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Kokomo Tribune (Newspaper) - May 8, 1994, Kokomo, Indiana Brief Summary of Prescribing Information as ot January 1993 SELDANED9 tertenadine and psaudoephedrine hydrochloride ExtendedRelease Tablets WARNING BOX QT INTERVAL ARRHYTHMIA RARE GASES OF SERIOUS CARDIOVASCULAR ADVERSE EVENTS INCLUDING DEATH CARDIAC ARREST TORSADES DE POINTES AND OTHER VENTRICULAR ARRHYTHMIAS HAVE BEEN OBSERVED IN THE FOLLOWING CLINICAL SETTINGS FREQUENTLY IN ASSOCIATION WITH INCREASED TERFEN ADINE LEVELS WHICH LEAD TO ELECTROCARDIOGRAPHS QT PROLONGATION 1 CONCOMITANT ADMINISTRATION OF KETOCONAZOLE NKORALJOR ITRACONAZOLE SPORANOX 2 OVERDOSE INCLUDING SINGLE TERFENADINE DOSES AS LOW AS 360 MG 3 CONCOMITANT ADMINISTRATION OF CLARITHROMYCIN ERYTHROMYCIN OH TROLEANDOMYCIN 4 SIGNIFICANT HEPATIC DYSFUNCTION TEHFENADINE IS CONTRAINDICATED IN PATIENTS TAKING KETOCONAZOLE ITRACONAZOLE ERYTHROMYCIH CLARITHRO MYCIN OR TROLEANDOMYCIN AND IN PATIENTS WITH SIGNIFICANT HEPATIC DYSFUNCTION DO NOT EXCEED RECOMMENDED DOSE IN SOME CASES SEVERE ARRHYTHMIAS HAVE BEEN PRECEDED BY EPISODES OF SYNCOPE SYNCOPE IN PATIENTS RECEIVING TERFENADINE SHOULD LEAD TO DISCONTINUATION OF TREAT MENT AND FULL EVALUATION OF POTENTIAL ARRHYTHMIAS See CONTRAINDICATIONS WARNINGS CLINICAL PHARMA COLOGY AND PRECAUTIONS DRUG DESCRIPTION SELDANED terfenadlne and pseudoephedrlne hydrochloride ExtendedRelease Tablets are available for oral administration Each tablet contains 60 mg terfenadlne and 10 mg of pseudoephedrlne hydrochloride In an outer presscoat for Immediate release and 110 mg pseudoephedrine hydrochloride In an extendedrelease core Tablets also contain as inactive Ingredients colloidal silicon dioxide ethylcel lulose glycerin hydroxypropyl cellulose hydroxypropyl methylcellu lose 2208 hydroxypropyl methylcellulose 2910 lactose magnesium stearate mlcrocrystalllne cellulose polysorbale 80 precipitated calcium carbonate pregelatlnlzed corn starch sodium lauryl sulfate sodium starch grycolate talc Mum dioxide and zinc slearate INDICATIONS AND USAGE SELDANED Is Indicated for the relief of symptoms associated with seasonal allergic rhinitis such as sneezing rhinorrhea pruritus lacrlmatlon and nasal congestion It should be administered when both the antlhlstamlnic properties of SELDANE terfenadlne and the nasal decongestant activity of pseudoephedrlne hydrochloride are desired see CLINICAL SELDANED has not been studied for effectiveness In relieving the symptoms of the common cold CONTRAINDICATIONS CONCOMITANT ADMINISTRATION OF SELDANED WITH KETOCONA ZOLE NIZORAL OR ITRACONAZOLE SPORANOX IS CONTRAINDI CATED SELDANED IS ALSO CONTRAINDICATED IN PATIENTS WITH DISEASE STATES OR OTHER CONCOMITANT MEDICATIONS KNOWN TO IMPAIR ITS METABOLISM INCLUDING SIGNIFICANT HEPATIC DYSFUNCTION AND CONCURRENT USE OF CLARITHROMYCIN ERYTHROMYCIN OR TROLEANDOMYCIN QT PROLONGATION HAS BEEN DEMONSTRATED IN SOME PATIENTS TAKING TERFENADINE IN THESE SETTINGS AND RARE CASES OF SERIOUS CARDIOVASCULAR EVENTS INCLUDING DEATH CARDIAC ARREST AND TORSADES DE POINTES HAVE BEEN REPORTED IN THESE PATIENT POPULATIONS See WARNINGS and PRECAUTIONS Drug SELDANED is contralndlcattd In nursing mothers patients with severe hypertension or severe coronary artery disease patients receiving monoamine oxidase MAO Inhibitor therapy and In pajents with a known hyprsensibvily toany of Its Ingredients see DESCRIPTION WARNINGS Terfenadlne undergoes extensive metabolism in the liver by a specific cytochrome P450 isoenzynw This metabolic pathway may be Impaired in patients with hepatic dysfunction alcoholic cirrhosis lienis or who are taking drugs such as tatownazwjtraconazoie or clartthromycln erythromycln orlroleandomycln macrolldt or other potent inhibitors of this isoenzyme Interference with this metabolism can to elevated tertenadine plasma levels associated with QT protonot and increased risk of ventricular tactiyarrhythmlas such as torsades de pgintes ventricular tachycardia and ventricular fibrillation at the with these conditions W WARNING BOX CONTRAWDICATW and Other patients who may be at risk for these adverse cardiovascular events include patients who miy experience new or increased QT proton gallon while receMta certain drugs or having conditions which lead to QT proMon Thaii piM lakft beprUII certain psycMtropfcs probuco or aitemjzote patients with ai as hypowjmla or hyponiagnesemla or as needed and NOT TO EXCEED THE PRESCRIBED DOSE Patients should be Questioned about use of any other prescription or overthe counter medication and should be cautioned regarding the potential for lifethreatening arrhythmias with concurrent use of ketoconazole itraconazole claritnromydn erythromycln or troleandomycln Patients should be advised to consult the physician before concurrent use of other medications with terfenadlne Patients should be questioned about pregnancy or lactation before starting SELDANED therapy since the drug Is contralndicated in nursing women and should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus Patients should be directed to swallow the tablet whole Patients should also be Instructed to store this medication in a tightly closed container in a cool dry place away from heat moisture or direct sunlight and away Irom children Dmnlnlertcllnns see CONTRAINDICATIONS Monoamine oxidase MAO Inhibitors and betaadrenerglc agonists Increase the effect of sympathomlmetlc amines Sympathomimetic amines may reduce the antihypertenslve effects of melhyldopa mecamylamine and reserplne MAO inhibitors may prolong and inten sify the effects of antlhlstamines Care should be taken In the administration of SEIDANED concomi faulty with other sympalhomimetic amines because combined effects on the cardiovascular system may be harmful to the patient Ketoconizole Spontaneous adverse reaction reports of patients taking concomitant ketoconazole with recommended doses of lerienadlne demonstrate QT interval prolongation and rare serious cardiac events death cardiac arrest and ventricular arrhythmia Including torsades de polntes Pharmacokinetic data indicate that ketoconazole markedly Inhibits the metabolism of tertenadine resulting In elevated plasma terfenadlne levels Presence of unchanged teiienadine is associated with statistically significant prolongation of the QT and OTc Intervals Concomitant administration ol kelownszole and SELDANED It contnindlcatid see CONTRAINDICATIONS WARNINGS and ADVERSE Iraconazole Torsades de polntes and elevated parent terienadlne levels have been reported during concomitant use of teiienadine and Itraconazole In clinical trials of itraconazole and from foreign postmarketing sources One death has also been reported from foreign postmarketing sources Concomitant admtalstnllon of itnuonazoli and SELDANED It contraindlealed see CONTRAINDICATIONS WARNINGS and ADVERSE Due to the chemical similarity of other azoletype antlfungal agents including fluconazole metronidazole and miconazole to ketoconazole and Itraconazole concomitant use of these products with SELDANED Is not recommended pending full examination ol potential Interactions Macrolldts Clinical drug Interactions studies indicate that erythromycln and clarithromycln can exert an effect on tertenadine metabolism by a mechanism which may be similar to that of ketoconazole but to a lesser extent Although erythromycin measurably decreases the clear ance of the tertenadine add metabolite Its Influence on tertenadine plasma levels Is still under investigation A lew spontaneous accounts of QT interval prolongation with ventricular arrhythmia Including de pointes have been reported In patients receiving erythromycln and troleandomycln Concomitant administration ol SELDANED with clirltttromyiin enrttronwcln or troleandomytlo It contraindlealed see CONTRAINDI CATIONS WARNINGS and ADVERSE Pending lull characterization of potential Interactions concomitant administration of SELDANED with other macrollde antibiotics Including azitiuornycin is not recommended Studies to evaluate potential interaction of terten adine with azlthromycln are In progress cfiiogenio potential iMveoeen of SELDANED Oral dotes ol tertenadine corresponding to 63 times the recommended human daily dote In mice for 18 months or In rats for 24 months revealed no evidence of tumorlgenWry Microbial and mlcronucleus list assays with terlenadlne have mealed no evidence ot mutagenesis Reproduction and fertility studies with terlenadlne In rats showed no effects on male or female fertility at oral doses of up to 21 limes Uw human dally dose At 63 times the human dafdose there was a small but significant reduction In implants and at 125 times the human dally dose reduced Implants and Increased postImplantation losses were obMryri which to maternal npoductlonjtutaft has shown to produce reduced Mi at 42 timet the human dose and delayed o mg a mean increase in QTc of 10 range 4 to controlled studies In over 300 patients In which SELDANED was compared to extendedrelease pseudoephedrlne adverse reactions reported for greater than 1 of the patients receiving SELDANED were not clinically different from those reported for patients receiving pseudoephedrine see Table In pregnant women SEIDANED MrKwcauseddicreaMd pup w given doses 63 tjmw and 125 times he Frequently Reported Adverse Events for SELDANED In Doubleblind Parallel Controlled Clinical Adverse of Patients Central Nervous System Increased Blurring of Asergy Sore Infection Upper Respiratory Taste pseudoephedrlne 120 mg Pseudoephedrine may cause epIudrineIUte reactions such as tachy cardia palpitations headache dizziness or nausea Sympathomimetic drugs have also been associated with certain untoward reactions including fear anxiety tenseness restlessness tremor weakness pallor respiratory difficulty dysurla insomnia hallucinations convulsions CMS depression arrhythmias and cardiovascular collapse with hypotension In controlled clinical trials with terfenadlne using the recommended dally dose of 60 mg the incidence ot adverse events In patients receiving terfenadlne was similar to that reported in patients receiving placebo These effects included Central Nervous Syitem Drowsiness headache fatigue dizziness e used dWa pfeoriancy only risk to the Wus H gain and survival in rats ndaly dose throughout Gaslrolnlesllnal System Abdominal distress nausea vomiting change In towel habffs Eye Ear Nose and Throat Dry cough sore throat epislaxis Skin Eruption including rash and urticaria or Itching Also reported spontaneously during the marketing of terlenadlne were alopecia hair toss or anaphyfaxls anglosdema bronchospum confusion depression gaTactorrnu Insomnia menstrual disorders Including musculosJcelelal symptoms nightmares paresuiesla photosensMty rapid flare of psoriasis seizures sinus tachycardia sweating thrombocytopenia tremor urinary frequency and visual disturbances Also In clinical trials several Instances of mild or in one case moderate transiminsse elevations were seen In patients receiving tertenadine Mild elevations were also seen In placebo treated patients Marketing experiences Include Isolated reports of jaundice chototatio hepatitis and hepatitis In most cases available information Is Incomplete QVEROOSAGE Information concerning possible overdosage and its treatment appears in Full Prescribing Information D08AQEANOADMINI8TRATION 12years and older one tablet swallowed whole IN EXCESS OF ONE TABLET IS NOT RECOM f OF THE INCREASED POTENTIAL FOR OT INTERVAL AND ADVERSE CARDIAC EVENTS See WARNING TANE0 HmTJENTSWITH SIGNIFICANT HEPATIC IN PATIENTS TAKING KETOCONAZOLE ITRACONA YCIN ERYTHROMYCIN OR TROLEANDOMVCIN IS i WARNINGS and ol BEUMNEQ in chlkjrin below the ajeol 12 years have not been etlaWshed wjthaOTrnpanyiriol in more likely tg hive idvuse reasons to sympath D should be used with caution In patients wtth diabetes carfiovjscuJir dlseue and nypirrMctlvity to epiirini torsades de and cardiac Rare reports have been 60 mg of terfenadlne and 10 r jrlde In an puter presscoat for immi releiw and pwVdowhedrlne hydrotluoridi In an extended core are supplied 85 follows NOC Bottles Ot 100 UbHU 0 Store at ontrolled room Protect from moiilgre Prescribing Information is of Jtnuvy 1993 lOowPhjrrnjceullcalslnc onMerreJIDgwIw Patents JFm MARIQNMERREUOOWINC r KANSAS CITV MO 04114 MARILYN BY MARILYN VOS SAVANT Do you think grades would be increased among high school students if they could choose more of their instead of being forced to take cer tain classes that do not pertain to their interests or goals I never plan to trace another nerve from a frogs foot to his brain although I was able to do Moseley Frederick Md I do think grades would be higher but thats not the point of education Learn ing how to make your mind operate in a wide variety of disciplines actually enables it to operate better in just one area of specialty later an area that now seems remote For example learning the rigorous logic of mathe matics makes a far superior physician learning the uncertainties of biological systems makes a far superior physicist and learning the limits of physical sci ence makes a far superior poet A wheelbarrowmaker would sit down with a pile of lumber working over it until a fine product was pro duced It took a full day for a wheel barrow to be completed One day an efficiency expert offered to help the barrowmaker improve Ms lot With detailed calculations the ex pert suggested that demand for barrows would support the manu facture of two each day and this demand would maintain the price Two barrows were produced the following day the makers earnings doubled and everyone seemed sat someone who asked What was taken away from the first wheelbarrow so that the sec ond barrow could be madeP Time is not the answer What was ItP Sharp Fremont Calif Maybe it was the wheels A wheelbar row is only one kind of barrow an other kind is a which re quires parrying by hand because it has no wheels But you can call either of them by the broader name of barrow How do you like to spend free timeP Hoover South Bend Ind I love to get all dressed up and go out dancing But until I find time for a few more lessons Im afraid Im darned near dangerous You know those amber flash ing lights that warn people away from a hazard on the highway Well I should have them around roe on the dance floor If yw have for Marilyn vot vwrt who it Hited Book of World Records Hall of Fame for lend it to Att Marilyn PA MflWUM WHW OtttM PAQg 18 MAY e 1884 PARADC MAQAJINB
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