ware equal to or greater than three limes the human therapeutic value (based on a 60-mg twice-daily fexofenadine hydrochloride dose). Pregnancy Teretogenlc Effects: Category C. There was no evidence ol lerato- ganlclty in rats or rabbits at oral terfenadine doses up to 300 mg/kg: these doses produced fexofenadine plasma AUC values that were up to 4 and 37 times the human therapeutic value (based on a 60-mg twice-daily fexofanadlna hydrochlonde dose), respectively. There are no adequate and well-controlled studies In pregnant women. Fexolenadine hydrochloride should be used during pregnancy only if the potential benefit justifies to polenta! risk to the fetus. Nonuralogenlc Effects, dose-related decreases In pup weight gain and survival ware observed In rats exposed to oral doses equal to and greater than 1 SO mg/kg ot terienadlne; at these doses the plasma AUC values of fexolenadine were equal to or greater than 3 times he human therapeutic values (based on a 60-mg twice-daily texolenadlne hydrochloride dose). Nursing liQlhet* There are no adequate and well-controlled studies In women during lactation. Because many drugs are excreted In human milk, caution should be exercised when fexolenadine hydrochloride is administered to a nursing woman. etdjiujcjiu Safety and eleclivaness of AUEGRA™ In pedlatric patents under the age ol 12 yean have not been established. Across well-controlled clinical trials In patterns with seasonal aHarglc rhinitis, a total ol 205 patonu between the ages of 12 to 16 years received doses ranging Irom 20 mg to 240 mg twice daily lor up to two weeks. Adverse events were similar In this group compared to patients above the ago of 16 yean. Oerialrli! Uae In placebo-controlled trials, 42 palienu. age 60 to 68 years, received doses ol 20 mo. to 240 mg of fexolenadine twice daily for up to two weeks. Adverse events ware similar in this group to patients under age 60 yean. ADVERSE REACTIONS In placebo-controlled clinical triala, which included 2461 patients loceMng fexofenadine hydrochloride at dosee ol 20 mg to 240 mg twice dally, advene events were similar in lexofenadine hydrochloride and placebo-treated patienta. The incidence ol adverse events. Including drowsiness, waa not dose related and was similar across subgroups defined by age, gender, and race. The percent ot patients who withdrew prematurely because ol advene events waa 2.2% wiln lexolenadlne hydrochloride vs 3.3% with placebo. AH advene events that were reported by greater than 1% ol pationta who received the recommended dally dose of lexofenadlne hydrochlorida (60 mg twice- daily), and that were more common with lexolenadlne than placebo, are listed In trie following table. Adverae Experiences Reported In Placebo-Controlled Seasonal Allergic RhlnKle Clinical Triala at Halt* ol Greater Than 1% Twice dally 7M» Daily AOytna eifontne* <ru97S) ln-6711 Viral Infection (odd. flu) 2.5% t .5% Nausea 1.6% 1.5% Oysmenormea 1.5% 0.3% Drowsiness 1.3% 0.9% 1.3% 0.6% 1.3% 0.9% Adverse events occurring In greater than 1% ol fexolenadine hydnxhlo- ride-vutad patwnta (60 mg twice daily), but that were more common In the placabo-uaalad group. Include headache and ihroat Irritation. The frequency and magnitude of laboratory abnormalities were similar In lsxol*naone hyoVochlortde and placebo-treated patients. Prescribing Information a» ol July l»»6 Hoachat Marion RousMl. Inc. Kansas City, MO 64137 USA allMTMcl Hoechst Marion RouMel tlucchu Kliiiun Xinmcl, Inc. • Kinui Cily, MO MIX A member ol lh< Hocchit Grow? HoechstH Allergies on the Thirty years ago people, with allergies were advised to move to desert climates like that of Arizona to find relief. No more. With denser populations — who have cultivated, gardened, and created generally lusher environs—these desert areas are no longer the pollen' free Utopias they once were thought to be. Still, desert and mountain pollen counts are lower than those in the North, East, and South. Another rub: if you're allergic to, say, sagebrush in Colorado, don't think moving will help. Even if you relocate to another area, experts say you'll probably wind up developing allergies in two to three years to something else in your new locale. Best bet? Stay put and seek treatment from your doctor or allergist. While people with seasonal allergies aren't allergic to alcohol itself, it can escalate your symptoms. Alcohol dilates blood vessels, including those in your nose, causing the nasal passages to swell. This makes an uncomfortable situation even more uncom/ortable. Worst drink you could possibly have? Red wine. This actually stimulates histamine production, causing a steep spiraling effect of your symptoms. Best bet? Avoid alcohol during allergy season. 96086105/I720N6 (0 1996, Hoec/ut Marion Round, lite.
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