The Salina Journal from Salina, Kansas on May 11, 1997 · Page 58
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The Salina Journal from Salina, Kansas · Page 58

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Sunday, May 11, 1997
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Please read this summary carefully, and then ask your doctor about PRILOSEC. No advertisement This advertisement does not take the place of caretul discussions with your doctor Only youi doc prescription drug (or you. PRILOSEC** (OMEPRAZOLE) Delayod-Release Capsules BRIEF SUMMARY c.in provide .1 lor has the tr, CLINICAL PHARMACOLOGY MwnucoUMUct mrj MmttoHmi Ompnuolt - In pharmacokr«tic studies of single 20 mg omeprazole doses, an increase m AUC of approximately tour-fold was noted in Asian suojects compared to Caucasans. Dose adiustment. particularly where maintenance ol tesng o' erosive esopnagitis is indicated, for the hepaticaty impaired and Asian subjects should be considered. INDICATIONS ANO USAGE DuorJtntl IHctr PRILOSEC is indcated lor snort-term treatment ol adve duodenal ulcer. Most patents heal within 4 weeks. Some patents may require an additional 4 vreeks of therapy. PRILOSEC. in combination wrtn darithromydn, is also indicated for treatment of patients win H. pylori infection and active duodenal ulcer to eradCate H. pylori. Eraoication of H. pylori has been shown to reduce the risk ol duodenal ulcer recurrence, in patients who fail therapy, susceptic-iity testing should be done. If resistance to darithromyc n is demonstrated or suscep- ttoiity testing is net possible, alternative antime-obial therapy should be instituted. (See the cMhromycin package insert, MCROBOLOGY section.) Owl/*: (liar. PRILOSEC is iidicated lor snort-term treatment (4-8 weeks) of active benign gastric ulcer. DMtnwil o/ OuirMtopfijgM/ Mta Dattu fBEHOj: Symptomatic OEM) - PRILOSEC is indicated la- the treatment ol heartburn and other symptoms associated with GERD. Erarn EMprugWi - PRILOSEC is indicated for Ihe short-term treatment (4-8 weeks) ol erosive esophagitis wtuch has been diagnosed by endoscopy. The elfcacy of PfllLOSEC used lor longer than 8 weeks in these patients has not been established. In tne rare instance of a patient not responding to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If here is recurrence of erosive esophagitis or GERD symptoms (e.g. heartburn), add'tional 4-8 week courses o! omeprazole may be considered. Muntuuact ol Huang o/Eret/n EMpni«ttfc PRILOSEC is inoicated to maintain healing of erosive esophagitis. Controllea studies do not extend beyond 12 months. ArttofegfciJ Hnmtcntory ConoVftorw PRILOSEC is indicated lor the tang-term treatment ol palnotogcal hypersecretory conditions (e.g.,Z<*iger-Elson syndrome, multiple endocnne aoenomas and systemic mastocytosis). CONTRAINDICATIONS Ompwofc PRILOSEC Delayed-Release Capsuks are contraindicated in patients wth known nypersensitjvrty to any component of Ine formulation. CMtfvofnycin: Clarilhromyon is contraindicated in patients with a known hypersenstMty to any macrolide antibiotic, and In patients receiving terfenadine therapy who have pre-existing cardiac abnormalities or eksctrolyle disturbances. (Rease refer to full prescribing information for darithrornycin before prescnbirtg.) WARNING: ClvtUmnydn: CLAIUTHROMVCM SHOULD NOT BE USED IN PREGNANT WOMEN EXCEPT IN CLINICAL CIRCUMSTANCES WHERE NO ALTERNATIVE THERAPY 18 APPROPRIATE If PREGNANCY OCCURS WHILE TAKING CLARTTHROMVCIN, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE rtTUS. |«M WARNINGS In prwcfWng Wormrton lor ctarthromycln.) PRECAUTIONS Gmni Symptomate response lo therapy with omeprazole does not preckjde the presence ol gastnc rra&gnancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long- term wth omep'azote. Womuftw torPtUtatt: PRILOSEC Delayed-Release Capsules should be taken before eating. Patients should be cautoned that the PRILOSEC Delayeo-Release Capsule should rat be opened, chewed or crushed, and shojld be swallowed whote. Drug fnfmclfoni: Othtr - Omeprazoe can prolong the eSmination ol diazepam. warfarin aid phenytoin, drugs that are metabolized by oxidation in the liver. Although in normal subjects no interaction with theophyline or proprandoi was found, the^ have been dWca! reports of interaction with other drugs metaixtad via tne cytochrome P-450 system (e.g, cydosporine. disu*am. benzodiazepines). Patients shouW be monitored to detenrine if it is necessary to adjust the dosage ol these drugs when taken concomitanlly wth PRILOSEC Because of its profound aid long lasting inhibiton of gastrk; acid secretion, it is theoretically possible that omeprazole may interfere wth aosorpton ol drugs where gastric pH is an important determinant of tner boavalabilny (e.g.. ketoconazote. arrpioilin esters, and ron salts), h the dmcal trials, antacids were used concomitant.!/ with the administration ol PRILOSEC. Combination Therapy wttti CUrtthromycIn - Co-administration ol omeprazole and clantnromydn may result in increases in plasma levels ol omeprazole. darithrornycin, and 14-hydroxy-ctanthromycin. (See CLINICAL PHARMACOLOGY. PtamacoMnelrcs: Combination Therapy with CWrVomjon u\ M Presorting Information.) Cardragtrmii, HvHtmuli, ImpaJrmanl o/ftrtaHy: m two 24-month cargnogeniciiy sludes in rals, omeprazole at daily doses of 1.7,3.4,13.8.44.0 and 140.8 mg/kg/day (approximately 4 to 352 tines the human dose, based on a patient weight ol 50 kg ana a human dose ol 20 mg) produced gastnc ECL eel carcinoids in a dose-re ated manner in both mate and lemaie rats: the incidence ol this affect was markedly higher in female rats, which had higher blood levels ol oxeprazole. Gastnc carcinoios seldom occur in ihe untreated ral. In addition. ECL eel hyperplasia was present in it treated groups of both sexes In one ol these stud.es. female rals were treated with '3.8 mo/kg/day omeprazole (approxmately 35 times the human dose) tor 1 year, men foiowea lor an additional year without the drug. No carcinotds were seen in iriese rats. An increased incidence ol treatment-related ECL eel hyperplasia was observed at the end of 1 year (94% (reateo vs 1C~ controls). By the second year He difference between treated and control rats was much smaller (46% vs 26%) bjt si 11 snowed nore hyperpiasia m the treated group. An unusual prunary malignant tumor in the stomach was seen In one rat (2%). No simiar tumor was seen \r male or 'emale rats treated for 2 years. For this strain o' rat no similar tumor nas been noted historcaSy, but a f.nd,ng rvrAng ony one tumor is difficult to Werprel. A 78-week mouse ca'drx>gan«ci!y stuoy of omeprazoie did not show increases tumor occurrence, but the study was not condusrve Orneprazols was not mutagenic .n an in vnro Ames S&mmala typrrnwun assay, an in vitro mouse lymphoma cell assay and an in wvo lat In* UNA damage assay. A mouse mcronuclejs lest at 625 and 6250 tmes the human oose gave a terete** result, as did an in wvo bone marrow crwnosome aberration test. A second mouse micronucieus study at 2000 limes the human dcse, but with different (suboptimal) sampling times, v,ss negative. Pregnancy: Omtfmofe Pregnancy Category C - In raocxts. omeprazole in a dose range of 6.9 lo 69.1 mg/kg/day (approximately 17 to 172 times the human dose) produced oose-relaled increases n embryo-letnalny. letal resorptions and pregnancy disruptions. In rals, dose-related embryo/feta toxicity and postnatal development toxidty were observed ft oflspnng resulting from parents treated with omeprazole 13.8 to 138.0 mg/kg/day (approximately 35 lo 345 times the human dose). There a'e no adequate or well-controliea studies in pregnant women. Sporadic reports have been received ol congervia 1 abnormalrtes occurring in rtants born lo women who have received omeprazote during pregnancy. Omeprazoie snouid be used during pregnancy only rt tne potential benefit justifies tne potential risk to the fetus. ClarMvomydn: Prtguncy Ciltgory C - See WARNING (above) ano full prescr&ng information lor darithromyon before using in pregnant women. Hurting Uotim: It is not known whether omeprazole is exoeted in human m*. In rats, omeprazole administration during late gestation and fetation at doses of 13.8 to 138 mgltg/day (35 to 345 times the human dose) resulted in decreased weight gain In peps. Because many drugs are excreted in human milk, oecause of tne potential for serious adverse reactons in nurs^g slants from omeprazole, and because of tne potential tor tumori- gervcity shown for omeprazole in rat carcnogen'oty stuoies. a decision should be made whether to discontinue nursing or discontinue tr« drug, taking into account the knportance of Ihe drug to the mother. AtoHalric UM; Safety and effectiveness in cludien nave not been established. ADVERK REACTIONS: In the U.S. cinical tnal population ol 465 patients (Including duooena! ulcer, Zodnger-EUison syndrome and resistant ulcer patients), the following adverse experiences were reported to occur m 1% o' more of patients on therapy with PRILOSEC Numbers ii parentneses uxlicate percentages of the adverse experiences ccn&dereo by nvestigalors as possibly, probably, or defntely telated to trie drug. The loUowing adverse reactions which occurred in 1% or more ol omeprazole-treated patients have been reported in international doubte-btnd, and open-label, clnfcal trials in which 2,631 patients and subjects received omeprazole. Headacne Diarrhea Abdominal Pain Nausea URI Doziness Vomiting Rasn Constipaton Cough Asthenia Back Pain Omeprazoain:465l 6.9 M 3.0(1.9) 24 1,0.4) 22(0.9) 1.9 1.5(0.6) 1.5(0.4) 1.611.1) 1.1(0.9) 1.1 1.1(0.2) 1.1 Placebo (n=64l 6.3 3.1(1.6) 3.1 3.1 1.6 0.0 4.7 0.0 0.0 0.0 1.6(1.6) 0.0 Ranlidine (n=195l 7,7(2.6) 21 10.5, 2.1 4.1 (0,5) 2.6 2.6(1.0) 15(0.5) 0.0 0.0 1.6 1.5(1.0) 05 •Registered trademark ol Astia AB Incidence ol Adverse Experiences 2 1 % Causal Reblonship not Assessed Sorjy as a Whole, srre unspecified O'rjeslrw System Abdominal pain Asthenia Constipation Diarrhea Flatuence Nausea Acid regurgitatton Headache OmecKgote (n=2631) 5.2 1.3 1.5 3.7 2.7 4.0 3.2 1.9 2.9 3.3 0.8 0.8 2.5 5.8 6.7 10.0 3.3 2.5 Additional adverse experiences occurring n <1% of patients or subjects ft domestk; enoVor uitemational trials, or occurring since the drug was marketed, ere shown below witNn each body system. In many Instances, the relationship to PRILOSEC' (omeprajole) was unclear. Bocry As a Wrote: Fever, pain, fat^ue, malaise, abdominal swrjlng. Cardiovascular Chest pain or angina, tachycardia, bradycardia. palplation, elevated blood pressure, peripheral edema. GaslroMesiinaf Pancreatitis (some latai), anorexia, irritable colon, flatulence, fees discoloration, esophageal candidtos, mucosal atrophy ol the tongue, dry mouth. During treatment with omeprazole. gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversibte when treatment Is dscontjnued. Gastro-rJuodenal care/aids have been reported in patients with ZE syndrome on long-term treatment with PRILOSEC. This find^g is beleved to be a manifestation of the undenying condition, which Is known to be associated with such tumors. Hepafc: Mild ano, rarely, marked elevations ol liver function tests (ALT (SGPTj, AST (SCOT), yglutamyl transpeptidase, alkane pnosghatase. and Mrubin (jaundice)]. In rare Mances. overt It.w disease has occurred, including hepatoceUar, chotestatic. or mixed hepetitis, liver necrosis (some fatal), hepatic fafcre (some fatal), and hepatic encepnatooathy. Meabofc/NutnSona/: Hvponatremia, hypoglycemla, welgnt gain. MuscufoskefeJarV Muscle cramps, myalgia, musde weakness, joint pan, leg pain. Nervous Syslem/PsjcWalri:; Psychic disturbances indud'ng depression, aggression, halrjdnations. confusion, insomn'a. nervousness, tremors, apathy, somnolence, anxWy, dream abnormalities; vertigo; paresthesia; herrifacal dysesthesia. ftepfilory: Eplsiaxis, pharyrijeal pain. SJon: Rash and. very rarely, cases ol severe generalized skin reactions induing toxic epidermal necrolysls (TEN; some ratal), Stevens-Johnson syndrome, and erythema muMoime (some severe); skin Mlammaton. urticaria, angioedema, pnjntus, alopecia, dry skin, hyperhidrosis. Special Senses: Tmnitjs. taste perversion. Urogente/: Interstitial nephritis (some with positive rechalenge), urinary tract infection, mcroscrjpc pyu™. """any frequency, elevated senjm creatinine, proleinuria, hematuria. gr/cosuna, testcuto pain, gynecomasta. Hemalotorjc; Rare instances of pancylopenia, agranulocytosis (some fatal), thrombocytopenia, neutropenia, anemia, leucocytosis, and hemdytic anemia have been reported. Combination Itmpy with ClvftVoflwcfn: In clirdcal trials using combination therapy with PRILOSEC and dariihromycin, no adverse expenences pecuiar to In* drug combiiation have been observed. Adverse experiences that have occurred have been limned to those that nave been previously reported wi'.h omeprazole or clanthromycin. Adverse experiences observed in controlled clinical mis using combination therapy viith PRILOSEC and darithromydn (n=346) which differed tan tnose previously described for omeprazole alone ware: Taste perversion (15%), tongue discoloration (2%), rtiinitis (2%). pharyngitis (1%), and flu syndrome (1%). For more informatton on darttlvomyen. refer to Ihe darithramycin package Insert, ADVERSE REACTIONS secton. OVERDOMG£ Rare reports have been received of overdosage with omeprazole. Doses ranged from 320 mg to 900 mg (16-45 limes toe usual recommended clinical dose). Manjfestatons were varable. but uxluded confus.on, drowsiness, bluned vision, tachycarrja, nausea, rjaphcresis. flushing, headache, and dry mouth. Symptoms were transient, and ro serious dried outcome has been reported. No specific antaole for omeprazole overdosage Is known. Omeprazrjle is extensively protein bound and is. therefore, not readily dialyzable. In the event of overdosage. treatment should be symptomatic and supportive. OOMOE ANO MWWISTHATION Ouxtaut (few Short-Term Treatment of Act™ Duodenal Uter The recommended adult oral dose of PRILOSEC is 20 mg once daily, Most patients heal wthin 4 weeks. Some patients may require an additional 4 weeks ol therapy. (See INDICATIONS ANO USAGE.) Reducton of the Risk of Duodenal Ulcer Recurrence: Combination Therapy with Clanthromycii Days 1-14: Days 15-28: PHILOSEC 40 mg Q.d. («l the morning) plus danthromydn 500 mg tid. PRILOSEC 20 mg q.rj. Please reler lo darithromyon tul presenting Information for CONTRAINDICATIONS and WARNING, ana lor rtormaton regarding dosing in elderty and renalty rnpaired patents (PRECAUTIONS: General, PRECAUTIONS: Geriatric Use and PRECAUTIONS: Drug tileractws). Qmtrtc War: The recomrmoed adult oral dose is 40 mg once a day for 4 to 8 weeks. (Sea INDICATIONS AND USAGE. Gaslrc Ulcer.) QHtroHCfhtgHl Mb* OkMW IQfRD): The recommended aoult oral dose lor the treatment ol patients with symptomatc GERD and no esophageal teaons is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment ol pa'jents with ero&\3 esophagitis and accompanying symptoms ole to GERD is 20 mg daily lor 4 to 8 weeks. (See INOCATBNS AND USAGE.) IMnlinjKt of Huang ol ErwVi etopratHa: The recommended adult oral dose is 20 rr>g daiy. flitfwtogfc*/ HnmKrtoiy CorxJWcw The dosage o! PRILOSEC n patents witti pathological hypersecretory conditkms va-tes with the nividual patent. The recoinmended adult ora) starting dose is 60 mg once a day. Doses should be adjusted to OTdivrtJual patient needs and should continue for as long as dinicalfy inricated. Doses up to 120 mg t.l.d. have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. No oosage adjustment is necessary lor patients with renal impairment, hepatic d/sfunction or for the elderly. attributed fy.- MUCK Wayne, * '3<W USA PRC-16VI2/96 Manx & Co., West Point, PA 19m USA December 1996 PRI23 NOTE: Thta lummy providM lmport»nt Inhmnition (bout PHL08EC. H you wouUiu mor* intonation, ttk your doctor or ph»rmad«l lo M you raid UK prol*Mloncl dbdkig and ttwn rjicuu H w* (htm. POP CULTURE & TRENDS Wftk MUSIC Hall of Fame welcomes the Jackson 5, Jonl Mitchell. Reviewing the rock hall's class of '97 The Rock and Roll Hall of Fame and Museum in Cleveland — where an exhibit on '60s psychedelic rock opens this weekend — just inducted its '97 honorees. A glance at this year's class and notable collections of their music. COLLFCTION Best of Buffalo Springfle/d... Retrospective (Atco). Trie definitive Jackson 5 box is Sou/sat/on/ (4 CDs, Rhino). Early years: Polygram's 2-volume Best of the Bee Gees. Disco phase: Bee Gees Greatest Mitchell's Hits (Reprise) contains 15 favorites. Tear the Roof Off (Casablanca) is a 2-CD compilation of Parliament hits, plus 12-inch mixes. The FunkadaNcequMtent Music tortour Mother (Westbound 55). cs/v (Atlantic), a 4-CD boxed set, includes many unreleased songs. 2-CDAntto/ojy (1965-72> from fihino has the hits plus a few album cuts. The folk and country icckeis made 3 classic albums in 1967, '68. The Jackson 5, fronted by Michael, hit No. 1 with their first 4 singes in 1970. Pop and disco kings the IM QMS scored their biggest hits on the huge Saturday Night Fever soundtrack. Singer-songwriter- guitarist Jonl MHchell made her reputation with 1970's Blue. hvHMMtand FunliadiMc. George Clinton's two bands pioneered the 70s funk sound, which has its latest echo In West Coast rap. Folk-y Crab* Stills & Naih, with over 2 decades of successful records and tours. The soul-flavored (MM*) Rue*, whose biggest hit was Good Loviri. 3O USA WEEKEND • May 8-11,1887

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